Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 12:51 PM
Study NCT ID:
NCT04411420
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2020-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Veteran Access to Integrated Management of Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joseph.l.brothers@duke.edu', 'phone': '919-668-8322', 'title': 'Leo Brothers', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months', 'description': 'Adverse Events were collected on survey participants only. A non-systematic method was implemented. Adverse events were collected via unsolicited participant self-report during follow-up study surveys. Study staff attempted to verify reported adverse events via medical record review. All hospitalizations were considered serious and Emergency Department visits were considered important medical events. All events were assessed for study relatedness. All events were reviewed by the Durham VA IRB.', 'eventGroups': [{'id': 'EG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.', 'otherNumAtRisk': 516, 'deathsNumAtRisk': 516, 'otherNumAffected': 12, 'seriousNumAtRisk': 516, 'deathsNumAffected': 1, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.', 'otherNumAtRisk': 480, 'deathsNumAtRisk': 480, 'otherNumAffected': 20, 'seriousNumAtRisk': 480, 'deathsNumAffected': 2, 'seriousNumAffected': 30}], 'otherEvents': [{'term': 'Important Medical Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain Interference Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'OG000'}, {'value': '527', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'OG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.67', 'spread': '7.22', 'groupId': 'OG000'}, {'value': '-2.04', 'spread': '6.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.169', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.59', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '0.37', 'pValueComment': 'Threshold for significance is 0.025 due to dual primary outcomes.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway 3-month change minus Coordinated Care Management Pathway 3-month change.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, three months post baseline', 'description': 'The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater pain interference.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected at both timepoints.'}, {'type': 'PRIMARY', 'title': 'Change in Physical Function Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'OG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.87', 'spread': '5.70', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '5.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.139', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.59', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '1.52', 'pValueComment': 'Threshold for significance is 0.025 due to dual primary outcomes.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway 3-month change minus Coordinated Care Management Pathway 3-month change.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, three months post baseline', 'description': 'The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates better physical function.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Change in Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'OG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.56', 'spread': '7.35', 'groupId': 'OG000'}, {'value': '-2.06', 'spread': '8.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.417', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '0.72', 'pValueComment': 'P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, three months post baseline', 'description': 'The PROMIS Short form scores will be collected in the medical record by the provider at baseline, and three months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater sleep disturbance.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Change in Patient Reported Outcomes--PROMIS Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'OG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'classes': [{'title': 'Baseline to 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.35', 'spread': '6.92', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '6.60', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'spread': '6.65', 'groupId': 'OG000'}, {'value': '-1.66', 'spread': '6.89', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.25', 'spread': '7.14', 'groupId': 'OG000'}, {'value': '-1.26', 'spread': '7.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.409', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-1.37', 'ciUpperLimit': '0.57', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 3 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.899', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '0.91', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.946', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '1.08', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 12 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates greater sleep disturbance.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected collected at both timepoints needed to calculate a change.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Opioid Use--Chronic User', 'denoms': [{'units': 'Participants', 'counts': [{'value': '811', 'groupId': 'OG000'}, {'value': '1006', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'OG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.992', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.004', 'ciLowerLimit': '-4.62', 'ciUpperLimit': '4.61', 'pValueComment': 'P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Odds Ratio calculated for Integrated Sequenced Care Pathway relative to Coordinated Care Management Pathway.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, twelve months post baseline', 'description': 'Opioid use will be defined at baseline and 12 months post baseline as a binary variable based on whether a chronic opioid user or not at baseline and at twelve months. Opioid use is chronic if participant had at least one prescription with a total day supply of at least 120 days or if there were at least 10 prescription fills in the 12 months prior to the specified timepoint (baseline, 12 months post baseline).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Opioid Use - Morphine Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '811', 'groupId': 'OG000'}, {'value': '1006', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'OG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.62', 'spread': '36.3', 'groupId': 'OG000'}, {'value': '-2.69', 'spread': '52.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.262', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.67', 'ciLowerLimit': '-7.52', 'ciUpperLimit': '2.18', 'pValueComment': 'P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, twelve months post baseline', 'description': 'Opioid use--morphine dose will be defined at baseline and 12 months post baseline as a continuous variable measuring morphine equivalents for opioid dose at baseline and twelve months. Change in total milligrams of morphine equivalents (MME) use is reported.', 'unitOfMeasure': 'MME', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Patient Reported Outcomes--PROMIS Pain Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'OG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'classes': [{'title': 'Baseline to 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.44', 'spread': '6.19', 'groupId': 'OG000'}, {'value': '-1.10', 'spread': '6.08', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.64', 'spread': '6.29', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '6.69', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.77', 'spread': '6.50', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '6.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.40', 'ciLowerLimit': '-1.31', 'ciUpperLimit': '0.50', 'pValueComment': 'Threshold for significance is 0.025 due to dual primary outcomes.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 3 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.57', 'ciLowerLimit': '-1.54', 'ciUpperLimit': '0.39', 'pValueComment': 'Threshold for significance is 0.025 due to dual primary outcomes.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.45', 'ciLowerLimit': '-1.43', 'ciUpperLimit': '0.54', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 12 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates greater pain interference.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected collected at both timepoints needed to calculate a change.'}, {'type': 'SECONDARY', 'title': 'Change in Patient Reported Outcomes--PROMIS Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'OG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'classes': [{'title': 'Baseline to 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '4.55', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '4.62', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '5.07', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '4.83', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '5.02', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '5.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.727', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.11', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.72', 'pValueComment': 'Threshold for significance is 0.025 due to dual primary outcomes.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 3 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.478', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.24', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '0.91', 'pValueComment': 'Threshold for significance is 0.025 due to dual primary outcomes.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.894', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.05', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.66', 'pValueComment': 'Threshold for significance is 0.025 due to dual primary outcomes.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 12 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates better physical function.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected collected at both timepoints needed to calculate a change.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Patient Reported Outcomes--Catastrophizing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'OG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'classes': [{'title': 'Baseline to 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.222', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.04', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 3 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.988', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.09', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.269', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.05', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 12 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'Catastrophizing questions from the NIH recommended minimum data set will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate catastrophizing with two agree (1) / disagree (0) questions. Responses marked as DK/Ref/Missing are coded as missing. Responses are then summed across the two questions; possible outcome values are 0, 1, 2. A higher score indicates greater catastrophizing.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected collected at both timepoints needed to calculate a change.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'OG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'classes': [{'title': 'Baseline to 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '1.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.477', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.10', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 3 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.877', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.17', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.360', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.11', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 12 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'The AUDIT-C form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure alcohol use. The AUDIT-C form asks the participant to rate three alcohol use questions on a scale of 0-4 with zero representing a better outcome. The total score is the sum of the non-missing responses to the three questions, with range of possible values 0-12.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected collected at both timepoints needed to calculate a change.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'OG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'classes': [{'title': 'Baseline to 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '1.94', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'OG000'}, {'value': '382', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.44', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '2.05', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.38', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '2.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.858', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.28', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 3 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.688', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.21', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.833', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.26', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 12 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'The PEG screening tool scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain intensity. The PEG form asks the participant to rate a series of pain intensity related questions on a scale of 0-10 with 0 representing a better outcome. The total score is the sum of responses to the three questions and is missing if any of the three questions is missing. The range of possible values is 0-30.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected collected at both timepoints needed to calculate a change.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'OG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'classes': [{'title': 'Baseline to 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '2.82', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '3.02', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '2.98', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '2.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.259', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.64', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 3 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.068', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.81', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.514', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.57', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 12 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'Pain Self-Efficacy Questionnaire from the PSEQ-2 form will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate self-efficacy on a scale of 0-6 with zero representing a worse outcome. The total score is the sum of responses to the two questions and is missing if either of the two questions is missing. The range of possible values is 0-12.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected collected at both timepoints needed to calculate a change.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Patient Reported Outcomes--Depressed Mood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'OG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'classes': [{'title': 'Baseline to 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '1.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.895', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.20', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 3 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.438', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.30', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.890', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.21', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 12 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'The Patient Health Questionnaire-2 (PHQ2) form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure depressed mood. The PHQ2 form asks the participant to answer two questions about potential depressed mood within the past week with ratings between 0 and 3. The total score is the sum of responses to the two questions and is missing if either of the two questions is missing. The range of possible values is 0-6. A higher score indicates greater depressed mood.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected collected at both timepoints needed to calculate a change.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Patient Reported Outcomes--Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'OG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'classes': [{'title': 'Baseline to 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.508', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.02', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 3 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.992', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.03', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}, {'pValue': '0.389', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.02', 'pValueComment': 'P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.', 'estimateComment': 'Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.', 'groupDescription': 'Baseline to 12 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'The EuroQoL five-item quality of life questionnaire, EQ-5D-5L, will be administered by interviewers at baseline, three, six, and twelve months post baseline to measure quality of life. The EQ-5D-5L asks the participant five questions related to quality of life on a scale of 1-5. If all questions are answered, the responses are concatenated to form a 5-digit state in the order mobility, self care, usual activities, pain discomfort, anxiety/depression. This 5-digit state is then converted to an index between 0 and 1. A higher score indicates greater quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected collected at both timepoints needed to calculate a change.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'FG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}], 'periods': [{'title': 'Overall Study (All Participants)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '811'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '1006'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '461'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '537'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '350'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '469'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '350'}, {'groupId': 'FG001', 'numSubjects': '469'}]}]}, {'title': 'Survey Subset', 'milestones': [{'type': 'STARTED', 'comment': 'A subset of the overall population was recruited to participate in a series of telephone surveys.', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '516'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '480'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '382'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '360'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '134'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '120'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '120'}]}]}], 'typeUnitsAnalyzed': 'Primary Care Clinics', 'preAssignmentDetails': 'A subset of the overall population was recruited to participate in a series of telephone surveys.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '811', 'groupId': 'BG000'}, {'value': '1006', 'groupId': 'BG001'}, {'value': '1817', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.'}, {'id': 'BG001', 'title': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '811', 'groupId': 'BG000'}, {'value': '1006', 'groupId': 'BG001'}, {'value': '1817', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53.4', 'spread': '15.4', 'groupId': 'BG000'}, {'value': '52.7', 'spread': '15.9', 'groupId': 'BG001'}, {'value': '53', 'spread': '15.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '996', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51.4', 'spread': '15.1', 'groupId': 'BG000'}, {'value': '52.0', 'spread': '15.6', 'groupId': 'BG001'}, {'value': '51.7', 'spread': '15.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'A subset of the overall participants was recruited to participate in a series of telephone surveys.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '811', 'groupId': 'BG000'}, {'value': '1006', 'groupId': 'BG001'}, {'value': '1817', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '701', 'groupId': 'BG000'}, {'value': '896', 'groupId': 'BG001'}, {'value': '1597', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '996', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '451', 'groupId': 'BG000'}, {'value': '436', 'groupId': 'BG001'}, {'value': '887', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'A subset of the overall participants was recruited to participate in a series of telephone surveys.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '811', 'groupId': 'BG000'}, {'value': '1006', 'groupId': 'BG001'}, {'value': '1817', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '766', 'groupId': 'BG000'}, {'value': '920', 'groupId': 'BG001'}, {'value': '1686', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '996', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '476', 'groupId': 'BG000'}, {'value': '429', 'groupId': 'BG001'}, {'value': '905', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'A subset of the overall participants was recruited to participate in a series of telephone surveys.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '811', 'groupId': 'BG000'}, {'value': '1006', 'groupId': 'BG001'}, {'value': '1817', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '466', 'groupId': 'BG000'}, {'value': '703', 'groupId': 'BG001'}, {'value': '1169', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '996', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '326', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'A subset of the overall participants was recruited to participate in a series of telephone surveys.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '811', 'groupId': 'BG000'}, {'value': '1006', 'groupId': 'BG001'}, {'value': '1817', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '811', 'groupId': 'BG000'}, {'value': '1006', 'groupId': 'BG001'}, {'value': '1817', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Due to AIM-BACK being a cluster randomized trial design, there is some enrollment variability across clinics.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-25', 'size': 1441673, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-11T12:24', 'hasProtocol': True}, {'date': '2020-12-01', 'size': 230674, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-14T14:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The only blinded members of the project include the VA research and Duke Clinical Research Institute (DCRI) research staff members administering the consent and follow up survey data collection processes. All other team members will be unblinded due to the pragmatic design.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a 4-year cluster randomized pragmatic trial comparing the effectiveness of a sequenced, multi-modal integrated care pathway for lower back pain (LBP) to a care management by pain navigator program for LBP. The study target population is veterans seeking services for lower back pain in participating VA clinics.\n\nWe plan to enroll 16 VA clinics randomized in a 1:1 Ratio using a covariate constrained randomization.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1817}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2020-05-27', 'resultsFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2020-06-01', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-10', 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Patient Reported Outcomes--Catastrophizing', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'Catastrophizing questions from the NIH recommended minimum data set will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate catastrophizing with two agree (1) / disagree (0) questions. Responses marked as DK/Ref/Missing are coded as missing. Responses are then summed across the two questions; possible outcome values are 0, 1, 2. A higher score indicates greater catastrophizing.'}, {'measure': 'Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C)', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'The AUDIT-C form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure alcohol use. The AUDIT-C form asks the participant to rate three alcohol use questions on a scale of 0-4 with zero representing a better outcome. The total score is the sum of the non-missing responses to the three questions, with range of possible values 0-12.'}, {'measure': 'Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'The PEG screening tool scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain intensity. The PEG form asks the participant to rate a series of pain intensity related questions on a scale of 0-10 with 0 representing a better outcome. The total score is the sum of responses to the three questions and is missing if any of the three questions is missing. The range of possible values is 0-30.'}, {'measure': 'Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2)', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'Pain Self-Efficacy Questionnaire from the PSEQ-2 form will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate self-efficacy on a scale of 0-6 with zero representing a worse outcome. The total score is the sum of responses to the two questions and is missing if either of the two questions is missing. The range of possible values is 0-12.'}, {'measure': 'Change in Patient Reported Outcomes--Depressed Mood', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'The Patient Health Questionnaire-2 (PHQ2) form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure depressed mood. The PHQ2 form asks the participant to answer two questions about potential depressed mood within the past week with ratings between 0 and 3. The total score is the sum of responses to the two questions and is missing if either of the two questions is missing. The range of possible values is 0-6. A higher score indicates greater depressed mood.'}, {'measure': 'Change in Patient Reported Outcomes--Quality of Life', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'The EuroQoL five-item quality of life questionnaire, EQ-5D-5L, will be administered by interviewers at baseline, three, six, and twelve months post baseline to measure quality of life. The EQ-5D-5L asks the participant five questions related to quality of life on a scale of 1-5. If all questions are answered, the responses are concatenated to form a 5-digit state in the order mobility, self care, usual activities, pain discomfort, anxiety/depression. This 5-digit state is then converted to an index between 0 and 1. A higher score indicates greater quality of life.'}], 'primaryOutcomes': [{'measure': 'Change in Pain Interference Measure', 'timeFrame': 'Baseline, three months post baseline', 'description': 'The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater pain interference.'}, {'measure': 'Change in Physical Function Measure', 'timeFrame': 'Baseline, three months post baseline', 'description': 'The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates better physical function.'}], 'secondaryOutcomes': [{'measure': 'Change in Sleep Disturbance', 'timeFrame': 'Baseline, three months post baseline', 'description': 'The PROMIS Short form scores will be collected in the medical record by the provider at baseline, and three months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater sleep disturbance.'}, {'measure': 'Change in Patient Reported Outcomes--PROMIS Sleep Disturbance', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates greater sleep disturbance.'}, {'measure': 'Number of Participants With Opioid Use--Chronic User', 'timeFrame': 'Baseline, twelve months post baseline', 'description': 'Opioid use will be defined at baseline and 12 months post baseline as a binary variable based on whether a chronic opioid user or not at baseline and at twelve months. Opioid use is chronic if participant had at least one prescription with a total day supply of at least 120 days or if there were at least 10 prescription fills in the 12 months prior to the specified timepoint (baseline, 12 months post baseline).'}, {'measure': 'Change in Opioid Use - Morphine Dose', 'timeFrame': 'Baseline, twelve months post baseline', 'description': 'Opioid use--morphine dose will be defined at baseline and 12 months post baseline as a continuous variable measuring morphine equivalents for opioid dose at baseline and twelve months. Change in total milligrams of morphine equivalents (MME) use is reported.'}, {'measure': 'Change in Patient Reported Outcomes--PROMIS Pain Interference', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates greater pain interference.'}, {'measure': 'Change in Patient Reported Outcomes--PROMIS Physical Function', 'timeFrame': 'Baseline, three, six, and twelve months', 'description': 'The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates better physical function.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['clinical pathway', 'veterans', 'low back pain'], 'conditions': ['Low Back Pain', 'Veterans Family']}, 'referencesModule': {'references': [{'pmid': '33313728', 'type': 'BACKGROUND', 'citation': 'George SZ, Coffman CJ, Allen KD, Lentz TA, Choate A, Goode AP, Simon CB, Grubber JM, King H, Cook CE, Keefe FJ, Ballengee LA, Naylor J, Brothers JL, Stanwyck C, Alkon A, Hastings SN. Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial. Pain Med. 2020 Dec 12;21(Suppl 2):S62-S72. doi: 10.1093/pm/pnaa348.'}, {'pmid': '37756618', 'type': 'BACKGROUND', 'citation': 'Lentz TA, Coffman CJ, Cope T, Stearns Z, Simon CB, Choate A, Gladney M, France C, Hastings SN, George SZ. If You Build It, Will They Come? Patient and Provider Use of a Novel Hybrid Telehealth Care Pathway for Low Back Pain. Phys Ther. 2024 Feb 1;104(2):pzad127. doi: 10.1093/ptj/pzad127.'}, {'pmid': '37269070', 'type': 'BACKGROUND', 'citation': 'Ballengee LA, King HA, Simon C, Lentz TA, Allen KD, Stanwyck C, Gladney M, George SZ, Hastings SN. Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial. Clin Trials. 2023 Oct;20(5):463-472. doi: 10.1177/17407745231178789. Epub 2023 Jun 2.'}, {'pmid': '39649618', 'type': 'DERIVED', 'citation': 'George SZ, France C, Coffman CJ, Allen KD, Lentz TA, North R, Choate A, Goode AP, Simon CB, Grubber JM, King H, Cook CE, Keefe FJ, Ballengee LA, Naylor J, Brothers JL, Stanwyck C, Linton T, Tumminello C, Hastings SN. Cohort Profile: Baseline Characteristics of Veterans from Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) - an Embedded Pragmatic, Cluster Randomized Trial in the United States. medRxiv [Preprint]. 2024 Nov 26:2024.11.23.24317833. doi: 10.1101/2024.11.23.24317833.'}], 'seeAlsoLinks': [{'url': 'https://www.medrxiv.org/content/10.1101/2023.12.22.23300382v1', 'label': 'Updated Statistical Analysis Plan Preprint'}]}, 'descriptionModule': {'briefSummary': 'The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Clinic eligibility:\n\n* Volunteer and return signed clinic participation agreement\n* Availability of clinical personnel willing to deliver the treatment interventions (in either arm).\n* Staff and location need to be distinct from other enrolled clinics.\n* Clinics can have a variable number of providers, but together meet criteria for range of monthly visits for low back pain.\n\nParticipant Survey Eligibility Criteria:\n\nInclusion Criteria:\n\n1. Age \\>= 18\n2. Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic\n3. Provider determines LBP is appropriate for conservative management\n4. Referred to integrated ICP pathway or CCP pathway by participating clinic provider\n\nExclusion Criteria:\n\n1. Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults)\n2. No documented phone number in the electronic health record.'}, 'identificationModule': {'nctId': 'NCT04411420', 'acronym': 'AIM-BACK', 'briefTitle': 'Improving Veteran Access to Integrated Management of Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Improving Veteran Access to Integrated Management of Back Pain: A Pragmatic, Cluster Randomized Trial', 'orgStudyIdInfo': {'id': 'Pro00101938'}, 'secondaryIdInfos': [{'id': 'UH3AT009790', 'link': 'https://reporter.nih.gov/quickSearch/UH3AT009790', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Integrated Care Pathway', 'description': 'The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.', 'interventionNames': ['Behavioral: Pain modulation with physical pain treatment', 'Behavioral: Telephone delivered self-management counseling for increasing physical activity', 'Behavioral: Telephone delivered behavioral treatment for participants with high risk for continued disability']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Coordinated Care Management Pathway', 'description': 'The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.', 'interventionNames': ['Behavioral: Patient preference treatment protocol', 'Behavioral: Nonpharmacological guideline adherent treatment protocol', 'Behavioral: Facilitated referrals to existing VA or non-VA pain management resources']}], 'interventions': [{'name': 'Pain modulation with physical pain treatment', 'type': 'BEHAVIORAL', 'description': 'Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation', 'armGroupLabels': ['Integrated Care Pathway']}, {'name': 'Telephone delivered self-management counseling for increasing physical activity', 'type': 'BEHAVIORAL', 'description': 'Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient', 'armGroupLabels': ['Integrated Care Pathway']}, {'name': 'Telephone delivered behavioral treatment for participants with high risk for continued disability', 'type': 'BEHAVIORAL', 'description': 'Patients with a higher risk of developing chronic or persistent back pain will be identified using the nine question risk stratification start back screening tool (SBST) and will receive six additional weeks of physical activity instructions and additional pain modulation treatments as needed.', 'armGroupLabels': ['Integrated Care Pathway']}, {'name': 'Patient preference treatment protocol', 'type': 'BEHAVIORAL', 'description': 'the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol', 'armGroupLabels': ['Coordinated Care Management Pathway']}, {'name': 'Nonpharmacological guideline adherent treatment protocol', 'type': 'BEHAVIORAL', 'description': 'the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient', 'armGroupLabels': ['Coordinated Care Management Pathway']}, {'name': 'Facilitated referrals to existing VA or non-VA pain management resources', 'type': 'BEHAVIORAL', 'description': 'the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.', 'armGroupLabels': ['Coordinated Care Management Pathway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Susan N Hastings, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University / Durham VA'}, {'name': 'Steven Z George, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The data and other resources referenced will be available one year after the date of publication for the primary analyses, which is in alignment with the VA Office of Research and Development.', 'ipdSharing': 'YES', 'description': 'Study data sets will be shared a timely manner with privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website. To enable broad resource sharing, the study statistician will create de-identified, publication-specific datasets including all variables presented in the publication. The PIs hold responsibility for ensuring that the individuals cannot be re-identified. No data or code that could lead to re-identification of individuals will be released. The analytical datasets and statistical code used will be retained in accordance with VA record retention policy. Study manuals and clinical tools will be shared with the NIH PMC3 Collaboratory and VA health care system facilities. If successful outcomes justify broader dissemination, we will seek to do so by placing relevant materials into the public domain.', 'accessCriteria': "We plan on using a de-identified dataset is not subject to HIPAA's minimum necessary standards and would not require a data use agreement. Typically datasets will be provided in SAS transport files using CDISC standards via a website. Requesters will have to enter a valid email, phone number and address to request data. The data provided will be made available under certain requirements and approved on a case by case basis. Requirements include:\n\n* data will be used for research purposes and not to identify subjects\n* data must be secured using appropriate computer technology\n* data must be destroyed or returned after any analysis are complete\n* authors of any manuscript resulting from this data must acknowledge the source of the data\n* analyses for the purpose of presentations, abstracts, and/or publications must be coordinated through the Publications Committee, to avoid overlap\n* coauthors must be given a chance for review and approval of a draft manuscript prior to submission"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Durham VA Medical Center', 'class': 'FED'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}