Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-28 @ 5:07 PM
Study NCT ID:
NCT04477304
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2020-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: EHR Nudges
Sponsor:
Organization:
Raw JSON
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This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.', 'otherNumAtRisk': 233, 'deathsNumAtRisk': 233, 'otherNumAffected': 0, 'seriousNumAtRisk': 233, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Average Per-clinician Log Total Weekly MME Between Baseline and Intervention for Opioid Naïve and At-Risk Patients (Below 50 MME Daily Dose Rxs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Intervention Arm', 'description': 'Clinicians in clinics randomized to the intervention group receive guideline education and will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. 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Historical Rxs, suppositories/injectionables, control clinicians who erroneously received alerts, and Rxs prescribed to patients diagnosed with cancer, or who were under 18 years, were excluded.'}, {'type': 'PRIMARY', 'title': 'Change in Average Per-clinician Log Total Weekly MME Between Baseline and Intervention for Chronic Opioid Patients (=> 50 MME Daily Dose Rxs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Intervention Arm', 'description': 'Clinicians in clinics randomized to the intervention group will receive guideline education and be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. 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Historical Rxs, suppositories/injectionables, control clinicians who erroneously received alerts, and Rxs prescribed to patients diagnosed with cancer, or who were under 18 years, were excluded.'}, {'type': 'SECONDARY', 'title': 'Change in Average Per-clinician Weekly Proportion of Chronic Patients Prescribed a High Dose Opioid (=> 50 MME Daily Dose Rxs) Between Baseline and Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Intervention Arm', 'description': 'Clinicians in clinics randomized to the intervention group receive guideline education and will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '-0.06', 'pValueComment': 'The threshold for statistical significance was p = 0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.01', 'groupDescription': 'Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6-month baseline and 18-month intervention', 'description': 'Change = (18-month intervention average per-clinician weekly proportion - 6-month baseline average per-clinician weekly proportion). 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Historical Rxs, suppositories/injectionables, control clinicians who erroneously received alerts, and Rxs prescribed to patients diagnosed with cancer, or who were under 18 years, were excluded.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Average Per-clinician Log Total Weekly MME Between Baseline and Post-intervention for Opioid Naïve and At-Risk Patients (Below 50 MME Daily Dose Rxs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Intervention Arm', 'description': 'Clinicians in clinics randomized to the intervention group will receive guideline education and be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '-0.03', 'pValueComment': 'The threshold for statistical significance was p = 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.01', 'groupDescription': 'Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Left-Censored Tobit Regression'}], 'paramType': 'MEAN', 'timeFrame': '6-month baseline and 6-month post-intervention', 'description': 'Change = (6-month post-intervention average of natural log MME summed per-clinician, per-week - the 18-month baseline average of natural log MME summed per-clinician, per-week). 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Proportion = number of chronic patients who received Rx =\\> 50 MME per-clinician, per-week/total patients who received opioid Rx per-clinician, per-week', 'unitOfMeasure': 'Mean weekly proportion of chronic pts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinicians enrolled at AltaMed and Northwestern University who prescribed an opioid Rx during study period. Historical Rxs, suppositories/injectionables, control clinicians who erroneously received alerts, and Rxs prescribed to patients diagnosed with cancer, or who were under 18 years, were excluded.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Average Per-clinician Log Total Weekly MME Between Baseline and Post-intervention for Chronic Opioid Patients (=> 50 MME Daily Dose Rxs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Intervention Arm', 'description': 'Clinicians in clinics randomized to the intervention group will receive guideline education and be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. 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Log(total MME) = log(Rx strength x number of pills x opioid conversion factor)', 'unitOfMeasure': 'chg in avg per-clin log total weekly MME', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinicians enrolled at AltaMed and Northwestern University who prescribed an opioid Rx =\\> 50 MME during study period. Historical Rxs, suppositories/injectionables, control clinicians who erroneously received alerts, and Rxs prescribed to patients diagnosed with cancer, or who were under 18 years, were excluded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Behavioral Intervention Arm', 'description': 'Clinicians in clinics randomized to the intervention group will receive guideline education and be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '43', 'numSubjects': '322'}, {'groupId': 'FG001', 'numUnits': '43', 'numSubjects': '233'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '43', 'numSubjects': '275'}, {'groupId': 'FG001', 'numUnits': '42', 'numSubjects': '207'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '47'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'No valid opioid prescriptions during study timeframe', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '26'}]}]}], 'typeUnitsAnalyzed': 'Clinics'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '555', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Behavioral Intervention Arm', 'description': 'Clinicians in clinics randomized to the intervention group receive guideline education and will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Unknown/Not reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '555', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '322', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '555', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '555', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '334', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '555', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}, {'title': 'Unknown/Not reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '555', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '555', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '322', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '555', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-18', 'size': 1692785, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-19T14:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 555}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2020-07-14', 'resultsFirstSubmitDate': '2024-08-02', 'studyFirstSubmitQcDate': '2020-07-14', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-14', 'studyFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Average Per-clinician Log Total Weekly MME Between Baseline and Post-intervention for Opioid Naïve and At-Risk Patients (Below 50 MME Daily Dose Rxs)', 'timeFrame': '6-month baseline and 6-month post-intervention', 'description': 'Change = (6-month post-intervention average of natural log MME summed per-clinician, per-week - the 18-month baseline average of natural log MME summed per-clinician, per-week). Log(total MME) = log(Rx strength x number of pills x opioid conversion factor)'}, {'measure': 'Change in Average Per-clinician Weekly Proportion of Chronic Patients Prescribed a High Dose Opioid (=> 50 MME Daily Dose Rxs) Between Baseline and Post-intervention', 'timeFrame': '6-month baseline and 6-month post-intervention', 'description': 'Change = (6-month post-intervention average per-clinician weekly proportion - 6-month baseline average per-clinician weekly proportion). Proportion = number of chronic patients who received Rx =\\> 50 MME per-clinician, per-week/total patients who received opioid Rx per-clinician, per-week'}, {'measure': 'Change in Average Per-clinician Log Total Weekly MME Between Baseline and Post-intervention for Chronic Opioid Patients (=> 50 MME Daily Dose Rxs)', 'timeFrame': '6-month baseline and 6-month post-intervention', 'description': 'Change = (6-month post-intervention average of natural log MME summed per-clinician, per-week - the 6-month baseline average of natural log MME summed per-clinician, per-week). Log(total MME) = log(Rx strength x number of pills x opioid conversion factor)'}], 'primaryOutcomes': [{'measure': 'Change in Average Per-clinician Log Total Weekly MME Between Baseline and Intervention for Opioid Naïve and At-Risk Patients (Below 50 MME Daily Dose Rxs)', 'timeFrame': '6-month baseline and 18-month intervention', 'description': 'Change = (18-month intervention average of natural log MME summed per-clinician, per-week - 6-month baseline average of natural log MME summed per-clinician, per-week). Log(total MME) = log(Rx strength x number of pills x opioid conversion factor)'}, {'measure': 'Change in Average Per-clinician Log Total Weekly MME Between Baseline and Intervention for Chronic Opioid Patients (=> 50 MME Daily Dose Rxs)', 'timeFrame': '6-month baseline and 18-month intervention', 'description': 'Change = (18-month intervention average of natural log MME summed per-clinician, per-week - 6-month baseline average of natural log MME summed per-clinician, per-week). Log(total MME) = log(Rx strength x number of pills x opioid conversion factor)'}], 'secondaryOutcomes': [{'measure': 'Change in Average Per-clinician Weekly Proportion of Chronic Patients Prescribed a High Dose Opioid (=> 50 MME Daily Dose Rxs) Between Baseline and Intervention', 'timeFrame': '6-month baseline and 18-month intervention', 'description': 'Change = (18-month intervention average per-clinician weekly proportion - 6-month baseline average per-clinician weekly proportion). Proportion = number of chronic patients who received Rx =\\> 50 MME per-clinician, per-week/total patients who received opioid Rx per-clinician, per-week'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['opioid use disorder', 'randomized control trial', 'behavioral economics', 'nudges'], 'conditions': ['Opioid Abuse, Unspecified']}, 'referencesModule': {'references': [{'pmid': '33636344', 'type': 'BACKGROUND', 'citation': 'Kelley MA, Persell SD, Linder JA, Friedberg MW, Meeker D, Fox CR, Goldstein NJ, Knight TK, Zein D, Rowe TA, Sullivan MD, Doctor JN. The protocol of the Application of Economics & Social psychology to improve Opioid Prescribing Safety Trial 1 (AESOPS-1): Electronic health record nudges. Contemp Clin Trials. 2021 Apr;103:106329. doi: 10.1016/j.cct.2021.106329. Epub 2021 Feb 24.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.cct.2021.106329', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The opioid epidemic has had a tremendous negative impact on the health of persons in the U.S. The objective of the trial 1 of Application of Economics \\& Social psychology to improve Opioid Prescribing Safety (AESOPS-T1), is to discourage unnecessary opioid prescribing through the application of "behavioral insights"-empirically-tested social and psychological interventions that affect choice.', 'detailedDescription': 'A multisite study, AESOPS-T1 randomizes clinics to behavioral intervention or control. Clinics randomized to the behavioral intervention arm receive electronic health record (EHR)-based nudges. Eligible participants are clinicians who practice ambulatory primary care at the participating clinical sites in Illinois and California. At the time of opioid prescribing, clinicians in clinics randomized to the intervention group will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three mutually exclusive categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient. These EHR-based nudges include accountable justification, defaults and precommitments. The control arm receives no EHR-based intervention. Both arms receive guideline education. The primary outcome is the change in clinician aggregate weekly milligram morphine equivalent (MME) dose and the secondary outcome is the proportion of dosages that equal or exceed 50 MME per day. These outcomes will be estimated by treatment arm with an intent-to-treat difference-in-differences framework using a mixed-effects regression model on clinician MME daily dose. The intervention period will be 18-months, with a 6-month follow-up period to measure the persistence of effects after the interventions conclude.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Providers of clinics that see patients ≥ 18 years old and for whom clinic leadership agrees to participate.\n\nExclusion Criteria:\n\n* Visits will be excluded from intervention when the patient has active cancer.'}, 'identificationModule': {'nctId': 'NCT04477304', 'acronym': 'AESOPS-T1', 'briefTitle': 'Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: EHR Nudges', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: Electronic Health Record Nudges', 'orgStudyIdInfo': {'id': 'R33AG057395', 'link': 'https://reporter.nih.gov/quickSearch/R33AG057395', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R33AG057395', 'link': 'https://reporter.nih.gov/quickSearch/R33AG057395', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Intervention Arm', 'description': 'Clinicians in clinics randomized to the intervention group will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient. These EHR-based nudges include elements of accountable justification, defaults and precommitments. Clinicians will also receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.', 'interventionNames': ['Behavioral: Opioid Naive, OR', 'Behavioral: At-risk for long-term use, OR', 'Behavioral: Long-term opioid recipient']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.'}], 'interventions': [{'name': 'Opioid Naive, OR', 'type': 'BEHAVIORAL', 'description': 'Visits where the order is for an included opioid and there is no prior opioid prescription with a start date of greater than 1 day and less than 91 days and clinician is on the clinic list as a treating member of the clinic', 'armGroupLabels': ['Behavioral Intervention Arm']}, {'name': 'At-risk for long-term use, OR', 'type': 'BEHAVIORAL', 'description': 'Visit where the order is for an included opioid, there is a prior opioid prescription with a start date greater than 1 day and less than 91 days, and there is no prior opioid prescription with a start date greater than 90 days and clinician is on the clinic list as a treating member of the clinic', 'armGroupLabels': ['Behavioral Intervention Arm']}, {'name': 'Long-term opioid recipient', 'type': 'BEHAVIORAL', 'description': 'Total opioid doses are at least 50 MME per day, there are two or more prior opioid prescriptions with two different start dates both greater than 1 day and less than 91 days, and there is a prior opioid prescription with a start date greater than 90 days and less than 181 days and clinician is on the clinic list as a treating member of the clinic', 'armGroupLabels': ['Behavioral Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jason N Doctor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'AltaMed Health Services Corporation', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jason Doctor', 'investigatorAffiliation': 'University of Southern California'}}}}