Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT05426902
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2022-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amanda.eudy@duke.edu', 'phone': '919-681-1811', 'title': 'Amanda Eudy, MSPH, Ph.D.', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Providers', 'description': 'Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic are eligible to participate in the SLE@Duke intervention. Participants complete a baseline survey and training in the Type 1 \\& 2 SLE Model. They are asked to perform the intervention for all eligible patients over 4 weeks. Patients complete a survey at the end of their clinic visit, and providers complete a survey at the end of the 4 week intervention period. All participating providers were invited to an in-depth interview at the end of the intervention period.\n\nSLE@Duke: SLE@Duke is a set of tools to implement the Type 1 \\& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \\& 2 SLE.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patients (Survey)', 'description': 'Patients who completed an anonymous survey at the end of their clinic visit during the 4-week baseline period and 4-week intervention period.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Patients (EMR)', 'description': 'Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and 3-month follow-up.', 'otherNumAtRisk': 115, 'deathsNumAtRisk': 115, 'otherNumAffected': 0, 'seriousNumAtRisk': 115, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Number of Patients' Rheumatologists Using SLE@Duke", 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients (EMR)', 'description': 'Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Intervention period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Baseline (month 1) vs. intervention period (month 2)', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Collected from EMR (electronic medical record). This is a composite measure that includes documentation in the clinic note of any component of SLE@Duke: (1) Type 1 \\& 2 SLE Model mentioned, (2) dotphrase used, (3) Type 1 \\& Type 2 PGAs (Physician Global Assessments) scored in note, (4) handout mentioned, (5) Type 2 symptoms discussed, or (6) purple sheet documented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to the Patients (EMR) group. 36 patient medical records were reviewed during the 4-week baseline period. 31 patient medical records were reviewed during the 4-week intervention period.'}, {'type': 'PRIMARY', 'title': 'Length of Clinic Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients (EMR)', 'description': 'Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.'}], 'classes': [{'title': 'Baseline (month 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.8', 'spread': '22.4', 'groupId': 'OG000'}]}]}, {'title': 'Intervention period (month 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.9', 'spread': '28.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.6', 'groupIds': ['OG000'], 'groupDescription': 'Baseline (month 1) vs. intervention period (month 2)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Collected from EMR (electronic medical record).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to the Patients (EMR) group. 36 patient medical records were reviewed during the 4-week baseline period. 31 patient medical records were reviewed during the 4-week intervention period.'}, {'type': 'PRIMARY', 'title': 'Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Providers', 'description': 'Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic were eligible to participate in the SLE@Duke intervention. Participants completed a baseline survey and training on the Type 1 \\& 2 SLE Model. They were asked to perform the intervention for all eligible patients over 4 weeks. Patients completed a survey at the end of their clinic visit, and providers completed a survey at the end of the 4-week intervention period. All participating providers were invited to participate in an in-depth interview at the end of the intervention period.\n\nSLE@Duke: SLE@Duke is a set of tools to implement the Type 1 \\& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \\& 2 SLE.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.44', 'spread': '0.73', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.2', 'groupIds': ['OG000'], 'groupDescription': 'Baseline (month 1) vs. intervention period (month 2)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Satisfaction was measured on a scale of 1-5, where 1 = never and 5 = always in response to the statement: "After seeing a patient with lupus, I leave the exam room feeling satisfied with the encounter."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the baseline and follow-up surveys. Only applies to the Providers group.'}, {'type': 'PRIMARY', 'title': 'Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients (EMR)', 'description': 'Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.'}], 'classes': [{'title': 'Baseline (month 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Intervention period (month 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Baseline (month 1) vs. intervention period (month 2)', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Collected from EMR (electronic medical record).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to the Patients (EMR) group. 36 patient medical records were reviewed during the 4-week baseline period. 31 patient medical records were reviewed during the 4-week intervention period.'}, {'type': 'PRIMARY', 'title': 'Number of Lupus Patients With Type 2 SLE Treatment in Note', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients (EMR)', 'description': 'Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.'}], 'classes': [{'title': 'Baseline (month 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Intervention period (month 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.4', 'groupIds': ['OG000'], 'groupDescription': 'Baseline (month 1) vs. intervention period (month 2)', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Collected from EMR (electronic medical record).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to the Patients (EMR) group. 36 patient medical records were reviewed during the 4-week baseline period. 31 patient medical records were reviewed during the 4-week intervention period.'}, {'type': 'PRIMARY', 'title': 'Perceived Benefits of SLE@Duke, as Measured by Provider Interviews', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Providers', 'description': 'Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic were eligible to participate in the SLE@Duke intervention. Participants completed a baseline survey and training on the Type 1 \\& 2 SLE Model. They were asked to perform the intervention for all eligible patients over 4 weeks. Patients completed a survey at the end of their clinic visit, and providers completed a survey at the end of the 4-week intervention period. All participating providers were invited to participate in an in-depth interview at the end of the intervention period.\n\nSLE@Duke: SLE@Duke is a set of tools to implement the Type 1 \\& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \\& 2 SLE.'}], 'classes': [{'title': 'Improved conversations with patients', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Improved patient understanding', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Improved quality of care', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Validation of patient experiences', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to the Providers group. Participants who completed the interview.'}, {'type': 'PRIMARY', 'title': 'Perceived Barriers of SLE@Duke, as Measured by Provider Interviews', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Providers', 'description': 'Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic were eligible to participate in the SLE@Duke intervention. Participants completed a baseline survey and training on the Type 1 \\& 2 SLE Model. They were asked to perform the intervention for all eligible patients over 4 weeks. Patients completed a survey at the end of their clinic visit, and providers completed a survey at the end of the 4-week intervention period. All participating providers were invited to participate in an in-depth interview at the end of the intervention period.\n\nSLE@Duke: SLE@Duke is a set of tools to implement the Type 1 \\& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \\& 2 SLE.'}], 'classes': [{'title': 'Need for more training', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Slows down the clinic visit', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Not seeing a lot of lupus patients', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Need for more information on treating Type 2 SLE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Staff buy-in', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to the Providers group. Participants who completed the interview.'}, {'type': 'PRIMARY', 'title': 'How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Providers', 'description': 'Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic were eligible to participate in the SLE@Duke intervention. Participants completed a baseline survey and training on the Type 1 \\& 2 SLE Model. They were asked to perform the intervention for all eligible patients over 4 weeks. Patients completed a survey at the end of their clinic visit, and providers completed a survey at the end of the 4-week intervention period. All participating providers were invited to participate in an in-depth interview at the end of the intervention period.\n\nSLE@Duke: SLE@Duke is a set of tools to implement the Type 1 \\& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \\& 2 SLE.'}], 'classes': [{'title': 'Staff needed more training', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Providers needed more clinic support staff', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Providers had difficulty getting into a routine because of small lupus population in their clinic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Providers needed a more systematic way of collecting patient surveys', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'No impact on work flow', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to the Providers group. Participants who completed the interview.'}, {'type': 'PRIMARY', 'title': 'Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients (EMR)', 'description': 'Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.'}], 'classes': [{'title': 'Intervention period (month 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up (month 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intervention period (month 2), month 5', 'description': 'Collected from EMR (electronic medical record).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to the Patients (EMR) group. 31 patient medical records were reviewed during the 4-week intervention period. 48 patient medical records were reviewed during the 4-week 3-month follow-up period.'}, {'type': 'PRIMARY', 'title': 'Difference in Perceived Quality of Visit, as Measured by Patient Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients (Survey)', 'description': 'Patients who completed an anonymous survey at the end of their clinic visit during the 4-week baseline period and 4-week intervention period.'}], 'classes': [{'title': 'I feel good about my medical visit.', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'My rheumatologist gave me his/her full attention.', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'I was able to say everything I wanted to say to my rheumatologist.', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.7', 'groupIds': ['OG000'], 'groupDescription': '"I feel good about my medical visit" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8', 'groupIds': ['OG000'], 'groupDescription': '"My rheumatologist gave me his/her full attention" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0', 'groupIds': ['OG000'], 'groupDescription': '"I was able to say everything I wanted to say to my rheumatologist" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Each question pertaining to quality of visit was measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to the Patients (Survey) group. 19 patients completed surveys during the 4-week baseline period. 30 different patients completed surveys during the 4-week intervention period.'}, {'type': 'PRIMARY', 'title': 'Discussion of the Type 1 and 2 Model, as Measured by Patient Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients (Survey)', 'description': 'Patients who completed an anonymous survey at the end of their clinic visit during the 4-week baseline period and 4-week intervention period.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intervention period (month 2)', 'description': 'The patient survey asked patients to respond "Yes" or "No" in response to the statement: "My rheumatologist discussed Type 1 \\& Type 2 lupus with me today."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to the Patients (Survey) group. Patients who responded to the question.'}, {'type': 'PRIMARY', 'title': 'Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients (Survey)', 'description': 'Patients who completed an anonymous survey at the end of their clinic visit during the 4-week baseline period and 4-week intervention period.'}], 'classes': [{'title': 'My rheumatologist and I agreed on how active my lupus was today.', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'I understand the care recommendations that my doctor or provider gave me today.', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.7', 'groupIds': ['OG000'], 'groupDescription': '"My rheumatologist and I agreed on how active my lupus was today" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8', 'groupIds': ['OG000'], 'groupDescription': '"I understand the care recommendations that my doctor or provider gave me today" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Questions pertaining to understanding were measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to Patients (Survey) group. 19 patients completed surveys during the 4-week baseline period. 30 different patients completed surveys during the 4-week intervention period.'}, {'type': 'PRIMARY', 'title': 'Change in Discussion of the Type 1 and 2 Model, as Measured by Provider Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Providers', 'description': 'Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic were eligible to participate in the SLE@Duke intervention. Participants completed a baseline survey and training on the Type 1 \\& 2 SLE Model. They were asked to perform the intervention for all eligible patients over 4 weeks. Patients completed a survey at the end of their clinic visit, and providers completed a survey at the end of the 4-week intervention period. All participating providers were invited to participate in an in-depth interview at the end of the intervention period.\n\nSLE@Duke: SLE@Duke is a set of tools to implement the Type 1 \\& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \\& 2 SLE.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000'], 'groupDescription': 'Baseline vs. Follow-Up', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Discussion of the Type 1 \\& 2 SLE Model was measured on a scale of 1-5, where 1 = "never" and 5 = "always" in response to the statement: "I discuss the Type 1 \\& 2 SLE Model with the patient."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to the Providers group. Participants who completed the survey.'}, {'type': 'PRIMARY', 'title': 'Change in Acceptability of SLE@Duke, as Measured by Provider Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Providers', 'description': 'Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic were eligible to participate in the SLE@Duke intervention. Participants completed a baseline survey and training on the Type 1 \\& 2 SLE Model. They were asked to perform the intervention for all eligible patients over 4 weeks. Patients completed a survey at the end of their clinic visit, and providers completed a survey at the end of the 4-week intervention period. All participating providers were invited to participate in an in-depth interview at the end of the intervention period.\n\nSLE@Duke: SLE@Duke is a set of tools to implement the Type 1 \\& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \\& 2 SLE.'}], 'classes': [{'title': 'SLE@Duke meets my approval.', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'SLE@Duke is appealing to me.', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'I like SLE@Duke.', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'I welcome SLE@Duke.', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.7', 'groupIds': ['OG000'], 'groupDescription': '"SLE@Duke meets my approval" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0', 'groupIds': ['OG000'], 'groupDescription': '"SLE@Duke is appealing to me" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5', 'groupIds': ['OG000'], 'groupDescription': '"I like SLE@Duke" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6', 'groupIds': ['OG000'], 'groupDescription': '"I welcome SLE@Duke" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Questions pertaining to acceptability of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to the Providers group. Participants who completed the survey.'}, {'type': 'PRIMARY', 'title': 'Change in Appropriateness of SLE@Duke, as Measured by Provider Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Providers', 'description': 'Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic were eligible to participate in the SLE@Duke intervention. Participants completed a baseline survey and training on the Type 1 \\& 2 SLE Model. They were asked to perform the intervention for all eligible patients over 4 weeks. Patients completed a survey at the end of their clinic visit, and providers completed a survey at the end of the 4-week intervention period. All participating providers were invited to participate in an in-depth interview at the end of the intervention period.\n\nSLE@Duke: SLE@Duke is a set of tools to implement the Type 1 \\& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \\& 2 SLE.'}], 'classes': [{'title': 'SLE@Duke seems fitting.', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'SLE@Duke seems suitable.', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'SLE@Duke seems applicable.', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'SLE@Duke seems like a good match.', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.7', 'groupIds': ['OG000'], 'groupDescription': '"SLE@Duke seems fitting" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7', 'groupIds': ['OG000'], 'groupDescription': '"SLE@Duke seems suitable" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0', 'groupIds': ['OG000'], 'groupDescription': '"SLE@Duke seems applicable" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0', 'groupIds': ['OG000'], 'groupDescription': '"SLE@Duke seems like a good match" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Questions pertaining to the appropriateness of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to the Providers group. Participants who completed the survey.'}, {'type': 'PRIMARY', 'title': 'Change in Feasibility of SLE@Duke, as Measured by Provider Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Providers', 'description': 'Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic were eligible to participate in the SLE@Duke intervention. Participants completed a baseline survey and training on the Type 1 \\& 2 SLE Model. They were asked to perform the intervention for all eligible patients over 4 weeks. Patients completed a survey at the end of their clinic visit, and providers completed a survey at the end of the 4-week intervention period. All participating providers were invited to participate in an in-depth interview at the end of the intervention period.\n\nSLE@Duke: SLE@Duke is a set of tools to implement the Type 1 \\& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \\& 2 SLE.'}], 'classes': [{'title': 'SLE@Duke seems implementable.', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'SLE@Duke seems possible.', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'SLE@Duke seems doable.', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'SLE@Duke seems easy to use.', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.3', 'groupIds': ['OG000'], 'groupDescription': '"SLE@Duke seems implementable" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3', 'groupIds': ['OG000'], 'groupDescription': '"SLE@Duke seems possible" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4', 'groupIds': ['OG000'], 'groupDescription': '"SLE@Duke seems doable" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3', 'groupIds': ['OG000'], 'groupDescription': '"SLE@Duke seems easy to use" at baseline (month 1) vs. intervention period (month 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Questions concerning feasibility of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only applies to the Providers group. Participants who completed the survey.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Providers', 'description': 'Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic were eligible to participate in the SLE@Duke intervention. Participants completed a baseline survey and training on the Type 1 \\& 2 SLE Model. They were asked to perform the intervention for all eligible patients over 4 weeks. Patients completed a survey at the end of their clinic visit, and providers completed a survey at the end of the 4-week intervention period. All participating providers were invited to participate in an in-depth interview at the end of the intervention period.\n\nSLE@Duke: SLE@Duke is a set of tools to implement the Type 1 \\& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \\& 2 SLE.'}, {'id': 'FG001', 'title': 'Patients (Survey)', 'description': 'Patients who completed an anonymous survey at the end of their clinic visit during the 4-week baseline period and 4-week intervention period.'}, {'id': 'FG002', 'title': 'Patients (EMR)', 'description': 'Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '115'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Patients provided data for this study via survey and EMR (electronic medical record), but were not considered enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Providers', 'description': 'Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic were eligible to participate in the SLE@Duke intervention. Participants completed a baseline survey and training on the Type 1 \\& 2 SLE Model. They were asked to perform the intervention for all eligible patients over 4 weeks. Patients completed a survey at the end of their clinic visit, and providers completed a survey at the end of the 4-week intervention period. All participating providers were invited to participate in an in-depth interview at the end of the intervention period.\n\nSLE@Duke: SLE@Duke is a set of tools to implement the Type 1 \\& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \\& 2 SLE.'}, {'id': 'BG001', 'title': 'Patients (Survey)', 'description': 'Patients who completed an anonymous survey at the end of their clinic visit during the 4-week baseline period and 4-week intervention period.'}, {'id': 'BG002', 'title': 'Patients (EMR)', 'description': 'Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '48.0', 'spread': '16.2', 'groupId': 'BG002'}, {'value': '48', 'spread': '16.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age data was not collected on Providers or the Patients (Survey) group.'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex/Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics data was not collected on the Patients (Survey) group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-09', 'size': 239739, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-25T12:14', 'hasProtocol': True}, {'date': '2021-12-22', 'size': 183703, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-06-22T12:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2022-06-16', 'resultsFirstSubmitDate': '2023-06-20', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-05', 'studyFirstPostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of Patients' Rheumatologists Using SLE@Duke", 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Collected from EMR (electronic medical record). This is a composite measure that includes documentation in the clinic note of any component of SLE@Duke: (1) Type 1 \\& 2 SLE Model mentioned, (2) dotphrase used, (3) Type 1 \\& Type 2 PGAs (Physician Global Assessments) scored in note, (4) handout mentioned, (5) Type 2 symptoms discussed, or (6) purple sheet documented.'}, {'measure': 'Length of Clinic Visits', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Collected from EMR (electronic medical record).'}, {'measure': 'Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Satisfaction was measured on a scale of 1-5, where 1 = never and 5 = always in response to the statement: "After seeing a patient with lupus, I leave the exam room feeling satisfied with the encounter."'}, {'measure': 'Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Collected from EMR (electronic medical record).'}, {'measure': 'Number of Lupus Patients With Type 2 SLE Treatment in Note', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Collected from EMR (electronic medical record).'}, {'measure': 'Perceived Benefits of SLE@Duke, as Measured by Provider Interviews', 'timeFrame': '4 weeks', 'description': 'In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.'}, {'measure': 'Perceived Barriers of SLE@Duke, as Measured by Provider Interviews', 'timeFrame': '4 weeks', 'description': 'In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.'}, {'measure': 'How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews', 'timeFrame': '4 weeks', 'description': 'In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.'}, {'measure': 'Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note', 'timeFrame': 'Intervention period (month 2), month 5', 'description': 'Collected from EMR (electronic medical record).'}, {'measure': 'Difference in Perceived Quality of Visit, as Measured by Patient Survey', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Each question pertaining to quality of visit was measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.'}, {'measure': 'Discussion of the Type 1 and 2 Model, as Measured by Patient Survey', 'timeFrame': 'Intervention period (month 2)', 'description': 'The patient survey asked patients to respond "Yes" or "No" in response to the statement: "My rheumatologist discussed Type 1 \\& Type 2 lupus with me today."'}, {'measure': 'Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Questions pertaining to understanding were measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.'}, {'measure': 'Change in Discussion of the Type 1 and 2 Model, as Measured by Provider Survey', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Discussion of the Type 1 \\& 2 SLE Model was measured on a scale of 1-5, where 1 = "never" and 5 = "always" in response to the statement: "I discuss the Type 1 \\& 2 SLE Model with the patient."'}, {'measure': 'Change in Acceptability of SLE@Duke, as Measured by Provider Survey', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Questions pertaining to acceptability of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.'}, {'measure': 'Change in Appropriateness of SLE@Duke, as Measured by Provider Survey', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Questions pertaining to the appropriateness of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.'}, {'measure': 'Change in Feasibility of SLE@Duke, as Measured by Provider Survey', 'timeFrame': 'Baseline (month 1), intervention period (month 2)', 'description': 'Questions concerning feasibility of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic Lupus Erythematosus'], 'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to pilot test SLE@Duke, a set of tools to implement the Type 1 \\& 2 SLE Model in a clinical setting, as well as to gain an in-depth understanding of providers experiences using the intervention during clinic visits with patients with systemic lupus erythematosus.\n\nThis record represents Aim 3 of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All providers in Duke Rheumatology who practice outside of the Duke Lupus Clinic are eligible.\n* Patients are eligible to participate if they have an established diagnosis of SLE and are followed in Duke Rheumatology.\n* All patients with a SLE diagnosis will be included in the analysis. SLE diagnosis will be based on an ICD-10 code for SLE (M32.1\\*, M32.8, M32.9) in the EMR.\n\nExclusion Criteria:\n\n* New patients will be excluded'}, 'identificationModule': {'nctId': 'NCT05426902', 'briefTitle': 'Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)', 'orgStudyIdInfo': {'id': 'Pro00102300'}, 'secondaryIdInfos': [{'id': 'KL2TR002554', 'link': 'https://reporter.nih.gov/quickSearch/KL2TR002554', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLE@Duke', 'description': 'Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic are eligible to participate in the SLE@Duke intervention. Participants complete a baseline survey and training in the Type 1 \\& 2 SLE Model. They are asked to perform the intervention for all eligible patients over 4 weeks. Patients complete a survey at the end of their clinic visit, and providers complete a survey at the end of the 4 week intervention period. All participating providers were invited to an in-depth interview at the end of the intervention period.', 'interventionNames': ['Behavioral: SLE@Duke']}], 'interventions': [{'name': 'SLE@Duke', 'type': 'BEHAVIORAL', 'description': 'SLE@Duke is a set of tools to implement the Type 1 \\& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \\& 2 SLE.', 'armGroupLabels': ['SLE@Duke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Amanda Eudy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}