Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-05 @ 8:02 PM
Study NCT ID:
NCT05256394
Status:
COMPLETED
Last Update Posted:
2025-11-04
First Post:
2022-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-Centered Chronic Pain Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-19', 'size': 178882, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-10-31T07:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a stepped-wedge, cluster randomized trial using mixed methods to assess the multilevel determinants of CDS implementation success. The investigators will use both quantitative and qualitative data to provide a comprehensive understanding of the clinical context of the participating sites before and after the trial, and identify system, clinic and provider-level factors that may influence the implementation process. In summary, this is a complete, open-cohort stepped-wedge cluster-randomized design with 5 time periods (including the baseline), with each period spanning 1 month and 2 clinics switching from control to intervention at each of the 4 steps (for a total study duration of 5 months).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2022-01-28', 'studyFirstSubmitQcDate': '2022-02-24', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adoption', 'timeFrame': 'During the implementation trial (5 months total)', 'description': 'Rate of qualifying patients seen for whom CDS use is documented'}], 'secondaryOutcomes': [{'measure': 'Reach', 'timeFrame': 'During the implementation trial (5 months total)', 'description': 'Rate of clinic encounters where CDS is documented'}, {'measure': 'Shared decision making', 'timeFrame': 'Immediately after the intervention', 'description': 'SDM-Q-9 questionnaire: 9-item Shared Decision Making Questionnaire'}, {'measure': 'Pain and function', 'timeFrame': 'Baseline/pre-intervention, and at 1 and 3 months', 'description': 'PEG-3: 3-item scale that measures pain on average, its interference with enjoyment of life, and with general activity'}, {'measure': 'Any opioid prescription', 'timeFrame': 'Baseline/pre-intervention, and at 1 and 3 months', 'description': 'Binary measure of treatment choice that increases opioid-related risks'}, {'measure': 'Opioid prescriptions ≥50 MME/day', 'timeFrame': 'Baseline/pre-intervention, and at 1 and 3 months', 'description': 'Binary measure of treatment choice that increases opioid-related risks'}, {'measure': 'Opioid prescriptions ≥90 MME/day', 'timeFrame': 'Baseline/pre-intervention, and at 1 and 3 months', 'description': 'Binary measure of treatment choice that increases opioid-related risks'}, {'measure': 'Benzodiazepine prescription concurrent with opioid prescription', 'timeFrame': 'Baseline/pre-intervention, and at 1 and 3 months', 'description': 'Binary measure of treatment choice that increases opioid-related risks'}, {'measure': 'Prescriptions for non-opioid pain medications', 'timeFrame': 'Baseline/pre-intervention, and at 1 and 3 months', 'description': 'Binary measure recommended by the CDC to decrease opioid-related risks'}, {'measure': 'Prescriptions for non-pharmacologic pain treatments', 'timeFrame': 'Baseline/pre-intervention, and at 1 and 3 months', 'description': 'Binary measure recommended by the CDC to decrease opioid-related risks'}, {'measure': 'Urine drug screen orders', 'timeFrame': 'Baseline/pre-intervention, and at 1 and 3 months', 'description': 'Binary measure recommended by the CDC to decrease opioid-related risks'}, {'measure': 'Naloxone prescriptions', 'timeFrame': 'Baseline/pre-intervention, and at 1 and 3 months', 'description': 'Binary measure recommended by the CDC to decrease opioid-related risks'}, {'measure': 'Prescription or referral for medication-assisted therapy (MAT)', 'timeFrame': 'Baseline/pre-intervention, and at 1 and 3 months', 'description': 'Binary measure recommended by the CDC to decrease opioid-related risks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain', 'Opioid Use', 'Musculoskeletal Pain']}, 'referencesModule': {'references': [{'pmid': '35841043', 'type': 'DERIVED', 'citation': 'Salloum RG, Bilello L, Bian J, Diiulio J, Paz LG, Gurka MJ, Gutierrez M, Hurley RW, Jones RE, Martinez-Wittinghan F, Marcial L, Masri G, McDonnell C, Militello LG, Modave F, Nguyen K, Rhodes B, Siler K, Willis D, Harle CA. Study protocol for a type III hybrid effectiveness-implementation trial to evaluate scaling interoperable clinical decision support for patient-centered chronic pain management in primary care. Implement Sci. 2022 Jul 15;17(1):44. doi: 10.1186/s13012-022-01217-4.'}]}, 'descriptionModule': {'briefSummary': 'This study will adapt and scale existing AHRQ-supported interoperable CDS for patient-centered chronic pain care. The objective of this project is to study the adaptation and implementation of an existing interoperable CDS tool for pain treatment shared decision making, with tailored implementation support, in primary care clinical settings. The central hypothesis is that tailored implementation support will increase CDS adoption and shared decision making.', 'detailedDescription': 'This study will adapt and scale the use of existing AHRQ-supported interoperable CDS that aids patient-centered chronic pain treatment decision making. The research will generate critical evidence on scalable strategies to implement and evaluate interoperable CDS in real-world settings across different types of EHRs. The pragmatic trial will enhance the reach of interoperable CDS to more diverse populations. Together, these efforts will lead to important new technology and evidence that patients, clinicians, and health systems can use to improve care for millions of Americans who suffer from pain and other chronic conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary care patients receiving care at a participating clinic\n* Patients with chronic non-cancer musculoskeletal pain and with a recent history of opioid use\n\nExclusion Criteria:\n\n* Due to the fact that the clinical decision support tool is currently available in English only, non-English speaking patients will not be eligible to participate'}, 'identificationModule': {'nctId': 'NCT05256394', 'acronym': 'IPRO', 'briefTitle': 'Patient-Centered Chronic Pain Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Scaling Interoperable Clinical Decision Support for Patient-Centered Chronic Pain Care', 'orgStudyIdInfo': {'id': 'IRB202101931'}, 'secondaryIdInfos': [{'id': '1R18HS028584-01', 'link': 'https://reporter.nih.gov/quickSearch/1R18HS028584-01', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pain Manager + tailored implementation support Pain Manager', 'description': 'Pain Manager is a decision support tool. All study clinics will begin the trial with Pain Manager integrated and available in their EHR. Consistent with the stepped-wedge design, intensive implementation support (e.g, administrative support, technical support)will be provided to two clinics at once by a multidisciplinary team.', 'interventionNames': ['Behavioral: Pain Manager + tailored implementation support']}, {'type': 'NO_INTERVENTION', 'label': 'Pain Manager implementation in EHR', 'description': 'Pain Manager is a decision support tool. All study clinics will begin the trial with Pain Manager integrated and available in their EHR. The other 6 clinics will have no additional tailor support.'}], 'interventions': [{'name': 'Pain Manager + tailored implementation support', 'type': 'BEHAVIORAL', 'description': 'Individualized training, technical assistance, and workflow assessments.', 'armGroupLabels': ['Pain Manager + tailored implementation support Pain Manager']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32254', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health Family Medicine - Commonwealth', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Christopher Harle, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}