Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-29 @ 3:58 PM
Study NCT ID:
NCT05160233
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2021-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-10', 'releaseDate': '2025-08-21'}, {'resetDate': '2025-11-05', 'releaseDate': '2025-10-22'}], 'estimatedResultsFirstSubmitDate': '2025-08-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'All outcomes are derived from secondary administrative data.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Cluster-randomized trial with 2x2 factorial randomization of two experimental strategies resulting in four arms: 2x2 factorial design to four approaches: (1) "standard implementation"; (2) "standard implementation plus practice facilitation"; (3) "standard implementation plus health coach"; and (4) "standard implementation plus both.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13000}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2021-12-03', 'studyFirstSubmitQcDate': '2021-12-03', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reach-2', 'timeFrame': '12 months', 'description': 'The proportion of patients prescribed reSET or reSET-O'}, {'measure': 'Fidelity-2', 'timeFrame': '15 months', 'description': 'Mean number of weeks in which patients use at least 1 module/week'}, {'measure': 'Sustainment', 'timeFrame': '12 months', 'description': 'The proportion of patients who are reached during the sustainment period'}, {'measure': 'Substance use', 'timeFrame': 'Up to 18 months from the patients index visit date', 'description': 'The proportion of patients who are reached and reduce their substance use'}, {'measure': 'Abstinence', 'timeFrame': 'Up to 18 months from the patients index visit date', 'description': 'The proportion of patients who are reached and are abstinent from substances'}], 'primaryOutcomes': [{'measure': 'Reach of the digital therapeutic to patients in the primary care clinic', 'timeFrame': '12 months', 'description': 'The proportion of patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module.'}, {'measure': "Fidelity of patients' use of the digital therapeutic to clinical recommendations", 'timeFrame': '15 months', 'description': "Mean number of weeks during patients' 12-week prescription in which patients use 4 app modules/week and have visited a clinician in the past 30 days"}], 'secondaryOutcomes': [{'measure': 'Engagement', 'timeFrame': '15 months', 'description': 'Mean number of months in which patients make ≥1 visit for substance use disorder'}, {'measure': 'Economic costs', 'timeFrame': '12 months', 'description': 'Costs from the perspective of a health system and payer including implementation, direct intervention, operating, and other indirect health care costs. This measure will be used to calculate the population-level cost effectiveness of increasing reach, fidelity, and engagement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['substance use disorders', 'mHealth', 'digital therapeutics', 'primary care', 'implementation science', 'randomized controlled trial', 'factorial trial', 'opioid use disorders'], 'conditions': ['Drug Use Disorders', 'Illicit Drug Use', 'Alcohol-Related Disorders', 'Opioid Use Disorder']}, 'referencesModule': {'references': [{'pmid': '36726127', 'type': 'DERIVED', 'citation': 'Glass JE, Dorsey CN, Beatty T, Bobb JF, Wong ES, Palazzo L, King D, Mogk J, Stefanik-Guizlo K, Idu A, Key D, Fortney JC, Thomas R, McWethy AG, Caldeiro RM, Bradley KA. Study protocol for a factorial-randomized controlled trial evaluating the implementation, costs, effectiveness, and sustainment of digital therapeutics for substance use disorder in primary care (DIGITS Trial). Implement Sci. 2023 Feb 1;18(1):3. doi: 10.1186/s13012-022-01258-9.'}]}, 'descriptionModule': {'briefSummary': 'The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. The DIGITS Trial is a partnership between Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, and Kaiser Permanente Washington, a healthcare delivery system in Washington State.\n\nIn this study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in Kaiser Permanente Washington primary care clinics. The study will evaluate the extent to which two implementation strategy interventions, health coaching and practice coaching, improve the implementation. Primary care clinics are randomized to receive these implementation strategy interventions. Each clinic will have a 12-month active implementation period beginning on its date of randomization. To study the continued use of reSET and reSET-O after the active implementation period is completed, a sustainment period of up 12 months will follow the active implementation period.', 'detailedDescription': 'Specific Aims of the DIGITS Trial are to:\n\n1. Estimate the effect of practice facilitation and health coaching implementation strategies in increasing the reach and fidelity of a digital therapeutic for substance use disorders in primary care clinics.\n2. Compare the population-level cost-effectiveness of each implementation strategy in increasing reach, fidelity, and abstinence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n* Had a primary care visit in a participating clinic during the active implementation period or sustainment period\n* Screened positive for substance use on the day of the visit or in the prior year\n* Adult aged 18 years or older at time of visit\n\nClinic Inclusion Criteria:\n\n\\- At least 1 clinician trained in the use of reSET/reSET-O\n\nPatient Exclusion Criteria:\n\n\\- Patients who have requested through their health system to opt out of research\n\nClinic Exclusion Criteria:\n\n\\- Previously participated in a pilot implementation of reSET/reSET-O'}, 'identificationModule': {'nctId': 'NCT05160233', 'acronym': 'DIGITS', 'briefTitle': 'Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Digital Treatments for Opioids and Other Substance Use Disorders (DIGITS) in Primary Care: A Hybrid Type-III Implementation Trial', 'orgStudyIdInfo': {'id': '1794767'}, 'secondaryIdInfos': [{'id': 'R01DA047954', 'link': 'https://reporter.nih.gov/quickSearch/R01DA047954', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Implementation', 'description': 'All primary care clinics will implement reSET and reSET-O using standard implementation approach.', 'interventionNames': ['Behavioral: Standard implementation']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Implementation Plus Health Coaching', 'description': 'The clinics in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O.', 'interventionNames': ['Behavioral: Standard implementation', 'Behavioral: Health Coaching']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Implementation Plus Practice Facilitation', 'description': 'The clinics in this arm will implement reSET and reSET-O with a standard implementation strategy and a practice facilitator will provide the clinic with support for implementation.', 'interventionNames': ['Behavioral: Standard implementation', 'Behavioral: Practice Facilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Implementation Plus Health Coaching and Practice Facilitation', 'description': 'The clinics in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O. Additionally, a practice facilitator will provide the clinic with support for implementation.', 'interventionNames': ['Behavioral: Standard implementation', 'Behavioral: Health Coaching', 'Behavioral: Practice Facilitation']}], 'interventions': [{'name': 'Standard implementation', 'type': 'BEHAVIORAL', 'description': 'Brief clinician training and an implementation toolkit consisting of job aids, patient educational materials, scripted conversations, electronic health record tools, and a population management workbench.', 'armGroupLabels': ['Standard Implementation', 'Standard Implementation Plus Health Coaching', 'Standard Implementation Plus Health Coaching and Practice Facilitation', 'Standard Implementation Plus Practice Facilitation']}, {'name': 'Health Coaching', 'type': 'BEHAVIORAL', 'description': 'The clinic is provided access to a health coach who conducts outreach with patients. The health coach facilitates engagement with the digital therapeutic and encourages contact with the care team.', 'armGroupLabels': ['Standard Implementation Plus Health Coaching', 'Standard Implementation Plus Health Coaching and Practice Facilitation']}, {'name': 'Practice Facilitation', 'type': 'BEHAVIORAL', 'description': 'A trained facilitator provides support for implementation by delivering the following interventions to clinic staff: Bolster Education, Audit and Provide Feedback, Support Plan-Do-Study-Act Cycles, Engage Others in Change.', 'armGroupLabels': ['Standard Implementation Plus Health Coaching and Practice Facilitation', 'Standard Implementation Plus Practice Facilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Kaiser Permanente Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Joseph E Glass, PhD, MSW', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-21', 'type': 'RELEASE'}, {'date': '2025-09-10', 'type': 'RESET'}, {'date': '2025-10-22', 'type': 'RELEASE'}, {'date': '2025-11-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Kaiser Permanente'}}}}