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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04907045
Other study ID # 218046
Secondary ID R01DA047954
Status Completed
Phase N/A
First received
Last updated
Start date May 6, 2021
Est. completion date December 4, 2023

Study information

Verified date May 2024
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement. The pilot is comprised of a 3-month period in which a standard approach to implementing reSET and reSET-O is applied in the two primary care clinics "standard implementation", followed by a second 3-month period in which the study will test and refine the two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing) in the same clinics. This study will also pilot economic data collection tools and collect qualitative data for a formative evaluation. The analytic goals are to inform the statistical design and data collection processes for the subsequent cluster-randomized DIGITS Trial.


Recruitment information / eligibility

Status Completed
Enrollment 1552
Est. completion date December 4, 2023
Est. primary completion date December 4, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Had a primary care visit in a participating clinic during the pilot - Screened positive for substance use - Adult aged 18 years or older at time of visit Exclusion Criteria: - None

Study Design


Intervention

Behavioral:
Health Coaching
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.
Practice Facilitation
In the context of a supportive relationship, a trained facilitator delivers the following interventions to clinic staff: Bolster Education, Audit and Provide Feedback, Support Plan-Do-Study-Act Cycles, Engage Others in Change.
Standard Implementation
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.

Locations

Country Name City State
United States Kaiser Permanente Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Kaiser Permanente National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Reach-2 The proportion of patients prescribed reSET or reSET-O 6 months
Other Reach-3 The proportion of patients who download and unlock reSET or reSET-O 6 months
Other Fidelity-2 Mean number of weeks in which patients use at least 1 module/week 9 months
Other Fidelity-3 Mean number of weeks in which patients use at least 4 modules/week 9 months
Other Adoption The proportion of other healthcare providers initiating a patient on reSET or reSET-O, overall and by provider type 6 months
Primary Reach of the digital therapeutic to patients in the primary care clinic 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 6 months
Primary Fidelity of patients use of the digital therapeutic to clinical recommendations Mean number of weeks in which patients use 4 app modules/week and have visited a clinician in the past month 9 months
Secondary Effectiveness Mean number of months in which patients make monthly visits for substance use disorder 9 months
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