An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care

Alcohol-Related Disorders Clinical Trial

— DIGITS Pilot  

Official title:

Digital Therapeutics for Opioids and Other Substance Use Disorders in Primary Care Pilot (DIGITS Trial Pilot)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04907045
• Other study ID #: 218046
• Secondary ID: R01DA047954
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Drug Use Disorders
• Illicit Drug Use
• Substance-Related Disorders

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