An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care (DIGITS Pilot)

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

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 study will test and refine the two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing). 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol-Related Disorders; Drug Use Disorders; Illicit Drug Use
• Intervention / Treatment: Behavioral: Health Coaching; Behavioral: Standard Implementation; Behavioral: Practice Facilitation

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph E Glass, PhD, MSW; Phone Number: 206-287-4266; Email: joseph.e.glass@kp.org
• Study Contact Backup: Name: Tara C Beatty, MA; Phone Number: 206-442-4012; Email: tara.c.beatty@kp.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Kaiser Permanente Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Implementation Plus Health Coaching; The clinic 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.	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.; Behavioral: 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.
Experimental: Standard Implementation Plus Health Coaching and Practice Facilitation; The clinic 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.	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.; Behavioral: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness	Mean number of months in which patients make monthly visits for substance use disorder	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach-2	The proportion of patients prescribed reSET or reSET-O	3 months
Reach-3	The proportion of patients who download and unlock reSET or reSET-O	3 months
Fidelity-2	Mean number of weeks in which patients use at least 1 module/week	6 months
Fidelity-3	Mean number of weeks in which patients use at least 4 modules/week	6 months
Adoption	The proportion of other healthcare providers initiating a patient on reSET or reSET-O, overall and by provider type	3 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Joseph E Glass, PhD, MSW, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Actual): April 29, 2022
• Study Completion (Estimated): July 9, 2024

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Primary Health Care; Implementation Science; Quality Improvement; Drug Use Disorders; Mobile Applications
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Alcohol-Related Disorders
• Other Study ID Numbers: 218046; R01DA047954 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No