Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care (DIGITS)

Digital Treatments for Opioids and Other Substance Use Disorders (DIGITS) in Primary Care: A Hybrid Type-III Implementation Trial

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.

In 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.

Study Overview

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

Detailed Description

Specific Aims of the DIGITS Trial are to:

1. 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.
2. Compare the population-level cost-effectiveness of each implementation strategy in increasing reach, fidelity, and abstinence.

• Study Type: Interventional
• Enrollment (Estimated): 13000
• Phase: Not Applicable

Contacts and Locations

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

Patient Inclusion Criteria:

• Had a primary care visit in a participating clinic during the active implementation period or sustainment period
• Screened positive for substance use on the day of the visit or in the prior year
• Adult aged 18 years or older at time of visit

Clinic Inclusion Criteria:

- At least 1 clinician trained in the use of reSET/reSET-O

Patient Exclusion Criteria:

- Patients who have requested through their health system to opt out of research

Clinic Exclusion Criteria:

- Previously participated in a pilot implementation of reSET/reSET-O

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Implementation; All primary care clinics will implement reSET and reSET-O using standard implementation approach.	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; 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.	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: 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.
Experimental: Standard Implementation Plus Practice Facilitation; 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.	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; 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.
Experimental: Standard Implementation Plus Health Coaching and Practice Facilitation; 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.	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: 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: Practice Facilitation; 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.

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.	12 months
Fidelity of patients' use of the digital therapeutic to clinical recommendations	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	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement	Mean number of months in which patients make ≥1 visit for substance use disorder	15 months
Economic costs	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.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach-2	The proportion of patients prescribed reSET or reSET-O	12 months
Fidelity-2	Mean number of weeks in which patients use at least 1 module/week	15 months
Sustainment	The proportion of patients who are reached during the sustainment period	12 months
Substance use	The proportion of patients who are reached and reduce their substance use	Up to 18 months from the patients index visit date
Abstinence	The proportion of patients who are reached and are abstinent from substances	Up to 18 months from the patients index visit date

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): December 9, 2021
• Primary Completion (Estimated): March 9, 2024
• Study Completion (Estimated): September 9, 2024

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; primary care; mHealth; implementation science; substance use disorders; factorial trial; opioid use disorders; digital therapeutics
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders; Alcohol-Related Disorders
• Other Study ID Numbers: 1794767; 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