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

Sponsor

Kaiser Permanente (Other)

Overall Status

Recruiting

CT.gov ID

NCT05160233

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

13,000

Enrollment

Location

Arms

Anticipated Duration (Months)

419.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Drug Use Disorders Illicit Drug Use Alcohol-Related Disorders Opioid Use Disorder	Behavioral: Standard implementation Behavioral: Health Coaching Behavioral: Practice Facilitation	N/A

Detailed Description

Specific Aims of the DIGITS Trial are to:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

13000 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

All outcomes are derived from secondary administrative data.

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Dec 9, 2021

Anticipated Primary Completion Date :

Mar 9, 2023

Anticipated Study Completion Date :

Jul 9, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Reach of the digital therapeutic to patients in the primary care clinic [12 months]
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.
Fidelity of patients' use of the digital therapeutic to clinical recommendations [15 months]
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

Secondary Outcome Measures

Engagement [15 months]
Mean number of months in which patients make ≥1 visit for substance use disorder
Economic costs [12 months]
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.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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