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

Opioid Use Disorder Clinical Trial

— DIGITS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05160233
• Other study ID #: 1794767
• Secondary ID: R01DA047954
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 9, 2021
• Est. completion date: September 9, 2024

Study information

• Verified date: December 2023
• 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13000
• Est. completion date: September 9, 2024
• Est. primary completion date: March 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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
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.

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	12 months
Other	Fidelity-2	Mean number of weeks in which patients use at least 1 module/week	15 months
Other	Sustainment	The proportion of patients who are reached during the sustainment period	12 months
Other	Substance use	The proportion of patients who are reached and reduce their substance use	Up to 18 months from the patients index visit date
Other	Abstinence	The proportion of patients who are reached and are abstinent from substances	Up to 18 months from the patients index visit date
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.	12 months
Primary	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	Engagement	Mean number of months in which patients make =1 visit for substance use disorder	15 months
Secondary	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