Clinical trial NCT05160233: Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care
Official title: Digital Treatments for Opioids and Other Substance Use Disorders (DIGITS) in Primary Care: A Hybrid Type-III Implementation Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Drug Use Disorders
Illicit Drug Use
Alcohol-Related Disorders
Opioid Use Disorder
Keywords: substance use disorders
mHealth
digital therapeutics
primary care
implementation science
randomized controlled trial
factorial trial
opioid use disorders
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-12-16
Enrollment: 13000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reach of the digital therapeutic to patients in the primary care clinic
timeFrame: 12 months
measure: Fidelity of patients' use of the digital therapeutic to clinical recommendations
timeFrame: 15 months
Secondary outcomes:
measure: Engagement
timeFrame: 15 months
measure: Economic costs
timeFrame: 12 months
Other outcomes:
measure: Reach-2
timeFrame: 12 months
measure: Fidelity-2
timeFrame: 15 months
measure: Sustainment
timeFrame: 12 months
measure: Substance use
timeFrame: Up to 18 months from the patients index visit date
measure: Abstinence
timeFrame: Up to 18 months from the patients index visit date
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Joseph E Glass, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References: