Drug Use DisordersDIGITSNCT05160233
Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care
A study testing Standard implementation, Health Coaching and Practice Facilitation in people with Drug Use Disorders and Illicit Drug Use, run by Kaiser Permanente at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Use Disorders, Illicit Drug Use, Alcohol-Related Disorders
- What is being tested?
- Standard implementation, Health Coaching and Practice Facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,430 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2021to 27 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington
Seattle, Washington, 98101
About this study
Official title: 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.
Read the 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.
- Being tested
- Standard implementation, Health Coaching, Practice Facilitation
- Keywords
- substance use disorders, mHealth, digital therapeutics, primary care, implementation science, randomized controlled trial, factorial trial, opioid use disorders
- Medical subject headings
- Substance-Related Disorders, Alcohol-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard implementationBehavioural
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 CoachingBehavioural
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 FacilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Implementation | Active comparator | All primary care clinics will implement reSET and reSET-O using standard implementation approach. Receives: Behavioral: Standard implementation |
| Standard Implementation Plus Health Coaching | Experimental | 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. Receives: Behavioral: Standard implementation; Behavioral: Health Coaching |
| Standard Implementation Plus Practice Facilitation | Experimental | 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. Receives: Behavioral: Standard implementation; Behavioral: Practice Facilitation |
| Standard Implementation Plus Health Coaching and Practice Facilitation | Experimental | 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. Receives: Behavioral: Standard implementation; Behavioral: Health Coaching; Behavioral: Practice Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach of the Digital Therapeutic to Patients in the Primary Care Clinic
Patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module. The measure is reported as the number of patients reached per 10,000 patients, calculated at a clinic level.
Measured: 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. This measure is reported as the number of patient weeks per 10,000 patients, calculated at a clinic level.
For each patient, to identify whether a week was one with fidelity, we identify each patient's reSET activation date and examine for module use during the following 12 weeks. Possible followup for all patients in a clinic extends up to 15 months after the clinic's start date (allowing 12 months for active implementation plus an additional 12 weeks to examine fidelity for patients who are reached on the last day of active implementation).
Measured: 15 months
Secondary outcomes (2)
Engagement
Mean number of months in which patients make ≥1 visit for substance use disorder.
This measure is reported as the number of patient month per 10,000 patients, calculated at a clinic level.
For each patient, to identify whether a month was one with engagement, we identify each patient's reSET activation date and examine for module use during the following 3 months. Possible followup for all patients in a clinic extends up to 15 months after the clinic's start date (allowing 12 months for active implementation plus an additional 3 months to examine engagement for patients who are reached on the last day of active implementation).
Measured: 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. We calculated costs incurred during all 37 months of the trial period, plus costs incurred during the 13 months prior to the trial period.
Measured: 37 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start9 Dec 2021
- Primary completion22 Aug 2024
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Drug Use DisordersStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18,430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Joseph E Glass, PhD, MSW, Principal investigator, Chestnut Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160233
- Sponsor's protocol ID
- 1794767
- Other IDs
- R01DA047954
- Acronym
- DIGITS
- Status last verified
- Mar 2026
- First submitted
- 3 Dec 2021
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data were collected with a waiver of informed consent, some of the collected data is protected by 42 CFR part 2 regulations, participants in the study are from a vulnerable population.
Publications
Xie CX, Toader AM, De Simoni A, Eldridge S, Glass JE, Pinnock H, Relton C. Impact of using routine healthcare data on the efficiency of implementation trials: a qualitative comparative case study. Trials. 2026 Apr 11;27(1):373. doi: 10.1186/s13063-026-09706-3.
PubMed 41965800Wong ES, Dorsey CN, Beatty TC, Bobb JF, Stefanik-Guizlo K, Key DL, Ramaprasan A, Idu AE, Fortney JC, Mogk J, Palazzo L, Caldeiro RM, King D, McWethy AG, Glass JE. Economic cost of strategic implementation approaches to increase uptake of digital therapeutics for substance use disorders in a large integrated health system. PLOS Digit Health. 2026 Jan 8;5(1):e0001145. doi: 10.1371/journal.pdig.0001145. eCollection 2026 Jan.
PubMed 41505485Mogk J, Idu AE, Bobb JF, Key D, Wong ES, Palazzo L, Stefanik-Guizlo K, King D, Beatty T, Dorsey CN, Caldeiro RM, Garza McWethy A, Glass JE. Prescription Digital Therapeutics for Substance Use Disorder in Primary Care: Mixed Methods Evaluation of a Pilot Implementation Study. JMIR Form Res. 2024 Sep 2;8:e59088. doi: 10.2196/59088.
PubMed 39222348Glass JE, Dorsey CN, Beatty T, Bobb JF, Wong ES, Palazzo L, King D, Mogk J, Stefanik-Guizlo K, Idu A, Key D, Fortney JC, Thomas R, McWethy AG, Caldeiro RM, Bradley KA. Study protocol for a factorial-randomized controlled trial evaluating the implementation, costs, effectiveness, and sustainment of digital therapeutics for substance use disorder in primary care (DIGITS Trial). Implement Sci. 2023 Feb 1;18(1):3. doi: 10.1186/s13012-022-01258-9.
PubMed 36726127
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Treatments for Opioids and Other Substance Use Disorders (DIGITS) in Primary Care: A Hybrid Type-III Implementation Trial
- ClinicalTrials.gov ID
- NCT05160233
- Acronym / sponsor ID
- DIGITS / 1794767
- Keywords
- substance use disorders, mHealth, digital therapeutics, primary care, implementation science, randomized controlled trial, factorial trial, opioid use disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,430 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Posted 8 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Implementation | Active comparator | Behavioral: Standard implementationAll primary care clinics will implement reSET and reSET-O using standard implementation approach. |
| Standard Implementation Plus Health Coaching | Experimental | Behavioral: Standard implementation, Behavioral: Health CoachingThe 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. |
| Standard Implementation Plus Practice Facilitation | Experimental | Behavioral: Standard implementation, Behavioral: Practice FacilitationThe 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. |
| Standard Implementation Plus Health Coaching and Practice Facilitation | Experimental | Behavioral: Standard implementation, Behavioral: Health Coaching, Behavioral: Practice FacilitationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard implementationBrief clinician training and an implementation toolkit consisting of job aids, patient educational materials, scripted conversations, electronic health record tools, and a population management workbench. | Behavioural | Standard Implementation, Standard Implementation Plus Health Coaching, Standard Implementation Plus Health Coaching and Practice Facilitation, Standard Implementation Plus Practice Facilitation |
| Health CoachingThe 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. | Behavioural | Standard Implementation Plus Health Coaching, Standard Implementation Plus Health Coaching and Practice Facilitation |
| Practice FacilitationA 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. | Behavioural | Standard Implementation Plus Health Coaching and Practice Facilitation, Standard Implementation Plus Practice Facilitation |
Primary outcome
Reach of the Digital Therapeutic to Patients in the Primary Care Clinic
Time frame: 12 months
Patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module. The measure is reported as the number of patients reached per 10,000 patients, calculated at a clinic level.
Fidelity of Patients' Use of the Digital Therapeutic to Clinical Recommendations
Time frame: 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. This measure is reported as the number of patient weeks per 10,000 patients, calculated at a clinic level. For each patient, to identify whether a week was one with fidelity, we identify each patient's reSET activation date and examine for module use during the following 12 weeks. Possible followup for all patients in a clinic extends up to 15 months after the clinic's start date (allowing 12 months for active implementation plus an additional 12 weeks to examine fidelity for patients who are reached on the last day of active implementation).
2 secondary outcomes
Engagement
Time frame: 15 months
Economic Costs
Time frame: 37 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41965800Xie CX, Toader AM, De Simoni A, Eldridge S, Glass JE, Pinnock H, Relton C. Impact of using routine healthcare data on the efficiency of implementation trials: a qualitative comparative case study. Trials. 2026 Apr 11;27(1):373. doi: 10.1186/s13063-026-09706-3.
- Derived from this study: PubMed 41505485Wong ES, Dorsey CN, Beatty TC, Bobb JF, Stefanik-Guizlo K, Key DL, Ramaprasan A, Idu AE, Fortney JC, Mogk J, Palazzo L, Caldeiro RM, King D, McWethy AG, Glass JE. Economic cost of strategic implementation approaches to increase uptake of digital therapeutics for substance use disorders in a large integrated health system. PLOS Digit Health. 2026 Jan 8;5(1):e0001145. doi: 10.1371/journal.pdig.0001145. eCollection 2026 Jan.
- Derived from this study: PubMed 39222348Mogk J, Idu AE, Bobb JF, Key D, Wong ES, Palazzo L, Stefanik-Guizlo K, King D, Beatty T, Dorsey CN, Caldeiro RM, Garza McWethy A, Glass JE. Prescription Digital Therapeutics for Substance Use Disorder in Primary Care: Mixed Methods Evaluation of a Pilot Implementation Study. JMIR Form Res. 2024 Sep 2;8:e59088. doi: 10.2196/59088.
- Derived from this study: PubMed 36726127Glass JE, Dorsey CN, Beatty T, Bobb JF, Wong ES, Palazzo L, King D, Mogk J, Stefanik-Guizlo K, Idu A, Key D, Fortney JC, Thomas R, McWethy AG, Caldeiro RM, Bradley KA. Study protocol for a factorial-randomized controlled trial evaluating the implementation, costs, effectiveness, and sustainment of digital therapeutics for substance use disorder in primary care (DIGITS Trial). Implement Sci. 2023 Feb 1;18(1):3. doi: 10.1186/s13012-022-01258-9.
- Individual participant dataSharing planned: No. Study data were collected with a waiver of informed consent, some of the collected data is protected by 42 CFR part 2 regulations, participants in the study are from a vulnerable population.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph E Glass, PhD, MSW principal investigator
Chestnut Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard implementation, Health Coaching and Practice Facilitation in people with Drug Use Disorders and Illicit Drug Use, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach of the Digital Therapeutic to Patients in the Primary Care Clinic (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05160233, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.