Drug Use DisordersDIGITS PilotNCT04907045
An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care
A study testing Health Coaching, Practice Facilitation and Standard Implementation 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. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement. 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?
- Health Coaching, Practice Facilitation and Standard Implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,552 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2021to 4 Dec 2023
- 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
Who may be able to join
- Had a primary care visit in a participating clinic during the pilot
- Screened positive for substance use
- Adult aged 18 years or older at time of visit
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington
Seattle, Washington, 98101
About this study
Official title: Digital Therapeutics for Opioids and Other Substance Use Disorders in Primary Care Pilot (DIGITS Trial Pilot)
The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement. The pilot is comprised of a 3-month period in which a standard approach to implementing reSET and reSET-O is applied in the two primary care clinics "standard implementation", followed by a second 3-month period in which the study will test and refine the two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing) in the same clinics. This study will also pilot economic data collection tools and collect qualitative data for a formative evaluation. The analytic goals are to inform the statistical design and data collection processes for the subsequent cluster-randomized DIGITS Trial.
- Being tested
- Health Coaching, Practice Facilitation, Standard Implementation
- Keywords
- Implementation Science, Mobile Applications, Drug Use Disorders, Quality Improvement, Primary Health Care
- Medical subject headings
- Substance-Related Disorders, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
In the context of a supportive relationship, a trained facilitator delivers the following interventions to clinic staff: Bolster Education, Audit and Provide Feedback, Support Plan-Do-Study-Act Cycles, Engage Others in Change.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Implementation Plus Health Coaching | Experimental | The clinic 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: Health Coaching; Behavioral: Standard Implementation |
| Standard Implementation Plus Health Coaching and Practice Facilitation | Experimental | The clinic 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: Health Coaching; Behavioral: Practice Facilitation; Behavioral: Standard Implementation |
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
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
Measured: 6 months
Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations
Mean number of weeks in which patients use 4 app modules/week and have visited a clinician in the past month
Measured: 9 months
Secondary outcomes (1)
Effectiveness
Mean number of months in which patients make monthly visits for substance use disorder
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start6 May 2021
- Primary completion4 Dec 2023
- Study completion4 Dec 2023
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 (1)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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized parallel groups pilot study to evaluate intervention delivery, data collection, and analysis procedures. Two primary care clinics will implement the reSET and reSET-O digital therapeutics for substance use disorders. There will be one clinic per arm in this pilot study. Implementation strategies will be varied across arms.
- Masking
- None (open label)
- Enrolment
- 1,552 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, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907045
- Sponsor's protocol ID
- 218046
- Other IDs
- R01DA047954
- Acronym
- DIGITS Pilot
- Status last verified
- Jul 2025
- First submitted
- 25 May 2021
- Last updated
- 6 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mogk 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 39222348
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Therapeutics for Opioids and Other Substance Use Disorders in Primary Care Pilot (DIGITS Trial Pilot)
- ClinicalTrials.gov ID
- NCT04907045
- Acronym / sponsor ID
- DIGITS Pilot / 218046
- Keywords
- Implementation Science, Mobile Applications, Drug Use Disorders, Quality Improvement, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,552 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 May 2021 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Posted 6 Aug 2025
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. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement. The pilot is comprised of a 3-month period in which a standard approach to implementing reSET and reSET-O is applied in the two primary care clinics "standard implementation", followed by a second 3-month period in which the study will test and refine the two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing) in the same clinics. This study will also pilot economic data collection tools and collect qualitative data for a formative evaluation. The analytic goals are to inform the statistical design and data collection processes for the subsequent cluster-randomized DIGITS Trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized parallel groups pilot study to evaluate intervention delivery, data collection, and analysis procedures. Two primary care clinics will implement the reSET and reSET-O digital therapeutics for substance use disorders. There will be one clinic per arm in this pilot study. Implementation strategies will be varied across arms.
| Arm | Type | Receives |
|---|---|---|
| Standard Implementation Plus Health Coaching | Experimental | Behavioral: Health Coaching, Behavioral: Standard ImplementationThe clinic 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 Health Coaching and Practice Facilitation | Experimental | Behavioral: Health Coaching, Behavioral: Practice Facilitation, Behavioral: Standard ImplementationThe clinic 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
Key inclusion criteria (3 listed)
- Had a primary care visit in a participating clinic during the pilot
- Screened positive for substance use
- Adult aged 18 years or older at time of visit
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| 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 FacilitationIn the context of a supportive relationship, a trained facilitator delivers 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 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 Plus Health Coaching, Standard Implementation Plus Health Coaching and Practice Facilitation |
Primary outcome
Reach of the Digital Therapeutic to Patients in the Primary Care Clinic
Time frame: 6 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
Time frame: 9 months
Mean number of weeks in which patients use 4 app modules/week and have visited a clinician in the past month
1 secondary outcome
Effectiveness
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Individual participant dataSharing planned: No
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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
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching, Practice Facilitation and Standard Implementation 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?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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 6 Aug 2025. 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 6 Aug 2025). 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: 6 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 NCT04907045, which also lists 1 linked publication.
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 6 Aug 2025.