Opioid-use DisorderNCT04198428
Clinical Decision Support for Opioid Use Disorders in Medical Settings (COMPUTE 2.0)
A study testing Opioid Wizard in people with Opioid-use Disorder, run by HealthPartners Institute at 3 sites in United States.
Trial summary
Through CTN-0076-Ot (Clinical Decision Support for Opioid Use Disorders in Medical Settings: Pilot Usability Testing in an EMR (COMPUTE)), our team has iteratively developed and piloted a web-based and electronic health record (EHR)-integrated Opioid Use Disorder (OUD) Clinical Decision Support (CDS) system to offer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Opioid Wizard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,891 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Nov 2019to 31 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be aged 18-75 years, inclusive, at the time of an index visit;
- have been diagnosed with OUD, currently prescribed MOUD, or identified by study algorithms as being at high risk of OUD.
- Be a patient at a study randomized clinic
Who cannot join
- those receiving active parenteral chemotherapy within the last year,
- those with stage 4 or equivalent cancer diagnosis
- those enrolled in hospice care or palliative care programs.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
HealthPartners
Bloomington, Minnesota, 55425
Geisinger
Danville, Pennsylvania, 17822-4400
Essentia Health
Duluth, Minnesota, 55805
About this study
Official title: Clinic-Randomized Trial of Clinical Decision Support for Opioid Use Disorders in Medical Settings (COMPUTE 2.0)
Through CTN-0076-Ot (Clinical Decision Support for Opioid Use Disorders in Medical Settings: Pilot Usability Testing in an EMR (COMPUTE)), our team has iteratively developed and piloted a web-based and electronic health record (EHR)-integrated Opioid Use Disorder (OUD) Clinical Decision Support (CDS) system to offer expert guidance to primary care providers (PCPs) on the diagnosis and management of OUD. The OUD-CDS has been implemented within the EPIC EHR of one large care system and was piloted with 55 providers to ensure content validity and provider satisfaction. The team will now implement this OUD-CDS in a large multi-site clinic-randomized controlled trial to evaluate its impact on practice process measures and patient outcomes. The investigators also aim to prepare for scalability (i.e., integration into usual primary care practice after the study is complete) and dissemination by evaluating facilitators and barriers to implementation, determining the costs of implementation and maintenance, and assessing the short-term cost impacts of the OUD-CDS.
The study will include three large diverse care systems and randomize a minimum of 30 clinics to receive the OUD-CDS intervention or usual care (UC). In intervention clinics, the OUD-CDS will identify patients who are at high risk for OUD or diagnosed with OUD; use data stored in the EHR for each eligible patient to assemble treatment recommendations tailored to each patient's current needs; display these recommendations to PCPs via the OUD-CDS user interface; and store analytic data from all targeted visits. In UC clinics, the OUD-CDS will run invisibly in the background to identify high-risk or OUD patients, assemble treatment recommendations tailored to each eligible patient's needs, and store analytic data from all targeted visits.
Read the detailed description
The proposed study will include 3 large diverse healthcare systems and randomize a minimum of 30 clinics equally within each system to receive the OUD-CDS intervention or UC. In intervention and UC clinics, the OUD-CDS will identify study-eligible patients, those who are at high risk for OUD or diagnosed with OUD; and will use data stored in the EHR to assemble treatment recommendations tailored to the needs of each study-eligible patient. In intervention clinics, these treatment recommendations will be displayed via the OUD-CDS user interface. Finally, data from all targeted visits in all randomized clinics will be stored in a data repository for analysis and reporting needs. The targeted visits for each study-eligible patient in all randomized clinics will be the index visit, the first visit at which the OUD-CDS identifies that the patient is study eligible, and all post-index visits through the end of the intervention period, regardless of continued eligibility. This pragmatic cluster-randomized design is the optimal design to effectively and efficiently implement this tool in primary care clinics while protecting against study contamination and allowing for collection of process and outcome data at UC clinics.
Mixed Methods Approach: Virtually every evidence-based intervention in medicine has turned out to be difficult to implement and maintain in real life practice and to fall far short of fidelity to the process used in randomized trials. As a result, a whole new field of dissemination and implementation research has been developing over the last 20 years. These studies have now gone well beyond the previous paradigm of focusing on changing the attitudes and behaviors of individual physicians to a growing awareness that the need instead is to alter the environment in which physicians work so that it is easier to do the desired evidence-based thing than to stick with old established habit patterns. That means focusing change efforts on organizational factors and practice systems. The Solberg conceptual framework has proven to be particularly helpful in clarifying this new approach.
Simultaneously, there has been increasing interest in transitioning effectiveness clinical trials from traditionally highly selective and controlled circumstances to pragmatic trials that make use of normal care delivery processes and patients.[35] The measurement of such trials has been facilitated by the development of a conceptual framework called RE-AIM, an acronym for 5 key facets of such studies - Reach, Effectiveness, Adoption, Implementation, and Maintenance. Recently, the developers of RE-AIM have recognized the need for more flexible use of this framework, greater use of qualitative methods to understand why interventions are not used consistently, and making adaptations in the implementation approach based on such understandings. The investigators propose to use the RE-AIM framework to guide (1) a monitoring system for intervention problems, (2) a mixed methods evaluation of the reasons for those problems, and (3) modification of the intervention to reduce those problems. These steps will be reiterated in a cyclic fashion, resulting in a more sophisticated approach to the long-standing quality improvement emphasis on Plan-Do-Study-Act rapid cycle tests of change. Furthermore, the team will take advantage of the staggered implementation of the study through three different care systems to ensure that the solutions for intervention problems in Site 1 are not assumed to be the same as the approach in subsequent sites without further RE-AIM monitoring and evaluation.
- Conditions
- Opioid-use Disorder
- Being tested
- Opioid Wizard
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid WizardOther
The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
| Study group | Role | What they receive |
|---|---|---|
| Receives OUD-CDS | Experimental | Clinics will have access to the OUD-CDS (Opioid Wizard) Receives: Other: Opioid Wizard |
| Does not Receive the OUD-CDS | No intervention | Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With OUD Diagnosis
Patient has an ICD10 diagnosis code for OUD assigned at an encounter or added to the problem list
Measured: Index visit date through 30 days post-index, inclusive.
Number of Patients With Naloxone Rescue Kit Order
Patient has a medication order for a naloxone rescue kit
Measured: Index visit date through 30 days post-index, inclusive.
Number of Patients With a MOUD Order or Referral
Patient has a medication order for a MOUD or referral for addiction treatment
Measured: Index visit date through 30 days post-index, inclusive.
Days Covered by MOUD Prescription
The sum of unique days covered by a MOUD order
Measured: Index visit date through 90 days post-index, inclusive, with 0 days assigned if there were no MOUD orders.
Secondary outcomes (5)
Emergency Department Visits Per Patient-year
Measured: pre: one year through one day prior to the index visit; post: index visit through one year post-index or date of death, whichever was first.
Hospitalizations Per Patient-year
Measured: pre: one year through one day prior to the index visit; post: index visit through one year post-index or date of death, whichever was first.
Healthcare Costs
Healthcare costs for prescribed medications and clinical inpatient, emergency, and outpatient services incurred, as documented in insurance claims or clinical encounter data.
Measured: pre: one year through one day prior to the index visit; post: index visit through one year post-index or date of death, whichever was first.
All-cause Mortality Per 100 Patient-years.
Measured: index visit through one year post-index, inclusive
Overdoses Per 100 Patient-years.
Measured: pre: one year through one day prior to the index visit; post: index visit through one year post-index or date of death, whichever was first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start12 Nov 2019
- Primary completion31 Dec 2023
- Study completion31 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 (3)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,891 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC, Hennepin Healthcare Research Institute, Geisinger Clinic, Essentia Health
- Responsible party
- Sponsor
- Investigators
- Gavin Bart, MD PhD FACP DFASAM, Principal investigator, Hennepin HealthcareRebecca Rossom, MD, MSCR, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198428
- Sponsor's protocol ID
- CTN - 0095
- Other IDs
- UG1DA040316
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2019
- Last updated
- 2 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rossom RC, Crain AL, Wright EA, Olson AW, Haller I, Haapala J, Dehmer SP, Hooker SA, Solberg L, O'Connor PJ, Borgert-Spaniol C, Gorodisher J, Miley K, Romagnoli K, Allen C, Tusing L, Ekstrom H, Appana D, Sperl-Hillen JM, Kobylinski M, Huntley K, McCormack J, Chen W, Bart G. Clinical Decision Support System for Primary Care of Opioid Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2025 Sep 1;185(9):1079-1089. doi: 10.1001/jamainternmed.2025.2535.
PubMed 40658392Olson AW, Bucaloiu A, Allen CI, Tusing LD, Henzler-Buckingham HA, Gregor CM, Freitag LA, Hooker SA, Rossom RC, Solberg LI, Wright EA, Haller IV, Romagnoli KM. 'Do they care?': a qualitative examination of patient perspectives on primary care clinician communication related to opioids in the USA. BMJ Open. 2025 Jan 7;15(1):e090462. doi: 10.1136/bmjopen-2024-090462.
PubMed 39773800Olson AW, Haapala JL, Hooker SA, Solberg LI, Borgert-Spaniol CM, Romagnoli KM, Allen CI, Tusing LD, Wright EA, Haller IV, Rossom RC. The potential impact of clinical decision support on nonwaivered primary care clinicians' prescribing of buprenorphine. Health Aff Sch. 2023 Oct 11;1(4):qxad051. doi: 10.1093/haschl/qxad051. eCollection 2023 Oct.
PubMed 38756745
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic-Randomized Trial of Clinical Decision Support for Opioid Use Disorders in Medical Settings (COMPUTE 2.0)
- ClinicalTrials.gov ID
- NCT04198428
- Acronym / sponsor ID
- CTN - 0095
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,891 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC, Hennepin Healthcare Research Institute, Geisinger Clinic, Essentia Health
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Posted 2 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Through CTN-0076-Ot (Clinical Decision Support for Opioid Use Disorders in Medical Settings: Pilot Usability Testing in an EMR (COMPUTE)), our team has iteratively developed and piloted a web-based and electronic health record (EHR)-integrated Opioid Use Disorder (OUD) Clinical Decision Support (CDS) system to offer expert guidance to primary care providers (PCPs) on the diagnosis and management of OUD. The OUD-CDS has been implemented within the EPIC EHR of one large care system and was piloted with 55 providers to ensure content validity and provider satisfaction. The team will now implement this OUD-CDS in a large multi-site clinic-randomized controlled trial to evaluate its impact on practice process measures and patient outcomes. The investigators also aim to prepare for scalability (i.e., integration into usual primary care practice after the study is complete) and dissemination by evaluating facilitators and barriers to implementation, determining the costs of implementation and maintenance, and assessing the short-term cost impacts of the OUD-CDS.
The study will include three large diverse care systems and randomize a minimum of 30 clinics to receive the OUD-CDS intervention or usual care (UC). In intervention clinics, the OUD-CDS will identify patients who are at high risk for OUD or diagnosed with OUD; use data stored in the EHR for each eligible patient to assemble treatment recommendations tailored to each patient's current needs; display these recommendations to PCPs via the OUD-CDS user interface; and store analytic data from all targeted visits. In UC clinics, the OUD-CDS will run invisibly in the background to identify high-risk or OUD patients, assemble treatment recommendations tailored to each eligible patient's needs, and store analytic data from all targeted visits.
Detailed description
The proposed study will include 3 large diverse healthcare systems and randomize a minimum of 30 clinics equally within each system to receive the OUD-CDS intervention or UC. In intervention and UC clinics, the OUD-CDS will identify study-eligible patients, those who are at high risk for OUD or diagnosed with OUD; and will use data stored in the EHR to assemble treatment recommendations tailored to the needs of each study-eligible patient. In intervention clinics, these treatment recommendations will be displayed via the OUD-CDS user interface. Finally, data from all targeted visits in all randomized clinics will be stored in a data repository for analysis and reporting needs. The targeted visits for each study-eligible patient in all randomized clinics will be the index visit, the first visit at which the OUD-CDS identifies that the patient is study eligible, and all post-index visits through the end of the intervention period, regardless of continued eligibility. This pragmatic cluster-randomized design is the optimal design to effectively and efficiently implement this tool in primary care clinics while protecting against study contamination and allowing for collection of process and outcome data at UC clinics.
Mixed Methods Approach: Virtually every evidence-based intervention in medicine has turned out to be difficult to implement and maintain in real life practice and to fall far short of fidelity to the process used in randomized trials. As a result, a whole new field of dissemination and implementation research has been developing over the last 20 years. These studies have now gone well beyond the previous paradigm of focusing on changing the attitudes and behaviors of individual physicians to a growing awareness that the need instead is to alter the environment in which physicians work so that it is easier to do the desired evidence-based thing than to stick with old established habit patterns. That means focusing change efforts on organizational factors and practice systems. The Solberg conceptual framework has proven to be particularly helpful in clarifying this new approach.
Simultaneously, there has been increasing interest in transitioning effectiveness clinical trials from traditionally highly selective and controlled circumstances to pragmatic trials that make use of normal care delivery processes and patients.[35] The measurement of such trials has been facilitated by the development of a conceptual framework called RE-AIM, an acronym for 5 key facets of such studies - Reach, Effectiveness, Adoption, Implementation, and Maintenance. Recently, the developers of RE-AIM have recognized the need for more flexible use of this framework, greater use of qualitative methods to understand why interventions are not used consistently, and making adaptations in the implementation approach based on such understandings. The investigators propose to use the RE-AIM framework to guide (1) a monitoring system for intervention problems, (2) a mixed methods evaluation of the reasons for those problems, and (3) modification of the intervention to reduce those problems. These steps will be reiterated in a cyclic fashion, resulting in a more sophisticated approach to the long-standing quality improvement emphasis on Plan-Do-Study-Act rapid cycle tests of change. Furthermore, the team will take advantage of the staggered implementation of the study through three different care systems to ensure that the solutions for intervention problems in Site 1 are not assumed to be the same as the approach in subsequent sites without further RE-AIM monitoring and evaluation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receives OUD-CDS | Experimental | Other: Opioid WizardClinics will have access to the OUD-CDS (Opioid Wizard) |
| Does not Receive the OUD-CDS | No intervention | –Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be aged 18-75 years, inclusive, at the time of an index visit;
- have been diagnosed with OUD, currently prescribed MOUD, or identified by study algorithms as being at high risk of OUD.
- Be a patient at a study randomized clinic
Key exclusion criteria (3 listed)
- those receiving active parenteral chemotherapy within the last year,
- those with stage 4 or equivalent cancer diagnosis
- those enrolled in hospice care or palliative care programs.
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 |
|---|---|---|
| Opioid WizardThe Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate). | Other | Receives OUD-CDS |
Primary outcome
Number of Patients With OUD Diagnosis
Time frame: Index visit date through 30 days post-index, inclusive.
Patient has an ICD10 diagnosis code for OUD assigned at an encounter or added to the problem list
Number of Patients With Naloxone Rescue Kit Order
Time frame: Index visit date through 30 days post-index, inclusive.
Patient has a medication order for a naloxone rescue kit
Number of Patients With a MOUD Order or Referral
Time frame: Index visit date through 30 days post-index, inclusive.
Patient has a medication order for a MOUD or referral for addiction treatment
Days Covered by MOUD Prescription
Time frame: Index visit date through 90 days post-index, inclusive, with 0 days assigned if there were no MOUD orders.
The sum of unique days covered by a MOUD order
5 secondary outcomes
Emergency Department Visits Per Patient-year
Time frame: pre: one year through one day prior to the index visit; post: index visit through one year post-index or date of death, whichever was first.
Hospitalizations Per Patient-year
Time frame: pre: one year through one day prior to the index visit; post: index visit through one year post-index or date of death, whichever was first.
Healthcare Costs
Time frame: pre: one year through one day prior to the index visit; post: index visit through one year post-index or date of death, whichever was first.
All-cause Mortality Per 100 Patient-years.
Time frame: index visit through one year post-index, inclusive
Overdoses Per 100 Patient-years.
Time frame: pre: one year through one day prior to the index visit; post: index visit through one year post-index or date of death, whichever was first.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40658392Rossom RC, Crain AL, Wright EA, Olson AW, Haller I, Haapala J, Dehmer SP, Hooker SA, Solberg L, O'Connor PJ, Borgert-Spaniol C, Gorodisher J, Miley K, Romagnoli K, Allen C, Tusing L, Ekstrom H, Appana D, Sperl-Hillen JM, Kobylinski M, Huntley K, McCormack J, Chen W, Bart G. Clinical Decision Support System for Primary Care of Opioid Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2025 Sep 1;185(9):1079-1089. doi: 10.1001/jamainternmed.2025.2535.
- Derived from this study: PubMed 39773800Olson AW, Bucaloiu A, Allen CI, Tusing LD, Henzler-Buckingham HA, Gregor CM, Freitag LA, Hooker SA, Rossom RC, Solberg LI, Wright EA, Haller IV, Romagnoli KM. 'Do they care?': a qualitative examination of patient perspectives on primary care clinician communication related to opioids in the USA. BMJ Open. 2025 Jan 7;15(1):e090462. doi: 10.1136/bmjopen-2024-090462.
- Derived from this study: PubMed 38756745Olson AW, Haapala JL, Hooker SA, Solberg LI, Borgert-Spaniol CM, Romagnoli KM, Allen CI, Tusing LD, Wright EA, Haller IV, Rossom RC. The potential impact of clinical decision support on nonwaivered primary care clinicians' prescribing of buprenorphine. Health Aff Sch. 2023 Oct 11;1(4):qxad051. doi: 10.1093/haschl/qxad051. eCollection 2023 Oct.
- 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.
Gavin Bart, MD PhD FACP DFASAM principal investigator
Hennepin Healthcare
Rebecca Rossom, MD, MSCR principal investigator
HealthPartners Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Wizard in people with Opioid-use Disorder, run by HealthPartners Institute at 3 sites 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 3 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 Oct 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?
Number of Patients With OUD Diagnosis (time frame: Index visit date through 30 days post-index, inclusive.). The study lists 4 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 NCT04198428, which also lists 3 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 2 Oct 2025.