Clinical Decision Support for Opioid Use Disorders in Medical Settings (COMPUTE 2.0)

NCT04198428 | Completed Results DMC

• 2 other identifiers: CTN - 0095UG1DA040316
• Study Type: interventional
• Target: 10,891
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (4)

• Number of Patients With OUD Diagnosis

  Patient has an ICD10 diagnosis code for OUD assigned at an encounter or added to the problem list

  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

  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

  Index visit date through 30 days post-index, inclusive.

• Days Covered by MOUD Prescription

  The sum of unique days covered by a MOUD order

  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

  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

  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

  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.

  index visit through one year post-index, inclusive

• Overdoses Per 100 Patient-years.

  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.

Study Arms (2)

Receives OUD-CDS

EXPERIMENTAL

Clinics will have access to the OUD-CDS (Opioid Wizard)

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.

Interventions

Opioid Wizard OTHER

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).

Receives OUD-CDS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• HealthPartners Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator
• The Emmes Company, LLC: collaborator
• Hennepin Healthcare Research Institute: collaborator
• Geisinger Clinic: collaborator
• Essentia Health: collaborator

Study Sites (3)

HealthPartners

Bloomington, Minnesota, 55425, United States

Location

Essentia Health

Duluth, Minnesota, 55805, United States

Location

Geisinger

Danville, Pennsylvania, 17822-4400, United States

Location

Related Publications (3)

• 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.

  PMID: 40658392 DERIVED

• Olson 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.

  PMID: 39773800 DERIVED

• Olson 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.

  PMID: 38756745 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Rebecca Rossom, Co-Principal Investigator
• Organization: HealthPartners Institute

Rebecca.C.Rossom@HealthPartners.com

952-883-5466

Study Officials

• Gavin Bart, MD PhD FACP DFASAM

  Hennepin Healthcare

  PRINCIPAL INVESTIGATOR

• Rebecca Rossom, MD, MSCR

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 13, 2019
• Study Start: November 12, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 2, 2025
• Results First Posted: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)