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

• ClinicalTrials.gov Identifier: NCT04198428
• Recruitment Status: Completed
• First Posted: December 13, 2019
• Last Update Posted: March 8, 2024
• Sponsor: HealthPartners Institute
• Collaborators: National Institute on Drug Abuse (NIDA); The Emmes Company, LLC; Hennepin Healthcare Research Institute; Geisinger Clinic; Essentia Health
• Information provided by (Responsible Party): HealthPartners Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Opioid-use Disorder	Other: Opioid Wizard	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10898 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Clinic-Randomized Trial of Clinical Decision Support for Opioid Use Disorders in Medical Settings (COMPUTE 2.0)
• Actual Study Start Date: November 12, 2019
• Actual Primary Completion Date: December 31, 2023
• Actual Study Completion Date: December 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Receives OUD-CDS; Clinics will have access to the OUD-CDS (Opioid Wizard)	Other: Opioid Wizard; 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).
No Intervention: Does not Receive the OUD-CDS; Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.

Outcome Measures

Primary Outcome Measures :

1. Calculate differences in rates of OUD diagnosis [ Time Frame: This will be calculated at the end of the study, approximately month 53 ]
   Patients previously undiagnosed with OUD but identified as high risk by the OUD-CDS at an index visit have a higher rate of OUD diagnosis (in the problem list or as an ICD-10 visit code) in intervention clinics when compared to UC clinics within 30 days post-index.
2. Calculate differences in rate of naloxone rescue kit ordering [ Time Frame: This will be calculated at the end of the study, approximately month 53 ]
   Patients previously diagnosed with OUD or identified as high risk by the OUD-CDS at an index visit will have a higher proportion of naloxone rescue kits ordered in the intervention clinics when compared to the UC clinics within 30 days post-index.
3. Calculate differences in rate of MOUD orders or referrals [ Time Frame: This will be calculated at the end of the study, approximately month 53 ]
   Patients identified as having OUD or as being at high-risk for OUD by the OUD-CDS at an index visit will have a higher rate of MOUD orders or referral for OUD treatment within 30 days post-index in intervention clinics when compared to UC clinics.
4. Calculate differences in average days covered by MOUD prescription [ Time Frame: This will be calculated at the end of the study, approximately month 53 ]
   Patients identified as having OUD or as being at high-risk for OUD by the OUD-CDS at an index visit will have significantly more days covered by a MOUD prescription at 90 days post-index in intervention clinics when compared to UC clinics.A generalized linear mixed model will compare the average number of covered days among patients in intervention relative to control clinics

Secondary Outcome Measures :

1. Difference between number of Emergency Department visits for intervention and control patients [ Time Frame: This will be calculated at the end of the study, approximately month 53 ]
   Patients with OUD or identified as high-risk for OUD by the OUD-CDS who are cared for in intervention clinics will have significantly fewer post-index ED visits during the observation period (i.e., the period between each patient's index date and last observation) compared to patients cared for in UC clinics.
2. Differences in the number of hospitalizations for intervention and control patients [ Time Frame: This will be calculated at the end of the study, approximately month 53 ]
   Patients with OUD or identified as high-risk for OUD by the OUD-CDS who are cared for in intervention clinics will have significantly fewer post-index hospitalizations during the observation period (i.e., the period between each patient's index date and last observation) compared to patients cared for in UC clinics.
3. Intervention patients will have lower healthcare compared to patients from usual care clinics [ Time Frame: This will be calculated at the end of the study, approximately month 53 ]
   After controlling for demographics, baseline clinical status and prior costs of care, patients with OUD or identified as high risk for OUD by the OUD-CDS will have lower healthcare costs in intervention clinics compared to UC clinics during the observation period (i.e., savings from lower ED visits and hospitalizations will outweigh increased costs of OUD treatment and naloxone rescue kits and OUD-CDS implementation and maintenance). Healthcare costs will be calculated for each patient using outpatient, inpatient, emergency, and pharmacy utilization and then compared between intervention and control groups.
4. Comparing all-cause mortality rates between intervention and control clinic patients [ Time Frame: This will be calculated at the end of the study, approximately month 53 ]
   Comparing rates of of all-cause death among patients with OUD or identified as high-risk for OUD cared for in intervention clinics during the intervention period compared to similar patients in UC clinics during the observation period.
5. Comparing rates of fatal and non-fatal overdoses between intervention and control clinic patients [ Time Frame: This will be calculated at the end of the study, approximately month 53 ]
   Among patients with OUD or identified as high-risk for OUD, we will calculate rates of fatal and non-fatal overdoses in patients cared for in intervention clinics and compare to the rates for similar patients in the usual care clinics during the intervention period

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, Minnesota

HealthPartners

Bloomington, Minnesota, United States, 55425

Essentia Health

Duluth, Minnesota, United States, 55805

United States, Pennsylvania

Geisinger

Danville, Pennsylvania, United States, 17822-4400

Sponsors and Collaborators

HealthPartners Institute

National Institute on Drug Abuse (NIDA)

The Emmes Company, LLC

Hennepin Healthcare Research Institute

Geisinger Clinic

Essentia Health

  Study Documents (Full-Text)

Documents provided by HealthPartners Institute:

Study Protocol and Statistical Analysis Plan  [PDF] March 31, 2023

More Information

• Responsible Party: HealthPartners Institute
• ClinicalTrials.gov Identifier: NCT04198428
• Other Study ID Numbers: CTN - 0095; UG1DA040316 ( U.S. NIH Grant/Contract )
• First Posted: December 13, 2019
• Last Update Posted: March 8, 2024
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Opioid-Related Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents