Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support

Study Overview
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Brief Summary
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The investigators propose to develop a novel intervention that targets the system (Collaborative Care), PCP (computerized decision support for opioid therapy) and veteran (CM-delivered MI) to reduce problematic prescription opioid use and encourage non-opioid pain management alternatives.

Detailed Description
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The investigators will develop and test the acceptability, feasibility, and preliminary efficacy of a Collaborative Care intervention in which one of two Care Managers delivering both interventions will assist primary care providers (PCPs) by using Motivational Interviewing to communicate computer-based ATHENA-OT (opioid therapy) decision support guidelines to veterans with chronic pain. Specifically, after honing the intervention, the investigators will conduct a pilot randomized controlled trial of Collaborative Care/Motivational Interviewing in 100 veterans (ages 18 and older) with chronic pain in primary care who are prescribed opioid pain medications and exhibit at least one high-risk opioid use behavior (e.g. obtaining early opioid refills, etc.). Using ATHENA-OT decision support, PCPs will make guideline-concordant recommendations to all enrolled study patients and initiate a Pain Care Plan. Veterans randomized to Collaborative Care, will have one MI session with their assigned study Care Manager followed by 3 Care Manager-delivered telephone MI/monitoring sessions; patients randomized to the Attention Control arm will have one brief session with their assigned Care Manager, followed by 3 Care Manager-delivered neutral telephone sessions

Official Title
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Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Motivational Interviewing
* Behavioral: Attention Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current Male or Female patient at San Francisco VA Medical Center or affiliated VA clinics Must be older than 18 years Chronic musculoskeletal pain of at least 6 months duration and Prescribed one or more opioid pain medication for more than three months and Evidence of being a high-risk opioid user as determined by PI, electronic medical record, and study measures Exclusion Criteria: Non-English speakers Plans to relocate within 6 months; not able to come to San Francisco VA Medical Center for three in-person visits Cancer or other terminal illness involving palliative care with opioid medications Serious or untreated mental illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Attention Control<br>The neutral 10-15 minute visit with the Care Manager will consist of a brief review of ATHENA-OT safety education and the patient's Pain Care Plan. The CM will answer patient questions, but will avoid using Motivational Interviewing communication. The Care Manager will review upcoming telephone check-in and assessment sessions. | Behavioral: Attention Control<br> <br> |
| Experimental: Collaborative Care<br>Collaborative Care intervention in which one of two Care Managers delivering both interventions will assist primary care providers (PCPs) by using Motivational Interviewing to communicate computer-based ATHENA-OT (opioid therapy) decision support guidelines to veterans with chronic pain. | Behavioral: Motivational Interviewing<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the feasibility, acceptability, and usability of augmenting ATHENA-OT decision support with a Collaborative Care intervention. | PCPs and the CM in the Collaborative Care arm will report greater self-efficacy in communicating ATHENA-OT pain management recommendations and in developing a Pain Care Plan with chronic pain patients The CM will conduct MI communication with high fidelity. Veterans in the Collaborative Care arm will report greater satisfaction with pain-related care. | 20 weeks post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To preliminarily evaluate the efficacy of ATHENA-OT decision support plus Collaborative Care (CC) to improve prescription opioid safety and adherence to non-opioid pain management alternatives among primary care patients. | Compared to ATHENA-OT plus Attention Control: H2.a. Veterans randomized to Collaborative Care (CC) will be more likely to achieve a decrease in opioid risk behavior that is sustained during an 8-week post-intervention period of no contact. H2.b. Veterans randomized to CC are more likely to initiate and sustain ≥ 1 non-opioid strategies. H2.c. Veterans randomized to CC are more likely to report sustained improvements in pain disability. H2.d. Substance use disorders and treatment will moderate CC efficacy; Care Manager MI-consistent communication in the CC arm will correlate with reduced opioid risk behavior in veterans. | 20 weeks post baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioids, chronic pain, collaborative care