Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support (OPTI)

San Francisco Veterans Affairs Medical Center

Status and phase: Completed; Phase 1

Conditions: Chronic Pain

Treatments: Behavioral: Motivational Interviewing; Behavioral: Attention Control

Study type: Interventional

Funder types: Other U.S. Federal agency; NIH

Identifiers

NCT02230722

R34AT008319-01 (U.S. NIH Grant/Contract)

13-11892

Details and patient eligibility

About

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.

Full description

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Attention Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Attention Control

Collaborative Care

Experimental group

Description:

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.

Treatment:

Behavioral: Motivational Interviewing