Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-06-12

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.

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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

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Attention Control

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.

Group Type ACTIVE_COMPARATOR

Attention Control

Intervention Type BEHAVIORAL

Collaborative Care

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.

Group Type EXPERIMENTAL

Motivational Interviewing

Intervention Type BEHAVIORAL

Interventions

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Motivational Interviewing

Intervention Type BEHAVIORAL

Attention Control

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No