Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support
- Conditions
- Chronic Pain
- Registration Number
- NCT02230722
- Lead Sponsor
- San Francisco Veterans Affairs Medical Center
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the feasibility, acceptability, and usability of augmenting ATHENA-OT decision support with a Collaborative Care intervention. 20 weeks post baseline * 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.
- Secondary Outcome Measures
Name Time Method 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. 20 weeks post baseline 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.
Trial Locations
- Locations (1)
San Francisco VA Medical Center
🇺🇸San Francisco, California, United States
San Francisco VA Medical Center🇺🇸San Francisco, California, United States