Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support
- Conditions
- Chronic Pain
- Interventions
- Behavioral: Attention ControlBehavioral: Motivational Interviewing
- 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
- Arm && Interventions
Group Intervention Description Attention Control 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. Collaborative Care Motivational Interviewing 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.
- 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