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Clinical Trials/NCT02230722
NCT02230722
Completed
Phase 1

Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support

San Francisco Veterans Affairs Medical Center1 site in 1 country100 target enrollmentNovember 2014
ConditionsChronic Pain

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
San Francisco Veterans Affairs Medical Center
Enrollment
100
Locations
1
Primary Endpoint
To evaluate the feasibility, acceptability, and usability of augmenting ATHENA-OT decision support with a Collaborative Care intervention.
Status
Completed
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
June 12, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
San Francisco Veterans Affairs Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Karen Seal

Principal Investigator

San Francisco Veterans Affairs Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

To evaluate the feasibility, acceptability, and usability of augmenting ATHENA-OT decision support with a Collaborative Care intervention.

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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