Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support
OPTI
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 chronic-pain
Started Nov 2014
Typical duration for phase_1 chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2014
CompletedFirst Posted
Study publicly available on registry
September 3, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2017
CompletedJuly 2, 2017
June 1, 2017
2.6 years
August 25, 2014
June 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the feasibility, acceptability, and usability of augmenting ATHENA-OT decision support with a Collaborative Care intervention.
* 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.
20 weeks post baseline
Secondary Outcomes (1)
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 Arms (2)
Attention Control
ACTIVE COMPARATORThe 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
EXPERIMENTALCollaborative 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco VA Medical Center
San Francisco, California, 94121, United States
Related Publications (5)
Okie S. A flood of opioids, a rising tide of deaths. N Engl J Med. 2010 Nov 18;363(21):1981-5. doi: 10.1056/NEJMp1011512. No abstract available.
PMID: 21083382BACKGROUNDPaulozzi LJ, Kilbourne EM, Desai HA. Prescription drug monitoring programs and death rates from drug overdose. Pain Med. 2011 May;12(5):747-54. doi: 10.1111/j.1526-4637.2011.01062.x. Epub 2011 Feb 18.
PMID: 21332934BACKGROUNDBoudreau D, Von Korff M, Rutter CM, Saunders K, Ray GT, Sullivan MD, Campbell CI, Merrill JO, Silverberg MJ, Banta-Green C, Weisner C. Trends in long-term opioid therapy for chronic non-cancer pain. Pharmacoepidemiol Drug Saf. 2009 Dec;18(12):1166-75. doi: 10.1002/pds.1833.
PMID: 19718704BACKGROUNDPaulozzi LJ; Centers for Disease Control and Prevention (CDC). Drug-induced deaths - United States, 2003-2007. MMWR Suppl. 2011 Jan 14;60(1):60-1. No abstract available.
PMID: 21430623BACKGROUNDSeal KH, Shi Y, Cohen G, Cohen BE, Maguen S, Krebs EE, Neylan TC. Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan. JAMA. 2012 Mar 7;307(9):940-7. doi: 10.1001/jama.2012.234.
PMID: 22396516BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Seal, MD, MPH
SFVAMC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 25, 2014
First Posted
September 3, 2014
Study Start
November 1, 2014
Primary Completion
June 12, 2017
Study Completion
June 12, 2017
Last Updated
July 2, 2017
Record last verified: 2017-06