Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support

Chronic Pain Clinical Trial

— OPTI  

Official title:

Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230722
• Other study ID #: 13-11892
• Secondary ID: R34AT008319-01
• Status: Completed
• Phase: Phase 1
• First received: August 25, 2014
• Last updated: June 29, 2017
• Start date: November 2014
• Est. completion date: June 12, 2017

Study information

• Verified date: June 2017
• Source: San Francisco Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 12, 2017
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Motivational Interviewing

• Attention Control

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
San Francisco Veterans Affairs Medical Center	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Boudreau 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. — View Citation

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. Erratum in: N Engl J Med. 2011 Jan 20;364(3):290. — View Citation

Paulozzi 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. — View Citation

Paulozzi LJ; Centers for Disease Control and Prevention (CDC). Drug-induced deaths - United States, 2003-2007. MMWR Suppl. 2011 Jan 14;60(1):60-1. — View Citation

Seal 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. Erratum in: JAMA. 2012 Jun 20;307(23):2489. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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.	20 weeks post baseline

External Links

•   Veterans Return Home Research Group