Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support (OPTI)

• ClinicalTrials.gov Identifier: NCT02230722
• Recruitment Status: Completed
• First Posted: September 3, 2014
• Last Update Posted: July 2, 2017
• Sponsor: San Francisco Veterans Affairs Medical Center
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Karen Seal, San Francisco Veterans Affairs Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Behavioral: Motivational Interviewing; Behavioral: Attention Control	Phase 1

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support
• Study Start Date: November 2014
• Actual Primary Completion Date: June 12, 2017
• Actual Study Completion Date: June 12, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Behavioral: Attention Control
Experimental: Collaborative Care; 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.	Behavioral: Motivational Interviewing

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

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. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

San Francisco VA Medical Center

San Francisco, California, United States, 94121

Sponsors and Collaborators

San Francisco Veterans Affairs Medical Center

National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Karen Seal, MD, MPH; SFVAMC

More Information

Additional Information:

Veterans Return Home Research Group 

Publications:

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.

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.

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.

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.

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.

• Responsible Party: Karen Seal, Principal Investigator, San Francisco Veterans Affairs Medical Center
• ClinicalTrials.gov Identifier: NCT02230722 History of Changes
• Other Study ID Numbers: 13-11892; R34AT008319-01 ( U.S. NIH Grant/Contract )
• First Posted: September 3, 2014
• Last Update Posted: July 2, 2017
• Last Verified: June 2017

Keywords provided by Karen Seal, San Francisco Veterans Affairs Medical Center:

opioids; chronic pain; collaborative care

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents