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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Attention Control
Sponsored by
San Francisco Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring opioids, chronic pain, collaborative care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Francisco VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Attention Control

Collaborative Care

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 25, 2014
Last Updated
June 29, 2017
Sponsor
San Francisco Veterans Affairs Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02230722
Brief Title
Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support
Acronym
OPTI
Official Title
Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 12, 2017 (Actual)
Study Completion Date
June 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Francisco Veterans Affairs Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
opioids, chronic pain, collaborative care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Collaborative Care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Primary Outcome Measure Information:
Title
To evaluate the feasibility, acceptability, and usability of augmenting ATHENA-OT decision support with a Collaborative Care intervention.
Description
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.
Time Frame
20 weeks post baseline
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
20 weeks post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Seal, MD, MPH
Organizational Affiliation
SFVAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21083382
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. No abstract available. Erratum In: N Engl J Med. 2011 Jan 20;364(3):290.
Results Reference
background
PubMed Identifier
21332934
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.
Results Reference
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PubMed Identifier
19718704
Citation
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.
Results Reference
background
PubMed Identifier
21430623
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. No abstract available.
Results Reference
background
PubMed Identifier
22396516
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.
Results Reference
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Links:
URL
http://vetsreturnhome.com/index.html
Description
Veterans Return Home Research Group

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Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support

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