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

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

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

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



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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230722


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

Additional Information:
Publications:
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    Key Record Dates
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:
Central Nervous System Depressants
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Narcotics
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents