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Trial record 47 of 1598 for:    veterans affairs medical center

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

Tracking Information
First Submitted Date  ICMJE August 25, 2014
First Posted Date  ICMJE September 3, 2014
Last Update Posted Date July 2, 2017
Study Start Date  ICMJE November 2014
Actual Primary Completion Date June 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02230722 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support
Official Title  ICMJE Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Behavioral: Motivational Interviewing
  • Behavioral: Attention Control
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Motivational Interviewing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2017)
100
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2014)
120
Actual Study Completion Date  ICMJE June 12, 2017
Actual Primary Completion Date June 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02230722
Other Study ID Numbers  ICMJE 13-11892
R34AT008319-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karen Seal, San Francisco Veterans Affairs Medical Center
Study Sponsor  ICMJE San Francisco Veterans Affairs Medical Center
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Karen Seal, MD, MPH SFVAMC
PRS Account San Francisco Veterans Affairs Medical Center
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP