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Prescribe to Save Lives (PTSL)

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ClinicalTrials.gov Identifier: NCT03175640
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The Miriam Hospital
Boston Medical Center
Rhode Island Hospital
Information provided by (Responsible Party):
Peter D. Friedmann, MD, Baystate Medical Center

Brief Summary:
The U.S. is in the midst of an epidemic of opioid overdose deaths. The common use of opioids among persons living with HIV, along with their common use of benzodiazepines, has resulted in high rates of opioid overdose among this population. This study will test the implementation of evidence-based training, mentoring, technical support, and academic detailing to encourage HIV physicians to adopt evidence-based interventions to reduce overdose risk and treat opioid addiction.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug Overdose Behavioral: Implementation intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementation to Motivate Physician Response to Opioid Dependence in HIV Settings
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Implementation intervention Behavioral: Implementation intervention
The implementation intervention includes peer-to-peer training, post-training outreach, proactive expert support, and assistance with addressing environmental barriers.




Primary Outcome Measures :
  1. Change in naloxone prescribing behavior [ Time Frame: baseline to 6 months ]
    Number of clinicians that prescribe naloxone. This information will be collected from electronic medical record (EMR) data.


Secondary Outcome Measures :
  1. Change in perception about pharmacotherapy for opioid use disorder; 6-month [ Time Frame: baseline to 6 months ]
    Opinions About Medication Assisted Treatment (OAMAT) survey

  2. Change in perception about pharmacotherapy for opioid use disorder; 12-month [ Time Frame: baseline to 12 months ]
    Opinions About Medication Assisted Treatment (OAMAT) survey

  3. Change in prescribing motivation; 6 months [ Time Frame: baseline to 6 months ]
    Change in Motivation Scale

  4. Change in prescribing motivation; 12 months [ Time Frame: baseline to 12 months ]
    Change in Motivation Scale

  5. Change in prescriber training [ Time Frame: baseline to 12 months ]
    Number of prescribers that have completed buprenorphine training.

  6. Change in buprenorphine prescribing behavior [ Time Frame: baseline to 12 months ]
    Prevalence of buprenorphine prescription. This information will be collected from EMR data.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinicians and staff of HIV practice sites that:

  • Receive Ryan White Funding;
  • Treat adults with HIV;
  • Have 3 or more prescribing clinicians;
  • Have an electronic medical record (EMR) with an electronic medication list.

Exclusion Criteria:

  • Sites located in states with fewer than 500 Persons Living With HIV (PLWH) will be excluded

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): NCT03175640


Contacts
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Contact: Randall A Hoskinson, Jr. 413-794-7034 randall.hoskinson@baystatehealth.org
Contact: Michelle McKenzie 401-793-4790 mmckenzie@lifespan.org

Locations
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United States, Massachusetts
University of Massachusetts Medical School - Baystate Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Randall A Hoskinson, Jr.    413-794-7034    randall.hoskinson@baystatehealth.org   
Principal Investigator: Peter D Friedmann, MD, MPH         
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Michelle McKenzie    413-793-4790    mmckenzie@lifespan.org   
Principal Investigator: Josiah D RIch, MD, MPH         
Sponsors and Collaborators
Baystate Medical Center
National Institute on Drug Abuse (NIDA)
The Miriam Hospital
Boston Medical Center
Rhode Island Hospital
Investigators
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Principal Investigator: Peter D Friedmann, MD, MPH University of Massachusetts Medical School - Baystate
Principal Investigator: Josiah D Rich, MD, MPH The Miriam Hospital

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Responsible Party: Peter D. Friedmann, MD, Chief Research Officer and Endowed Chair for Clinical Research, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT03175640     History of Changes
Other Study ID Numbers: BH-15-259
R01DA038082 ( U.S. NIH Grant/Contract )
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will make study data available to the community of scientists and the public in keeping with NIDA policies. After all data have been collected and the results of the major papers are in press, de-identified data will be made available to other qualified researchers on request. The request will be evaluated by Dr. Friedmann to ensure that it meets reasonable standards of scientific integrity. Ultimately, it is anticipated that de-identified data and codebooks will be warehoused and available through the ICPSR and SAMHDA websites. This data sharing plan will comply with the requirements of the privacy rule and federal regulations under HIPAA and 42 CFR Part 2 that govern the protection of individually identifiable information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Opioid-Related Disorders
Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders