Prescribe to Save Lives (PTSL)

Implementation to Motivate Physician Response to Opioid Dependence in HIV Settings

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.

Study Overview

• Status: Completed
• Conditions: Opioid-Related Disorders; Drug Overdose
• Intervention / Treatment: Behavioral: Implementation intervention

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • University of Massachusetts Medical School - Baystate
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in naloxone prescribing behavior	Number of clinicians that prescribe naloxone. This information will be collected from electronic medical record (EMR) data.	baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perception about pharmacotherapy for opioid use disorder; 6-month	Opinions About Medication Assisted Treatment (OAMAT) survey	baseline to 6 months
Change in perception about pharmacotherapy for opioid use disorder; 12-month	Opinions About Medication Assisted Treatment (OAMAT) survey	baseline to 12 months
Change in prescribing motivation; 6 months	Change in Motivation Scale	baseline to 6 months
Change in prescribing motivation; 12 months	Change in Motivation Scale	baseline to 12 months
Change in prescriber training	Number of prescribers that have completed buprenorphine training.	baseline to 12 months
Change in buprenorphine prescribing behavior	Prevalence of buprenorphine prescription. This information will be collected from EMR data.	baseline to 12 months

Collaborators and Investigators

• Sponsor: Baystate Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA); The Miriam Hospital; Boston Medical Center; Rhode Island Hospital
• Investigators: Principal Investigator: Peter D Friedmann, MD, MPH, University of Massachusetts Medical School - Baystate; Principal Investigator: Josiah D Rich, MD, MPH, The Miriam Hospital

Publications and helpful links

General Publications

• Jawa R, Walley AY, Wilson DJ, Green TC, McKenzie M, Hoskinson R Jr, Bratberg J, Ramsey S, Rich JD, Friedmann PD. Prescribe to Save Lives: Improving Buprenorphine Prescribing Among HIV Clinicians. J Acquir Immune Defic Syndr. 2022 Aug 15;90(5):546-552. doi: 10.1097/QAI.0000000000003001.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Drug Overdose
• Other Study ID Numbers: BH-15-259; R01DA038082 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No