PTSL: Prescribe to Save Lives

• Sponsor: Baystate Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03175640
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), The Miriam Hospital (Other), Boston Medical Center (Other), Rhode Island Hospital (Other)
• Enrollment: 294
• Locations: 2
• Arm: 1
• Actual Duration (Months): 29.6
• Patients Per Site: 147
• Patients Per Site Per Month: 5

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 294 participants
• Allocation: N/A
• 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: Jul 12, 2017
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in naloxone prescribing behavior [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 [baseline to 6 months]

   Opinions About Medication Assisted Treatment (OAMAT) survey

2. Change in perception about pharmacotherapy for opioid use disorder; 12-month [baseline to 12 months]

   Opinions About Medication Assisted Treatment (OAMAT) survey

3. Change in prescribing motivation; 6 months [baseline to 6 months]

   Change in Motivation Scale

4. Change in prescribing motivation; 12 months [baseline to 12 months]

   Change in Motivation Scale

5. Change in prescriber training [baseline to 12 months]

   Number of prescribers that have completed buprenorphine training.

6. Change in buprenorphine prescribing behavior [baseline to 12 months]

   Prevalence of buprenorphine prescription. This information will be collected from EMR data.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Massachusetts Medical School - Baystate	Springfield	Massachusetts	United States	01199
2	The Miriam Hospital	Providence	Rhode Island	United States	02906

Sponsors and Collaborators

• Baystate Medical Center
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Friedmann, Chief Research Officer and Endowed Chair for Clinical Research, Baystate Medical Center
• ClinicalTrials.gov Identifier: NCT03175640
• Other Study ID Numbers: BH-15-259; R01DA038082
• First Posted: Jun 5, 2017
• Last Update Posted: Dec 21, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Opioid-Related Disorders; Drug Overdose

Study Results

No Results Posted as of Dec 21, 2020