Promoting Medications for Alcohol Use Disorder on the General Medicine Service

May 9, 2022 updated by: Yale University

Promoting Medications for Alcohol Use Disorder on the General Medicine Service at Yale New Haven Hospital: a Pilot Study

Medications for Alcohol use disorder (MAUD) (acamprosate, naltrexone, and disulfiram) remain underutilized despite guideline recommendations and rising alcohol-related morbidity and mortality. Alcohol use disorder (AUD)-related hospitalizations are opportunities to initiate MAUD, but optimal implementation strategies are unclear. We will complete a 6 month pilot implementation intervention involving audit and feedback, educational meetings, and academic detailing for health professionals at Yale New Haven Hospital to determine the impact on: 1) health professional satisfaction with intervention components, 2) health professional knowledge and attitudes about medications for alcohol use disorder, 3) receipt of medication among hospitalized patients diagnosed with an alcohol use disorder and 4) 30 day readmission among hospitalized patients with alcohol use disorder. Health professional satisfaction and knowledge with be assessed using a pre-post design and receipt of medications and 30 day readmission will be assessed using a interrupted time series design. We hypothesize health professional knowledge and attitudes about MAUD will be greater after the pilot intervention compared to before. We hypothesize receipt of MAUD will be greater after the pilot intervention compared to before. We hypothesize 30 day readmission will be less after the pilot intervention compared to before.

Study Overview

Detailed Description

Medications for Alcohol use disorder (MAUD) (acamprosate, naltrexone, and disulfiram) remain underutilized despite guideline recommendations and rising alcohol-related morbidity and mortality. Alcohol use disorder (AUD)-related hospitalizations are opportunities to initiate MAUD, but optimal implementation strategies are unclear. We will complete a 6 month pilot implementation intervention involving audit and feedback, educational meetings, and academic detailing for health professionals at Yale New Haven Hospital (YNHH) to determine the impact on: 1) health professional satisfaction with intervention components, 2) health professional knowledge and attitudes about medications for alcohol use disorder, 3) receipt of medication among hospitalized patients diagnosed with an alcohol use disorder and 4) 30 day readmission among hospitalized patients with alcohol use disorder. Health professional satisfaction and knowledge with be assessed using a pre-post design and receipt of medications and 30 day readmission will be assessed using a interrupted time series design. We hypothesize health professional knowledge and attitudes of MAUD will be greater after the pilot intervention compared to before. We hypothesize receipt of MAUD will be greater after the pilot intervention compared to before. We hypothesize 30 day readmission will be less after the pilot intervention compared to before.

Population and setting for implementation intervention:

Health professionals (physicians, advanced practice providers, pharmacists, social workers, and nurses) who work on the designated general medicine services (9-5, 4-6 and 4-7) at Yale New Haven Hospital.

Implementation intervention:

Our implementation intervention will incorporate the following strategies: 1) Formation of an alcohol-related care working group. This voluntary working group will consist of members of the research team and volunteer health professionals from YNHH. The group with supervise and support the other intervention components. 2) We will develop medication for alcohol use disorder marketing (posters and buttons) materials and educational (pamphlet) materials and distribute these materials to health professionals. 3) Building on the existing infrastructure and collaboration, the research team will assist in revising existing alcohol-related care daily monitoring systems to support auditing and feedback on the adoption of medications for alcohol use disorder at YNHH. 4) The research team will hold educational meetings and educational outreach visits (academic detailing) when invited during regular noon conferences and team meetings.

Health professional outcomes: health professional satisfaction and knowledge Using the pre-post design, data collection will consist of two surveys. One survey will assess health professional knowledge and attitudes about MAUD at baseline and then again at 6 months post intervention. A follow up survey will assess health professional satisfaction with the intervention components collected following educational events and at 6 months post intervention.

Patients with AUD outcomes: receipt of medication among hospitalized patients diagnosed with an alcohol use disorder (primary outcome) and 30 day readmission among patient with alcohol use disorder. Using an interrupted time series design, data will be obtained from Epic electronic medical record at Yale New Haven Hospital in partnership with the Joint Data Analytics Team (JDAT) to whom we will submit our formal data request. Patients discharged from the general medicine service at Yale New Haven Hospital York street campus following hospitalization for an alcohol related diagnosis 18 months before and 12 months after the start (January 1st 2020) of the implementation intervention.

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Health professionals (physicians, advanced practice providers, pharmacists, social workers, and nurses) who work on the 9-5, 4-6 and 4-7 general medicine services at Yale New Haven Hospital. The intervention will be conducted on 9-5, 4-6 and 4-7 general medicine services at Yale New Haven Hospital.

Description

Inclusion Criteria:

  • Health professionals (physicians, advanced practice providers, pharmacists, social workers, and nurses) who work on the 9-5, 4-6 and 4-7 general medicine services at Yale New Haven Hospital. The intervention will be conducted on 9-5, 4-6 and 4-7 general medicine services at Yale New Haven Hospital.

Exclusion Criteria:

  • Physicians trainees (student, residents, and fellows) will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Health professionals after intervention
Health professionals (physicians, advanced practice providers, pharmacists, social workers, and nurses) who work on the designated general medicine services at Yale New Haven Hospital after implementation intervention (July 2020)
Our implementation intervention will incorporate the following strategies: 1) Formation of an alcohol-related care working group. This voluntary working group will consist of members of the research team and volunteer health professionals from YNHH. The group with supervise and support the other intervention components. 2) We will develop medication for alcohol use disorder marketing (posters and buttons) materials and educational (pamphlet) materials and distribute these materials to health professionals. 3) Building on the existing infrastructure and collaboration, the research team will assist in revising existing alcohol-related care daily monitoring systems to support auditing and feedback on the adoption of medications for alcohol use disorder at YNHH. 4) The research team will hold educational meetings and educational outreach visits (academic detailing) when invited during regular noon conferences and team meetings.
Hospitalized patient before intervention
Patients discharged from the general medicine service at Yale New Haven Hospital York street campus following hospitalization for an alcohol related diagnosis 18 months before the start (January 1st 2020) of the implementation intervention
Increased receipt of medications for alcohol use disorder facilitated by the implementation intervention.
Other Names:
  • FDA medications for alcohol use disorder
Health professionals before intervention
Health professionals (physicians, advanced practice providers, pharmacists, social workers, and nurses) who work on the designated general medicine services at Yale New Haven Hospital after implementation intervention (December 2019)
Hospitalized patient after intervention
Patients discharged from the general medicine service at Yale New Haven Hospital York street campus following hospitalization for an alcohol related diagnosis 12 months after the start (January 1st 2020) of the implementation intervention
Increased receipt of medications for alcohol use disorder facilitated by the implementation intervention.
Other Names:
  • FDA medications for alcohol use disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Before and after intervention change in receipt of medication
Time Frame: 18 months before and 12 months after the start (January 1st 2020) of the implementation intervention

receipt of medication among hospitalized patients diagnosed with an alcohol use disorder (patients discharged from the general medicine service at Yale New Haven Hospital York street campus following hospitalization for an alcohol related diagnosis) The primary outcome, receipt of medication, can occur with any of four events:

  1. Administration of intramuscular naltrexone during hospitalization (Y/N)
  2. Discharge outpatient prescription of acamprosate (Y/N)
  3. Discharge outpatient prescription of naltrexone (Y/N)
  4. Discharge outpatient prescription of disulfiram (Y/N)
18 months before and 12 months after the start (January 1st 2020) of the implementation intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Before and after intervention change in 30 day readmission
Time Frame: 18 months before and 12 months after the start (January 1st 2020) of the implementation intervention
30 day readmission (Y/N) among hospitalized patients with alcohol use disorder. Patients discharged from the general medicine service at Yale New Haven Hospital York street campus following hospitalization for an alcohol related diagnosis
18 months before and 12 months after the start (January 1st 2020) of the implementation intervention
Before and after intervention change in health professional acceptability
Time Frame: December 2019 and July 2020
Pre-post Acceptability Rating Profile survey, maximum value 6 and minimum value 1 with higher scores indicating greater acceptability
December 2019 and July 2020
Before and after intervention change in health professional knowledge
Time Frame: December 2019 and July 2020
Pre-post survey adapted Physician Competence in Substance Abuse Test
December 2019 and July 2020
Before and after intervention change in health professional appropriateness
Time Frame: December 2019 and July 2020
Pre-post Parenting Strategies Questionnaire, maximum 6 and minimum 1 with higher scores indicating greater appropriateness
December 2019 and July 2020
Before and after intervention change in health professional feasibility
Time Frame: December 2019 and July 2020
Pre-post Ratings of Threshold Assessment Grid feasibility, maximum 6 and minimum 1 with higher scores indicating greater feasibility
December 2019 and July 2020
Post intervention acceptability of education materials among health professionals
Time Frame: July 2020
Post intervention Manual Acceptability Rating Scale, maximum 3 and minimum 1 with higher scored indicating great acceptability of educational materials
July 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Paul J Joudrey, MD MPH, Yale School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alcohol Use Disorder

Clinical Trials on audit and feedback, educational meetings, and academic detailing to promote medication receipt

3
Subscribe