Promoting Medications for Alcohol Use Disorder on the General Medicine Service

Sponsor
Yale University (Other)
Overall Status
Terminated
CT.gov ID
NCT04287790
Collaborator
(none)
67
1
13
5.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: audit and feedback, educational meetings, and academic detailing to promote medication receipt
  • Drug: Acamprosate, naltrexone, or disulfiram

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 Design

Study Type:
Observational
Actual Enrollment :
67 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Promoting Medications for Alcohol Use Disorder on the General Medicine Service at Yale New Haven Hospital: a Pilot Study
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Jun 1, 2020
Actual Study Completion Date :
Feb 1, 2021

Arms and Interventions

Arm 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)

Behavioral: audit and feedback, educational meetings, and academic detailing to promote medication receipt
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

Drug: Acamprosate, naltrexone, or disulfiram
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

    Drug: Acamprosate, naltrexone, or disulfiram
    Increased receipt of medications for alcohol use disorder facilitated by the implementation intervention.
    Other Names:
  • FDA medications for alcohol use disorder
  • Outcome Measures

    Primary Outcome Measures

    1. Before and after intervention change in receipt of medication [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: Administration of intramuscular naltrexone during hospitalization (Y/N) Discharge outpatient prescription of acamprosate (Y/N) Discharge outpatient prescription of naltrexone (Y/N) Discharge outpatient prescription of disulfiram (Y/N)

    Secondary Outcome Measures

    1. Before and after intervention change in 30 day readmission [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

    2. Before and after intervention change in health professional acceptability [December 2019 and July 2020]

      Pre-post Acceptability Rating Profile survey, maximum value 6 and minimum value 1 with higher scores indicating greater acceptability

    3. Before and after intervention change in health professional knowledge [December 2019 and July 2020]

      Pre-post survey adapted Physician Competence in Substance Abuse Test

    4. Before and after intervention change in health professional appropriateness [December 2019 and July 2020]

      Pre-post Parenting Strategies Questionnaire, maximum 6 and minimum 1 with higher scores indicating greater appropriateness

    5. Before and after intervention change in health professional feasibility [December 2019 and July 2020]

      Pre-post Ratings of Threshold Assessment Grid feasibility, maximum 6 and minimum 1 with higher scores indicating greater feasibility

    6. Post intervention acceptability of education materials among health professionals [July 2020]

      Post intervention Manual Acceptability Rating Scale, maximum 3 and minimum 1 with higher scored indicating great acceptability of educational materials

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale School of Medicine New Haven Connecticut United States 06520

    Sponsors and Collaborators

    • Yale University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT04287790
    Other Study ID Numbers:
    • 2000026722
    First Posted:
    Feb 27, 2020
    Last Update Posted:
    May 11, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Yale University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 11, 2022