Promoting Medications for Alcohol Use Disorder on the General Medicine Service

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04287790
• Other study ID #: 2000026722
• Status: Terminated
• Start date: January 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: May 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: February 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Disease

Intervention

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.

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

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Before and after intervention change in receipt of medication	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)	18 months before and 12 months after the start (January 1st 2020) of the implementation intervention
Secondary	Before and after intervention change in 30 day readmission	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
Secondary	Before and after intervention change in health professional acceptability	Pre-post Acceptability Rating Profile survey, maximum value 6 and minimum value 1 with higher scores indicating greater acceptability	December 2019 and July 2020
Secondary	Before and after intervention change in health professional knowledge	Pre-post survey adapted Physician Competence in Substance Abuse Test	December 2019 and July 2020
Secondary	Before and after intervention change in health professional appropriateness	Pre-post Parenting Strategies Questionnaire, maximum 6 and minimum 1 with higher scores indicating greater appropriateness	December 2019 and July 2020
Secondary	Before and after intervention change in health professional feasibility	Pre-post Ratings of Threshold Assessment Grid feasibility, maximum 6 and minimum 1 with higher scores indicating greater feasibility	December 2019 and July 2020
Secondary	Post intervention acceptability of education materials among health professionals	Post intervention Manual Acceptability Rating Scale, maximum 3 and minimum 1 with higher scored indicating great acceptability of educational materials	July 2020