- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04287790
Promoting Medications for Alcohol Use Disorder on the General Medicine Service
Promoting Medications for Alcohol Use Disorder on the General Medicine Service at Yale New Haven Hospital: a Pilot Study
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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:
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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
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Increased receipt of medications for alcohol use disorder facilitated by the implementation intervention.
Other Names:
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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:
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18 months before and 12 months after the start (January 1st 2020) of the implementation intervention
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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
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18 months before and 12 months after the start (January 1st 2020) of the implementation intervention
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Before and after intervention change in health professional acceptability
Time Frame: December 2019 and July 2020
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Pre-post Acceptability Rating Profile survey, maximum value 6 and minimum value 1 with higher scores indicating greater acceptability
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December 2019 and July 2020
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Before and after intervention change in health professional knowledge
Time Frame: December 2019 and July 2020
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Pre-post survey adapted Physician Competence in Substance Abuse Test
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December 2019 and July 2020
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Before and after intervention change in health professional appropriateness
Time Frame: December 2019 and July 2020
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Pre-post Parenting Strategies Questionnaire, maximum 6 and minimum 1 with higher scores indicating greater appropriateness
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December 2019 and July 2020
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Before and after intervention change in health professional feasibility
Time Frame: December 2019 and July 2020
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Pre-post Ratings of Threshold Assessment Grid feasibility, maximum 6 and minimum 1 with higher scores indicating greater feasibility
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December 2019 and July 2020
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Post intervention acceptability of education materials among health professionals
Time Frame: July 2020
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Post intervention Manual Acceptability Rating Scale, maximum 3 and minimum 1 with higher scored indicating great acceptability of educational materials
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July 2020
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul J Joudrey, MD MPH, Yale School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Drinking Behavior
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcohol Drinking
- Alcoholism
- Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Narcotic Antagonists
- Alcohol Deterrents
- Acetaldehyde Dehydrogenase Inhibitors
- Naltrexone
- Acamprosate
- Disulfiram
Other Study ID Numbers
- 2000026722
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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