Alcohol Use DisorderNCT04287790
Promoting Medications for Alcohol Use Disorder on the General Medicine Service
An observational study of Alcohol Use Disorder, run by Yale University at 1 site in United States.
Trial summary
Medications for Alcohol use disorder (MAUD) (acamprosate, naltrexone, and disulfiram) remain underutilized despite guideline recommendations and rising alcohol-related morbidity and mortality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- audit and feedback, educational meetings, and academic detailing to promote medication receipt and Acamprosate, naltrexone, or disulfiram
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Physicians trainees (student, residents, and fellows) will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06520
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- audit and feedback, educational meetings, and academic detailing to promote medication receipt, Acamprosate, naltrexone, or disulfiram
- Keywords
- Implementation, Medications for alcohol use disorder, Pharmacotherapy
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
audit and feedback, educational meetings, and academic detailing to promote medication receiptBehavioural
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.
Acamprosate, naltrexone, or disulfiramDrug
Also called FDA medications for alcohol use disorder
Increased receipt of medications for alcohol use disorder facilitated by the implementation intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: audit and feedback, educational meetings, and academic detailing to promote medication receipt | |
| 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 Receives: Drug: Acamprosate, naltrexone, or disulfiram | |
| 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 Receives: Drug: Acamprosate, naltrexone, or disulfiram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 18 months before and 12 months after the start (January 1st 2020) of the implementation intervention
Secondary outcomes (6)
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
Measured: 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
Pre-post Acceptability Rating Profile survey, maximum value 6 and minimum value 1 with higher scores indicating greater acceptability
Measured: December 2019 and July 2020
Before and after intervention change in health professional knowledge
Pre-post survey adapted Physician Competence in Substance Abuse Test
Measured: December 2019 and July 2020
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
Measured: December 2019 and July 2020
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
Measured: December 2019 and July 2020
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
Measured: July 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Jan 2020
- Primary completion1 Jun 2020
- Study completion1 Feb 2021
Why it stopped: COVID-19 disrupted recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul J Joudrey, MD MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287790
- Sponsor's protocol ID
- 2000026722
- Status last verified
- May 2022
- First submitted
- 17 Feb 2020
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Medications for Alcohol Use Disorder on the General Medicine Service at Yale New Haven Hospital: a Pilot Study
- ClinicalTrials.gov ID
- NCT04287790
- Acronym / sponsor ID
- 2000026722
- Conditions
- Alcohol Use Disorder
- Keywords
- Implementation, Medications for alcohol use disorder, Pharmacotherapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19 disrupted recruitment
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Health professionals after intervention | – | Behavioral: audit and feedback, educational meetings, and academic detailing to promote medication receiptHealth 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) |
| Hospitalized patient before intervention | – | Drug: Acamprosate, naltrexone, or disulfiramPatients 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 |
| 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 | – | Drug: Acamprosate, naltrexone, or disulfiramPatients 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Physicians trainees (student, residents, and fellows) will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| audit and feedback, educational meetings, and academic detailing to promote medication receiptOur 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. | Behavioural | Health professionals after intervention |
| Acamprosate, naltrexone, or disulfiramAlso: FDA medications for alcohol use disorderIncreased receipt of medications for alcohol use disorder facilitated by the implementation intervention. | Drug | Hospitalized patient after intervention, Hospitalized patient before intervention |
Primary outcome
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)
6 secondary outcomes
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
Before and after intervention change in health professional acceptability
Time frame: December 2019 and July 2020
Before and after intervention change in health professional knowledge
Time frame: December 2019 and July 2020
Before and after intervention change in health professional appropriateness
Time frame: December 2019 and July 2020
Before and after intervention change in health professional feasibility
Time frame: December 2019 and July 2020
Post intervention acceptability of education materials among health professionals
Time frame: July 2020
Results and safety
The study was stopped early (reason given: COVID-19 disrupted recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Joudrey, MD MPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 disrupted recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.