Study of an Emergency Department-based Intervention to Reduce Alcohol Misuse in Older Adults

Alcohol Abuse Clinical Trial

Official title:

Pilot Trial of Emergency Department Intervention and Referral for Alcohol Misuse in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236494
• Other study ID #: 13-3446
• Secondary ID: R03AG048090
• Status: Completed
• Phase: N/A
• First received: September 8, 2014
• Last updated: July 10, 2017
• Start date: October 2014
• Est. completion date: July 10, 2017

Study information

• Verified date: July 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized trial to assess the value of an emergency department-based intervention to reduce hazardous alcohol use among older adults. We hypothesize that the intervention will result in a 25% reduction in the prevalence of hazardous alcohol use while the control group will only have a 5% reduction.

Description:

The goal of this project is to perform a pilot, randomized, controlled trial of a brief intervention and referral for treatment among older adults in the emergency department (ED) with alcohol misuse. The pilot data would then be used to design a larger study. The intervention for this trial will consist of a Brief Negotiation Interview (BNI) with a stratified referral for further treatment, compared with usual care. The BNI is a standardized, well-described intervention that has been implemented in a broad range of clinical settings but has not been specifically tested in older adults in the ED. Following the BNI, we will provide a referral for further care for the patient that is stratified by severity of alcohol misuse. Patients with hazardous or harmful alcohol use will follow-up with a primary care physician; patients with alcohol abuse or dependence will follow-up with an outpatient alcohol and substance abuse program; those at risk for complicated withdrawal will be recommended for inpatient treatment. In all cases we will contact the referral physician to help transition the patient's care, and ensure the patient receives a consistent message regarding their alcohol use across the different care settings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: July 10, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age 65 and older

• Receiving care in the emergency department

• Hazardous alcohol use, defined as reporting drinking more than 7 drinks per week on an average week during the three months prior to the visit, and whether they have consumed more than three drinks on any given occasion.

Exclusion Criteria:

• Prisoner

• psychosis or psychiatric hold

• nursing home

• life-threatening condition

• current hospice care

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Emergencies

Intervention

Behavioral:
• Brief Negotiated Interview
As per arm
• General Health Information
As per arm (this is the active comparator)

Locations

Country	Name	City	State
United States	UNC Hospitals Emergency Department	Chapel Hill	North Carolina

Sponsors (5)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Aging (NIA), North Carolina Translational and Clinical Sciences Institute, Society for Academic Emergency Medicine, The American Geriatrics Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol misuse	Self-reported alcohol misuse is defined as patient self-report of either drinking >7 drinks per week or >3 drinks per occasion in the past month.	6 months
Primary	Subgroup analysis of patients who met hazardous alcohol use criteria based on time-line follow back method of assessing alcohol consumption	Analysis of rate of hazardous alcohol use in the control and intervention arms within the subgroup of patients who met hazardous drinking criteria of >7 drinks in the past 7 days, or >3 drinks per occasion within the last 28 days using the time-line follow back method.	6 months
Secondary	Alcohol misuse	Alcohol misuse is defined as patient self-report of either drinking >7 drinks per week or >3 drinks per day in the past month.	3 months, 12 months
Secondary	Function	Activities of Daily Living	6,12 months
Secondary	Alcohol consumption	Average drinks per week and episodes of >3 drinks in past 3 months	3,6,12 months
Secondary	Alcohol abuse	AUDIT Score	3,6,12 months
Secondary	General Health	Mobility, depression, and presence of chronic pain	3,6,12 months
Secondary	Risk-taking behavior	Driving after drinking	6,12 months
Secondary	Trauma	Injuries, falls, and motor vehicle collisions within the last 6 months, alcohol use preceding and medical care following the injury	6,12 months
Secondary	Healthcare Utilization	Number of primary care, urgent care, and ED visits, and hospitalization days within the last 6 months, and any relation of these visits to alcohol use.	6,12 months