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

NCT ID: NCT02236494

Last Updated: 2017-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-07-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alcohol Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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General Health Information Pamphlet

This group will not receive a brief intervention in the ED. They will receive a pamphlet with general health information for older adults, as well as contact information for an outpatient alcohol treatment center where they have the option to follow-up for alcohol treatment at their discretion. The patient's readiness to change their alcohol habits will be measured using a 1-10 scale with a visual cue.

Group Type ACTIVE_COMPARATOR

General Health Information

Intervention Type BEHAVIORAL

As per arm (this is the active comparator)

Brief Negotiated Interview

The BNI will follow standard steps (7, 63): 1. The research assistant (RA) will ask permission to discuss the patient's alcohol use with them. 2. They will provide feedback regarding the patient's alcohol use, and will review guidelines drinking in older adults. Where relevant, the RA will discuss how the patient's current visit may relate to their alcohol use. 3. The RA will assess the patient's readiness to change using a 1-10 scale, and will enhance motivation. 4. The RA will negotiate a goal for the patient's drinking and give advice. The patient will be asked to sign a drinking agreement.

Group Type EXPERIMENTAL

Brief Negotiated Interview

Intervention Type BEHAVIORAL

As per arm

Interventions

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Brief Negotiated Interview

As per arm

Intervention Type BEHAVIORAL

General Health Information

As per arm (this is the active comparator)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The American Geriatrics Society

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Society for Academic Emergency Medicine

OTHER

Sponsor Role collaborator

North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina Shenvi, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Timothy F Platts-Mills, MD,MSc

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

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UNC Hospitals Emergency Department

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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R03AG048090

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-3446

Identifier Type: -

Identifier Source: org_study_id

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