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

NCT02236494 | Completed

• 2 other identifiers: 13-3446R03AG048090
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Abuse

Keywords

alcoholism; dangerous behavior; aged; emergency medicine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Alcohol misuse

  3 months, 12 months

• Function

  6,12 months

• Alcohol consumption

  3,6,12 months

• Alcohol abuse

  3,6,12 months

• General Health

  3,6,12 months

Study Arms (2)

General Health Information Pamphlet

ACTIVE COMPARATOR

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.

Behavioral: General Health Information

Brief Negotiated Interview

EXPERIMENTAL

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.

Behavioral: Brief Negotiated Interview

Interventions

Brief Negotiated Interview BEHAVIORAL

As per arm

Brief Negotiated Interview

General Health Information BEHAVIORAL

As per arm (this is the active comparator)

General Health Information Pamphlet

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prisoner
• psychosis or psychiatric hold
• nursing home
• life-threatening condition
• current hospice care

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• The American Geriatrics Society: collaborator
• National Institute on Aging (NIA): collaborator
• Society for Academic Emergency Medicine: collaborator
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

UNC Hospitals Emergency Department

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Alcoholism; Dangerous Behavior

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Christina Shenvi, MD,PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

• Timothy F Platts-Mills, MD,MSc

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 10, 2014
• Study Start: October 1, 2014
• Primary Completion: July 10, 2017
• Study Completion: July 10, 2017
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

US (1)