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Completed

NCT Number: NCT02236494

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

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.

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Key information

Conditions

Alcohol Abuse Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Dangerous Behavior Mental Disorders Substance-Related Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Hospitals Emergency Department

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Negotiated Interview

Behavioral

As per arm

General health information

Behavioral

As per arm (this is the active comparator)

Primary outcomes

  1. Alcohol misuse

    Time frame: 6 months

    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.

  2. Subgroup analysis of patients who met hazardous alcohol use criteria based on time-line follow back method of assessing alcohol consumption

    Time frame: 6 months

    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.

Secondary outcomes

  1. Alcohol misuse

    Time frame: 3 months, 12 months

    Alcohol misuse is defined as patient self-report of either drinking >7 drinks per week or >3 drinks per day in the past month.

  2. Function

    Time frame: 6,12 months

    Activities of Daily Living

  3. Alcohol consumption

    Time frame: 3,6,12 months

    Average drinks per week and episodes of >3 drinks in past 3 months

  4. Alcohol abuse

    Time frame: 3,6,12 months

    AUDIT Score

  5. General Health

    Time frame: 3,6,12 months

    Mobility, depression, and presence of chronic pain

  6. Risk-taking behavior

    Time frame: 6,12 months

    Driving after drinking

  7. Trauma

    Time frame: 6,12 months

    Injuries, falls, and motor vehicle collisions within the last 6 months, alcohol use preceding and medical care following the injury

  8. Healthcare Utilization

    Time frame: 6,12 months

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Aging (NIA)
  • North Carolina Translational and Clinical Sciences Institute
  • Society for Academic Emergency Medicine
  • The American Geriatrics Society

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 10, 2014
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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