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

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ClinicalTrials.gov Identifier: NCT02236494
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : July 12, 2017
Sponsor:
Collaborators:
The American Geriatrics Society
National Institute on Aging (NIA)
Society for Academic Emergency Medicine
North Carolina Translational and Clinical Sciences Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Alcohol Abuse Behavioral: Brief Negotiated Interview Behavioral: General Health Information Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of Emergency Department Intervention and Referral for Alcohol Misuse in Older Adults
Actual Study Start Date : October 2014
Actual Primary Completion Date : July 10, 2017
Actual Study Completion Date : July 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: General Health Information
As per arm (this is the active comparator)

Experimental: 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.
Behavioral: Brief Negotiated Interview
As per arm




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236494


Locations
United States, North Carolina
UNC Hospitals Emergency Department
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
The American Geriatrics Society
National Institute on Aging (NIA)
Society for Academic Emergency Medicine
North Carolina Translational and Clinical Sciences Institute
Investigators
Principal Investigator: Christina Shenvi, MD,PhD UNC Chapel Hill
Principal Investigator: Timothy F Platts-Mills, MD,MSc UNC Chapel Hill

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02236494     History of Changes
Other Study ID Numbers: 13-3446
R03AG048090 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017

Keywords provided by University of North Carolina, Chapel Hill:
alcoholism
dangerous behavior
aged
emergency medicine

Additional relevant MeSH terms:
Emergencies
Alcoholism
Disease Attributes
Pathologic Processes
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs