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

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Negotiated Interview
General Health Information
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring alcoholism, dangerous behavior, aged, emergency medicine

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNC Hospitals Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

General Health Information Pamphlet

Brief Negotiated Interview

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Function
Activities of Daily Living
Alcohol consumption
Average drinks per week and episodes of >3 drinks in past 3 months
Alcohol abuse
AUDIT Score
General Health
Mobility, depression, and presence of chronic pain
Risk-taking behavior
Driving after drinking
Trauma
Injuries, falls, and motor vehicle collisions within the last 6 months, alcohol use preceding and medical care following the injury
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.

Full Information

First Posted
September 8, 2014
Last Updated
July 10, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
The American Geriatrics Society, National Institute on Aging (NIA), Society for Academic Emergency Medicine, North Carolina Translational and Clinical Sciences Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02236494
Brief Title
Study of an Emergency Department-based Intervention to Reduce Alcohol Misuse in Older Adults
Official Title
Pilot Trial of Emergency Department Intervention and Referral for Alcohol Misuse in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
July 10, 2017 (Actual)
Study Completion Date
July 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
The American Geriatrics Society, National Institute on Aging (NIA), Society for Academic Emergency Medicine, North Carolina Translational and Clinical Sciences Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
Keywords
alcoholism, dangerous behavior, aged, emergency medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General Health Information Pamphlet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Brief Negotiated Interview
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Negotiated Interview
Intervention Description
As per arm
Intervention Type
Behavioral
Intervention Name(s)
General Health Information
Intervention Description
As per arm (this is the active comparator)
Primary Outcome Measure Information:
Title
Alcohol misuse
Description
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.
Time Frame
6 months
Title
Subgroup analysis of patients who met hazardous alcohol use criteria based on time-line follow back method of assessing alcohol consumption
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Alcohol misuse
Description
Alcohol misuse is defined as patient self-report of either drinking >7 drinks per week or >3 drinks per day in the past month.
Time Frame
3 months, 12 months
Title
Function
Description
Activities of Daily Living
Time Frame
6,12 months
Title
Alcohol consumption
Description
Average drinks per week and episodes of >3 drinks in past 3 months
Time Frame
3,6,12 months
Title
Alcohol abuse
Description
AUDIT Score
Time Frame
3,6,12 months
Title
General Health
Description
Mobility, depression, and presence of chronic pain
Time Frame
3,6,12 months
Title
Risk-taking behavior
Description
Driving after drinking
Time Frame
6,12 months
Title
Trauma
Description
Injuries, falls, and motor vehicle collisions within the last 6 months, alcohol use preceding and medical care following the injury
Time Frame
6,12 months
Title
Healthcare Utilization
Description
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.
Time Frame
6,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Shenvi, MD,PhD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy F Platts-Mills, MD,MSc
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Hospitals Emergency Department
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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

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