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
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Abuse||Behavioral: Brief Negotiated Interview Behavioral: General Health Information||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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.
- Function [ Time Frame: 6,12 months ]Activities of Daily Living
- Alcohol consumption [ Time Frame: 3,6,12 months ]Average drinks per week and episodes of >3 drinks in past 3 months
- Alcohol abuse [ Time Frame: 3,6,12 months ]AUDIT Score
- General Health [ Time Frame: 3,6,12 months ]Mobility, depression, and presence of chronic pain
- Risk-taking behavior [ Time Frame: 6,12 months ]Driving after drinking
- 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
- 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.
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
|United States, North Carolina|
|UNC Hospitals Emergency Department|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Christina Shenvi, MD,PhD||UNC Chapel Hill|
|Principal Investigator:||Timothy F Platts-Mills, MD,MSc||UNC Chapel Hill|