Alcohol AbuseNCT02236494
Study of an Emergency Department-based Intervention to Reduce Alcohol Misuse in Older Adults
A study testing Brief Negotiated Interview and General Health Information in people with Alcohol Abuse, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Brief Negotiated Interview and General Health Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 10 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Prisoner
- psychosis or psychiatric hold
- nursing home
- life-threatening condition
- current hospice care
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Hospitals Emergency Department
Chapel Hill, North Carolina, 27599
About this study
Official title: Pilot Trial of Emergency Department Intervention and Referral for 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.
Read the 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.
- Conditions
- Alcohol Abuse
- Being tested
- Brief Negotiated Interview, General Health Information
- Keywords
- alcoholism, dangerous behavior, aged, emergency medicine
- Medical subject headings
- Alcoholism, Dangerous Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Negotiated InterviewBehavioural
As per arm
General Health InformationBehavioural
As per arm (this is the active comparator)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Brief Negotiated Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (8)
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.
Measured: 3 months, 12 months
Function
Activities of Daily Living
Measured: 6,12 months
Alcohol consumption
Average drinks per week and episodes of >3 drinks in past 3 months
Measured: 3,6,12 months
Alcohol abuse
AUDIT Score
Measured: 3,6,12 months
General Health
Mobility, depression, and presence of chronic pain
Measured: 3,6,12 months
Risk-taking behavior
Driving after drinking
Measured: 6,12 months
Trauma
Injuries, falls, and motor vehicle collisions within the last 6 months, alcohol use preceding and medical care following the injury
Measured: 6,12 months
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.
Measured: 6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startOct 2014
- Primary completion10 Jul 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- The American Geriatrics Society, National Institute on Aging (NIA), Society for Academic Emergency Medicine, North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Christina Shenvi, MD,PhD, Principal investigator, UNC Chapel HillTimothy F Platts-Mills, MD,MSc, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236494
- Sponsor's protocol ID
- 13-3446
- Other IDs
- R03AG048090
- Status last verified
- Jul 2017
- First submitted
- 8 Sep 2014
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Emergency Department Intervention and Referral for Alcohol Misuse in Older Adults
- ClinicalTrials.gov ID
- NCT02236494
- Acronym / sponsor ID
- 13-3446
- Conditions
- Alcohol Abuse
- Keywords
- alcoholism, dangerous behavior, aged, emergency medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- The American Geriatrics Society, National Institute on Aging (NIA), Society for Academic Emergency Medicine, North Carolina Translational and Clinical Sciences Institute
- Study start
- Oct 2014 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Health Information Pamphlet | Active comparator | Behavioral: General Health InformationThis 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. |
| Brief Negotiated Interview | Experimental | Behavioral: Brief Negotiated InterviewThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Prisoner
- psychosis or psychiatric hold
- nursing home
- life-threatening condition
- current hospice care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Negotiated InterviewAs per arm | Behavioural | Brief Negotiated Interview |
| General Health InformationAs per arm (this is the active comparator) | Behavioural | General Health Information Pamphlet |
Primary outcome
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.
8 secondary outcomes
Alcohol misuse
Time frame: 3 months, 12 months
Function
Time frame: 6,12 months
Alcohol consumption
Time frame: 3,6,12 months
Alcohol abuse
Time frame: 3,6,12 months
General Health
Time frame: 3,6,12 months
Risk-taking behavior
Time frame: 6,12 months
Trauma
Time frame: 6,12 months
Healthcare Utilization
Time frame: 6,12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Shenvi, MD,PhD principal investigator
UNC Chapel Hill
Timothy F Platts-Mills, MD,MSc principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Negotiated Interview and General Health Information in people with Alcohol Abuse, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol misuse (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.