Feasibility and Effectiveness of a Specialized Brief Intervention for Hazardous Drinkers in an Emergency Department. (PPAU)
Primary Purpose
Alcohol Drinking
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brief Intervention
Sponsored by

About this trial
This is an interventional treatment trial for Alcohol Drinking
Eligibility Criteria
Inclusion Criteria:
- All patients aged 18 or older attending to the emergency department were potentially eligible patients
- Patients with an AUDIT-C score higher than 6 points for men and 5 for woman were invited to participate
Exclusion Criteria:
- Cognitive impairment
- Medically unstable
- Patients explicitly demanding alcohol treatment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Patients received a brief intervention on alcohol use. This brief intervention was a little chat based on motivational techniques to enhance motivation to reduce alcohol use or to initiate treatment. Patients were referred to specialized treatment when indicated.
Informative leaflets regarding alcohol use
Outcomes
Primary Outcome Measures
Proportion of Risky Drinkers Measured by AUDIT-C
We assessed participants with AUDIT-C (a tool to assess alcohol consumption). Main outcome 1 is the proportion of patients who score more than 6 i men and 5 in women in this scale.
AUDIT-C is the short version of the AUDIT scale (Alcohol use disorders identification test). Consists of a three items scale ( frequency of alcohol consumption, amount of alcohol units per day of consumption and frequency of binge drinking), and ranges from 0 (abstinence) to 12 (very high alcohol use). The higher the score is, the more important the alcohol use is, and more risk of presenting an alcohol use disorder.
Proportion of Patients Attending to Specialized Treatment
Proportion of patients that initate specialized treatment to reduce alcohol use
Secondary Outcome Measures
Full Information
NCT ID
NCT03273283
First Posted
August 31, 2017
Last Updated
May 14, 2020
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT03273283
Brief Title
Feasibility and Effectiveness of a Specialized Brief Intervention for Hazardous Drinkers in an Emergency Department.
Acronym
PPAU
Official Title
Prevenció Dels Problemes Relacionats Amb Alcohol a urgències.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Alcohol use and its consequences represent an important public health problem. As well as alcohol dependence, hazardous drinking also contributes to a high burden in terms of morbidity and mortality. To improve these patients' prognosis and decrease associated social and health care costs, it is necessary to increase early detection, intervention and treatment for these problems. For these reasons, SBIRT programmes (Screening Brief Intervention and Referral to Treatment) have been developed, evaluated and shown to be effective, particularly in primary care and general practice. Nevertheless, effectiveness of SBIRT in emergency departments (ED) has not been clearly established.
The investigators aimed to evaluate the feasibility and efficacy of an SBIRT programme in the ED of a tertiary hospital.
Detailed Description
The investigators conducted a randomized controlled trial to study the feasibility and efficacy of an SBIRT programme for hazardous drinkers presenting in an ED. All patients older than 18 years old attending the emergency department were potentially eligible. Cognitively impaired or medically unstable patients were excluded. Patients seeking treatment for alcohol use were also excluded. Patients were randomized to two groups, with the control group receiving two leaflets - one regarding alcohol use, and the other giving information about the study protocol. The intervention group received the same leaflets as well as a brief motivational intervention on alcohol use; and, where appropriate, a referral to specialised treatment. The primary outcomes were the proportion of hazardous drinkers measured by AUDIT-C scale and the proportion of patients attending specialised treatment at 1.5 and 4.5 months and 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients received a brief intervention on alcohol use. This brief intervention was a little chat based on motivational techniques to enhance motivation to reduce alcohol use or to initiate treatment. Patients were referred to specialized treatment when indicated.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Informative leaflets regarding alcohol use
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention
Other Intervention Name(s)
Referral to treatment
Intervention Description
Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated.
Primary Outcome Measure Information:
Title
Proportion of Risky Drinkers Measured by AUDIT-C
Description
We assessed participants with AUDIT-C (a tool to assess alcohol consumption). Main outcome 1 is the proportion of patients who score more than 6 i men and 5 in women in this scale.
AUDIT-C is the short version of the AUDIT scale (Alcohol use disorders identification test). Consists of a three items scale ( frequency of alcohol consumption, amount of alcohol units per day of consumption and frequency of binge drinking), and ranges from 0 (abstinence) to 12 (very high alcohol use). The higher the score is, the more important the alcohol use is, and more risk of presenting an alcohol use disorder.
Time Frame
6 weeks
Title
Proportion of Patients Attending to Specialized Treatment
Description
Proportion of patients that initate specialized treatment to reduce alcohol use
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients aged 18 or older attending to the emergency department were potentially eligible patients
Patients with an AUDIT-C score higher than 6 points for men and 5 for woman were invited to participate
Exclusion Criteria:
Cognitive impairment
Medically unstable
Patients explicitly demanding alcohol treatment
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
There is nno plan, but we have already shared and will continue sharing them
IPD Sharing Time Frame
Since de beginning and for 5 years
IPD Sharing Access Criteria
For scientific purposes
Citations:
PubMed Identifier
33709997
Citation
Bruguera P, Barrio P, Manthey J, Oliveras C, Lopez-Pelayo H, Nuno L, Miquel L, Lopez-Lazcano A, Blithikioti C, Caballeria E, Matrai S, Rehm J, Vieta E, Gual A. Mid and long-term effects of a SBIRT program for at-risk drinkers attending to an emergency department. Follow-up results from a randomized controlled trial. Eur J Emerg Med. 2021 Oct 1;28(5):373-379. doi: 10.1097/MEJ.0000000000000810.
Results Reference
derived
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Feasibility and Effectiveness of a Specialized Brief Intervention for Hazardous Drinkers in an Emergency Department.
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