Feasibility and Effectiveness of a Specialized Brief Intervention for Hazardous Drinkers in an Emergency Department. (PPAU)

Prevenció Dels Problemes Relacionats Amb Alcohol a urgències.

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking
• Intervention / Treatment: Behavioral: Brief Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Behavioral: Brief Intervention; Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated.; Other Names: Referral to treatment
No Intervention: Control; Informative leaflets regarding alcohol use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks
Proportion of Patients Attending to Specialized Treatment	Proportion of patients that initate specialized treatment to reduce alcohol use	6 weeks

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: September 4, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: PPAU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No