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

NCT ID: NCT03273283

Last Updated: 2020-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2018-05-01

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.

Conditions

Alcohol Drinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Brief Intervention

Intervention Type: BEHAVIORAL

Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated.

Control

Informative leaflets regarding alcohol use

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brief Intervention

Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated.

Intervention Type: BEHAVIORAL

Other Intervention Names

Referral to treatment

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Antoni Gual

Head of the Addiction Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 33709997 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PPAU

Identifier Type: -

Identifier Source: org_study_id