NCT03273283

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

May 15, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

August 31, 2017

Results QC Date

April 20, 2020

Last Update Submit

May 14, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Informative leaflets regarding alcohol use

Interventions

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

Also known as: Referral to treatment
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cognitive impairment
  • Medically unstable
  • Patients explicitly demanding alcohol treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Pol Bruguera Soler
Organization
Hospital Clínic de Barcelona

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Addiction Unit

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 6, 2017

Study Start

June 1, 2016

Primary Completion

February 28, 2018

Study Completion

May 1, 2018

Last Updated

May 15, 2020

Results First Posted

May 15, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

There is nno plan, but we have already shared and will continue sharing them

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Since de beginning and for 5 years
Access Criteria
For scientific purposes