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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03273283
Other study ID # PPAU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2016
Est. completion date May 1, 2018

Study information

Verified date May 2020
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 1, 2018
Est. primary completion date February 28, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Proportion of Patients Attending to Specialized Treatment Proportion of patients that initate specialized treatment to reduce alcohol use 6 weeks
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