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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
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 31, 2017
    Last Updated
    May 14, 2020
    Sponsor
    Hospital Clinic of Barcelona
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    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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