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Scale-up of Prevention and Management of Alcohol Use Disorders and Comorbid Depression in Latin America (SCALA)

Primary Purpose

Alcohol Use Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention municipality
Sponsored by
Maastricht University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Use Disorder focused on measuring Heavy drinking, Primary health care, Training, Community

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Any fully trained medical practitioner, nurse or practice assistant
  • Non-temporary employment contract
  • Working in the selected primary health care centre
  • Involved in medical and/or preventive care

Exclusion Criteria:

  • Not a fully trained medical practitioner, nurse or practice assistant
  • Having a temporary employment contract
  • Not working in the selected primary health care centre
  • Not involved in medical and/or preventive care

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention municipality

    Comparator municipality

    Arm Description

    In the intervention municipalities, primary health care providers will receive ongoing training and support in undertaking screening and brief advice for heavy drinking. They will also receive community-based five adoption mechanisms and five support systems.

    In the comparator municipalities, the primary health care providers will be given a summary card of screening and brief advice for heavy drinking, with no instruction

    Outcomes

    Primary Outcome Measures

    Proportion of consulting adult patients (aged 18+ years) intervened
    The number of AUDIT-C positive patients that received oral advice or referral for advice to another provider in or outside the primary health care centre (PHCC), divided by the total number of adult consultations of the participating providers per provider and per PHCC

    Secondary Outcome Measures

    Proportion of patients screened
    The proportion of patients screened will be calculated as the number of completed screens divided by the total number of consultations of all adult patients per participating provider, and averaged per participating PHCC
    Proportion of patients advised
    The proportion of patients advised will be calculated as the number of brief interventions delivered (received oral brief advice, and/or were referred to another provider in or outside the practice), divided by the total number of screen positives per participating provider and averaged per participating PHCC

    Full Information

    First Posted
    May 2, 2018
    Last Updated
    May 31, 2018
    Sponsor
    Maastricht University
    Collaborators
    Newcastle University, Technische Universität Dresden
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03524599
    Brief Title
    Scale-up of Prevention and Management of Alcohol Use Disorders and Comorbid Depression in Latin America
    Acronym
    SCALA
    Official Title
    Scale-up of Prevention and Management of Alcohol Use Disorders and Comorbid Depression in Latin America
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2018 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    June 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Maastricht University
    Collaborators
    Newcastle University, Technische Universität Dresden

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A quasi-experimental study will compare primary health care-based prevention and management of alcohol use disorder, operationalized by heavy drinking, in three intervention cities from Colombia, Mexico and Peru with three comparator cities from the same countries. In the implementation cities, primary health care units (PHCUs) will receive training embedded within ongoing supportive municipal action over an 18-month implementation period. In the comparator cities, practice as usual will continue at both municipal and PHCU levels. The primary outcome will be the proportion of consulting adult patients intervened with (screened and advice given to screen positives).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder
    Keywords
    Heavy drinking, Primary health care, Training, Community

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    540 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention municipality
    Arm Type
    Experimental
    Arm Description
    In the intervention municipalities, primary health care providers will receive ongoing training and support in undertaking screening and brief advice for heavy drinking. They will also receive community-based five adoption mechanisms and five support systems.
    Arm Title
    Comparator municipality
    Arm Type
    No Intervention
    Arm Description
    In the comparator municipalities, the primary health care providers will be given a summary card of screening and brief advice for heavy drinking, with no instruction
    Intervention Type
    Other
    Intervention Name(s)
    Intervention municipality
    Intervention Description
    In intervention municipalities, primary health care centres and the providers working within them will receive training and a range of community support mechanisms.
    Primary Outcome Measure Information:
    Title
    Proportion of consulting adult patients (aged 18+ years) intervened
    Description
    The number of AUDIT-C positive patients that received oral advice or referral for advice to another provider in or outside the primary health care centre (PHCC), divided by the total number of adult consultations of the participating providers per provider and per PHCC
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Proportion of patients screened
    Description
    The proportion of patients screened will be calculated as the number of completed screens divided by the total number of consultations of all adult patients per participating provider, and averaged per participating PHCC
    Time Frame
    18 months
    Title
    Proportion of patients advised
    Description
    The proportion of patients advised will be calculated as the number of brief interventions delivered (received oral brief advice, and/or were referred to another provider in or outside the practice), divided by the total number of screen positives per participating provider and averaged per participating PHCC
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Any fully trained medical practitioner, nurse or practice assistant Non-temporary employment contract Working in the selected primary health care centre Involved in medical and/or preventive care Exclusion Criteria: Not a fully trained medical practitioner, nurse or practice assistant Having a temporary employment contract Not working in the selected primary health care centre Not involved in medical and/or preventive care
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peter Anderson, MD, PhD
    Phone
    +34 618075217
    Email
    peter.anderson@maastrichtuniversity.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter Anderson, MD, PhD
    Organizational Affiliation
    Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35032246
    Citation
    Solovei A, Jane-Llopis E, Mercken L, Bustamante I, Kokole D, Mejia-Trujillo J, Medina Aguilar PS, Natera Rey G, O'Donnell A, Piazza M, Schmidt CS, Anderson P, de Vries H. Effect of Community Support on the Implementation of Primary Health Care-Based Measurement of Alcohol Consumption. Prev Sci. 2022 Feb;23(2):224-236. doi: 10.1007/s11121-021-01329-1. Epub 2022 Jan 15.
    Results Reference
    derived
    PubMed Identifier
    33469752
    Citation
    Anderson P, Manthey J, Llopis EJ, Rey GN, Bustamante IV, Piazza M, Aguilar PSM, Mejia-Trujillo J, Perez-Gomez A, Rowlands G, Lopez-Pelayo H, Mercken L, Kokole D, O'Donnell A, Solovei A, Kaner E, Schulte B, de Vries H, Schmidt C, Gual A, Rehm J. Impact of Training and Municipal Support on Primary Health Care-Based Measurement of Alcohol Consumption in Three Latin American Countries: 5-Month Outcome Results of the Quasi-experimental Randomized SCALA Trial. J Gen Intern Med. 2021 Sep;36(9):2663-2671. doi: 10.1007/s11606-020-06503-9. Epub 2021 Jan 19.
    Results Reference
    derived

    Learn more about this trial

    Scale-up of Prevention and Management of Alcohol Use Disorders and Comorbid Depression in Latin America

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