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
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
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
NCT ID
NCT03524599
First Posted
May 2, 2018
Last Updated
May 31, 2018
Sponsor
Maastricht University
Collaborators
Newcastle University, Technische Universität Dresden
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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