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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - SCALA (Scale-up of Prevention and Management of Alcohol Use Disorders and Comorbid Depression in Latin America)

Teaser

Summary

SCALA is a quasi-experimental study that tests the implementation of primary health care (PHC)-based programmes to measure, assess, advise and treat heavy drinking and comorbid depression at municipal level in three Latin American middle-income countries, Colombia, Mexico and Peru. Primary Health Care Units (PHCU) are the study participants, the units of allocation and analysis. The three interventions for the PHCU are:
i. Intensity of clinical package and training (standard, versus short, versus none);
ii. Training of providers (present, versus absent); and,
iii. Community integration and support (municipal action present, versus absent).

The main outcome is the proportion of the adult (aged 18+ years) population registered with the PHCU that has their alcohol consumption measured. Three hypotheses are tested:
Hypothesis 1: Municipal action leads to more sustainable coverage. After 18 months, the difference in coverage between municipal action present and municipal action absent is larger than after 12 months;
Hypothesis 2: The short clinical package and short training lead to higher coverage than no training; and,
Hypotheses 3: In the presence of municipal action, the short clinical package and short training do not lead to less coverage than the standard clinical package and standard training.

Intervention and comparator municipal areas are investigator-selected from BogotÃ¡ (Colombia), Mexico City (Mexico) and Lima (Peru). The units of allocation and analysis, study participants, are primary health care units (PHCUs) and the providers working in them. For the first six months of an 18-month implementation and test period, a four-arm design is adopted. Within the comparator municipal area, four PHCU are randomly allocated to control (Arm 1), and five PHCU to receive short training to implement a short clinical package (Arm 2). Within the intervention municipal area, in which all PHCU receive municipal action, five PHCU are randomly allocated to receive short training to implement a short clinical package (Arm 3), and four PHCU to receive standard training to implement a standard clinical package (Arm 4). By month 6 of the 18-month implementation period, non-superiority of Arm 4 (longer package with municipal action and training) over Arm 3 (short package with municipal action and training) will be tested. In the presence of clinical equivalence of a relative difference of cumulative coverage of patients whose alcohol consumption is measured of less than 10%, Arm 4 will be replaced by Arm 3 from month 8 onwards.

The final outcome of SCALA will be a fully validated SCALA Framework and Strategy, which will detail the adoption mechanisms and support systems, and the organisational and resource requirements (data, personnel and financing) necessary for going to full-scale; it will provide the step-by-step information needed by users (including municipalities, researchers, healthcare providers, policy makers, and the public) to go to full-scale; it will detail the contextual, financial and political-economy backgrounds that might impact on success in going to full-scale.

Work performed

The first 18 months of the project have been the set-up phase, with all produced outputs publicly available, https://www.scalaproject.eu/index.php/project-outputs. During this phase, the following six areas of work have been undertaken:
1. Full adaptation, tailoring and preparation of all clinical materials needed by providers and patients for implementation and scale-up available in English and Spanish languages with variants for Colombia, Mexico and Peru;
2. Full adaptation, tailoring and preparation of all training materials needed by providers for implementation and scale-up available in English and Spanish languages with variants for Colombia, Mexico and Peru;
3. Recruitment of 54 primary health care centres (18 per country) and random allocation to each of the four arms;
4. Appointments of stakeholder members and meetings of Community Advisory Boards to oversee and advise on local implementation, preparing for widespread scale-up at the end of the project;
5. Full identification and preparation of municipal support mechanisms to be implemented in the intervention municipalities, including set-up of Community Advisory Boards, appointment of a local Project Champion, identification and specification of five adoption mechanisms, identification and specification of five support systems, and identification and specification of appropriate community-based communication campaigns; and,
6. Finalization and testing of all instruments required for outcome, process, and economic evaluations.

Final results

SCALA goes beyond the state of the art in two important ways:
i. It recognizes the importance of comorbid moderately severe and severe depression with heavy drinking, by building in identification and referral mechanisms, either through specialist services, or through additional specialist support to PHC.
ii. Based on evidence, it adopts a novel approach by embedding and scaling-up the PHC activity within municipalities, supported by a series of municipal-based adoption mechanisms and support systems, and communication campaigns, aiming to assist in building a new knowledge base, on which better policy could be based.

SCALA impacts health at two levels:
i. At the local level, and across the three intervention municipalities, we estimate that SCALA over the 18-month implementation period, will result in 180,000 new patients screened for heavy drinking, 9,000 new patients identified, and advised and treated for their heavy drinking, and over 3,000 new patients identified and treated for comorbid depression.
ii. SCALA will deliver a validated framework and strategy for going to full-scale for the prevention and management of heavy drinking and comorbid depression that is actionable in at least almost any municipality in low and middle-income countries, as well as municipalities in high-income countries, including European Union member states The SCALA Framework and Strategy will not only provide the what and how of scaling up the prevention and management of heavy drinking and comorbid depression at municipal level, but also the tools needed for adaptation and tailoring in different municipal environments, based on different health system structures and different drinking patterns. As such, SCALA will contribute to SDG 3 as a whole, â€˜Ensuring healthy lives and promoting the well-being for all at all agesâ€™, and a range of its targets, in particular 3.5 addressing harmful use of alcohol.