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INTRODUCTION: The Practical Approach to Care Kit (PACK) guide was localised for Brazil, where primary care doctors and nurses were trained to use it. METHODS: Twenty-four municipal clinics in Florianópolis were randomly allocated to receive outreach training and the guide, and 24 were allocated to receive only the guide. 6666 adult patients with asthma or chronic obstructive pulmonary disease (COPD) were enrolled, and trial outcomes were measured over 12 months, using electronic medical records. The primary outcomes were composite scores of treatment changes and spirometry, and new asthma and COPD diagnosis rates. RESULTS: Asthma scores in 2437 intervention group participants were higher (74.8%, 20.4% and 4.8% with scores of 0, 1 and 2, respectively) than in 2633 control group participants (80.0%, 16.8% and 3.2%) (OR for higher score 1.32, 95% CI 1.08 to 1.61, p=0.006). Adjusted for asthma scores recorded in each clinic before training started, the OR was 1.24 (95% CI 1.03 to 1.50, p=0.022). COPD scores in 1371 intervention group participants (77.7%, 17.9% and 4.3% with scores of 0, 1 and 2) did not differ from those in 1181 control group participants (80.5%, 15.8% and 3.7%) (OR 1.21, 95% CI 0.94 to 1.55, p=0.142). Rates of new asthma and COPD diagnoses, and hospital admission, and indicators of investigation, diagnosis and treatment of comorbid cardiovascular disease, diabetes and depression, and tobacco cessation did not differ between trial arms. CONCLUSION: PACK training increased guideline-based treatment and spirometry for asthma but did not affect COPD or comorbid conditions, or diagnosis rates. TRIAL REGISTRATION: NCT02786030 (https://clinicaltrials.gov/).
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Health technology is increasingly recognised as a feasible method of addressing health needs in low and middle-income countries (LMICs). Primary Care 101, now known as PACK (Practical Approach to Care Kit), is a printed, algorithmic, checklist-based, comprehensive clinical decision support tool. It assists clinicians with delivering evidence-based medicine for common primary care presentations and conditions. These assessment and treatment guides have been adopted widely in primary care clinics across South Africa. This paper focuses on the process of designing, developing, and implementing a digital version of the clinical decision support tool for use on a tablet computer. Lessons learnt throughout its development and pilot implementation could apply to the creation of electronic health interventions and the digitisation of clinical tools in LMICs.
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BACKGROUND: Despite significant reductions in mortality, preventable and treatable conditions remain the leading causes of death in children under five within South Africa. The WHO's Integrated Management of Childhood Illness (IMCI) programme has been widely implemented to address the most common causes of mortality in children under five. Although effective, limitations in IMCI scope and adherence have emerged. The Practical Approach to Care Kit (PACK) Child guide has been developed to expand on IMCI and address these limitations. It is intended as a clinical decision support tool for health workers with additional systems strengthening components, including active implementation and training strategy to address contextual and organisational factors hindering quality of care for children. Implementation is complex, requiring comprehensive pilot and process evaluation. The PACK Child pilot and feasibility study will sample 10 primary care facilities in the Western Cape Province. Staff will be trained to integrate the PACK Child guide into routine practice. The process evaluation will investigate implementation and health systems components to establish how to optimise delivery, strengthen IMCI principles and factors required to support effective and sustained uptake into everyday practice. METHODS: Mixed method process evaluation. Qualitative data include interviews with managers, staff, caregivers and policymakers; observations of training, consultations and clinic flow. Quantitative data include training logs and staff questionnaires. Quantitative and qualitative analysis will be integrated to describe study sites and develop explanations for implementation variation. DISCUSSION: The process evaluation will provide the opportunity to document implementation and refine the programme prior to a larger pragmatic trial or scale-up.
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Brazil's Sistema Único de Saúde, or Unified Health System policy, has delivered major improvements in health coverage and outcomes, but challenges remain, including the rise of non-communicable diseases (NCDs) and variations in quality of care across the country. Some of these challenges may be met through the adaptation and implementation of a South African primary care strategy, the Practical Approach to Care Kit (PACK). Developed by the University of Cape Town's Knowledge Translation Unit (KTU), PACK is intended for in-country adaptation by employing a mentorship model. Using this approach, the PACK Adult guide and training materials were localised for use in Florianópolis, Santa Catarina, Brazil, as part of an initiative to reform primary care, expand care for NCDs and make services more accessible and equitable. The value of the collaboration between the KTU and Florianópolis municipality is the transfer of skills and avoidance of duplication of effort involved in de-novo guide development, while ensuring that materials are locally acceptable and applicable. The collaboration has informed the development of the KTU's PACK mentorship package and led to a relationship between the groups of developers, ensuring ongoing learning and research, with the potential of assisting the further scale-up of PACK in Brazil.
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The Federal Ministry of Health, Ethiopia, recognised the potential of the Practical Approach to Care Kit (PACK) programme to promote integrated, comprehensive and evidence-informed primary care as a means to achieving universal health coverage. Localisation of the PACK guide to become the 'Ethiopian Primary Health Care Clinical Guidelines' (PHCG) was spearheaded by a core team of Ethiopian policy and technical experts, mentored by the Knowledge Translation Unit, University of Cape Town. A research collaboration, ASSET (heAlth Systems StrEngThening in sub-Saharan Africa), has brought together policy-makers from the Ministry of Health and health systems researchers from Ethiopia (Addis Ababa University) and overseas partners for the PACK localisation process, and will develop, implement and evaluate health systems strengthening interventions needed for a successful scale-up of the Ethiopian PHCG. Localisation of PACK for Ethiopia included expanding the guide to include a wider range of infectious diseases and an expanded age range (from 5 to 15 years). Early feedback from front-line primary healthcare (PHC) workers is positive: the guide gives them greater confidence and is easy to understand and use. A training cascade has been initiated, with a view to implementing in 400 PHC facilities in phase 1, followed by scale-up to all 3724 health centres in Ethiopia during 2019. Monitoring and evaluation of the Ministry of Health implementation at scale will be complemented by indepth evaluation by ASSET in demonstration districts. Anticipated challenges include availability of essential medications and laboratory investigations and the need for additional training and supervisory support to deliver care for non-communicable diseases and mental health. The strong leadership from the Ministry of Health of Ethiopia combined with a productive collaboration with health systems research partners can help to ensure that Ethiopian PHCG achieves standardisation of clinical practice at the primary care level and quality healthcare for all.
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Nigeria, in its quest to strengthen its primary healthcare system, is faced with a number of challenges including a shortage of clinicians and skills. Methods are being sought to better equip primary healthcare clinicians for the clinical demands that they face. Using a mentorship model between developers in South Africa and Nigerian clinicians, the Practical Approach to Care Kit (PACK) for adult patients, a health systems strengthening programme, has been localised and piloted in 51 primary healthcare facilities in three Nigerian states. Lessons learnt from this experience include the value of this remote model of localisation for rapid localisation, the importance of early, continuous stakeholder engagement, the need expressed by Nigeria's primary healthcare clinicians for clinical guidance that is user friendly and up-to-date, a preference for the tablet version of the PACK Adult guide over hard copies and the added value of WhatsApp groups to complement the programme of face-to-face continuous learning. Introduction of the PACK programme in Nigeria prompted uptake of evidence-informed recommendations within primary healthcare services.