Strengthening the quality of paediatric primary care in South Africa: Preliminary work for a pragmatic randomised trial.

There are important gaps in the primary care delivery of child health in low and middle income countries: there is little user-friendly guidance for health workers seeing children over the age of 5 or those with increasingly common long term conditions like asthma, and preventive care (like vaccinations and growth checks) is not smoothly integrated with sick-child services, making for disjointed care for children, their caregivers and health workers.

The Knowledge Translation Unit in Cape Town has developed a health systems intervention for adult primary care (Practical Approach to Care Kit - PACK) that has become entrenched in health services throughout South Africa and is being piloted elsewhere in Africa and in South America. PACK comprises a clinical guide, a training package and work at policy and management level to prepare the system and the health worker for its implementation. The unit has conducted rigorous implementation science studies showing that PACK improves care and patient outcomes. The reasons for PACK's success are that it takes a comprehensive, simple approach to clinical care while tackling the systems issues that make improving primary care difficult. A partnership with the British Medical Journal is helping take PACK to a global audience (www.pack.bmj.com).

In response to the gaps described above and to requests from those using PACK Adult, the KTU has now developed the first version of the PACK Child clinical guide in collaboration with local government in the Western Cape province of South Africa, and plans to implement it alongside PACK Adult in several countries. Before rollout, however, we need to work out two things: One, how best to implement the PACK Child programme in a system that has multiple other programmes and priorities - and limited capacity - and two, how best to evaluate whether PACK Child does indeed improve the care and health of children. This Foundation Grant will support the KTU to:
- Develop and pilot the PACK Child health systems intervention package.
- Design the research protocol to evaluate the PACK Child health systems intervention.
- Establish a PACK Child Advisory Board.

Each of these activities will draw on stakeholders from policy makers to nurses and doctors to children themselves to ensure that the PACK Child health systems intervention and its evaluation speaks to the needs of those who will use and benefit from it.

WHO's Integrated Management of Childhood Illnesses (IMCI) policy has improved primary care of children under 5 years. But it excludes many non-life-threatening yet common conditions and older children. The Knowledge Translation Unit (KTU) has implemented a programme to improve adult primary care, through algorithmic clinical guides, training and engagement with managers, which is used throughout South Africa and adapted for Brazil, Nigeria, Botswana and Ethiopia. KTU has now developed an equivalent guide for children, covering the 50 most common symptoms and 18 chronic conditions up to 13 years. This could fill the gaps left by IMCI, but effective implementation is complex. We plan a pragmatic randomised controlled trial to assess whether PACK Child, implemented through educational outreach to primary care professionals, is effective, safe, cost-effective and acceptable in improving outcomes of paediatric primary care in poor South African communities. To prepare for a full trial, we propose:

-Final development and piloting of the health systems intervention for PACK Child, including formative iterative process evaluation covering user and stakeholders' perspectives, training uptake, and analysis of each components of training.
-Three pilot surveys to inform the selection of the primary outcome, assess the feasibility of recruiting sufficient participants, of following up participants by telephonic interview and of triangulating data from interviews and medical record data on healthcare utilisation outcomes. We will also assess the feasibility of observing consultations to assess secondary outcomes including growth monitoring, appropriate responses to that monitoring, and detection and management of long-term health conditions.
-Formation of a PACK Child Advisory Board of stakeholders including local, national and global policymakers, implementing health workers and caregivers of children in the communities in which the future trial will take place.

We have identified eight stakeholder categories and outlined strategies and tools for their continuous engagement throughout the duration of the project in the Pathways to Impact: [1] local and national policymakers; [2] regional and global policymakers; [3] training providers; [4] health care workers responsible for the delivery of paediatric primary care; [5] children and their caregivers; [6] research participants; [7] academics and [8] potential funders of the future trial.

Local and national stakeholders are committed to implementing PACK Child in South Africa to complement PACK Adult (which is already well embedded throughout primary care) thereby promoting life course and family-orientated approaches in keeping with the WHO's strategy of Survive, Thrive and Transform for children, adolescents and women (http://www.who.int/life-course/partners/global-strategy/global-strategy-at-a-glance/en/). They are most concerned with how to optimise implementation. Co-design of the training and implementation components of PACK Child and research findings from this Foundation Grant will provide important lessons and insights in this regard as well as opportunities for continuous engagement prior to the start of the future trial or routine implementation.

Regional and global policymakers will want to understand whether PACK Child is able to strengthen the processes and outcomes of paediatric primary care services in resource-constrained settings and if it offers good value for money. They will be the primary target policymaking audience for the future trial. Inclusion of them at the Foundation Grant stage of intervention and trial design is critical to understanding what they would consider compelling and policy-important outcomes, and securing their participation in a future Trial Advisory Board and dissemination activities.

We need to engage with end-users throughout the design and evaluation process in order to design a health systems intervention that is highly acceptable and relevant, and likely to result in uptake of PACK Child into daily clinical practice. Training providers and health care workers responsible for the delivery of paediatric primary care will be included in the co-design of the intervention from the start, and their preferences and concerns systematically elicited and addressed through the parallel process evaluation.

Children and their caregivers are the ultimate beneficiaries of the PACK Child health systems intervention, and may have different views on what they consider to be important outcomes to those of the researchers or policymakers, which should be considered at the time of intervention and trial design.

This Foundation Grant proposes several research participants including health care workers, managers, policymakers, training providers, children and their caregivers. It is important that their welfare not be compromised in any way by their participation in the research process and that they be informed of the research findings. Measures to ensure their protection and fair treatment are described in Ethical Information.
A wide range of academics would be interested in the findings of this Foundation Grant, including health systems and implementation science researchers, clinicians, clinical trialists and methodologists.

Securing funding for the future trial will require sustained effort over at least a year, if not longer. Identifying potential funding sources, engaging with them and preparing submissions will be an important outcome of this Foundation Grant.

In summary, if and when PACK Child is ultimately shown to be effective, cost effective, feasible and desirable, it is likely to influence and improve paediatric primary care throughout South Africa, and to do the same in other low and middle income countries such as Nigeria, Brazil and Ethiopia. This has the potential to improve the health of millions of children.