PEN-Plus Initiation Grant Opportunity: Domestication and Implementation of the PEN-Plus Clinical Model in the Zambian Health System

In Zambia, NCDs are among the top 10 causes of mortality, and the current National Health Strategic Plan 2017-2021 has placed NCDs as a priority area for intervention, with the government and cooperating partners working to address this growing threat. Though population level data on NCDs is not available in Zambia, routine data collected from hospitals have shown a 22% increase in the total number of NCDs cases between 2010 and 2012 in all age groups. In the same period, cases of hypertension seen in the outpatient department (OPD) increased by 39% for all age groups. Cancer cases seen at the country's only Cancer Diseases Hospital (CDH) increased from 1282 in 2010 to 3021 in 2014, exhibiting an increase of over 50%. There is definite reason to change the interventional strategy if Zambia is to get anywhere towards attaining the WHO '25 x 25' global NCD targets, an important milestone towards the achieving the SDG No.3. To date, the rate of progress on NCDs has been patchy, uneven and largely off-track. The imperative for action is reinforced by persistent gaps and shortcomings in the response, ranging from lack of prioritization of NCDs, inadequate resources, a lack of preventative action, vulnerable and ill-equipped health systems to respond to the growing burden.

The WHO-PEN survey done in 2017 revealed gaps in primary health care capacity to manage NCDs in Zambia, with almost all health facilities failing to reach the minimum threshold. Only six (6) out of the 46 facilities surveyed were deemed ready to manage NCDs. The only first level hospital included in the survey just crossed the line. While it scored above the threshold for basic equipment, diagnostic capacity, essential medicines and essential services, it got a rather low score for counselling services. Overall urban and semi-urban facilities fared better than the rural facilities. This was a typical reflection of the Zambian health system which has remained focused on infectious rather than non-communicable diseases.

This protocol is developed for a mixed methods evaluation based on the United Kingdom's Medical Research Council (MRC) framework for complex interventions guided by the Proctor implementation frameworks. The evaluation is designed to reflect overarching research questions across all sites, but also allows for the considerable variability in implementation practices and needs across the ten countries. Here we aim to understand:

1. Clinical implementation outcomes: Are PEN-Plus clinics enrolling sufficient numbers of patients largely with severe chronic non communicable diseases, and particularly type 1 diabetes, and are they reaching the poorest? Is the care being provided at these new clinics acceptable and comparable in quality to tertiary chronic care facilities in their country? Are patients enrolled in these clinics being protected from further impoverishment? What is the cost of providing these services? Are patients' voices being heard?
2. Training outcomes: Over the course of the project, what is the readiness of the supported facilities to become national training centers for PEN-Plus? How many midlevel providers have been prepared to become PEN-Plus master trainers including a sufficient period of clinical practice precepted by internal medicine specialists, pediatricians, cardiologists, and endocrinologists? Is the PEN-Plus clinic space adequate for a training facility? What is the six-month retention of these midlevel providers?
3. Policy outcomes: Has the Ministry of Health, together with its partners, begun to develop the policies and strategies needed to enable the implementation of PEN-Plus services at a national scale? These policies and strategies include: disease management guidelines, medication formularies, patient medical record forms, health management information systems, training curricula and certification pathways for providers, national PEN-Plus operational plans, and resource mobilization plans.

1.6 Objective and Aim of the study 1.6.1 General Objective