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 The overarching objective/aim of the study is to adapt and pilot the PEN PLUS intervention using the Interactive Systems Framework (ISF) and then implement and monitor the impact. The ISF framework proposes and organizes several implementation strategies to achieve Evidence Based Implementation (EBI) adaptation, including dissemination, implementation processes, integration, capacity building and scale up strategies. We will apply these strategies at different levels to different actors to ensure local adaptation and scaleup of the WHO-PEN Plus in Zambia Aims Aim 1. Adapt WHO-PEN PLUS for screening and management of NCDs in Zambian Hospitals and health facilities - Engagement of Delivery System Actors: The following strategies shall be adopted

• Engagement of key stakeholders;

1. Formation of the Stakeholder Consultation Group
2. Establishment of the baseline of service availability for NCDs
3. Redefining the referral chain and identifying community structures

• Adaptation of WHO-PEN PLUS to the Zambian primary service delivery setting a. Identification of priority conditions (from the Zambia NCDI Poverty Commission) b. Identification of gaps between what is available and what would be ideal for dealing with these conditions.

1. Define Care Delivery Package (including diagnostics and treatment capacity)

• Evaluation of the implementation processes through real-time monitoring and evaluation.

1. Establish a localised patient records documentation system
2. Integrate patient records system with the existing DHIS2/SmartCare Engagement of Support System Actors: The following strategies shall be used

• Training of frontline healthworkers including Clinical Officers, Nurses and CHA/CHWs
• Audit and feedback
• Mentorship and facilitation with mid- and senior-level management within ministry of health (MoH) Zambia. Engagement of Synthesis \& Translation System Actors: The following strategies shall be deployed
• Evidence-based messaging of health effects of NCDs for patients
• Evidence-based messaging on the adverse effects of NCDs on outcomes for health care workers. Aim 2: Pilot the Adapted WHO-PEN Plus in two (2) selected First-Level Hospitals in both the Zambian peri-urban and rural primary care settings in the first funding phase then mirror this to two (2) more first level hospitals of the same nature in the next funding cycle.
• Operationalising the Clinic model in the hospitals We will select implementation strategies to act at different levels of the Zambian healthcare system to overcome barriers to NCD integration. During the pilot, we will explore facilitators and barriers to the implementation of the WHO PEN-PLUS. The intervention will be fully task-shifted to mid-levels cadres, Clinical Officers and nurses, for implementation and fully integrated into the existing primary health care system in the target districts and facilities.
• Establishment of PEN-Plus Training Centres The Clinics facilities shall be refurbished to include space for training and similar models shall be advocated in other hospitals which shall select the cadres for training. This shall be in preparation for national scaleup. Aim 3: Development of PEN-Plus Policies National Operational Plan In collaboration with the Ministry of Health and WHO Country Office, the processes for the development of the PEN-Plus national operation plan shall be evoked. This work will include assessing gaps in relevant clinical guidelines, formularies, clinical forms, regulations around scope of practice for mid-level providers such as nurses and Clinical Officers, and adaptation of training materials for national use in support of the Ministry of Health. The PEN-Plus national scale up will involve laying the foundation for national scale-up through a clear governance structure led by the MoH. The evolution of PEN-Plus planning shall benefit from MOH leadership and a wide variety of stakeholders including interdisciplinary MOH collaborators across several directorates and programs, implementing partners, academic institutions, civil society, wide-ranging clinical specialists, central hospitals, and funders. Specific objectives For Aim 1:
• To strengthen management of severe and complex non-communicable diseases through task-shifting and task-sharing to most accessible health care workers For Aim 2:
• To improve diagnostic capacities (skills and tools) for NCDs at first-level health facilities.
• To enhance capacities of staff at a first-level hospital through availability of treatment protocols for standardization of treatment of severe and complex NCDs. For Aim 3:
• To strengthen capacities for patient-centred services to improve adherence to NCDs treatment.