Protocol for an evaluation of the initiation of an integrated longitudinal outpatient care model for severe chronic non-communicable diseases (PEN-Plus) at secondary care facilities (district hospitals) in 10 lower-income countries.

INTRODUCTION: The Package of Essential Noncommunicable Disease Interventions-Plus (PEN-Plus) is a strategy decentralising care for severe non-communicable diseases (NCDs) including type 1 diabetes, rheumatic heart disease and sickle cell disease, to increase access to care. In the PEN-Plus model, mid-level clinicians in intermediary facilities in low and lower middle income countries are trained to provide integrated care for conditions where services traditionally were only available at tertiary referral facilities. For the upcoming phase of activities, 18 first-level hospitals in 9 countries and 1 state in India were selected for PEN-Plus expansion and will treat a variety of severe NCDs. Over 3 years, the countries and state are expected to: (1) establish PEN-Plus clinics in one or two district hospitals, (2) support these clinics to mature into training sites in preparation for national or state-level scale-up, and (3) work with the national or state-level stakeholders to describe, measure and advocate for PEN-Plus to support development of a national operational plan for scale-up. METHODS AND ANALYSIS: Guided by Proctor outcomes for implementation research, we are conducting a mixed-method evaluation consisting of 10 components to understand outcomes in clinical implementation, training and policy development. Data will be collected through a mix of quantitative surveys, routine reporting, routine clinical data and qualitative interviews. ETHICS AND DISSEMINATION: This protocol has been considered exempt or covered by central and local institutional review boards. Findings will be disseminated throughout the project's course, including through quarterly M&E discussions, semiannual formative assessments, dashboard mapping of progress, quarterly newsletters, regular feedback loops with national stakeholders and publication in peer-reviewed journals.

Peer Support in the Management of Diabetes to Improve Cardiovascular Disease Outcomes in Low- and Middle-Income Countries (LMICs).

Diabetes and cardiovascular disease (CVD) contribute to significant morbidity and mortality in low-resource settings. Living with diabetes can be overwhelming, isolating, and exhausting, even in settings of resource availability and health care access, while the psychosocial burden of living with diabetes and CVD can be exacerbated by an increased burden of social determinants of health in low-resource settings. Diabetes and CVD care heavily rely on self-management, and health care professionals are now recognizing the importance of peer support in supporting healthy behaviors, psychosocial well-being, and improved clinical outcomes. However, there is currently a lack of consistency in how peer support programs are defined, implemented, and evaluated.

Evaluating implementation of Diabetes Self-Management Education in Maryland County, Liberia: protocol for a pilot prospective cohort study.

INTRODUCTION: Achieving glycaemic targets for people living with diabetes (PLWD) is challenging, especially in settings with limited resources. Programmes need to address gaps in knowledge, skills and self-management. Diabetes Self-Management Education (DSME) is an evidence-based intervention to educate and empower PLWD to improve self-management activities. This protocol describes a pilot study assessing the feasibility, acceptability and effect on clinical outcomes of implementing DSME in clinics caring for people living with insulin-dependent diabetes in Liberia. METHODS AND ANALYSIS: Our protocol is a three-phased, mixed-methods, quasi-experimental prospective cohort study. Phase 1 focuses on (a) establishing a Patient Advisory Board and (b) training providers in DSME who provide care for PLWD. In phase 2, clinicians will implement DSME. In phase 3, we will train additional providers who interact with PLWD.We will assess whether this DSME programme can lead to increased provider knowledge of DSME, improvements in diabetes self-management behaviours, glycaemic control, diabetes knowledge and psychosocial well-being, and a reduction in severe adverse events. Primary outcomes of interest are implementation outcomes and change in frequency of self-management behaviours by patients. Secondary outcomes include change in haemoglobin A1c, psychosocial well-being, severe adverse events and change in provider knowledge of DSME. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Liberia Institutional Review Board (IRB) and the Brigham and Women's Hospital IRB. Findings from the study will be shared with local and national clinical and programmatic stakeholders and published in an open-access, peer-reviewed journal.

Feasibility and effectiveness of self-monitoring of blood glucose among insulin-dependent patients with type 2 diabetes: open randomized control trial in three rural districts in Rwanda.

BACKGROUND: The prevalence of type 2 diabetes in sub Saharan Africa (SSA) has been on the rise. Effective control of blood glucose is key towards reducing the risk of diabetes complications. Findings mainly from high-income countries have demonstrated the effectiveness of self-monitoring of blood-glucose (SMBG) in controlling blood glucose levels. However, there are limited studies describing the implementation of SMBG in rural SSA. This study explores the feasibility and effectiveness of implementing SMBG among patients diagnosed with insulin-dependent type 2 diabetes in rural Rwanda. METHODS: Participants were randomized into intervention (n = 42) and control (n = 38) groups. The intervention group received a glucose-meter, blood test-strips, log-book, waste management box and training on SMBG in addition to usual care. The control group continued with their usual care consisting of, routine monthly medical consultation and health education. The primary outcomes were adherence to the implementation of SMBG (testing schedule and recording data in the log-book) and change in hemoglobin A1c. Descriptive statistics and a paired t-test were used to analyze the primary outcomes. RESULTS: In both the intervention and control arms, majority of the participants were female (59.5% vs 52.6%) and married (71.4% vs 73.7%). Most had at most a primary level education (83.3% vs. 89.4%) and were farmers (54.8% vs. 50.0%). Among those in the intervention group, 63.4% showed good adherence to implementing SMBG based on the number of tests recorded in the glucose meter. Only 20.3% demonstrated accurate recording of the glucose level tests in log-books. The mean difference of the HbA1C from baseline to six months post-intervention was significantly better among the intervention group -0.94% (95% CI -1.46, -0.41) compared to the control group 0.73% (95% CI -0.09, 1.54) p < 0.001. CONCLUSION: Our study showed that among patients with insulin-dependent type 2 diabetes residing in rural Rwanda, SMBG was feasible and demonstrated positive outcomes in improving blood glucose control. However, there is need for strategies to enhance accuracy in recording blood glucose test results in the log-book. TRIAL REGISTRATION: The trial was registered retrospectively on the Pan African Clinical Trial Registry, on 17th May 2019. The registration number is PACTR201905538846394.

High rates of undiagnosed and uncontrolled hypertension upon a screening campaign in rural Rwanda: a cross-sectional study.

BACKGROUND: Hypertension remains the major risk factor for cardiovascular diseases (CVDs) worldwide with a prevalence and mortality in low- and middle-income countries (LMICs) among the highest. The early detection of hypertension risk factors is a crucial pillar for CVD prevention. DESIGN AND METHOD: This cross-sectional study included 4284 subjects, mean age 46 ± 16SD, 56.4% females and mean BMI 26.6 ± 3.7 SD. Data were collected through a screening campaign in rural area of Kirehe District, Eastern of Rwanda, with the objective to characterize and examine the prevalence of elevated blood pressure (BP) and other CVD risk factors. An adapted tool from the World Health Organization STEPwise Approach was used for data collection. Elevated BP was defined as ≥ 140/90 mm/Hg and elevated blood glucose as blood glucose ≥ 100 mg/dL after a 6-h fast. RESULTS: Of the sampled population, 21.2% (n = 910) had an elevated BP at screening; BP was elevated among individuals not previously known to have HTN in 18.7% (n = 752). Among individuals with a prior diagnosis of HTN, 62.2% (n = 158 of 254) BP was uncontrolled. Age, weight, smoking, alcohol history and waist circumference were associated with BP in both univariate analyses and multivariate analysis. CONCLUSION: High rates of elevated BP identified through a health screening campaign in this Rwandan district were surprising given the rural characteristics of the district and relatively low population age. These data highlight the need to implement an adequate strategy for the prevention, diagnosis, and control of HTN that includes rural areas of Rwanda as part of a multicomponent strategy for CVD prevention.

Implementation outcomes of national decentralization of integrated outpatient services for severe non-communicable diseases to district hospitals in Rwanda.

OBJECTIVES: Effective coverage of non-communicable disease (NCD) care in sub-Saharan Africa remains low, with the majority of services still largely restricted to central referral centres. Between 2015 and 2017, the Rwandan Ministry of Health implemented a strategy to decentralise outpatient care for severe chronic NCDs, including type 1 diabetes, heart failure and severe hypertension, to rural first-level hospitals. This study describes the facility-level implementation outcomes of this strategy. METHODS: In 2014, the Ministry of Health trained two nurses in each of the country's 42 first-level hospitals to implement and deliver nurse-led, integrated, outpatient NCD clinics, which focused on severe NCDs. Post-intervention evaluation occurred via repeated cross-sectional surveys, informal interviews and routinely collected clinical data over two rounds of visits in 2015 and 2017. Implementation outcomes included fidelity, feasibility and penetration. RESULTS: By 2017, all NCD clinics were staffed by at least one NCD-trained nurse. Among the approximately 27 000 nationally enrolled patients, hypertension was the most common diagnosis (70%), followed by type 2 diabetes (19%), chronic respiratory disease (5%), type 1 diabetes (4%) and heart failure (2%). With the exception of warfarin and beta-blockers, national essential medicines were available at more than 70% of facilities. Clinicians adhered to clinical protocols at approximately 70% agreement with evaluators. CONCLUSION: The government of Rwanda was able to scale a nurse-led outpatient NCD programme to all first-level hospitals with good fidelity, feasibility and penetration as to expand access to care for severe NCDs.

Availability, Costs and Stock-Outs of Essential NCD Drugs in Three Rural Rwandan Districts.

Background: To reduce the non-communicable diseases (NCDs) burden, the World Health Organization has set a target to reach 80% availability of the affordable essential medicines required to treat NCDs by 2025. Objectives: This study described the availability, costs, and stock-outs of essential NCD drugs in three rural Rwandan districts. Methods: We retrospectively assessed 54 NCD drugs listed for district hospitals or health centers in the Rwanda national essential medicines list. Data were collected from three district hospitals and 17 health centers that host NCD clinics. We extracted data on drug availability, quantity dispensed, costs, stock-outs, and the replenishing supplier for these drugs between January 1 and December 31, 2017. Results: Overall, 71% of essential medicines for health centers and 78% of essential medicines for district hospitals were available at facilities. Only 15% of health centers experienced a stock-out of beclomethasone, while 77% experienced at least one stock-out of amlodipine and metformin. The median length of stock-out ranged from nine to 72 days, and 78% of the stock-outs across all health centers were replenished by a Non-Governmental Organization (NGO) partner. Except for enoxaparin and metformin, all district hospitals experienced at least one stock-out of each drug. The median length of stock-out ranged from 3.5 to 228 days, and 82% of the stock-outs across all district hospitals were replenished by the Rwandan Ministry of Health (RMOH). The least expensive drug was digoxin ($0.02, Interquartile range (IQR): 0.01, 0.10), while the most expensive was beclomethasone ($9.35, IQR: 3.00, 13.20). Conclusions: This study shows the viability of drug-supported NCD care in rural settings of sub-Saharan Africa. Stock-outs are a challenge; our study emphasizes the importance of the MOH/NGO partnerships in this context. Medicine costs are also challenging, though, in these districts, drugs are more affordable through community-based health insurance, government, and NGO partner subsidies.

Implementation of blood glucose self-monitoring among insulin-dependent patients with type 2 diabetes in three rural districts in Rwanda: 6 months open randomised controlled trial.

INTRODUCTION: Most patients diagnosed with diabetes in sub-Saharan Africa (SSA) present with poorly controlled blood glucose, which is associated with increased risks of complications and greater financial burden on both the patients and health systems. Insulin-dependent patients with diabetes in SSA lack appropriate home-based monitoring technology to inform themselves and clinicians of the daily fluctuations in blood glucose. Without sufficient home-based data, insulin adjustments are not data driven and adopting individual behavioural change for glucose control in SSA does not have a systematic path towards improvement. METHODS AND ANALYSIS: This study explores the feasibility and impact of implementing self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes in rural Rwandan districts. This is an open randomised controlled trial comprising of two arms: (1) Intervention group-participants will receive a glucose metre, blood test strips, logbook, waste management box and training on how to conduct SMBG in additional to usual care and (2) Control group-participants will receive usual care, comprising of clinical consultations and routine monthly follow-up. We will conduct qualitative interviews at enrolment and at the end of the study to assess knowledge of diabetes. At the end of the study period, we will interview clinicians and participants to assess the perceived usefulness, facilitators and barriers of SMBG. The primary outcomes are change in haemoglobin A1c, fidelity to SMBG protocol by patients, appropriateness and adverse effects resulting from SMBG. Secondary outcomes include reliability and acceptability of SMBG and change in the quality of life of the participants. ETHICS AND DISSEMINATION: This study has been approved by the Rwanda National Ethics Committee (Kigali, Rwanda No.102/RNEC/2018). We will disseminate the findings of this study through presentations within our study settings, scientific conferences and publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: PACTR201905538846394; pre-results.

Integration of Chronic Oncology Services in Noncommunicable Disease Clinic in Rural Rwanda.

Background: In rural sub-Saharan Africa, access to care for severe non-communicable diseases (NCDs) is limited due to myriad delivery challenges. We describe the implementation, patient characteristics, and retention rate of an integrated NCD clinic inclusive of cancer services at a district hospital in rural Rwanda. Methods: In 2006, the Rwandan Ministry of Health at Rwinkwavu District Hospital (RDH) and Partners In Health established an integrated NCD clinic focused on nurse-led care of severe NCDs, within a single delivery platform. Implementation modifications were made in 2011 to include cancer services. For this descriptive study, we abstracted medical record data for 15 months after first clinic visit for all patients who enrolled in the NCD clinic between 1 July 2012 and 30 June 2014. We report descriptive statistics of patient characteristics and retention. Results: Three hundred forty-seven patients enrolled during the study period: oncology - 71.8%, hypertension - 10.4%, heart failure - 11.0%, diabetes - 5.5%, and chronic respiratory disease (CRD) - 1.4%. Twelve-month retention rates were: oncology - 81.6%, CRD - 60.0%, hypertension - 75.0%, diabetes - 73.7%, and heart failure - 47.4%. Conclusions: The integrated NCD clinic filled a gap in accessible care for severe NCDs, including cancer, at rural district hospitals. This novel approach has illustrated good retention rates.

Cost of integrated chronic care for severe non-communicable diseases at district hospitals in rural Rwanda.

BACKGROUND: Integrated clinical strategies to address non-communicable disease (NCDs) in sub-Saharan Africa have largely been directed to prevention and treatment of common conditions at primary health centres. This study examines the cost of organising integrated nurse-driven, physician-supervised chronic care for more severe NCDs at an outpatient specialty clinic associated with a district hospital in rural Rwanda. Conditions addressed included type 1 and type 2 diabetes, chronic respiratory disease, heart failure and rheumatic heart disease. METHODS: A retrospective costing analysis was conducted from the facility perspective using data from administrative sources and the electronic medical record systems of Butaro District Hospital in rural Rwanda. We determined initial start-up and annual operating financial cost of the Butaro district advanced NCD clinic for the fiscal year 2013-2014. Per-patient annual cost by disease category was determined. RESULTS: A total of US$47 976 in fixed start-up costs was necessary to establish a new advanced NCD clinic serving a population of approximately 300 000 people (US$0.16 per capita). The additional annual operating cost for this clinic was US$68 975 (US$0.23 per capita) to manage a 632-patient cohort and provide training, supervision and mentorship to primary health centres. Labour comprised 54% of total cost, followed by medications at 17%. Diabetes mellitus had the highest annual cost per patient (US$151), followed by heart failure (US$104), driven primarily by medication therapy and laboratory testing. CONCLUSIONS: This is the first study to evaluate the costs of integrated, decentralised chronic care for some severe NCDs in rural sub-Saharan Africa. The findings show that these services may be affordable to governments even in the most constrained health systems.

10-Year Heart Failure Outcomes From Nurse-Driven Clinics in Rural Sub-Saharan Africa.

Nurse-led delivery care models have the potential to address the significant burden of heart failure in sub-Saharan Africa. Starting in 2006, the Rwandan Ministry of Health, supported by Inshuti Mu Buzima (Partners In Health-Rwanda), decentralized heart failure diagnosis and care delivery in the context of advanced nurse-led integrated noncommunicable clinics at rural district hospitals. Here, the authors describe the first medium-term survival outcomes from the district level in rural sub-Saharan Africa based on their 10-year experience providing care in rural Rwanda. Kaplan-Meier methods were used to determine median time to event for: 1) composite event of known death from any cause, lost to follow-up, or transfer to estimate worst-case mortality; and 2) known death only. Five-year event-free rates were 41.7% for the composite outcome and 64.3% for known death. While death rates are encouraging, efforts to reduce loss to follow-up are needed.

Understanding the Etiology of Heart Failure Among the Rural Poor in Sub-Saharan Africa: A 10-Year Experience From District Hospitals in Rwanda.

BACKGROUND: Heart failure is a significant cause of morbidity and mortality in sub-Saharan Africa. Our understanding of the heart failure burden in this region has been limited mainly to registries from urban referral centers. Starting in 2006, a nurse-driven strategy was initiated to provide echocardiography and decentralized heart failure care within noncommunicable disease (NCD) clinics in rural district hospitals in Rwanda. METHODS AND RESULTS: We conducted a retrospective review of patients with cardiologist-confirmed heart failure treated at 3 district hospital NCD clinics in Rwanda from 2006 to 2017 to determine patient clinical characteristics and disease distribution. Over 10 years, 719 patients with confirmed heart failure were identified. Median age was 27 years overall, and 42 years in adults. Thirty-six percent were children (age <18 years), 68% were female, and 78% of adults were farmers. At entry, 39% were in New York Heart Association functional class III-IV. Among children, congenital heart disease (52%) and rheumatic heart disease (36%) were most common. In adults, cardiomyopathy (40%), rheumatic heart disease (27%), and hypertensive heart disease (13%) were most common. No patients were diagnosed with ischemic cardiomyopathy. CONCLUSIONS: The results of the largest single-country heart failure cohort from rural sub-Saharan Africa demonstrate a persistent burden of rheumatic disease and nonischemic cardiomyopathies.

Outcomes for patients with rheumatic heart disease after cardiac surgery followed at rural district hospitals in Rwanda.

BACKGROUND: In sub-Saharan Africa, continued clinical follow-up, after cardiac surgery, is only available at urban referral centres. We implemented a decentralised, integrated care model to provide longitudinal care for patients with advanced rheumatic heart disease (RHD) at district hospitals in rural Rwanda before and after heart surgery. METHODS: We collected data from charts at non-communicable disease (NCD) clinics at three rural district hospitals in Rwanda to describe the outcomes of 54 patients with RHD who received cardiac valve surgery during 2007-2015. RESULTS: The majority of patients were adults (46/54; 85%), and 74% were females. The median age at the time of surgery was 22 years in adults and 11 years in children. Advanced symptoms-New York Heart Association class III or IV-were present in 83% before surgery and only 4% afterwards. The mitral valve was the most common valve requiring surgery. Valvular surgery consisted mostly of a single valve (56%) and double valve (41%). Patients were followed for a median of 3 years (range 0.2-7.9) during which 7.4% of them died; all deaths were patients who had undergone bioprosthetic valve replacement. For patients with mechanical valves, anticoagulation was checked at 96% of visits. There were no known bleeding or thrombotic events requiring hospitalisation. CONCLUSION: Outcomes of postoperative patients with RHD tracked in rural Rwanda health facilities were generally good. With appropriate training and supervision, it is feasible to safely decentralise follow-up of patients with RHD to nurse-led specialised NCD clinics after cardiac surgery.

A Clinical Mentorship and Quality Improvement Program to Support Health Center Nurses Manage Type 2 Diabetes in Rural Rwanda.

INTRODUCTION: The prevalence of diabetes mellitus is rapidly rising in SSA. Interventions are needed to support the decentralization of services to improve and expand access to care. We describe a clinical mentorship and quality improvement program that connected nurse mentors with nurse mentees to support the decentralization of type 2 diabetes care in rural Rwanda. METHODS: This is a descriptive study. Routinely collected data from patients with type 2 diabetes cared for at rural health center NCD clinics between January 1, 2013 and December 31, 2015, were extracted from EMR system. Data collected as part of the clinical mentorship program were extracted from an electronic database. Summary statistics are reported. RESULTS: The patient population reflects the rural settings, with low rates of traditional NCD risk factors: 5.6% of patients were current smokers, 11.0% were current consumers of alcohol, and 11.9% were obese. Of 263 observed nurse mentee-patient encounters, mentor and mentee agreed on diagnosis 94.4% of the time. Similarly, agreement levels were high for medication, laboratory exam, and follow-up plans, at 86.3%, 87.1%, and 92.4%, respectively. CONCLUSION: Nurses that receive mentorship can adhere to a type 2 diabetes treatment protocol in rural Rwanda primary health care settings.

Pursuing equity in cancer care: implementation, challenges and preliminary findings of a public cancer referral center in rural Rwanda.

BACKGROUND: Cancer services are inaccessible in many low-income countries, and few published examples describe oncology programs within the public sector. In 2011, the Rwanda Ministry of Health (RMOH) established Butaro Cancer Center of Excellence (BCCOE) to expand cancer services nationally. In hopes of informing cancer care delivery in similar settings, we describe program-level experience implementing BCCOE, patient characteristics, and challenges encountered. METHODS: Butaro Cancer Center of Excellence was founded on diverse partnerships that emphasize capacity building. Services available include pathology-based diagnosis, basic imaging, chemotherapy, surgery, referral for radiotherapy, palliative care and socioeconomic access supports. Retrospective review of electronic medical records (EMR) of patients enrolled between July 1, 2012 and June 30, 2014 was conducted, supplemented by manual review of paper charts and programmatic records. RESULTS: In the program's first 2 years, 2326 patients presented for cancer-related care. Of these, 70.5% were female, 4.3% children, and 74.3% on public health insurance. In the first year, 66.3% (n = 1144) were diagnosed with cancer. Leading adult diagnoses were breast, cervical, and skin cancer. Among children, nephroblastoma, acute lymphoblastic leukemia, and Hodgkin lymphoma were predominant. As of June 30, 2013, 95 cancer patients had died. Challenges encountered include documentation gaps and staff shortages. CONCLUSION: Butaro Cancer Center of Excellence demonstrates that complex cancer care can be delivered in the most resource-constrained settings, accessible to vulnerable patients. Key attributes that have made BCCOE possible are: meaningful North-south partnerships, innovative task- and infrastructure-shifting, RMOH leadership, and an equity-driven agenda. Going forward, we will apply our experiences and lessons learned to further strengthen BCCOE, and employ the developed EMR system as a valuable platform to assess long-term clinical outcomes and improve care.

A simplified echocardiographic strategy for heart failure diagnosis and management within an integrated noncommunicable disease clinic at district hospital level for sub-Saharan Africa.

OBJECTIVES: This study sought to describe a decentralized strategy for heart failure diagnosis and management and report the clinical epidemiology at district hospitals in rural Rwanda. BACKGROUND: Heart failure contributes significantly to noncommunicable disease burden in sub-Saharan Africa. Specialized care is provided primarily at referral hospitals by physicians, limiting patients' access. Simplifying clinical strategies can facilitate decentralization of quality care to the district hospital level and improve care delivery. METHODS: Heart failure services were established within integrated advanced noncommunicable disease clinics in 2 rural district hospitals in Rwanda. Nurses, supervised by physicians, were trained to use simplified diagnostic and treatment algorithms including echocardiography with diagnoses confirmed by a cardiologist. Data on 192 heart failure patients treated between November 2006 and March 2011 were reviewed from an electronic medical record. RESULTS: In our study population, the median age was 35 years, 70% were women, 63% were subsistence farmers, and 6% smoked tobacco. At entry, 47% had New York Heart Association class III or IV functional status. Of children age <18 years (n = 54), rheumatic heart disease (48%), congenital heart disease (39%), and dilated cardiomyopathy (9%) were the leading diagnoses. Among adults (n = 138), dilated cardiomyopathy (54%), rheumatic heart disease (25%), and hypertensive heart disease (8%) were most common. During follow-up, 62% were retained in care, whereas 9% died and 29% were lost to follow-up. CONCLUSIONS: In rural Rwanda, the causes of heart failure are almost exclusively nonischemic even though patients often present with advanced symptoms. Training nurses, supervised by physicians, in simplified protocols and basic echocardiography is 1 approach to integrated, decentralized care for this vulnerable population.