Measuring fidelity, feasibility, costs: an implementation evaluation of a cluster-controlled trial of group antenatal care in rural Nepal.

BACKGROUND: Access to high-quality antenatal care services has been shown to be beneficial for maternal and child health. In 2016, the WHO published evidence-based recommendations for antenatal care that aim to improve utilization, quality of care, and the patient experience. Prior research in Nepal has shown that a lack of social support, birth planning, and resources are barriers to accessing services in rural communities. The success of CenteringPregnancy and participatory action women's groups suggests that group care models may both improve access to care and the quality of care delivered through women's empowerment and the creation of social networks. We present a group antenatal care model in rural Nepal, designed and implemented by the healthcare delivery organization Nyaya Health Nepal, as well as an assessment of implementation outcomes. METHODS: The study was conducted at Bayalata Hospital in Achham, Nepal, via a public private partnership between the Nepali non-profit, Nyaya Health Nepal, and the Ministry of Health and Population, with financial and technical assistance from the American non-profit, Possible. We implemented group antenatal care as a prospective non-randomized cluster-controlled, type I hybrid effectiveness-implementation study in six village clusters. The implementation approach allows for iterative improvement in design, making changes to improve the quality of the intervention. Assessments of implementation process and model fidelity were undertaken using a mobile checklist completed by nurse supervisors, and observation forms completed by program leadership. We evaluated data quarterly using descriptive statistics to identify trends. Qualitative interviews and team communications were analyzed through immersion crystallization to identify major themes that evolved during the implementation process. RESULTS: A total of 141 group antenatal sessions were run during the study period. This paper reports on implementation results, whereas we analyze and present patient-level effectiveness outcomes in a complementary paper in this journal. There was high process fidelity to the model, with 85.7% (95% CI 77.1-91.5%) of visits completing all process elements, and high content fidelity, with all village clusters meeting the minimum target frequency for 80% of topics. The annual per capita cost for group antenatal care was 0.50 USD. Qualitative analysis revealed the compromise of stable gestation-matched composition of the group members in order to make the intervention feasible. Major adaptations were made in training, documentation, feedback and logistics. CONCLUSION: Group antenatal care provided in collaboration with local government clinics has the potential to provide accessible and high quality antenatal care to women in rural Nepal. The intervention is a feasible and affordable alternative to individual antenatal care. Our experience has shown that adaptation from prior models was important for the program to be successful in the local context within the national healthcare system. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02330887, registered 01/05/2015, retroactively registered.

The power of peers: an effectiveness evaluation of a cluster-controlled trial of group antenatal care in rural Nepal.

BACKGROUND: Reducing the maternal mortality ratio to less than 70 per 100,000 live births globally is one of the Sustainable Development Goals. Approximately 830 women die from pregnancy- or childbirth-related complications every day. Almost 99% of these deaths occur in developing countries. Increasing antenatal care quality and completion, and institutional delivery are key strategies to reduce maternal mortality, however there are many implementation challenges in rural and resource-limited settings. In Nepal, 43% of deliveries do not take place in an institution and 31% of women have insufficient antenatal care. Context-specific and evidence-based strategies are needed to improve antenatal care completion and institutional birth. We present an assessment of effectiveness outcomes for an adaptation of a group antenatal care model delivered by community health workers and midwives in close collaboration with government staff in rural Nepal. METHODS: The study was conducted in Achham, Nepal, via a public private partnership between the Nepali non-profit, Nyaya Health Nepal, and the Ministry of Health and Population, with financial and technical assistance from the American non-profit, Possible. We implemented group antenatal care as a prospective non-randomized, cluster-controlled, type I hybrid effectiveness-implementation study in six village clusters. The implementation approach allowed for iterative improvement in design by making changes to improve the quality of the intervention. We evaluated effectiveness through a difference in difference analysis of institutional birth rates between groups prior to implementation of the intervention and 1 year after implementation. Additionally, we assessed the change in knowledge of key danger signs and the acceptability of the group model compared with individual visits in a nested cohort of women receiving home visit care and home visit care plus group antenatal care. Using a directed content and thematic approach, we analyzed qualitative interviews to identify major themes related to implementation. RESULTS: At baseline, there were 457 recently-delivered women in the six village clusters receiving home visit care and 214 in the seven village clusters receiving home visit care plus group antenatal care. At endline, there were 336 and 201, respectively. The difference in difference analysis did not show a significant change in institutional birth rates nor antenatal care visit completion rates between the groups. There was, however, a significant increase in both institutional birth and antenatal care completion in each group from baseline to endline. We enrolled a nested cohort of 52 participants receiving home visit care and 62 participants receiving home visit care plus group antenatal care. There was high acceptability of the group antenatal care intervention and home visit care, with no significant differences between groups. A significantly higher percentage of women who participated in group antenatal care found their visits to be 'very enjoyable' (83.9% vs 59.6%, p = 0.0056). In the nested cohort, knowledge of key danger signs during pregnancy significantly improved from baseline to endline in the intervention clusters only (2 to 31%, p < 0.001), while knowledge of key danger signs related to labor and childbirth, the postpartum period, and the newborn did not in either intervention or control groups. Qualitative analysis revealed that women found that the groups provided an opportunity for learning and discussion, and the groups were a source of social support and empowerment. They also reported an improvement in services available at their village clinic. Providers noted the importance of the community health workers in identifying pregnant women in the community and linking them to the village clinics. Challenges in birth planning were brought up by both participants and providers. CONCLUSION: While there was no significant change in institutional birth and antenatal care completion at the population level between groups, there was an increase of these outcomes in both groups. This may be secondary to the primary importance of community health worker involvement in both of these groups. Knowledge of key pregnancy danger signs was significantly improved in the home visit plus group antenatal care cohort compared with the home visit care only group. This initial study of Nyaya Health Nepal's adapted group care model demonstrates the potential for impacting women's antenatal care experience and should be studied over a longer period as an intervention embedded within a community health worker program. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02330887 , registered 01/05/2015, retroactively registered.

A Type II hybrid effectiveness-implementation study of an integrated CHW intervention to address maternal healthcare in rural Nepal.

Skilled care during pregnancy, childbirth, and postpartum is essential to prevent adverse maternal health outcomes, yet utilization of care remains low in many resource-limited countries, including Nepal. Community health workers (CHWs) can mitigate health system challenges and geographical barriers to achieving universal health coverage. Gaps remain, however, in understanding whether evidence-based interventions delivered by CHWs, closely aligned with WHO recommendations, are effective in Nepal's context. We conducted a type II hybrid effectiveness-implementation, mixed-methods study in two rural districts in Nepal to evaluate the effectiveness and the implementation of an evidence-based integrated maternal and child health intervention delivered by CHWs, using a mobile application. The intervention was implemented stepwise over four years (2014-2018), with 65 CHWs enrolling 30,785 families. We performed a mixed-effects Poisson regression to assess institutional birth rate (IBR) pre-and post-intervention. We used the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to evaluate the implementation during and after the study completion. There was an average 30% increase in IBR post-intervention, adjusting for confounding variables (p<0.0001). Study enrollment showed 35% of families identified as dalit, janjati, or other castes. About 78-89% of postpartum women received at least one CHW-counseled home visit within 60 days of childbirth. Ten (53% of planned) municipalities adopted the intervention during the study period. Implementation fidelity, measured by median counseled home visits, improved with intervention time. The intervention was institutionalized beyond the study period and expanded to four additional hubs, albeit with adjustments in management and supervision. Mechanisms of intervention impact include increased knowledge, timely referrals, and longitudinal CHW interaction. Full-time, supervised, and trained CHWs delivering evidence-based integrated care appears to be effective in improving maternal healthcare in rural Nepal. This study contributes to the growing body of evidence on the role of community health workers in achieving universal health coverage.

Community-based postpartum contraceptive counselling in rural Nepal: a mixed-methods evaluation.

Unmet need for postpartum contraception in rural Nepal remains high and expanding access to sexual and reproductive healthcare is essential to achieving universal healthcare. We evaluated the impact of an integrated intervention that employed community health workers aided by mobile technology to deliver patient-centred, home-based antenatal and postnatal counselling on postpartum modern contraceptive use. This was a pre-post-intervention study in seven village wards in a single municipality in rural Nepal. The primary outcome was modern contraceptive use among recently postpartum women. We performed a multivariable logistic regression to examine contraceptive use among postpartum women pre- and one-year post-intervention. We conducted qualitative interviews to explore the implementation process. There were 445 postpartum women in the pre-intervention group and 508 in the post-intervention group. Modern contraceptive use increased from 29% pre-intervention to 46% post-intervention (p < 0.0001). Adjusting for age, caste, and household expenditure, time since delivery and sex of child in the index pregnancy, postpartum women one-year post-intervention had twice the odds (OR 2.3; CI 1.7, 3.1; p < 0.0001) of using a modern contraceptive method as compared to pre-intervention. Factors at the individual, family, and systems level influenced women's contraceptive decisions. The intervention contributed to increasing contraceptive use through knowledge transfer, demand generation, referrals to healthcare facilities, and follow-up. A community-based, patient-centred contraceptive counselling intervention supported by mobile technology and integrated into longitudinal care delivered by community health workers appears to be an effective strategy for improving uptake of modern contraception among postpartum women in rural Nepal.

Costing Analysis of a Pilot Community Health Worker Program in Rural Nepal.

Community health workers (CHWs) are essential to primary health care systems and are a cost-effective strategy to achieve the Sustainable Development Goals (SDGs). Nepal is strongly committed to universal health coverage and the SDGs. In 2017, the Nepal Ministry of Health and Population partnered with the nongovernmental organization Nyaya Health Nepal to pilot a program aligned with the 2018 World Health Organization guidelines for CHWs. The program includes CHWs who: (1) receive regular financial compensation; (2) meet a minimum education level; (3) are well supervised; (4) are continuously trained; (5) are integrated into local primary health care systems; (6) use mobile health tools; (7) have consistent supply chain; (8) live in the communities they serve; and (9) provide service without point-of-care user fees. The pilot model has previously demonstrated improved institutional birth rate, antenatal care completion, and postpartum contraception utilization. Here, we performed a retrospective costing analysis from July 16, 2017 to July 15, 2018, in a catchment area population of 60,000. The average per capita annual cost is US$3.05 (range: US$1.94 to US$4.70 across 24 villages) of which 74% is personnel cost. Service delivery and administrative costs and per beneficiary costs for all services are also described. To address the current discourse among Nepali policy makers at the local and federal levels, we also present 3 alternative implementation scenarios that policy makers may consider. Given the Government of Nepal's commitment to increase health care spending (US$51.00 per capita) to 7.0% of the 2030 gross domestic product, paired with recent health care systems decentralization leading to expanded fiscal space in municipalities, this CHW program provides a feasible opportunity to make progress toward achieving universal health coverage and the health-related SDGs. This costing analysis offers insights and practical considerations for policy makers and locally elected officials for deploying a CHW cadre as a mechanism to achieve the SDG targets.

Designing and implementing an integrated non-communicable disease primary care intervention in rural Nepal.

Low-income and middle-income countries are struggling with a growing epidemic of non-communicable diseases. To achieve the Sustainable Development Goals, their healthcare systems need to be strengthened and redesigned. The Starfield 4Cs of primary care-first-contact access, care coordination, comprehensiveness and continuity-offer practical, high-quality design options for non-communicable disease care in low-income and middle-income countries. We describe an integrated non-communicable disease intervention in rural Nepal using the 4C principles. We present 18 months of retrospective assessment of implementation for patients with type II diabetes, hypertension and chronic obstructive pulmonary disease. We assessed feasibility using facility and community follow-up as proxy measures, and assessed effectiveness using singular 'at-goal' metrics for each condition. The median follow-up for diabetes, hypertension and chronic obstructive pulmonary disease was 6, 6 and 7 facility visits, and 10, 10 and 11 community visits, respectively (0.9 monthly patient touch-points). Loss-to-follow-up rates were 16%, 19% and 22%, respectively. The median time between visits was approximately 2 months for facility visits and 1 month for community visits. 'At-goal' status for patients with chronic obstructive pulmonary disease improved from baseline to endline (p=0.01), but not for diabetes or hypertension. This is the first integrated non-communicable disease intervention, based on the 4C principles, in Nepal. Our experience demonstrates high rates of facility and community follow-up, with comparatively low lost-to-follow-up rates. The mixed effectiveness results suggest that while this intervention may be valuable, it may not be sufficient to impact outcomes. To achieve the Sustainable Development Goals, further implementation research is urgently needed to determine how to optimise non-communicable disease interventions.

An integrated community health worker intervention in rural Nepal: a type 2 hybrid effectiveness-implementation study protocol.

BACKGROUND: Evidence-based medicines, technologies, and protocols exist to prevent many of the annual 300,000 maternal, 2.7 million neonatal, and 9 million child deaths, but they are not being effectively implemented and utilized in rural areas. Nepal, one of South Asia's poorest countries with over 80% of its population living in rural areas, exemplifies this challenge. Community health workers are an important cadre in low-income countries where human resources for health and health care infrastructure are limited. As local women, they are uniquely positioned to understand and successfully navigate barriers to health care access. Recent case studies of large community health worker programs have highlighted the importance of training, both initial and ongoing, and accountability through structured management, salaries, and ongoing monitoring and evaluation. A gap in the evidence regarding whether such community health worker systems can change health outcomes, as well as be sustainably adopted at scale, remains. In this study, we plan to evaluate a community health worker system delivering an evidence-based integrated reproductive, maternal, newborn, and child health intervention as it is scaled up in rural Nepal. METHODS: We will conduct a type 2 hybrid effectiveness-implementation study to test both the effect of an integrated reproductive, maternal, newborn, and child health intervention and the implementation process via a professional community health worker system. The intervention integrates five evidence-based approaches: (1) home-based antenatal care and post-natal care counseling and care coordination; (2) continuous surveillance of all reproductive age women, pregnancies, and children under age 2 years via a mobile application; (3) Community-Based Integrated Management of Newborn and Childhood Illness; (4) group antenatal and postnatal care; and 5) the Balanced Counseling Strategy to post-partum contraception. We will evaluate effectiveness using a pre-post quasi-experimental design with stepped implementation and implementation using the RE-AIM framework. DISCUSSION: This is the first hybrid effectiveness-implementation study of an integrated reproductive, maternal, newborn, and child health intervention in rural Nepal that we are aware of. As Nepal takes steps towards achieving the Sustainable Development Goals, the data from this three-year study will be useful in the detailed planning of a professionalized community health worker cadre delivering evidence-based reproductive, maternal, newborn, and child health interventions to the country's rural population. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03371186 , registered 04 December 2017, retrospectively registered.

Developing and deploying a community healthcare worker-driven, digitally- enabled integrated care system for municipalities in rural Nepal.

Integrating care at the home and facility level is a critical yet neglected function of healthcare delivery systems. There are few examples in practice or in the academic literature of affordable, digitally-enabled integrated care approaches embedded within healthcare delivery systems in low- and middle-income countries. Simultaneous advances in affordable digital technologies and community healthcare workers offer an opportunity to address this challenge. We describe the development of an integrated care system involving community healthcare worker networks that utilize a home-to-facility electronic health record platform for rural municipalities in Nepal. Key aspects of our approach of relevance to a global audience include: community healthcare workers continuously engaging with populations through household visits every three months; community healthcare workers using digital tools during the routine course of clinical care; individual and population-level data generated routinely being utilized for program improvement; and being responsive to privacy, security, and human rights concerns. We discuss implementation, lessons learned, challenges, and opportunities for future directions in integrated care delivery systems.

Accountable Care Reforms Improve Women's And Children's Health In Nepal.

Over the past decade the Ministry of Health of Nepal and the nonprofit Possible have partnered to deliver primary and secondary health care via a public-private partnership. We applied an accountable care framework that we previously developed to describe the delivery of their integrated reproductive, maternal, newborn, and child health services in the Achham district in rural Nepal. In a prospective pre-post study, examining pregnancies at baseline and 541 pregnancies in follow-up over the course of eighteen months, we found an improvement in population-level indicators linked to reducing maternal and infant mortality: receipt of four antenatal care visits (83 percent to 90 percent), institutional birth rate (81 percent to 93 percent), and the prevalence of postpartum contraception (19 percent to 47 percent). The intervention cost $3.40 per capita (at the population level) and $185 total per pregnant woman who received services. This study provides new analysis and evidence on the implementation of innovative care and financing models in resource-limited settings.

Power, potential, and pitfalls in global health academic partnerships: review and reflections on an approach in Nepal.

BACKGROUND: Global health academic partnerships are centered around a core tension: they often mirror or reproduce the very cross-national inequities they seek to alleviate. On the one hand, they risk worsening power dynamics that perpetuate health disparities; on the other, they form an essential response to the need for healthcare resources to reach marginalized populations across the globe. OBJECTIVES: This study characterizes the broader landscape of global health academic partnerships, including challenges to developing ethical, equitable, and sustainable models. It then lays out guiding principles of the specific partnership approach, and considers how lessons learned might be applied in other resource-limited settings. METHODS: The experience of a partnership between the Ministry of Health in Nepal, the non-profit healthcare provider Possible, and the Health Equity Action and Leadership Initiative at the University of California, San Francisco School of Medicine was reviewed. The quality and effectiveness of the partnership was assessed using the Tropical Health and Education Trust Principles of Partnership framework. RESULTS: Various strategies can be taken by partnerships to better align the perspectives of patients and public sector providers with those of expatriate physicians. Actions can also be taken to bring greater equity to the wealth and power gaps inherent within global health academic partnerships. CONCLUSIONS: This study provides recommendations gleaned from the analysis, with an aim towards both future refinement of the partnership and broader applications of its lessons and principles. It specifically highlights the importance of targeted engagements with academic medical centers and the need for efficient organizational work-flow practices. It considers how to both prioritize national and host institution goals, and meet the career development needs of global health clinicians.

Practical issues in the measurement of child survival in health systems trials: experience developing a digital community-based mortality surveillance programme in rural Nepal.

Child mortality measurement is essential to the impact evaluation of maternal and child healthcare systems interventions. In the absence of vital statistics systems, however, assessment methodologies for locally relevant interventions are severely challenged. Methods for assessing the under-5 mortality rate for cross-country comparisons, often used in determining progress towards development targets, pose challenges to implementers and researchers trying to assess the population impact of targeted interventions at more local levels. Here, we discuss the programmatic approach we have taken to mortality measurement in the context of delivering healthcare via a public-private partnership in rural Nepal. Both government officials and the delivery organisation, Possible, felt it was important to understand child mortality at a fine-grain spatial and temporal level. We discuss both the short-term and the long-term approach. In the short term, the team chose to use the under-2 mortality rate as a metric for mortality measurement for the following reasons: (1) as overall childhood mortality declines, like it has in rural Nepal, deaths concentrate among children under the age of 2; (2) 2-year cohorts are shorter and thus may show an impact more readily in the short term of intervention trials; and (3) 2-year cohorts are smaller, making prospective census cohorts more feasible in small populations. In the long term, Possible developed a digital continuous surveillance system to capture deaths as they occur, at which point under-5 mortality assessment would be desirable, largely owing to its role as a global standard.