Improving neonatal health with family-centered, early postnatal care: A quasi-experimental study in India.

Despite the global decline, neonatal mortality rates (NMR) remain high in India. Family members are often responsible for the postpartum care of neonates and mothers. Yet, low health literacy and varied beliefs can lead to poor health outcomes. Postpartum education for family caregivers, may improve the adoption of evidence-based neonatal care and health outcomes. The Care Companion Program (CCP) is a hospital-based, pre-discharge health training session where nurses teach key healthy behaviors to mothers and family members, including skills and an opportunity to practice them in the hospital. We conducted a quasi-experimental study to assess the effect of the CCP sessions on mortality outcomes among families seeking care in 28 public tertiary facilities across 4 Indian states. Neonatal mortality outcomes were reported post-discharge, collected via phone surveys at four weeks postpartum, between October 2018 to February 2020. Risk ratios (RR), adjusting for hospital-level clustering, were calculated by comparing mortality rates before and after CCP implementation. A total of 46,428 families participated in the pre-intervention group and 87,305 in the post-intervention group; 76% of families completed the phone survey. Among the 33,599 newborns born before the CCP implementation, there were 1386 deaths (NMR: 41.3 deaths per 1000 live births). After the intervention began, there were 2021 deaths out of 60,078 newborns born (crude NMR: 33.6 deaths per 1000 live births, RR = 0.82, 95% CI: 0.76, 0.87; cluster-adjusted RR = 0.82, 95% CI: 0.71, 0.94). There may be a substantial benefit to family-centered education in the early postnatal period to reduce neonatal mortality.

Qualitative assessment of family caregiver-centered neonatal education program in Karnataka, India.

Globally 2.5 million newborns die every year before they reach the age of one month; the majority of these deaths occur in low- and middle-income countries. Among other factors, inadequate knowledge and skills to take care of newborns contribute to these deaths. To fill this gap, training patients and family members on the behaviors needed to improve essential newborn care practices at home is a promising opportunity. One program that aims to do this is the Care Companion Program (CCP) which provides in-hospital, skills-based training on care of mothers and newborns to families. This study uses semi-structured interviews to understand how and why knowledge and behaviors of maternal and newborn care behaviors change (or don't change) as a result of CCP sessions and participants' perception of the impact of CCP on change. Interviews focused on knowledge and behaviors around key neonatal and newborn topics and health seeking behaviors for health complications. Forty-two in-depth interviews were conducted among families with recently-delivered babies at their homes from four districts in Karnataka, India. Respondents have a positive perception about CCP, found training useful and appreciated other family members presence during the training. CCP increased knowledge and awareness and provided critical details to key behaviors like breastfeeding. Respondents were more likely to be receptive toward details on already known topics, like hand washing before touching the baby. Awareness increased on newly learned behaviors, like skin-to-skin care, which don't conflict with cultural norms. The CCP did not influence nonrestrictive maternal diet as much, which cultural norms heavily influence. In-hospital family caregiver education programs, like CCP, can positively influence key neonatal behaviors by imparting knowledge and key skills. However, the effect is not universal across health behaviors.

Does Quality Certification Work? An Assessment of Manyata, a Childbirth Quality Program in India's Private Sector.

BACKGROUND: In India, more than 60% of hospital beds are in private facilities, yet several studies have observed suboptimal quality of care in private facilities. We aimed to understand the role of Manyata, a quality improvement initiative in private facilities focused on mentorship and clinical standards, to improve the knowledge and skills of health care providers, their adherence to key childbirth-related clinical practices, and health outcomes for women and newborns. METHODS: We conducted a secondary analysis of Manyata program data collected from 466 private facilities across 3 states (Jharkhand, Maharashtra, and Uttar Pradesh) in India from October 2016 to February 2019. We calculated means and 95% confidence intervals for knowledge and skills assessment, adherence to facility standards was analyzed by calculating the proportion of facilities passing a given quality standard at baseline and endline, and changes in pregnancy outcomes were assessed with autoregression modeling. RESULTS: From assessments conducted before and after training among providers in Manyata, we observed a significant increase in average knowledge score (6.3 vs. 13.2 of 20) and skill score (8.0 vs. 34.3 of 40). Overall, a significant increase occurred in adherence to clinical standards between baseline and endline assessments (29% vs. 93%). The standards with the greatest improvements were identification and management of eclampsia/preeclampsia, postpartum hemorrhage, and neonatal resuscitation. There were no significant changes over time in absolute rate of reported complications; however, referral rates from private facilities for preeclampsia and newborn sepsis identification and management declined. CONCLUSION: Our analysis indicates private facilities' adherence to quality standards and nurses' childbirth knowledge and practical skills increased during Manyata. Additional efforts are needed to ensure high-quality care during cesarean deliveries at private facilities. Future studies with rigorous design are required to evaluate the impact of this quality improvement initiative in improving pregnancy outcomes.

Principled Subpopulation Analysis of the BetterBirth Study and the Impact of WHO's Safe Childbirth Checklist Intervention.

The World Health Organization (WHO) developed the Safe Childbirth Checklist as an intervention to improve care and outcomes in maternal and newborn health. The original study reported that the intervention did not significantly improve the outcomes. In this work, we employ a principled data-driven analysis to identify subpopulations with divergent characteristics: 1) vulnerable subgroups with the highest risk of neonatal deaths and 2) subgroups in the intervention arm that benefited from the Checklist intervention with significantly reduced risks of deaths and complications. Results demonstrate that low birth weight represented the most vulnerable group, whereas mother-baby dyads described by normal gestational age at birth, known parity, and unknown number of abortions was found to benefit from the Checklist intervention (OR : 0.70, 95%CI : 0.62-0.79, p < 0.001). Generally, the flexibility of our approach helps to answer subgroup-based queries in the broader global health domain, which also provides further insights to domain experts.

Optimizing the development and evaluation of complex interventions: lessons learned from the BetterBirth Program and associated trial.

BACKGROUND: Despite extensive efforts to develop and refine intervention packages, complex interventions often fail to produce the desired health impacts in full-scale evaluations. A recent example of this phenomenon is BetterBirth, a complex intervention designed to implement the World Health Organization's Safe Childbirth Checklist and improve maternal and neonatal health. Using data from the BetterBirth Program and its associated trial as a case study, we identified lessons to assist in the development and evaluation of future complex interventions. METHODS: BetterBirth was refined across three sequential development phases prior to being tested in a matched-pair, cluster randomized trial in Uttar Pradesh, India. We reviewed published and internal materials from all three development phases to identify barriers hindering the identification of an optimal intervention package and identified corresponding lessons learned. For each lesson, we describe its importance and provide an example motivated by the BetterBirth Program's development to illustrate how it could be applied to future studies. RESULTS: We identified three lessons: (1) develop a robust theory of change (TOC); (2) define optimization outcomes, which are used to assess the effectiveness of the intervention across development phases, and corresponding criteria for success, which determine whether the intervention has been sufficiently optimized to warrant full-scale evaluation; and (3) create and capture variation in the implementation intensity of components. When applying these lessons to the BetterBirth intervention, we demonstrate how a TOC could have promoted more complete data collection. We propose an optimization outcome and related criteria for success and illustrate how they could have resulted in additional development phases prior to the full-scale trial. Finally, we show how variation in components' implementation intensities could have been used to identify effective intervention components. CONCLUSION: These lessons learned can be applied during both early and advanced stages of complex intervention development and evaluation. By using examples from a real-world study to demonstrate the relevance of these lessons and illustrating how they can be applied in practice, we hope to encourage future researchers to collect and analyze data in a way that promotes more effective complex intervention development and evaluation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02148952; registered on May 29, 2014.

Coaching Intensity, Adherence to Essential Birth Practices, and Health Outcomes in the BetterBirth Trial in Uttar Pradesh, India.

BACKGROUND: Coaching can improve the quality of care in primary-level birth facilities and promote birth attendant adherence to essential birth practices (EBPs) that reduce maternal and perinatal mortality. The intensity of coaching needed to promote and sustain behavior change is unknown. We investigated the relationship between coaching intensity, EBP adherence, and maternal and perinatal health outcomes using data from the BetterBirth Trial, which assessed the impact of a complex, coaching-based implementation of the World Health Organization's Safe Childbirth Checklist in Uttar Pradesh, India. METHODS: For each birth, we defined multiple coaching intensity metrics, including coaching frequency (coaching visits per month), cumulative coaching (total coaching visits accrued during the intervention), and scheduling adherence (coaching delivered as scheduled). We considered coaching delivered at both facility and birth attendant levels. We assessed the association between coaching intensity and birth attendant adherence to 18 EBPs and with maternal and perinatal health outcomes using regression models. RESULTS: Coaching frequency was associated with modestly increased EBP adherence. Delivering 6 coaching visits per month to facilities was associated with adherence to 1.3 additional EBPs (95% confidence interval [CI]=0.6, 1.9). High-frequency coaching delivered with high coverage among birth attendants was associated with greater improvements: providing 70% of birth attendants at a facility with at least 1 visit per month was associated with adherence to 2.0 additional EBPs (95% CI=1.0, 2.9). Neither cumulative coaching nor scheduling adherence was associated with EBP adherence. Coaching was generally not associated with health outcomes, possibly due to the small magnitude of association between coaching and EBP adherence. CONCLUSIONS: Frequent coaching may promote behavior change, especially if delivered with high coverage among birth attendants. However, the effects of coaching were modest and did not persist over time, suggesting that future coaching-based interventions should explore providing frequent coaching for longer periods.

Nurses' and auxiliary nurse midwives' adherence to essential birth practices with peer coaching in Uttar Pradesh, India: a secondary analysis of the BetterBirth trial.

BACKGROUND: The BetterBirth trial tested the effect of a peer coaching program around the WHO Safe Childbirth Checklist for birth attendants in primary-level facilities in Uttar Pradesh, India on a composite measure of perinatal and maternal mortality and maternal morbidity. This study aimed to examine the adherence to essential birth practices between two different cadres of birth attendants-nurses and auxiliary nurse midwives (ANMs)-during and after a peer coaching intervention for the WHO Safe Childbirth Checklist. METHODS: This is a secondary analysis of birth attendant characteristics, coaching visits, and behavior uptake during the BetterBirth trial through birth attendant surveys, coach observations, and independent observations. Descriptive statistics were calculated overall, and by staffing cadre (staff nurses and ANMs) for demographic characteristics. Logistic regression using the Pearson overdispersion correction (to account for clustering by site) was used to assess differences between staff nurses and ANMs in the intervention group during regular coaching (2-month time point) and 4 months after the coaching program ended (12-month time point). RESULTS: Of the 570 birth attendants who responded to the survey in intervention and control arms, 474 were staff nurses (83.2%) and 96 were ANMs (16.8%). In the intervention arm, more staff nurses (240/260, 92.3%) received coaching at all pause points compared to ANMs (40/53, 75.5%). At baseline, adherence to practices was similar between ANMs and staff nurses (~ 30%). Overall percent adherence to essential birth practices among ANMs and nurses was highest at 2 months after intervention initiation, when frequent coaching visits occurred (68.1% and 64.1%, respectively, p = 0.76). Practice adherence tapered to 49.2% among ANMs and 56.1% among staff nurses at 12 months, which was 4 months after coaching had ended (p = 0.68). CONCLUSIONS: Overall, ANMs and nurses responded similarly to the coaching intervention with the greatest increase in percent adherence to essential birth practices after 2 months of coaching and subsequent decrease in adherence 4 months after coaching ended. While coaching is an effective strategy to support some aspects of birth attendant competency, the structure, content, and frequency of coaching may need to be customized according to the birth attendant training and competency. TRIAL REGISTRATION: ClinicalTrials.gov: NCT2148952; Universal Trial Number: U1111-1131-5647.

Availability of Safe Childbirth Supplies in 284 Facilities in Uttar Pradesh, India.

Objectives Vital to implementation of the World Health Organization (WHO) Safe Childbirth Checklist (SCC), designed to improve delivery of 28 essential birth practices (EBPs), is the availability of safe birth supplies: 22 EBPs on the SCC require one or more supplies. Mapping availability of these supplies can determine the scope of shortages and need for supply chain strengthening. Methods A cross-sectional survey on the availability of functional and/or unexpired supplies was assessed in 284 public-sector facilities in 38 districts in Uttar Pradesh, India. The twenty-three supplies were categorized into three non-mutually exclusive groups: maternal (8), newborn (9), and infection control (6). Proportions and mean number of supplies available were calculated; means were compared across facility types using t-tests and across districts using a one-way ANOVA. Log-linear regression was used to evaluate facility characteristics associated with supply availability. Results Across 284 sites, an average of 16.9 (73.5%) of 23 basic childbirth supplies were available: 63.4% of maternal supplies, 79.1% of newborn supplies, and 78.7% of infection control supplies. No facility had all 23 supplies available and only 8.5% had all four medicines assessed. Significant variability was observed by facility type and district. In the linear model, facility type and distance from district hospital were significant predictors of higher supply availability. Conclusions for Practice In Uttar Pradesh, more remote sites, and primary and community health centers, were at higher risk of supply shortages. Supply chain management must be improved for facility-based delivery and quality of care initiatives to reduce maternal and neonatal harm.

Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

BACKGROUND: There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes. We designed and implemented a robust and integrated DQA system to sustain high-quality data throughout the trial. METHODS: We designed the Data Quality Monitoring and Improvement System (DQMIS) to reinforce six dimensions of data quality: accuracy, reliability, timeliness, completeness, precision, and integrity. The DQMIS was comprised of five functional components: 1) a monitoring and evaluation team to support the system; 2) a DQA protocol, including data collection audits and targets, rapid data feedback, and supportive supervision; 3) training; 4) standard operating procedures for data collection; and 5) an electronic data collection and reporting system. Routine audits by supervisors included double data entry, simultaneous delivery observations, and review of recorded calls to patients. Data feedback reports identified errors automatically, facilitating supportive supervision through a continuous quality improvement model. RESULTS: The five functional components of the DQMIS successfully reinforced data reliability, timeliness, completeness, precision, and integrity. The DQMIS also resulted in 98.33% accuracy across all data collection activities in the trial. All data collection activities demonstrated improvement in accuracy throughout implementation. Data collectors demonstrated a statistically significant (p = 0.0004) increase in accuracy throughout consecutive audits. The DQMIS was successful, despite an increase from 20 to 130 data collectors. CONCLUSIONS: In the absence of widely disseminated data quality methods and standards for large RCT interventions in limited-resource settings, we developed an integrated DQA system, combining auditing, rapid data feedback, and supportive supervision, which ensured high-quality data and could serve as a model for future health systems research trials. Future efforts should focus on standardization of DQA processes for health systems research. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02148952 . Registered on 13 February 2014.