Abstract
BackgroundPragmatic and adaptive trial designs are increasingly used in quality improvement (QI) interventions to provide the strongest evidence for effective implementation and impact prior to broader scale-up. We previously showed that an on-site coaching intervention focused on the World Health Organization Safe Childbirth Checklist (SCC) improved performance of essential birth practices (EBPs) in one facility in Karnataka, India. We report on the process and outcomes of adapting the intervention prior to larger-scale implementation in a randomized controlled trial in Uttar Pradesh (UP), India.MethodsInitially, we trained a local team of physicians and nurses to coach birth attendants in SCC use at two public facilities for 4–6 weeks. Trained observers evaluated adherence to EBPs before and after coaching. Using mixed methods and a systematic adaptation process, we modified and strengthened the intervention. The modified intervention was implemented in three additional facilities. Pre/post-change in EBP prevalence aggregated across facilities was analyzed.ResultsIn the first two facilities, limited improvement was seen in EBPs with the exception of post-partum oxytocin. Checklists were used <25 % of observations. We identified challenges in physicians coaching nurses, need to engage district and facility leadership to address system gaps, and inadequate strategy for motivating SCC uptake. Revisions included change to peer-to-peer coaching (nurse to nurse, physician to physician); strengthened coach training on behavior and system change; adapted strategy for effective leadership engagement; and an explicit motivation strategy to enhance professional pride and effectiveness. These modifications resulted in improvement in multiple EBPs from baseline including taking maternal blood pressure (0 to 16 %), post-partum oxytocin (36 to 97 %), early breastfeeding initiation (3 to 64 %), as well as checklist use (range 32 to 88 %), all p < 0.01. Further adaptations were implemented to increase the effectiveness prior to full trial launch.ConclusionsThe adaptive study design of implementation, evaluation, and feedback drove iterative redesign and successfully developed a SCC-focused coaching intervention that improved EBPs in UP facilities. This work was critical to develop a replicable BetterBirth package tailored to the local context. The multi-center pragmatic trial is underway measuring impact of the BetterBirth program on EBP and maternal-neonatal morbidity and mortality.Trial registrationClinical trials identifier: NCT02148952.
Highlights
Pragmatic and adaptive trial designs are increasingly used in quality improvement (QI) interventions to provide the strongest evidence for effective implementation and impact prior to broader scale-up
The only substantial improvement across the labor and delivery period was seen in appropriate delivery of oxytocin immediately post-partum (22 to 74 %), with the Safe Childbirth Checklist (SCC) used between 10 % and 39 % of observed care interactions
Physicians faced challenges in being effective and accepted coaches for nurses and auxiliary nurse midwives who comprised the overwhelming majority of the trained birth attendants
Summary
Pragmatic and adaptive trial designs are increasingly used in quality improvement (QI) interventions to provide the strongest evidence for effective implementation and impact prior to broader scale-up. High rates of maternal and neonatal morbidity and mortality persist in many resourcelimited settings (RLS), despite efforts to achieve the Millennium Development Goals through increasing uptake of facility-based deliveries [9,10,11] Much of this suffering is preventable, yet there remains an implementation gap between what we know works and the care received by women in labor and their infants in these facilities [12, 13]. The World Health Organization (WHO) Safe Childbirth Checklist (SCC) is designed to help birth attendants remember EBPs at four critical pause points (PP) in the delivery process: (1) at admission, (2) just prior to delivery, (3) in the immediate post-partum period, and (4) prior to discharge [15] This tool, when implemented effectively, has the potential to contribute to ongoing work to improve facility-based quality through scalable solutions and reach the goals of improved maternal and neonatal health. This work found that success required the following: (1) leadership engagement and commitment, (2) focused introduction of the checklist to end-users including understanding of existing quality gaps and benefits in addressing preventable causes of harm, (3) support through coaching to ensure ongoing use and sustainability, and (4) ongoing monitoring and feedback on intervention uptake and behavior change
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