Process evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial.

We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes’ findings.

The study protocol was approved by the Wake Forest University School of Medicine Institutional Review Board (IRB). Findings from this study will be disseminated through peer-reviewed journals and scientific conferences.

NCT05828823.

Stillbirth remains a major global health challenge, with India bearing a substantial share of the burden. Despite the availability of evidence-based interventions, stillbirth rates (SBRs) remain high due to gaps in healthcare access, quality and the effective delivery of maternal and neonatal care. This study aims to develop and implement an optimised, context-specific model to reduce SBRs in Sangrur district, Punjab.

This mixed-methods implementation research will adopt a sequential explanatory design. The study will be conducted over 3 years in four blocks of Sangrur. Data will be collected through baseline and endline surveys, verbal autopsies of stillbirths, direct observations of antenatal and intrapartum care, and qualitative interviews with community members and healthcare providers. The intervention package will focus on preconception and antepartum care, intrapartum care and strengthening health systems. The study will use the plan-do-check-act model for continuous improvement, and real-time data collection through electronic systems will support timely decision-making.

The study expects to achieve a 25% reduction in SBRs through the optimised delivery of high-quality antenatal and intrapartum care services. Additionally, the research will provide critical evidence on the barriers and facilitators to optimise service delivery, as well as insights into the health system and community factors influencing stillbirth outcomes. This study aims to create a scalable and adaptable intervention model to reduce SBRs in low-resource settings like Sangrur and Punjab. The findings will inform future maternal and neonatal health policies and provide a framework for the broader implementation of similar interventions in other regions of India.

The study protocol has been approved by the International Institute of Health Management Research, Delhi (IIHMR) Institutional Ethics Committee (IRB/2024-2025/01). The study is funded through a competitive call for proposals on stillbirths by the Indian Council of Medical Research (ICMR) under the National Health Research Priority Projects (5/7BMIPR/2022-RBMCH). The research has been awarded by ICMR (project ID NHRP05586) to IIHMR under grant number 5/7/BMIPR/2022-RCN.