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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.
Nurses' burnout, work instability (WI), and job satisfaction (JS) in their practice environment (PE) are well established in the literature. However, perinatal missed care (PMC), a subset of missed nursing care, remains underreported among maternity nurses.
To examine the mediating role of PE and burnout in the associations of WI, JS, and PMC among maternity nurses.
A cross-sectional and correlational study employed consecutive sampling to recruit maternity nurses (n = 312) from five hospitals in Saudi Arabia (three government and two private hospitals in Hail and Makkah regions, respectively). Maternity staff nurses, regardless of their sex, years of professional nursing experience, or nationality, who met inclusion criteria were included in this study. Data was collected from July to September 2024 using four standardized self-report scales. Structural equation modeling was utilized for statistical analyses.
Maternity nurses' WI negatively influenced PE (β = −0.23, p = 0.014), while positively affected PMC (β = 0.15, p = 0.031). The PE positively affected JS (β = 0.24, p = 0.034) but had a negative effect on burnout (β = −0.24, p = 0.007) and PMC (β = −0.21, p = 0.038). Burnout negatively affected JS (β = −0.25, p = 0.028), while positively associated with PMC (β = 0.20, p = 0.022). PE mediated the associations between WI and burnout (β = 0.05, p = 0.019), JS (β = −0.07, p = 0.020), and PMC (β = −0.06, p = 0.008). Meanwhile, burnout mediated between PE and JS (β = 0.05, p = 0.030) and PMC (β = −0.04, p = 0.023).
Understanding the relationships among maternity nurses' burnout, JS, PE, and PMC is key to improving the quality of perinatal care and ensuring the patients' well-being. By focusing on strategies to enhance the PE (e.g., adequate staffing and resources, improved nurse–patient ratio), reduce burnout (e.g., meditation and mindfulness programs, coping intervention programs), and improve JS (e.g., work schedule flexibility, facilitate work-life balance, staff professional development), healthcare organizations can mitigate the occurrence of PMC.
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