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.

Ambulatory care sensitive conditions (ACSCs) are conditions for which the provision of timely and skilled primary care can reduce risks of hospitalisation when preventing, treating or controlling a disease. For this reason, hospitalisations for ACSC have been commonly employed by health systems as an indicator of effectiveness for the primary level of care. This study aims to evaluate whether the provision of primary care services by physicians with residency training in family medicine is associated with rates of general hospitalisations for ACSCs in the Brazilian Unified Health System network in the city of Belo Horizonte, Brazil.

Longitudinal ecological study using a Generalised Linear Model for Gamma-distributed variables.

Primary healthcare centres in Belo Horizonte, Brazil, from January 2017 to December 2021, aggregated at the primary healthcare centres level.

Data aggregated at the primary healthcare centre level, encompassing socioeconomic, professional and health-related variables.

Incidence rates of hospitalisations for ACSCs, adjusted for age and sex.

After adjusting for age, sex and socioeconomic variables using the Health Vulnerability Index, a higher concentration of family physicians was significantly associated with a lower incidence of hospitalisations for ACSCs. If all physicians in the primary care network were family physicians, compared with a scenario in which none were, an estimated 11.89% reduction in hospitalisations would be expected (95% CI 7.3% to 16.3%, p

The findings suggest that specialisation in family medicine positively impacts health outcomes by reducing hospitalisations for ACSCs. These results can inform the development of evidence-based public policies to enhance primary care effectiveness.