{
  "abstract": "Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number NCT05828823.",
  "authors": [
    {
      "affiliations": [
        "Department of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"
      ],
      "name": "Mariana Murea"
    },
    {
      "affiliations": [
        "Department of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"
      ],
      "name": "Kristie L Foley"
    },
    {
      "affiliations": [
        "Department of Medicine, Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA"
      ],
      "name": "Samir C Gautam"
    },
    {
      "affiliations": [
        "University of North Carolina Kidney Center, Division of Nephrology and Hypertension, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA"
      ],
      "name": "Jennifer E Flythe"
    },
    {
      "affiliations": [
        "Renal Research Institute, New York, New York, USA"
      ],
      "name": "Jochen G Raimann"
    },
    {
      "affiliations": [
        "Division of Nephrology, University of Virginia Health System, Charlottesville, Virginia, USA"
      ],
      "name": "Emaad Abdel-Rahman"
    },
    {
      "affiliations": [
        "Division of Nephrology, University of Florida, Jacksonville, Florida, USA"
      ],
      "name": "Alaa S Awad"
    },
    {
      "affiliations": [
        "Department of Nephrology, Emory University School of Medicine, Atlanta, Georgia, USA"
      ],
      "name": "Vandana Dua Niyyar"
    },
    {
      "affiliations": [
        "Department of Kidney Medicine, Medical Specialties Institute, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, USA"
      ],
      "name": "Cassandra Kovach"
    },
    {
      "affiliations": [
        "External Relations and Patient Engagement, Kidney Research Institute and Center for Dialysis Innovation, Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington, USA"
      ],
      "name": "Glenda V Roberts"
    },
    {
      "affiliations": [
        "Home Dialyzors United, Columbia, Missouri, USA"
      ],
      "name": "Nicole M Jefferson"
    },
    {
      "affiliations": [
        "American Association of Kidney Patients, Tampa, Florida, USA"
      ],
      "name": "Paul T Conway"
    },
    {
      "affiliations": [
        "Renal Research Institute, New York, New York, USA"
      ],
      "name": "Laura M Rosales"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"
      ],
      "name": "Jobira Woldemichael"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"
      ],
      "name": "Hiba I Sheikh"
    },
    {
      "affiliations": [
        "Department of Medicine, Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA"
      ],
      "name": "Gaurav Raman"
    },
    {
      "affiliations": [
        "Department of Kidney Medicine, Medical Specialties Institute, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, USA"
      ],
      "name": "Anne M Huml"
    },
    {
      "affiliations": [
        "Division of Nephrology, University of Virginia Health System, Charlottesville, Virginia, USA"
      ],
      "name": "Daphne H Knicely"
    },
    {
      "affiliations": [
        "Division of Nephrology, University of Florida, Jacksonville, Florida, USA"
      ],
      "name": "Irtiza Hasan"
    },
    {
      "affiliations": [
        "Division of Nephrology, University of Florida, Jacksonville, Florida, USA"
      ],
      "name": "Bhaktidevi Makadia"
    },
    {
      "affiliations": [
        "Department of Nephrology, Emory University School of Medicine, Atlanta, Georgia, USA"
      ],
      "name": "Janice Lea"
    },
    {
      "affiliations": [
        "Division of Nephrology, Department of Medicine, University of Illinois College of Medicine at Chicago, Chicago, Illinois, USA"
      ],
      "name": "John T Daugirdas"
    },
    {
      "affiliations": [
        "Department of Foundations of Medicine, Division of Health Services Research, New York University Grossman School of Medicine, New York, New York, USA"
      ],
      "name": "Nihan Gencerliler"
    },
    {
      "affiliations": [
        "Department of Foundations of Medicine, Division of Health Services Research, New York University Grossman School of Medicine, New York, New York, USA"
      ],
      "name": "Jasmin Divers"
    },
    {
      "affiliations": [
        "Renal Research Institute, New York, New York, USA",
        "Icahn School of Medicine at Mount Sinai, New York, New York, USA"
      ],
      "name": "Peter Kotanko"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"
      ],
      "name": "The TwoPlus Research Consortium"
    },
    {
      "affiliations": [
        "Department of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"
      ],
      "name": "Ucheoma C Nwaozuru"
    }
  ],
  "title": "Protocol for the process evaluation of a randomised clinical trial of incremental-start versus conventional haemodialysis: the TwoPlus study",
  "uid": "975e5be8-b657-5931-95b5-cea7d70fab2f"
}