Strengths and limitations of this study
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This study involves patients, staff and other stakeholders in the design and implementation of a multicentre incremental dialysis programme.
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We will determine clinical outcomes as well as patient-reported experience and outcomes measures.
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The main limitation of this implementation study is that the single group design does not allow for comparison of findings to usual care or for the randomisation of participants.
Introduction
The global demand for kidney replacement therapy continues to grow rapidly as a result of an increase in the availability of dialysis, better survival of patients with end-stage kidney disease (ESKD), age demographics, the increased prevalence of hypertension and diabetes mellitus.1 2 Despite aggressive efforts to improve the uptake of home-based modalities in Canada, more than 80% of people with ESKD, receiving kidney replacement therapy, are treated with facility-based haemodialysis.3 The increasing prevalence of facility-based dialysis results in a substantial strain on healthcare resources as the growth tends to exceed existing capacity.
The standard of care for haemodialysis treatment in Canada is 3–4 hours of treatment delivered three times weekly. This guideline recommended4 prescription has been based on data from historical trials.5 6 For most patients, the transition to chronic haemodialysis treatment is challenging and is associated with increased levels of morbidity and mortality, and loss of residual kidney function (RKF), particularly within the first months.7 8 RKF has been found to be an important determinant of dialysis requirements and has been associated with cardiovascular outcomes, phosphorus control and middle molecule clearance.9
Currently, most patients initiating haemodialysis are given the same treatment prescription, regardless of patient preference and RKF. Incremental dialysis10 has been proposed as a more ‘gentle’ approach to dialysis initiation, where the dose of dialysis is low at the beginning and progressively increases over time in parallel to the reduction of RKF. Regular monitoring of symptoms is performed with dialysis adjusted accordingly. For many patients this means starting dialysis two times a week as opposed to three times a week, resulting in a 33% reduction in time on the dialysis unit.
A systematic review9 of 15 studies found that incremental dialysis allowed for longer preservation of RKF thus deferring full-dose dialysis on average by about 1 year, without an increased risk in mortality. These studies also reported improved quality of life in incremental dialysis patients when compared with conventional dialysis prescriptions. Accordingly, several clinical practice guidelines11 12 now endorse incremental dialysis and suggest that RKF should be considered in the dialysis prescription. While not widely translated into clinical practice, this approach, which is the paradigm of ‘personalised’ dialysis, also reflects the increasingly accepted notion that there is a need for personalised, patient-centred dialysis prescriptions.13
Implementation of an incremental dialysis approach has the potential to reduce burden on patients in terms of time and out-of-pocket costs associated with dialysis (eg, travel, parking) as well as reduce the per-patient cost of care delivery and increase treatment capacity in an overburdened healthcare system. In a survey of Canadian nephrologists,14 65% of physicians reported prescribing incremental dialysis; however, 98% reported there was no local policy or systematic programme of assessment or care for patients receiving this treatment.
To help improve the safety and quality of providing incremental dialysis care, we have designed an implementation study to evaluate the systematic assessment of patients beginning facility-based haemodialysis for eligibility for incremental dialysis, and the prescription and monitoring of incremental dialysis treatment.
Objectives
The primary aim of this study is to implement and evaluate the addition of incremental dialysis within the established care pathway within haemodialysis units in Alberta. The specific objectives are to:
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Co-design the implementation of a care pathway for incremental dialysis with health system administrators, front-line healthcare providers and patients.
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To evaluate the extent to which there is uptake of this intervention, and how it affects capacity to provide dialysis treatment in these healthcare facilities.
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To assess the safety and acceptability of the incremental dialysis care pathway with patients and providers.
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To determine the association between incremental dialysis prescription and clinical and patient-oriented outcomes.
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To conduct an economic evaluation to determine impact of incremental dialysis on costs and healthcare utilisation.
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To inform and develop a plan to scale and spread the programme throughout the province and sustain incremental dialysis practice across kidney care in Alberta.
Methods and analysis
Study design
An effectiveness-implementation hybrid design15 16 will be used to evaluate outcomes and to collect data on the implementation and effectiveness of the addition of an incremental dialysis care pathway to standard care (figure 1). This hybrid design allows for the simultaneous assessment of feasibility and/or potential impact of an implementation strategy as well as the effectiveness of the clinical intervention. We will use the Knowledge-to-Action cycle17 as a framework to design and implement the intervention (assessment, prescription and monitoring of treatment, see figure 2), we will then follow the principles of the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework18 (table 1) to evaluate dimensions of implementation. The anticipated timeline for this study is 2 years, with 1 year to recruit and 1 year to follow-up.
Incremental dialysis care pathway implementation study workflow. KDQOL-36, Kidney Disease Quality of Life 36-item short form survey; PACIC-20, Patient Assessment of Chronic Illness Care.
Knowledge-to-action cycle for the incremental dialysis programme implementation. KT, knowledge translation.
RE-AIM framework
Population and context
Alberta has a single-payer, government-funded healthcare system that provides universal access to care for outpatient, hospital, emergency department and physician services that are free at the point of care. This means that dialysis care is provided by the single healthcare provider (Alberta Health Services) at a variety of clinics across the province. All adult patients (>18 years old) with ESKD initiating chronic in-centre haemodialysis, including those who are awaiting a living transplant and patients transitioning from peritoneal dialysis, will be eligible for consideration of incremental dialysis. Those recovering from an acute kidney injury, with a planned or anticipated transition to a home therapy, or otherwise not continuing chronic in-centre haemodialysis, will not be considered or assessed. Patients that are ineligible during the intake assessment may be re-evaluated 4–8 weeks after dialysis initiation. This project will be implemented at six dialysis units in two large urban centres (Edmonton and Calgary) where dialysis is initiated, as well as satellite units that receive these patients. These sites were selected as most (~90%) of the new dialysis starts in the province occur at these units, while fluctuations occur Alberta has approximately 2000 patients on dialysis at a given time. The study was started in June 2021 with a planned completion of December 2023. In order to obtain consent from participants, healthcare providers will ask relevant patients if they consent to be contacted about the research opportunity. Those that give consent will be connected to the research team, who will provide additional information, ask for and obtain written informed consent. A written record of verbal consent will be noted for patients that participate in the virtual focus groups; which are a part of programme evaluation and quality improvement, and not formal research.
Patient and public involvement statement
Patient advisors were involved in the development of the incremental dialysis programme. This includes content development such as patient education materials, assessment forms, process maps and study design. They will continue to be involved throughout implementation and evaluation by reviewing and contributing to tools, troubleshooting, strategies and reports. Patients will also be recruited to participate in qualitative interviews, surveys and focus groups. There are no formal plans to disseminate the results to study participants, but patients that participate in qualitative research interviews will be offered the opportunity to receive a transcript of their interview.
Implementation components
Stakeholder consultation
To be successful in implementing the incremental dialysis project, we have formally consulted with patients currently receiving dialysis, nephrologists (nationally and locally), operational leadership (ie, Alberta Kidney Care), unit management, nursing staff and other allied health professionals within the planning stages. A national survey14 was disseminated to Canadian nephrologists indicating the practice of incremental dialysis is widespread, but discretionary, with no systematic approach to assessment and monitoring. Despite these barriers, 82% of nephrologists felt that incremental dialysis is feasible with their current resources and 78% agreed that with specific criteria, it is a safe option. Locally, we identified that physician rounding practices vary across the dialysis units so we consulted nephrologists and unit staff on how best to implement the incremental dialysis care pathway within their local areas. In addition to nephrologist and staff surveys, a patient focus group was held to help inform the project (online supplemental material 1). Patients were recruited for the focus group with the help of kidney care staff, posters in the dialysis clinics and dissemination of an electronic poster. Focus group participants were also given the opportunity to express continued interest in the initiative and invited to further participate in a patient advisory group. After implementation of the project, a local staff survey will be conducted to guide the future operationalisation of the care pathway for patient assessment and workflow. This staff survey will be co-designed with the Evaluation Working Group (see below) and will be an opportunity to obtain details on staff satisfaction and perceived barriers and facilitators to implementation.
Supplemental material
Process mapping
Process mapping supports better understanding of complex systems and adaptation of improvement interventions to their local context19; it also examines how we manage the patient journey, using the patient’s perspective to identify problems and suggest improvements. To understand existing practices and workflow at participating sites, process mapping will be conducted by project staff and a consultant with expertise in quality improvement. Small group sessions will be held with unit staff members which involves education on the rationale for incremental dialysis and quality improvement processes, an exercise that maps and describes the current state; followed by an exercise that maps the ideal state. Process mapping of current and ideal/future state will include referral to facility-based haemodialysis, patient education, staff education, assessments related to haemodialysis frequency, regular facility-based haemodialysis assessments, storage of assessment data, communication between healthcare team members and transfer of patient and information to another frequency, modality or site. Multidisciplinary team members (ideally nurse, educator, MD, unit clerk and manager) will be invited to participate in process mapping of both current and then ideal/future state (implementation of incremental dialysis). An applied quality improvement approach to process mapping will be used. Unit staff will also discuss anticipated challenges and potential solutions regarding implementation of incremental dialysis into practice. This will be completed in two 4-hour sessions and conducted virtually to facilitate staff availability. These processes will inform the project assessment tools, education and implementation plans.
Governance
To ensure feedback is effectively incorporated and to maintain accountability, this project will be governed by a Steering Committee, patient advisory group and working groups (figure 3). The Steering Committee will oversee, support and coordinate the various stages of the project. There will be representation from all stakeholder groups (ie, operational leadership, physicians, nurses, educators, patient advisors and project team members); this group will meet monthly or bimonthly depending on need and stage of implementation.
Study governance organisational structure.
Whereas the Steering Committee guides the project, three working groups will be established to develop, implement and evaluate the project:
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Incremental dialysis protocol and assessment Working Group; this group will work to develop a standardised project protocol and assessment criteria. This group will coordinate the process mapping, workflow and eligibility assessment tool development (see online supplemental material 2 for Initial Assessment and Eligibility Form).
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Education Working Group; this group will work to develop both the patient education materials and the staff education materials. Patient education materials will include education on defining incremental dialysis, differences between incremental dialysis and conventional dialysis, what to expect while on incremental dialysis and the role and responsibilities of incremental dialysis patients. Staff education material will include details on defining incremental dialysis, benefits of incremental dialysis, processes and workflow for incremental dialysis focusing on how to complete and communicate related assessments.
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Evaluation Working Group; this group will be responsible for creating an evaluation framework (table 1), determining the key performance indicators, setting targets, monitoring progress and completing the overall evaluation. KPIs that have been identified to date are outlined in table 2.
Overview of key performance indicators to be reported by site
All of these working groups, and the Steering Committee, will be governed by the project charter; which is an evidence-informed document that outlines the objectives, requirements and constraints of the incremental dialysis project. It will be used to help ensure a common understanding and shared vision among stakeholders and project team.
Patient involvement
The inclusion of patients’ perspectives and voices are integral to the planning and execution of the incremental dialysis project. As such, patients will be invited to co-design and shape the project development, implementation and evaluation. This project will have a patient advisory group, and patients from this group will also be invited to sit on the Steering Committee and other working groups. For the patient advisory group, we will recruit two to four individuals from our already established Patient and Family Advisory Committee which is part of the Medicine Strategic Clinical Network.20 A focus group of dialysis patients, which includes patients beyond the patient advisory group, will inform the project and solicit feedback and input on the content of the patient education materials (online supplemental material 1). These patients will be recruited from the Patient and Family Advisory committee as well as through referral/invitation from dialysis care staff, we will aim to have six to eight patients within each focus group. We plan to have an initial focus group to inform early programme development prior to programme launch as well as another to inform programme evaluation and sustainability towards the end of the formal evaluation period. Further, patient input will also inform how best to deliver and present the patient education. Efforts will be made to co-design the patient educational materials using patient perspectives.
Incremental dialysis intervention
Incremental dialysis is a personalised approach to dialysis initiation, where the frequency and duration of dialysis sessions are adjusted based on RKF which is assessed through 24-hour urine collection as well as patient symptoms and needs. For most patients this means starting dialysis two times a week as opposed to three times a week. Regular monitoring of patients for uraemic symptoms, volume status and RKF will be performed. It is anticipated that most participants initiating incremental dialysis will eventually convert to the conventional three times a week as RKF decreases.
Assessment for eligibility
Based on the literature, stakeholder consultation and process mapping, we will develop an eligibility assessment for the incremental dialysis project. Key components will likely include those supported by existing literature such as uraemic symptoms, volume status, RKF and patient preference. Attached is the Initial Assessment and Eligibility Form (online supplemental material 2). Criteria for transition to three times a week dialysis will also be determined using this approach (online supplemental material 3).
Outcomes
Metrics to support implementation
We will apply the RE-AIM framework to evaluate the impact and enhance the external validity of the incremental dialysis project. The RE-AIM framework has been widely used to evaluate health and health behaviour change interventions.21 22 A proposed implementation evaluation plan, grounded in the RE-AIM framework, has been created to assess the impact of the project (table 1). Key process metrics being considered include: number of patients (new chronic outpatients) ever assessed for incremental dialysis, number of patients eligible for incremental dialysis and number of patients on active incremental dialysis. These metrics will be reviewed monthly and results shared and discussed with operational leadership (Alberta Kidney Care). With the implementation of incremental dialysis it will be important to monitor key clinical parameters such as uraemic symptoms, volume overload and RKF. We will also capture the proportion of patients treated with incremental dialysis who received appropriate monthly follow-up and assessment. Follow-up surveys on provider and patient satisfaction will also be performed, frequency and exact questions will be determined by the evaluation working group.
Outcomes to support effectiveness
In addition to implementation metrics, we will evaluate the impact of the project on patient-reported outcomes and experiences measures. We will use the Kidney Disease Quality of Life 36-item short form survey (KDQOL-36),23 which is one of the most widely-used measures of health-related quality of life for patients with ESKD.24 The KDQOL includes both generic and kidney-specific scales, which facilitates comparison with other clinical subgroups as well as offering specificity and responsiveness to change for elements of quality of life important to patients with ESKD. Additionally, the Patient Assessment of Chronic Illness Care (PACIC-20) will be used to measure patient experience; this a 20-item questionnaire for patients (online supplemental material 4), which intends to measure chronic care delivery and which has been validated in chronic disease populations.25 26 The KDQOL and PACIC questionnaires will be completed at baseline and then quarterly for the first year of haemodialysis in all patients with incident ESKD assessed for incremental dialysis. Patients will be reviewed and assessed monthly using the proposed Monthly Assessment Form (online supplemental material 3). Safety outcomes to be monitored will include uraemic symptoms, volume status and RKF through 24-hour urine collection along with adverse events such as the number of hospitalisation and emergency visits and the mortality rate during the first year of treatment.
Economic and healthcare utilisation evaluation
We will collect details on facility-based haemodialysis capacity (number of new treatment spots created/month) and calculate the annual per-patient cost for incident patients receiving incremental compared with conventional haemodialysis. We will also obtain and evaluate healthcare utilisation through administrative data on hospitalisations and emergency visits. Although incremental dialysis will only be considered for patients that have already selected facility-based dialysis, we will monitor use of home dialysis modalities to ensure we do not negatively impact home therapy utilisation rates.
Sample size
Given this is primarily an implementation study, statistical power for patient outcomes is of less importance than the proportion of patients who would be offered incremental dialysis through the implementation of the new care pathway. Through programme data, it was determined that approximately 700 patients start dialysis per year in the province of Alberta. A site chart review of the last 100 patients to start haemodialysis suggested that approximately 50% of new patients could have been eligible for an incremental dialysis prescription. We anticipate that with the implementation of the incremental dialysis care pathway that the majority (target of 75%) of all new chronic outpatients at participating sites will be assessed for incremental dialysis.
Statistical analysis plan
Baseline descriptive data will be expressed as counts with percentage for categorical variables and median with IQR for continuous variables. Within participant differences over time will be compared using the χ2 test for categorical variables and Kruskal-Wallis tests for all continuous variables. Comparisons between patients on conventional versus incremental dialysis will be done through adjusted multivariable analyses comparing hospitalisations, healthcare utilisation, quality of life surveys and mortality. Analyses will be stratified by location of dialysis initiation as well as urgency of dialysis initiation (crash vs expected dialysis starts).
Ethics and dissemination
The evaluation of this implementation project has been reviewed and approved by the institutional review board at the University of Alberta (#Pro00105520). We propose that this effectiveness-implementation study will help inform the use of incremental dialysis within clinical practice in dialysis units. The end-of-grant knowledge translation (KT) will focus on dissemination of study findings at the local level as well as the broader clinical and academic communities. At the local level we will share the results with each programme through presentations to staff, the creation of an online dashboard with real-time data on uptake of the incremental dialysis care pathway and patient-outcome measures (eg, infographics). This information will provide operational leadership an opportunity to evaluate the success of implementation as well as adjust resource planning. Results will also be presented at medical grand rounds in nephrology and nephrologist staff meetings. We will present our findings and communicate with operational leadership as well as executive leadership of the healthcare system. To reach broader audiences, other KT efforts will include academic peer-reviewed publications and conference presentations to disseminate new knowledge regarding the effectiveness and implementation of the incremental dialysis care pathway to audiences in the field of nephrology. Further dissemination of our findings on the implementation of an incremental dialysis care pathway may involve partnering with organisations that work to advocate and improve kidney care such as the Kidney Foundation of Canada and Kidney Disease – Improving Global Outcomes.
Limitations
There are limitations to note in the design of this effectiveness-implementation hybrid study. The single group design does not allow for comparison of findings to usual care or for the randomisation of participants; as such there are threats to internal validity including maturation, history, testing and regression to the mean. Participation bias in the patients who choose to participate is also possible, however we will capture reasons for non-participation.
Discussion
Incremental dialysis has the potential to reduce the burden of dialysis for patients as well as reducing costs within the healthcare system. In the mission to provide patient-centred dialysis care, incremental dialysis should be offered to those who are eligible as part of the routine care pathway for the initiation of chronic facility-based haemodialysis. We expect to see an improvement in patient experience and quality of life, while maintaining patient clinical outcomes and safety when compared with conventional dialysis prescriptions. There is some indication in the literature that incremental dialysis may preserve urine volume output and RKF, thus possibly allowing a survival benefit.27 While evidence for incremental dialysis exists, there is little information available in terms of how best to implement and standardise an incremental dialysis approach within usual care. This protocol can serve as a blueprint for other jurisdictions wanting to evaluate the implementation of incremental dialysis in their hospital or healthcare system.
Incremental dialysis may benefit a subset of patients with ESKD as well as the overburdened healthcare system. Creating a standardised approach and care pathway, where clear criteria are used to initiate incremental dialysis an escalate therapy in appropriate patients, stands to be of substantial value for both patients and the healthcare system.
Ethics statements
Patient consent for publication
Acknowledgments
We gratefully acknowledge the contribution of all those involved in implementing and evaluating the incremental dialysis project including Zone Operations and the staff of Alberta Kidney Care. We specifically recognise the contributions of the patient advisors on this project: Steve Cutting, Taryn Gantar and Nancy Verdin. As well as the support from the following individuals from Alberta Health Services’ Strategic Clinical Networks: Anita Kozinski, Louise Morrin and Tracy Wasylak.
This post was originally published on https://bmjopen.bmj.com