The role of Advanced Practice Nurses in creating the Kidney Transplant candidate care map (APN-preKT): a convergent-parallel mixed methods research protocol

Against this backdrop, this project hypothesises that individuals with chronic kidney disease awaiting a kidney transplant have complex needs and require a care map led by an advanced practice nursing. The study aims to fulfil the following objectives:

In line with our objectives, this project will provide a detailed description of the current status of the role of the APN in access to KT and identify the practices that are in place and the interventions that could be optimised in order to improve the quality of care for this population. It will also provide an in-depth analysis of the role of the KT access nurse and the benefits that they can bring to the interdisciplinary team.

This study used a convergent parallel mixed methods design requiring the collection of quantitative and qualitative data, separate analysis, and comparison of the results to ascertain whether the findings confirmed or contradicted one another [34]. In order to address the main study objectives, 5 different substudies with interconnected approaches to the study questions were undertaken between July 2021 and April 2024.

This protocol is based on the GRAMMS (Good Reporting of A Mixed Methods Study) guidelines for high quality evidence-based methodology [35].

The study settings for this research protocol are KT access units in Spain and, more specifically, the KT Unit at the Hospital del Mar Nephrology Department in Barcelona. The results achieved after completing this study protocol may be extrapolated to contexts that are similar or not, depending on the phase of the study analyzed. Each KT unit has its care protocols determined by the specificities of its context and the population served. Despite this, the resulting data will be internationally understood and could be adapted.

To place some context in our major field of study, we are set in a tertiary level university hospital with more than 2,000 employees, 391 inpatient beds, more than 88,000 emergency visits per year, and more than 2,000 daily visits to outpatient and primary care units [36]. The Hospital del Mar Nephrology Department in Barcelona admits more than 700 patients annually and conducts more than 17,000 outpatient consultations a year. In the field of KT, a mean of 108.2 ± 13.6 procedures have been performed annually in recent years, involving an annual assessment of more than 500 individuals in KT access units, with a total of more than 180 people on average on the KT waiting list [37].

Drawing on the principles of adaptive methodology design [38]. this study protocol, which comprises different interconnected sections or substudies, can be adapted to similar settings and accommodate a wide range of modifications in order to achieve the required objectives. The substudies comprising this protocol are described below:

A descriptive cross-sectional study with a closed sample has been designed to address objective 1. In order to ensure methodological rigour, the standards for reporting observational studies set out in the STROBE (Strengthening the Reporting of Observational studies in Epidemiology) initiative statement [39] will be obeyed.

The sample will be selected using universal sampling linked to the professionals in the 39 adult KT units in Spain (Table 1). These professionals will be administered an ad hoc questionnaire based on the literature, consisting of 18 items in a dichotomous, polytomous, or open-ended response format (Table 2). In facilities with nurses caring for individuals with CKD in the KT outpatient setting, the IDREPA instrument (Instrumento de Definición del Rol de la Enfermera de Práctica Avanzada, ‘Advanced Practice Nurse Role Definition Instrument’), validated in Spanish [40], will also be administered to assess the level of skills development among these specialist nurses.

Data collection will be carried out remotely. The principal investigator of the study will contact the supervising nurse as a facilitator. Access to the two questionnaires will be provided via email after they have agreed to participate and have signed the informed consent form.

We are aware that there is a possibility that the sample may be insufficient to assess statistical significance between variables. It may also be necessary to contact other facilitators or use other means of communication to recruit participants from all planned facilities. It is also possible that some administrative, ethical or legal aspects may need to be addressed at each of the facilities in order to obtain the required data. Modifications to the original protocol will be described in a final report.

To address objective 2, a scoping review with narrative synthesis of the existing literature will be carried out in line with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines [41] and the five steps proposed by Arksey & O’Malley [42]. Scoping has been described as a technique for mapping the relevant literature in a particular field of interest. It tends to address broader topics in which many different study designs can be used [42, 43].

To plan the review, the research team will reach a consensus on the suitability of the descriptors, using the benchmark clinical practice guidelines for assessing KT candidates. Two researchers will conduct the review using broad, comprehensive, relevant, and freely available databases. English will be used as the search language, and articles published in English, Spanish, French, and/or Portuguese will be eligible for inclusion. Studies published in peer-reviewed healthcare journals in the past 20 years will be included to guarantee research quality. The following will be excluded: studies with paediatric patients, pilot methods, letters to the editor, study protocols without results, unavailable full-text articles, and duplicates. To synthesise the results, the findings of each included study will be summarised individually and will be grouped into consistent categories arranged by the topic describing the general idea they convey. This categorisation will enable more in-depth interpretation and a more efficient approach to addressing the review objective [44].

The results of this phase will allow us to gain a better understanding of patient needs arising from the KT access process and of the aspects that should be taken into consideration in the KT assessment process. As a result, a standardised nursing process (NP) may be developed in line with the NANDA-NIC-NOC nursing methodology [45‐47] for KT candidates, which can be applied to this population on an individual basis. The NP is a systematic method structured in phases (Assessment, Diagnosis, Planning, Implementation and Evaluation) that helps nurses to provide efficient, humanised care by focusing on the attainment of outcomes agreed with the individual (Nursing Outcomes Classification, NOC) and based on the scientific process followed by professional nurses. The NP can be used to create a care plan centred on human responses that treats people holistically and views them as unique individuals requiring care that focuses specifically on them and not just on their condition [48, 49]. The resulting proposal is intended to add value to the APN’s work in this area of care.

A descriptive cross-sectional study with a closed sample has been designed to address objective 3. For data collection, a comprehensive review of the electronic health records of individuals assessed retrospectively will be carried out. Methodological rigour will be guaranteed through compliance with the guidelines for reporting observational studies stated in the STROBE (Strengthening the Reporting of Observational studies in Epidemiology) initiative statement [39].

The study will include the data of all individuals assessed in KT access consultations, i.e. data on the variables of interest to this study objective (Table 3). These variables were agreed upon by the members of the research team and after a thorough review of the current evidence. The cost of each activity analysed will be based on the cost tables of the referral facility. This study will report the current profile of KT candidates in a tertiary hospital in order to assess the management for this group and the direct costs that can be incurred. This analysis will allow us to propose more efficient strategies for patients and for the health system as a whole.

In the event that the variables of any of the study cases cannot be defined, the subjects will be excluded from the final analysis, which will mean a decrease in the size of the final sample, estimated at 500 participants based on data obtained in previous years.

A quasi-experimental pre-post study will be carried out using a single-group. The substudy will use the standardised NP developed in the previous substudy based on the care needs of the study population and the results of the scoping review. It is assumed that care plans are sufficiently widespread in the nursing discipline, which prevents an experimental study design. The methodological rigour of this section will be based on the SQUIRE (Standards for QUality Improvement Reporting Excellence) standards for improving the quality and safety of healthcare [50].

Data will be collected for the duration of the KT candidate’s assessment, through to their inclusion in a KT programme. All patients in 2023 (estimated at 100 ± 20 subjects based on previous years’ records) will be invited to participate on a voluntary basis. The inclusion criteria will be having CKD and being under assessment for a potential KT with a minimum of three face-to-face consultations with the KT access nurse. The exclusion criterion will be declining to participate in the data collection process.

Figure 1 shows the procedure for this study. At the first visit, the nurse will recruit participants (who will voluntarily sign the informed consent form), seeking to ensure follow-up and study completion based on the participant retention strategies outlined in the relevant literature [51]. Once the patient has agreed to participate, they will be fully assessed, the nursing diagnoses will be made, and the desired outcome criteria will be planned before the final visit, along with the activities to be performed in order to achieve the proposed objectives. During the subsequent visits and at the final visit, these outcome criteria will be re-evaluated and the care plan redefined accordingly. At each of the visits, data will be collected to monitor the progress made and measure the impact of the visits and of the activities specifically designed for the participant. The approximate time frame for these visits is 3 months. Visits will be planned based on schedule availability, and the follow-up time will be reflected in the final report.

There is a possibility that the desired sample size may not be reached, may be insufficient for inferential analysis, or may not be representative of the study population due to participant refusal or loss to follow-up. In these cases, this segment of the population will be excluded and, depending on the sample size and results obtained, an extension of data collection over time may be considered in order to meet the objective.

This substudy will use a qualitative, phenomenological approach, an open sampling method [52, 53], and the consolidated criteria for reporting qualitative research (COREQ) checklist [54] for methodological rigour.

The participants’ accounts will be collected in order to gain insight into their experiences of the care process as KT candidates. Participants will be selected using theoretical convenience sampling and respecting the intersectionality framework [55, 56], in order to maximise the degree of narrative variability and eliminating the bias that any factor may offer. Thus, individuals with CKD being assessed for KT will be interviewed (Fig. 1), until theoretical data saturation is reached. In line with the relevant scientific literature [57, 58] and our overall research objectives, data will be collected using semi-structured interviews based on conversational techniques. An interview script has been designed, covering the most relevant ideas or topics (salient categories) to be investigated, and ensuring clarity and appropriateness (Table 4). Once informed consent to participate has been secured, interviews will be conducted face-to-face by the principal investigator between 2023 and 2024. Participants will be able to choose the space (at the hospital or in another location) where they feel most comfortable for the interview. Interviews will always take place in a room behind closed doors in the presence of the interviewer and the interviewee only and will last approximately 40–60 min. They will be audio-recorded for subsequent transcription, and both the recording and transcription will be anonymised by assigning numerical codes. The interviewer will take field notes to record significant aspects of the interview, which will be used in the analysis. The final sample will be determined by data saturation.

Taking a qualitative approach that harnesses the voices of patients themselves, this final section of the protocol will allow us to interpret and give meaning to the results from the previous phases and to the impact of the nurse’s role on patient care. The data obtained from the project as a whole will be methodologically triangulated to facilitate its interpretation, as outlined in the relevant literature [59]. Additionally, this final study also aims to eliminate the bias introduced by other interventions occurring at the same time as the study intervention, as informants are able to discern between them as they take the lead in their own care processes [60]. Once all the substudies are finished, new research proposals may emerge. Preliminarily, we consider possible gaps in the analysis of the needs of this process such as: family members, professionals, managers, etc.

For the quantitative part of the project, the results will be recorded and analysed using the databases agreed by the research team. This process will be completed by the principal investigator using the statistical software IBM SPSS statistics version 26 (IBM Corporation) and Microsoft Excel version 15.

The IT platform at the study facility (IMASIS) will also be used, as it ensures data confidentiality by transferring data to encrypted secondary databases, preventing codes from being associated with participants.

With regard to the analysis, the study variables will be presented using a descriptive approach, showing absolute and relative frequencies for qualitative variables; means and standard deviations for quantitative variables in the case of parametric distribution of the data; and medians and interquartile ranges in the case of non-parametric distribution of the data. Multivariate analysis will be considered for each of the sections depending on the variables and results found in order to further interpret the potential resulting inferences.

To analyse the data from the qualitative part of the project, the 7 phases proposed by Colazzi [61] will be followed using the Nvivo version 8 software. Coding into meanings and categories will be carried out by consensus among the members of the research team, who will meet on a regular basis to discuss the results obtained and the resulting analysis (researcher triangulation). This process will ensure that the criteria of credibility, transferability, dependability, and confirmability are maintained throughout the data collection and analysis process, as described in the literature [62]. The triangulation criteria will be set in line with the literature [63] and data saturation will be assessed by the members of the research team according to the established rules [64].

Once the results and analysis of the parallel quantitative and qualitative phases have been obtained, the research team will integrate the results to analyse them as a whole in a discursive way. This last phase, in accordance with the parallel mixed methods methodology, will allow obtaining a deeper vision from different perspectives and, at the same time, proposing future research strategies.