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  • Garg AX
  • Yohanna S
  • Naylor KL
  • McKenzie SQ
  • Mucsi I
  • et al.
JAMA Intern Med. 2023 Dec 1;183(12):1366-1375 doi: 10.1001/jamainternmed.2023.5802.
CET Conclusion
Reviewer: Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This is a report of a very complex and large study conducted across all transplant centres in Ontario, Canada. Randomization was done by CKD program, to permit the high level interventions that were being initiated.The multicomponent intervention was designed to address complex barriers at multiple levels that prevent kidney transplant and living donation. Support was provided from the central operations group, educational resources were made available and volunteer patients provided support. The primary outcome was assessed at the patient level and assessed the rate of steps completed towards live or deceased transplantation. 9780 patients entered the intervention group of the study during the 4 year inclusion period, and 10595 received usual care. Mean follow up was approximately 2 years. The step completion rate did not significantly differ between the intervention vs usual-care groups: 5334 vs 5638 steps; 24.8 vs 24.1 steps per 100 patient-years. There was also no significant difference in the secondary outcomes related to progress towards live donation. Despite a huge investment in monetary terms as well as professional time, and good uptake of interventions at both a program and patient level, there was no improvement in rate of progress towards renal transplantation. The COVID pandemic happened during the trial and is likely to have impacted on the delivery of the interventions. However, it highlights the difficulties of implementing a complex intervention in a healthcare system with multiple drivers and continuous staff turnover.
Aims: The aim of this study was to investigate whether a multicomponent intervention was effective in improving patient access to kidney transplant and living kidney donation.
Interventions: Chronic kidney disease (CKD) programs were randomised to either receive quality improvement intervention in addition to usual care or the usual care alone.
Participants: 26 CKD programs including 20375 potentially transplant-eligible patients with advanced CKD.
Outcomes: The primary endpoint was the rate of steps completed toward receiving a kidney transplant.
Follow Up: 90 days
IMPORTANCE:

Patients with advanced chronic kidney disease (CKD) have the best chance for a longer and healthier life if they receive a kidney transplant. However, many barriers prevent patients from receiving a transplant.

OBJECTIVES:

To evaluate the effect of a multicomponent intervention designed to target several barriers that prevent eligible patients from completing key steps toward receiving a kidney transplant.

DESIGN, SETTING, AND PARTICIPANTS:

This pragmatic, 2-arm, parallel-group, open-label, registry-based, superiority, cluster randomized clinical trial included all 26 CKD programs in Ontario, Canada, from November 1, 2017, to December 31, 2021. These programs provide care for patients with advanced CKD (patients approaching the need for dialysis or receiving maintenance dialysis).

INTERVENTIONS:

Using stratified, covariate-constrained randomization, allocation of the CKD programs at a 1:1 ratio was used to compare the multicomponent intervention vs usual care for 4.2 years. The intervention had 4 main components, (1) administrative support to establish local quality improvement teams; (2) transplant educational resources; (3) an initiative for transplant recipients and living donors to share stories and experiences; and (4) program-level performance reports and oversight by administrative leaders.

MAIN OUTCOMES AND MEASURES:

The primary outcome was the rate of steps completed toward receiving a kidney transplant. Each patient could complete up to 4 steps: step 1, referred to a transplant center for evaluation; step 2, had a potential living donor contact a transplant center for evaluation; step 3, added to the deceased donor waitlist; and step 4, received a transplant from a living or deceased donor.

RESULTS:

The 26 CKD programs (13 intervention, 13 usual care) during the trial period included 20 375 potentially transplant-eligible patients with advanced CKD (intervention group [n = 9780 patients], usual-care group [n = 10 595 patients]). Despite evidence of intervention uptake, the step completion rate did not significantly differ between the intervention vs usual-care groups: 5334 vs 5638 steps; 24.8 vs 24.1 steps per 100 patient-years; adjusted hazard ratio, 1.00 (95% CI, 0.87-1.15).

CONCLUSIONS AND RELEVANCE:

This novel multicomponent intervention did not significantly increase the rate of completed steps toward receiving a kidney transplant. Improving access to transplantation remains a global priority that requires substantial effort.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT03329521.

  • Steenvoorden TS
  • van Duin RE
  • Rood JAJ
  • Peters-Sengers H
  • Nurmohamed AS
  • et al.
Br J Clin Pharmacol. 2023 Dec;89(12):3629-3636 doi: 10.1111/bcp.15871.
CET Conclusion
Reviewer: Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This is a small study, albeit randomised. Only 5 patients received the alkaline phosphatase treatment and 6 placebo. Given the prior successful use of alkaline phosphatase in cardiac surgery patients could it not have been used in a larger study here, and therefore have more potential to identify any beneficial impact? The study was also conducted only in live kidney transplantation and therefore the potential impact on any ischeamia-reperfusion injury was relatively minimal. Donation after cardiac death is where any potential benefit lies. As it stands, the study showed no real difference between placebo and alkaline phosphatase. The study drug was safely administered in this small group of recipients.
Aims: The aim of this study was to assess the feasibility and safety of alkaline phosphatase for treating ischaemia–reperfusion injury in living donor kidney transplantation.
Interventions: Participants were randomised to either the alkaline phosphatase (bRESCAP) group or the placebo group.
Participants: 11 living donor kiney transplant recipients.
Outcomes: The primary endpoint was 1-year graft function. The secondary endpoints included (serious) AEs (SAEs), and urine and serum biomarkers.
Follow Up: 1 year posttransplantation
AIMS:

Ischemia-reperfusion injury (IRI) during kidney transplant procedures is associated with adverse outcome. Alkaline phosphatase (AP) is an enzyme that has the potential to dampen IRI. Prior to this study, it had not been tested in the setting of kidney transplantation. This study aimed to evaluate the safety and feasibility of peri-procedural AP administration in living donor kidney transplantation.

METHODS:

In this double blind, randomized, placebo-controlled, single-center pilot study, all eligible recipients of living donor kidneys were asked to give informed consent. AP (bRESCAP) or a placebo was administered intravenously over 24 hours after the transplantation procedure. The primary outcome-graft function at 1 year-was represented by iohexol measured glomerular filtration rate (mGFR). Serum and urine biomarkers within seven days after surgery were used as surrogate markers of kidney function and injury.

RESULTS:

Eleven patients were enrolled of whom five were treated with bRESCAP and six with placebo. After 1 year, mGFR was not different between groups. No specific adverse events were observed in the bRESCAP group. Urine expression of injury biomarkers CCL14, NGAL and Cystatin C was lower in the bRESCAP group at day seven. This was statistically significant.

CONCLUSION:

This study illustrates that bRESCAP treatment is feasible in kidney transplantation, might have a dampening effect on IRI induced renal inflammation, and raises no safety concerns. Future research will evaluate the effects of bRESCAP treatment in donation after circulatory death kidney transplantation where IRI is more pronounced.

  • Selzler AM
  • Davoodi PM
  • Klarenbach S
  • Lam NN
  • Smith T
  • et al.
Can J Kidney Health Dis. 2023 Oct 30;10:20543581231205340 doi: 10.1177/20543581231205340.
BACKGROUND:

Living donor kidney transplantation (LDKT) is the optimal treatment for eligible patients with kidney failure, although it is underutilized. Contextually tailored patient- and family-centered interventions may be effective to increase LDKT.

OBJECTIVE:

We outline a protocol to test the feasibility of the Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention designed to increase LDKT.

DESIGN:

Non-blinded single-center pilot randomized controlled trial with a qualitative interview component.

SETTING:

Academic transplant referral center in Northern Alberta Region with a population of more than 2 million in its catchment area.

PATIENTS:

English-speaking patients of the age range 18 to 75 years who are referred for kidney transplantation are eligible to participate.

MEASUREMENTS:

Feasibility will be assessed by indicators of recruitment, retention, and completion rates, treatment fidelity, adherence to intervention, engagement in intervention, and acceptability.

METHODS:

Participants will be randomly assigned 1:1 to either standard care (control) or the experimental group who receive standard care plus the MuST AKT intervention, a person-centered program designed to assist and enable the kidney transplant candidate to achieve what is required to receive an LDKT. The intervention consists of an introductory session and 4 intervention sessions delivered in-person or virtually.

LIMITATIONS:

Inferences cannot be drawn regarding the efficacy/effectiveness of the MuST AKT intervention. This study is non-blinded.

CONCLUSIONS:

This pilot study is the first step in our broader initiative to increase LDKT in our health care jurisdiction. The results of this study will be used to inform the development of a future definitive randomized controlled trial.

TRIAL REGISTRATION NUMBER:

NCT04666545.

  • Daw J
  • Verdery AM
  • Ortiz SE
  • Reed RD
  • Locke JE
  • et al.
Clin Transplant. 2023 Oct;37(10):e15064 doi: 10.1111/ctr.15064.
CET Conclusion
Reviewer: Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This paper details the protocol for a very interesting study in live kidney donation. Potential kidney transplant recipients will be randomised into four groups: 1) No intervention, 2) search intervention- advising patients on which social network members are most likely to be contraindication free, 3) script intervention- advises patients on how to initiate effective live kidney donor discussions, 4) both search and script interventions. The primary outcome is the receipt of a live kidney transplant. This study will be conducted in the USA, where there are currently large discrepancies in live donation rates between ethnic groups. The supplemental material online gives an excellent background to the study and thorough explanation of the rationale.
Aims: This protocol aims to provide the rationale behind the design of the Friends and Family of Kidney Transplant Patients Study (FFKTPS) and the planned analyses to test the efficacy of these interventions.
Interventions: Participants will be randomly assigned into four groups: no intervention, search only, script only, or both search and script.
Participants: Kidney transplant candidates.
Outcomes: The primary endpoint is living donor kidney transplantation (LDKT) recipient. The secondary endpoints are live kidney donor (LKD) screening and medical evaluations and outcomes.
Follow Up: 36 months
INTRODUCTION:

Racial/ethnic disparities in living donor kidney transplantation (LDKT) are a persistent challenge. Although nearly all directed donations are from members of patients' social networks, little is known about which social network members take steps toward living kidney donation, which do not, and what mechanisms contribute to racial/ethnic LDKT disparities.

METHODS:

We describe the design and rationale of the Friends and Family of Kidney Transplant Patients Study, a factorial experimental fielding two interventions designed to promote LKD discussions. Participants are kidney transplant candidates at two centers who are interviewed and delivered an intervention by trained center research coordinators. The search intervention advises patients on which social network members are most likely to be LKD contraindication-free; the script intervention advises patients on how to initiate effective LKD discussions. Participants are randomized into four conditions: no intervention, search only, script only, or both search and script. Patients also complete a survey and optionally provide social network member contact information so they can be surveyed directly. This study will seek to enroll 200 transplant candidates. The primary outcome is LDKT receipt. Secondary outcomes include live donor screening and medical evaluations and outcomes. Tertiary outcomes include LDKT self-efficacy, concerns, knowledge, and willingness, measured before and after the interventions.

CONCLUSION:

This study will assess the effectiveness of two interventions to promote LKD and ameliorate Black-White disparities. It will also collect unprecedented information on transplant candidates' social network members, enabling future work to address network member structural barriers to LKD.

  • Hou Y
  • Kang F
  • Liu H
  • Yang C
  • Han M
  • et al.
Heliyon. 2023 Mar 9;9(3):e14423 doi: 10.1016/j.heliyon.2023.e14423.
OBJECTIVE:

Living kidney donors (LKDs) experience perioperative anxiety. We designed the following study to evaluate the anxiolytic effect of transcutaneous electrical acupoint stimulation (TEAS) during the perioperative period in a group of LKDs undergoing laparotomy nephrectomy.

METHODS:

LKDs were randomly assigned to either the TEAS or control group. Participants in the TEAS group received 30min of intervention (6-15 mA, 2-100 Hz), at Yintang (EX-HN-3), bilateral Taichong (LR3) and Neiguan (PC6) one day before surgery (D0), before induction of anesthesia (D1) and one day after surgery (D2). The participants in the control group received the same placement of electrodes but without electrical stimulation. Venous blood was collected before each intervention. Anxiety levels and recovery profiles were recorded.

RESULTS:

LKDs in the TEAS group had lower anxiety level than those in the control group at D1, D2 and three days after surgery (D3). The percentage differences were: 33.3%, 25.0%, and 22.2%; [95% confidence interval (CI), (-55.1%, -11.6%), (-47.4%, -2.6%), and (-42.3%, -2.2%); P = 0.005, P = 0.034, and P = 0.035; respectively]. LKDs who received TEAS had better sleep quality and short-term recovery profiles than those in the control group. The plasma levels of 5-hydroxytryptamine (5-HT) and melatonin (MT) in the TEAS group were significantly higher than those in the control group at D1 and D2 (5-HT: P = 0.001, and P < 0.001; MT: P = 0.006, and P = 0.001). At the 3-month follow up, fewer LKDs in the TEAS group had incisional pain when compared to the control group (P = 0.032).

CONCLUSIONS:

Perioperative TEAS decreased perioperative anxiety and facilitated postoperative recovery in the LKDs, and potential decreased the development of chronic pain. Trial Registration: Registered at ChiCTR2000029891, http://www.chictr.org.cn/listbycreater.aspx.

  • Bailey PK
  • Caskey FJ
  • MacNeill S
  • Ashford R
  • Pryce L
  • et al.
Pilot Feasibility Stud. 2023 Jan 20;9(1):13 doi: 10.1186/s40814-023-01241-1.
BACKGROUND:

The UK's living-donor kidney transplant (LDKT) activity falls behind that of many other countries internationally, with less than 20% of those eligible receiving a LDKT each year. Certain individuals with kidney disease in the UK appear to be particularly disadvantaged in accessing a LDKT; the most socioeconomically deprived people with kidney disease are 60% less likely to receive a LDKT than the least deprived. Improving equity in living-donor kidney transplantation has been highlighted as an international research priority.

METHODS:

This feasibility trial was designed to determine the feasibility of delivery and acceptability of a multicomponent intervention designed to improve access to living-donor kidney transplantation. The intervention comprises three main components: (i) a meeting between a home educator and the transplant candidate for a dedicated discussion about living-donor kidney transplantation, living kidney donation and potential donors; (ii) a standardized letter from a healthcare professional to a candidate's potential donors and (iii) a home-based education and family engagement session including two home educators, the transplant candidate and their family. The primary objectives are to establish the feasibility (i) of delivering the developed intervention in existing care pathways and (ii) of undertaking a randomised controlled trial of the intervention. A mixed-methods parallel process evaluation will investigate the acceptability, implementation and mechanisms of impact of the intervention. The trial is based at two UK hospitals: a transplanting hospital and a non-transplanting referral hospital. Individuals are eligible if they are ≥ 18 years old, are active on the kidney transplant waiting list or have been referred for transplant listing and do not have a potential living-donor undergoing surgical assessment. Randomisation will be undertaken with concealed allocation. Participants will be randomly allocated 1:1 to (i) the intervention or (ii) usual care, stratified by site to ensure a balance in terms of local differences. Minimisation will be used to ensure balance in sex, age group and socioeconomic strata, with probability weighting of 0.8 in order to reduce predictability. The primary outcomes are recruitment (% of those eligible and invited who consent to randomisation) and retention (% of participants completing follow-up).

DISCUSSION:

Findings will inform the design of a future fully powered, randomised controlled trial to formally evaluate the effectiveness of the intervention at improving equitable access to living-donor kidney transplantation.

TRIAL REGISTRATION:

ISRCTN Registry ISRCTN10989132 Applied 30/10/20.

  • Shepherd L
  • O'Carroll RE
  • Ferguson E
Soc Sci Med. 2023 Jan;317:115545 doi: 10.1016/j.socscimed.2022.115545.
CET Conclusion
Reviewer: Reshma Rana Magar, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This study aimed to establish whether factors such as anticipated regret, the deceased wishes and next-of-kin attitudes could predict next-of-kin approval for organ donation, and to develop a model of next-of-kin decision making regarding organ donation in Wales, UK, which has an opt-out system. A total of 808 participants were randomly assigned to imagine whether a deceased relative had either opted-in, opted-out or had not registered a decision (deemed consent). The authors concluded that anticipated regret significantly influenced the next-of-kin approval for organ donation, and also that if the next-of kin had negative beliefs towards organ donation, they were less likely to follow the deceased wishes to donate. It is possible that the participants may have underestimated the influence of their emotions on future decision-making process; thus, how they believed they would act may be different from how they behave in real life. The authors do a good job of acknowledging this. However, the study did not assess ethnicity or religion, both of which have been found to affect the decision of the next-of-kin on organ donation. These could have acted as potential confounders in the analyses. Perhaps another factor the authors could have also considered is the type of relationship between the deceased donor and the next-of-kin. It would have been interesting to see if relatives with negative attitude towards organ donation were able to override their beliefs and follow the deceased donor’s wishes to donate if the deceased donor was an authority figure or a final decision maker when alive. For example, in cultures where fathers are the main decision makers, there may be a higher chance of sons/daughters respecting their deceased father’s wishes to donate despite their negative affective attitudes, in comparison to fathers respecting their deceased children’s wishes.
Aims: This study aimed to investigate how the deceased donor’s wishes, negative affective attitudes, perceived benefits and anticipated regret had an effect on the next-of-kin’s approval of organ donation under opt-out legislation.
Interventions: Participants were randomised to imagine if their deceased relative had either opted in, opted-out or not registered a decision (deemed consent).
Participants: Adults (≥18 years) living in Wales.
Outcomes: The outcome variables of interest included previous health-based philanthropy, uncertainty, anticipated regret, intention of next-of-kin to approve donation of organs, negative affective attitudes and perceived benefits.
Follow Up: Not reported
RATIONALE:

Family, and sometimes longstanding friends, have considerable influence over organ donation, through agreeing or disagreeing to the donation of a deceased individual's organs. To date, most research has been undertaken within opt-in systems.

OBJECTIVE:

This study advances on previous research by assessing next-of-kin approval under opt-out legislation. We tested whether next-of-kin approval varies when the deceased is a registered donor (opted-in), registered non-donor (opted-out) or has not registered a decision under an opt-out policy (deemed consent). We also tested if the deceased's wishes influenced next-of-kin approval through relatives anticipating regret for not donating and feelings of uncertainty. Finally, we assessed whether next-of-kin's own beliefs about organ donation influenced whether they followed the deceased's wishes.

METHODS:

Participants (N = 848) living in a country with opt-out legislation (Wales, UK) were asked to imagine a relative had died under an opt-out system and decided if their relatives' organs should be donated. Participants were randomly allocated to imagine the deceased had either (i) opted-in, (ii) opted-out or (iii) not registered a decision (deemed consent). The outcome variable was next-of-kin approval, with uncertainty and anticipated regret as potential mediators and next-of-kin's beliefs about organ donation as moderators.

RESULTS:

Next-of-kin approval was lower when the deceased had opted-out than under deemed consent. This was due to next-of-kin anticipating more regret for not donating under deemed consent than opt-out. Further analyses revealed the deceased's wishes influence next-of-kin approval, via anticipated regret, when next-of-kin did not hold negative beliefs about organ donation.

CONCLUSIONS:

The deceased's wishes were less likely to be followed when next-of-kin had negative beliefs towards donation. Developing large-scale campaigns to improve these beliefs in the general public should make people more likely to follow the deceased's wishes. As a result, these campaigns should improve the availability of donor organs.

  • Dixon SN
  • Naylor KL
  • Yohanna S
  • McKenzie S
  • Belenko D
  • et al.
Can J Kidney Health Dis. 2022 Nov 22;9:20543581221131201 doi: 10.1177/20543581221131201.
CET Conclusion
Reviewer: Mr John O'Callaghan, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This paper is the protocol for the statistical analysis plan for a randomised trial. The trial is an ambitious one across 26 centres in Canada, and including over 10,000 patients. The study will hopefully provide reliable results through several features described in this detailed statistical analysis plan. The primary outcome is the number of completed steps towards receiving a kidney transplant. 10 pre-specified subgroup analyses are described.
Aims: This protocol for a cluster-randomised trial aims to examine the effect of the Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) quality improvement intervention on completing key steps toward receiving a renal transplant.
Interventions: Participants will be randomised to either the EnAKT LKD intervention group or the usual care group.
Participants: Adult patients with advanced chronic kidney disease (CKD).
Outcomes: The main outcome of interest includes completed steps toward receiving a kidney transplant, which involves four unique steps per patient: (1) patient referral to a transplant center for evaluation (2) evalulation of a potential living kidney donor begins at a transplant center to donate a kidney to the patient, (3) inclusion of the patient to the deceased donor transplant waitlist, and (4) a living or deceased donor kidney transplant is received by the patient.
Follow Up: N/A
BACKGROUND:

Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) is a quality improvement intervention designed to enhance access to kidney transplantation and living kidney donation. We conducted a cluster-randomized clinical trial to evaluate the effect of the intervention versus usual care on completing key steps toward receiving a kidney transplant.

OBJECTIVE:

To prespecify the statistical analysis plan for the EnAKT LKD trial.

DESIGN:

The EnAKT LKD trial is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized, superiority, clinical trial. Randomization was performed at the level of the chronic kidney disease (CKD) programs (the "clusters").

SETTING:

Twenty-six CKD programs in Ontario, Canada.

PARTICIPANTS:

More than 10 000 patients with advanced CKD (ie, patients approaching the need for dialysis or receiving maintenance dialysis) with no recorded contraindication to receiving a kidney transplant.

METHODS:

The trial data (including patient characteristics and outcomes) will be obtained from linked administrative health care databases (the "registry"). Stratified covariate-constrained randomization was used to allocate the 26 CKD programs (1:1) to provide the intervention or usual care from November 1, 2017, to December 31, 2021 (4.17 years). CKD programs in the intervention arm received the following: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders.

OUTCOMES:

The primary outcome is completing key steps toward receiving a kidney transplant, where up to 4 unique steps per patient will be considered: (1) patient referred to a transplant center for evaluation, (2) a potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient, (3) patient added to the deceased donor transplant waitlist, and (4) patient receives a kidney transplant from a living or deceased donor.

ANALYSIS PLAN:

Using an intent-to-treat approach, the primary outcome will be analyzed using a patient-level constrained multistate model adjusting for the clustering in CKD programs.

TRIAL STATUS:

The EnAKT LKD trial period is November 1, 2017, to December 31, 2021. We expect to analyze and report the results once the data for the trial period is available in linked administrative health care databases.

TRIAL REGISTRATION:

The EnAKT LKD trial is registered with the U.S. National Institute of Health at clincaltrials.gov (NCT03329521 available at https://clinicaltrials.gov/ct2/show/NCT03329521).

STATISTICAL ANALYTIC PLAN:

Version 1.0 August 26, 2022.

  • Yohanna S
  • Wilson M
  • Naylor KL
  • Garg AX
  • Sontrop JM
  • et al.
Can J Kidney Health Dis. 2022 Mar 19;9:20543581221084502 doi: 10.1177/20543581221084502.
BACKGROUND:

Many patients who would benefit from a kidney transplant never receive one. The Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) pragmatic, cluster-randomized clinical trial is testing whether a multi-component quality improvement intervention, provided in chronic kidney disease (CKD) programs (vs. usual care), can help patients with CKD with no recorded contraindications to kidney transplant complete more steps toward receiving a transplant (primary outcome of the trial). The EnAKT LKD intervention has 4 components: (1) quality Improvement teams and administrative support, (2) improved transplant education for patients and healthcare providers, (3) access to support and (4) program-level performance monitoring.

OBJECTIVE:

To conduct a process evaluation of the EnAKT LKD quality improvement intervention to determine if the components were delivered, received, and enacted as designed (fidelity), and if the intervention addressed intended barriers (mechanisms of change).

DESIGN:

A mixed-methods process evaluation informed by new practice implementation and theories of behavior change.

SETTING:

Chronic kidney disease programs in Ontario, Canada, began receiving the EnAKT LKD intervention on November 1, 2017 and will continue to receive it until December 31, 2021. The process evaluation (interviews and surveys) will occur alongside the trial, between December 2020 to May 2021.

PARTICIPANTS:

Healthcare providers (eg, dialysis nurses, nephrologists, members of the multi-care kidney clinic team) at Ontario's 27 CKD programs.

METHODS:

We will survey and interview healthcare providers at each CKD program, and complete an intervention implementation checklist. Quantitative data from the surveys and the intervention implementation checklist will assess fidelity to the intervention, while quantitative and qualitative data from surveys and interviews will provide insight into the mechanisms of change.

LIMITATIONS:

The long trial period may result in poor participant recall.

CONCLUSION:

This process evaluation will enhance interpretation of the trial findings, guide improvements in the intervention components, and inform future implementation.

TRIAL REGISTRATION:

Clinicaltrials.gov; identifier: NCT03329521.

  • Oudmaijer CAJ
  • Minnee RC
  • Pol RA
  • van den Boogaard WMC
  • Komninos DSJ
  • et al.
Trials. 2022 Jan 6;23(1):18 doi: 10.1186/s13063-021-05950-x.
BACKGROUND:

One of the main effectors on the quality of life of living-kidney donors is postoperative fatigue. Caloric restriction (CR) and short-term fasting (STF) are associated with improved fitness and increased resistance to acute stress. CR/STF increases the expression of cytoprotective genes, increases immunomodulation via increased anti-inflammatory cytokine production, and decreases the expression of pro-inflammatory markers. As such, nutritional preconditioning by CR or STF represents a non-invasive and cost-effective method that could mitigate the effects of acute surgery-induced stress and postoperative fatigue. To investigate whether preoperative STF contributes to a reduction in fatigue after living-kidney donation, a randomized clinical trial is indicated.

METHODS:

We aim to determine whether 2.5 days of fasting reduces postoperative fatigue score in subjects undergoing living-kidney donation. In this randomized study, the intervention group will follow a preoperative fasting regime for 2.5 days with a low-dose laxative, while the control group will receive standard care. The main study endpoint is postoperative fatigue, 4 weeks after living-kidney donation. Secondary endpoints include the effect of preoperative fasting on postoperative hospital admission time, the feasibility of STF, and the postoperative recovery of donor and recipient kidney function. This study will provide us with knowledge of the feasibility of STF and confirm its effect on postoperative recovery.

DISCUSSION:

Our study will provide clinically relevant information on the merits of caloric restriction for living-kidney donors and recipients. We expect to reduce the postoperative fatigue in living-kidney donors and improve the postoperative recovery of living-kidney recipients. It will provide evidence on the clinical merits and potential caveats of preoperative dietary interventions.

TRIAL REGISTRATION:

Netherlands Trial Register NL9262 . EudraCT 2020-005445-16 . MEC Erasmus MC MEC-2020-0778. CCMO NL74623.078.21.