Implementation strategies for high impact nephrology trials: the end of the trial is just the beginning

Reidlinger, Donna; Johnson, David W.; Craig, Jonathan C.; McDonald, S.; Mallard, Alistair R.; Robison, Laura; Wong, Germaine; Hawley, Carmel

doi:10.1016/j.kint.2022.07.006

Cited by 7 publications

(4 citation statements)

References 9 publications

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“…The investigators acknowledge that PD nurses are the integral aspect of TEACH-PD and the key to its success, such that every effort has been made in designing this study to avoid excessive data collection and management burden. By following a pragmatic design with broad inclusion criteria, patient co-production and involvement of clinical staff in the research design, the ability to implement the trial's ndings have been maximized (25).…”

Section: Discussionmentioning

confidence: 99%

“…Our publication following nationwide survey of PD units con rmed that differences in PD training practices currently exist in Australia (22). It is hypothesized that a key center-related factor that may contribute to the variability in peritonitis risk is the variation in PD training (21,(23)(24)(25). The ISPD has developed guidelines for PD training in clinical practice which are primarily based on adult education principles (andragogy) (26).…”

Section: Background and Rationale {6a}mentioning

confidence: 91%

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Multi-center, pragmatic, cluster-randomized, controlled trial of standardized Peritoneal Dialysis (PD) training versus usual care on PD-related infections (The TEACH-PD Trial): Trial Protocol

Chow,

Boudville,

Cho

et al. 2023

Preprint

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Background Peritoneal dialysis (PD)-related infections, such as peritonitis, exit site, and tunnel infections, substantially impair the sustainability of PD. Accordingly, PD-related infection is the top-priority research outcome for patients and caregivers. While PD nurse trainers teach patients to perform their own PD, PD training curricula are not standardized or informed by an evidentiary base and may offer a potential approach to prevent PD infections. The Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes (TEACH-PD) trial evaluates whether a standardized training curriculum for PD nurse trainers and incident PD patients based on the International Society for Peritoneal Dialysis (ISPD) guidelines reduces PD-related infections compared to usual training practices. Methods The TEACH-PD trial is a registry-based, pragmatic, open-label, multi-center, binational, cluster-randomized controlled trial. TEACH-PD will recruit adults aged 18 years or older who have not previously undergone PD training at 42 PD treatment units (clusters) in Australia and New Zealand (ANZ) between July 2019 and June 2023. Clusters will be randomized 1:1 to standardized TEACH-PD training curriculum or usual training practice. The primary trial outcome is the time to the first occurrence of any PD-related infection (exit site infection, tunnel infection, or peritonitis). The secondary trial outcomes are the individual components of the primary outcome, infection-associated catheter removal, transfer to hemodialysis (greater than 30-days and 180-days), quality of life, hospitalization, all-cause death, a composite of transfer to hemodialysis or all-cause death, and cost-effectiveness. Participants are followed for a minimum of 12 months with a targeted average follow-up period of two years. Participant and outcome data are collected from the ANZ Dialysis and Transplant Registry (ANZDATA) and the New Zealand Peritoneal Dialysis (NZPD) Registry. This protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Discussion TEACH-PD is a registry-based, cluster-randomized pragmatic trial that aims to provide high-certainty evidence about whether an ISPD guideline-informed standardized PD training curriculum for PD nurse trainers and adult patients prevents PD-related infections. Trial Registration ClinicalTrials.gov NCT03816111. Registered on 24th January 2019.

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Section: Discussionmentioning

confidence: 99%

Section: Background and Rationale {6a}mentioning

confidence: 91%

Multi-center, pragmatic, cluster-randomized, controlled trial of standardized Peritoneal Dialysis (PD) training versus usual care on PD-related infections (The TEACH-PD Trial): Trial Protocol

Chow,

Boudville,

Cho

et al. 2023

Preprint

View full text Add to dashboard Cite

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“…Dissemination and implementation principles also provide investigators with tools needed to tailor and apply existing interventions to new populations and thus should be more systematically reported. 155,156 Moreover, cost and staffing issues remain barriers to the broad adoption of successful interventions, and strategies to the optimize sustainability of these developed interventions are needed to ensure appropriate funding by government agencies, industry partners, and hospital systems.…”

Section: Suggested Future Directionsmentioning

confidence: 99%

Mitigating Health Disparities in Transplantation Requires Equity, Not Equality

Reed,

Locke

2023

Transplantation

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Despite decades of research and evidence-based mitigation strategies, disparities in access to transplantation persist for all organ types and in all stages of the transplant process. Although some strategies have shown promise for alleviating disparities, others have fallen short of the equity goal by providing the same tools and resources to all rather than tailoring the tools and resources to one’s circumstances. Innovative solutions that engage all stakeholders are needed to achieve equity regardless of race, sex, age, socioeconomic status, or geography. Mitigation of disparities is paramount to ensure fair and equitable access for those with end-stage disease and to preserve the trust of the public, upon whom we rely for their willingness to donate organs. In this overview, we present a summary of recent literature demonstrating persistent disparities by stage in the transplant process, along with policies and interventions that have been implemented to combat these disparities and hypotheses for why some strategies have been more effective than others. We conclude with future directions that have been proposed by experts in the field and how these suggested strategies may help us finally arrive at equity in transplantation.

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“…However, clinical practice lags due to some modifiable factors (reimbursement policies, physicians’ attitudes, physicians’ knowledge). Why have we not embraced ‘implementation science’ such that we can achieve the best penetration of disease-modifying drugs for our patients and determine the best methods to enable uptake [ 2 , 34 ]?…”

mentioning

confidence: 99%

Unmet needs in clinical trials in CKD: questions we have not answered and answers we have not questioned

Levin

Borkum

2022

Clinical Kidney Journal

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Many advances have been made in the field of nephrology over the last decade. These include an increasing focus on patient-centred involvement in trials, exploration of innovative trial design and methodology, the growth of personalized medicine, and most importantly novel therapeutic agents which are disease-modifying for large groups of patients with and without diabetes and chronic kidney disease. Despite this progress, many questions remain unanswered and we have not critically evaluated some of our assumptions, practice and guidelines despite emerging evidence to challenge current paradigms and discrepant patient-preferred outcomes. How best to implement best practices, diagnose various conditions, examine better diagnostic tools, treat laboratory values versus patients, and understand prediction equations in the clinical context, remain unanswered. As we enter a new era in nephrology, there are extraordinary opportunities to change the culture and care. Rigorous research paradigms by which to enable both the generation and the use of new information should be explored. We identify here some key areas of interest and suggest renewed efforts to describe and address these gaps so that we can develop, design and execute trials of importance to all.

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Implementation strategies for high impact nephrology trials: the end of the trial is just the beginning

Cited by 7 publications

References 9 publications

Multi-center, pragmatic, cluster-randomized, controlled trial of standardized Peritoneal Dialysis (PD) training versus usual care on PD-related infections (The TEACH-PD Trial): Trial Protocol

Multi-center, pragmatic, cluster-randomized, controlled trial of standardized Peritoneal Dialysis (PD) training versus usual care on PD-related infections (The TEACH-PD Trial): Trial Protocol

Mitigating Health Disparities in Transplantation Requires Equity, Not Equality

Unmet needs in clinical trials in CKD: questions we have not answered and answers we have not questioned

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