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Kidney Week

Abstract: PO1083

Optimising Recruitment in Prepare for Kidney Care: A Clinical Trial Comparing Preparation for Dialysis vs. Responsive Management

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Realpe, Alba X., University of Bristol Faculty of Health Sciences, Bristol, Bristol, United Kingdom
  • Rooshenas, Leila, University of Bristol Faculty of Health Sciences, Bristol, Bristol, United Kingdom
  • Donovan, Jenny, University of Bristol Faculty of Health Sciences, Bristol, Bristol, United Kingdom
  • Gates, Emer R., North Bristol NHS Trust, Westbury on Trym, Bristol, United Kingdom
  • Winton, Helen L., University of Bristol Faculty of Health Sciences, Bristol, Bristol, United Kingdom
  • Caskey, Fergus J., University of Bristol Faculty of Health Sciences, Bristol, Bristol, United Kingdom

Group or Team Name

  • On behalf of Prepare for Kidney Care team
Background

Randomised Controlled Trials (RCTs) are core to evidence-based practice, but often close prematurely or are not attempted for fear of recruitment issues. Prepare for Kidney Care (‘Prepare’) randomises adults aged 80+/65+ with comorbidities to prepare for Renal Dialysis or Responsive Management -a form of conservative care. An RCT of this nature has never been attempted, with concerns about recruitment feasibility. The Prepare RCT integrated the Quintet Recruitment Intervention (QRI) – a complex intervention designed to rapidly diagnose and address recruitment issues in real-time. We report the root-causes of recruitment issues and how these were overcome using this novel methodology.

Methods

The QRI entailed monthly scrutiny of pre-randomisation screening data, interviews with nephrologists/nurses (n=27) and audio-recorded consultations between clinicians/patients (n=33). Data were triangulated, informing strategies to address recruitment issues.

Results

Recruitment was hampered by logistical issues that varied, requiring bespoke solutions by centre. More challenging to address were the underlying complex issues entwined with routine clinical practice, manifesting as reluctance to approach all eligible patients, and issues with conveying equipoise. Clinicians often only approached patients whom they felt could not decide between dialysis or conservative care, assuming other patients’ treatment intentions were fixed. Audio-recorded consultations indicated patients were not necessarily committed to treatments, and preferences were often complicated by misconceptions. Recordings also revealed recruiters’ tendencies to unknowingly undermine dialysis, and hesitancy in exploring preferences. The trial team iteratively produced guides/training to support equipoise communication and used presentations/clinical vignettes to challenge assumptions that patients have fixed treatment plans. As of May 2020, 246 patients have been randomised (48% of target of 512).

Conclusion

Factors hindering recruitment to this challenging RCT were complex, but amenable to change once well-understood. Novel methodologies, like the QRI, can unlock the potential to deliver seemingly impossible- but vitally important- RCTs to improve renal practice.

Funding

  • Government Support - Non-U.S.