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Abstract: SA-OR57

Using Internal Pilot Data to Create a Dynamic Recruitment Strategy: Experience from the NightLife Trial

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Hull, Katherine Leigh, University of Leicester College of Life Sciences, Leicester, United Kingdom
  • Quann, Niamh, University of Leicester Clinical Trials Unit, Leicester, United Kingdom
  • Fotheringham, James, The University of Sheffield, Sheffield, United Kingdom
  • Conefrey, Carmel, University of Bristol, Bristol, Bristol, United Kingdom
  • Burton, James, University of Leicester College of Life Sciences, Leicester, United Kingdom

Group or Team Name

  • NightLife Study Investigators.
Background

The NightLife study is a randomised controlled trial to evaluate the impact of in-centre nocturnal haemodialysis (INHD) compared to conventional haemodialysis on quality of life. At 12-months, an internal pilot review was completed to evaluate trial feasibility.

Methods

Recruitment and retention rates across sites were reviewed. The site set-up processes and associated timelines were mapped out. Findings were utilised to model the recruitment trajectory for the remaining 18-month study period.

Results

Eight dialysis units contributed to the internal pilot, achieving the 12-month site set-up target. Site set-up was completed in ≈14 months. Recruitment was below the 12-month target (30 participants randomised, 12-month target was 96). Participant retention was higher than expected; the crossover rate from intervention to control 3%, much below the anticipated 25%. Participating sites were categorised as naïve (require INHD service set-up) or established (existing INHD service). 63% of the recruited participants were obtained from a naïve site; recruitment occurred rapidly until INHD bed capacity was saturated. Recruitment from the established sites relied on natural flow of patients through the service (e.g. change in dialysis modality, transplantation), with a rate of ≈1 participant per month. Fifteen sites had expressed an interest to join the NightLife study; 14 were naïve. The recruitment trajectory was remodelled, demonstrating study feasibility (Figure 1).

Conclusion

Remodelling of NightLife study recruitment demonstrated it is non-linear with participants joining in a stepwise manner. This resulted in a shift in focus to assisting naïve sites in INHD service development. Understanding and modelling of bed capacity aids service design, alteration to dialysis regimens and research delivery.

NightLife study metrics: actual recruitment from Year 1 and projected recruitment for Year 2 and 3

Funding

  • Other NIH Support