Abstract: SA-OR57
Using Internal Pilot Data to Create a Dynamic Recruitment Strategy: Experience from the NightLife Trial
Session Information
- Hemodialysis Care: Cardiovascular and Patient-Reported Outcomes
November 04, 2023 | Location: Room 120, Pennsylvania Convention Center
Abstract Time: 05:51 PM - 06:00 PM
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