Feasibility of randomized controlled trials and long-term implementation of interventions: Insights from a qualitative process evaluation of the PEDAL trial.
Cathy Bulley, Pelagia Koufaki, Jamie Hugo Macdonald and 4 others
PMID 36817715WHAT IT FOUND
Running a trial of exercise during dialysis often fails long-term implementation because strict randomization alienates staff and patients.
Providers reported that minimizing workload impact helped recruitment but reduced ownership, making sustained delivery difficult without integrating the intervention into existing roles.
Key findings
01Strict trial fidelity, such as randomizing motivated patients to a control group, demotivated both staff and participants, jeopardizing long-term implementation.
02Minimizing the trial's impact on clinical workload helped recruitment but prevented providers from developing a sense of ownership, leading to resistance against future role changes.
03Sustainability was more likely in sites where the intervention was embedded into existing job descriptions and culture, rather than relying on dedicated trial staff.
STILL TO COME
How it was doneWhat they foundWhat it means for PTs
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What it does not show
The study focuses on the implementation of the trial itself, not the clinical efficacy of the exercise intervention, which was null in the main RCT. Findings are based on self-reported experiences and perceptions of staff and participants, which may be influenced by recall bias. The context is specific to hemodialysis units in the UK, and generalizability to other clinical settings or countries may be limited. Provider recruitment percentages could not be calculated due to fluctuating staff numbers, so the representativeness of the provider sample is unknown.
Declared interests
The project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme. The funding body did not influence study conduct or reporting.
The easy way to misread this
Do not interpret the positive qualitative reports of patient benefit as evidence that the exercise intervention improved quality of life. The main RCT found no statistically significant difference in the primary outcome, and these qualitative findings describe the experience of running the trial, not its clinical effectiveness.