TY - JOUR

T1 - Feasibility of Randomized Controlled Trials and long-term implementation of interventions: insights from a qualitative process evaluation of the PEDAL Trial

AU - Bulley, Cathy

AU - Koufaki, Pelagia

AU - Macdonald, Jamie

AU - Macdougall, Iain C

AU - Mercer, Thomas H

AU - Scullion, Jane

AU - Greenwood, Sharlene A.

PY - 2023/2/1

Y1 - 2023/2/1

N2 - Introduction: A multi-site randomized controlled trial was carried out between 2015and 2019 to evaluate the impacts on quality of life of an intradialytic exerciseprogramme for people living with chronic kidney disease. This included a qualitativeprocess evaluation which gave valuable insights in relation to feasibility of the trialand of the intervention in the long-term. These can inform future clinical Trialdesign and evaluation studies.Methods: A constructivist phenomenological approach underpinned face-to-face,semi-structured interviews. Purposive recruitment ensured inclusion of participants indifferent arms of the PEDAL Trial, providers with different roles and trial teammembers from seven Renal Units in five study regions. Following ethical review,those willing took part in one interview in the Renal Unit. Audio-recorded interviewswere transcribed (intelligent verbatim) and inductively thematically analyzed.Results: Participants (n = 65) (Intervention arm: 26% completed; 13% who did not; Usualcare arm: 13%; 46% women; 54% men; mean age 60 year) and providers (n = 39) wereinterviewed (23% PEDAL Trial team members). Three themes emerged: (1)Implementing the Intervention; (2) Implementing the trial; and (3) Engagement of theclinical team. Explanatory theory named “the Ideal Scenario” was developed,illustrating complex interactions between different aspects of intervention and trialimplementation with the clinical context. This describes characteristics likely tooptimize trial feasibility and intervention sustainability in the long-term. Key aspectsof this relate to careful integration of the trial within the clinical context to optimizepromotion of the trial in the short-term and engagement and ownership in the longterm. Strong leadership in both the clinical and trial teams is crucial to ensure aproactive and empowering culture.Conclusion: Novel explanatory theory is proposed with relevance for ImplementationScience. The “Ideal Scenario” is provided to guide trialists in pre-emptive andongoing risk analysis relating to trial feasibility and long-term interventionimplementation. Alternative study designs should be explored to minimize theresearch-to-practice gap and optimize the likelihood of informative findings andlong-term implementation. These might include Realist Randomized Controlled Trialsand Hybrid Effectiveness-Implementation studies.

AB - Introduction: A multi-site randomized controlled trial was carried out between 2015and 2019 to evaluate the impacts on quality of life of an intradialytic exerciseprogramme for people living with chronic kidney disease. This included a qualitativeprocess evaluation which gave valuable insights in relation to feasibility of the trialand of the intervention in the long-term. These can inform future clinical Trialdesign and evaluation studies.Methods: A constructivist phenomenological approach underpinned face-to-face,semi-structured interviews. Purposive recruitment ensured inclusion of participants indifferent arms of the PEDAL Trial, providers with different roles and trial teammembers from seven Renal Units in five study regions. Following ethical review,those willing took part in one interview in the Renal Unit. Audio-recorded interviewswere transcribed (intelligent verbatim) and inductively thematically analyzed.Results: Participants (n = 65) (Intervention arm: 26% completed; 13% who did not; Usualcare arm: 13%; 46% women; 54% men; mean age 60 year) and providers (n = 39) wereinterviewed (23% PEDAL Trial team members). Three themes emerged: (1)Implementing the Intervention; (2) Implementing the trial; and (3) Engagement of theclinical team. Explanatory theory named “the Ideal Scenario” was developed,illustrating complex interactions between different aspects of intervention and trialimplementation with the clinical context. This describes characteristics likely tooptimize trial feasibility and intervention sustainability in the long-term. Key aspectsof this relate to careful integration of the trial within the clinical context to optimizepromotion of the trial in the short-term and engagement and ownership in the longterm. Strong leadership in both the clinical and trial teams is crucial to ensure aproactive and empowering culture.Conclusion: Novel explanatory theory is proposed with relevance for ImplementationScience. The “Ideal Scenario” is provided to guide trialists in pre-emptive andongoing risk analysis relating to trial feasibility and long-term interventionimplementation. Alternative study designs should be explored to minimize theresearch-to-practice gap and optimize the likelihood of informative findings andlong-term implementation. These might include Realist Randomized Controlled Trialsand Hybrid Effectiveness-Implementation studies.

KW - implementation

KW - feasibilityqsustainability

KW - chronic kidney disease

KW - hemodialysis

KW - exercise

KW - quality of life

U2 - 10.3389/fresc.2023.1100084

DO - 10.3389/fresc.2023.1100084

M3 - Article

VL - 4

JO - Frontiers in Rehabilitation Sciences

JF - Frontiers in Rehabilitation Sciences

SN - 2673-6861

IS - 1

M1 - 1100084

ER -