Study team perspectives on a multisite randomized clinical trial with underserved rural populations: A mixed methods...

Area of Science:

• Pediatric Clinical Trials
• Rural Health Research
• Health Services Research

Background:

• Literature on clinical trial methodology often overlooks study staff perspectives.
• This is particularly true for rural and underserved pediatric clinical trials.
• Study staff are crucial influencers of trial success.

Purpose of the Study:

• To gather insights from study investigators and staff on barriers and facilitators in rural pediatric clinical trials.
• To identify actionable tips for improving recruitment, retention, and study procedures.
• To understand the operational feasibility of multi-site behavioral intervention trials in rural settings.

Main Methods:

• Employed a mixed-methods approach, combining qualitative and quantitative (survey) methodologies.
• Gathered data from study personnel involved in multi-state trials within the IDeA States Pediatric Clinical Trials Network (ISPCTN).
• Analyzed survey responses regarding recruitment methods and conducted qualitative analysis of identified themes.

Main Results:

• Quantitative analysis showed staff neutrality towards various recruitment methods (55%).
• Qualitative themes included: participant families feeling overwhelmed, importance of timely incentives, value of personal connections for engagement, preference for clear and family-friendly recruitment materials, enthusiasm for the intervention, and staff appreciation for working with rural populations.
• Staff are open to diverse recruitment strategies and enthusiastic about engaging with underserved rural families.

Conclusions:

• Personal connections and timely incentives are vital for participant engagement and retention in rural pediatric trials.
• Clear, family-friendly communication and materials can mitigate participant overwhelm.
• Study staff possess valuable insights and enthusiasm for conducting trials in rural, underserved areas, offering actionable strategies for future research.