Utilizing Community Engagement Studios to inform patient experience in a multicenter randomized control trial

Area of Science:

• Clinical research methodology
• Patient engagement strategies
• Pediatric infectious diseases

Background:

• Congenital cytomegalovirus (cCMV) is a leading infectious cause of sensorineural hearing loss in children.
• Clinical trials are crucial for evaluating treatment efficacy, but recruitment and retention can be challenging.
• Patient and family perspectives are vital for optimizing trial design and implementation.

Purpose of the Study:

• To assess the utility of a Community Engagement Studio (CE Studio) in gathering feedback for clinical trial improvement.
• To identify potential barriers and facilitators to participation in the ValEAR trial for cCMV-induced hearing loss.
• To inform the implementation of valuable measures for enhancing clinical trial outcomes.

Main Methods:

• A Community Engagement Studio (CE Studio) was conducted with parents of children affected by cCMV.
• Participants received information about the ValEAR trial, an NIH-funded study on valganciclovir for cCMV-induced hearing loss.
• Feedback was collected through targeted questions assessing perceived merits and weaknesses of trial participation.

Main Results:

• Thirteen parents participated, expressing a strong desire to advance research but emphasizing the need for clear risk-benefit information.
• Key requests included enhanced educational resources, printed materials, and improved access to researchers.
• Participants favored the use of patient stories and information dissemination via websites and social media.

Conclusions:

• The CE Studio effectively provided actionable feedback from a population representative of potential ValEAR trial enrollees.
• In response to feedback, two educational videos were developed: one on cCMV and one specific to the ValEAR trial.
• Incorporating CE Studios into study designs is recommended for researchers aiming to optimize clinical trial success.