Collaborative Staffing Model for Multiple Sites: Reducing the challenges of study coordination in complex, multi-site...

Area of Science:

• Clinical Trials
• Endocrinology
• Pediatrics

Background:

• Complex, multi-site clinical trials face significant challenges in recruitment, participant follow-up, and staff organization.
• The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study, sponsored by the National Institutes of Health (NIH), addresses type 2 diabetes in youth.

Purpose of the Study:

• To describe a unique collaborative staffing model involving program coordinators (PCs) and diabetes educators (DEs) in the TODAY study.
• To evaluate the impact of this model on managing challenges in complex clinical trial implementation.

Main Methods:

• A self-administered survey was distributed to PCs and DEs across all study sites.
• The survey assessed the degree of overlap and task sharing between PCs and DEs.
• Specific examples of collaborative problem-solving were collected.

Main Results:

• The collaborative model demonstrated significant task sharing and overlap between PCs and DEs.
• This approach provided mutual support, decreasing the burden typically placed on a single PC.
• Flexibility and cross-coverage were enhanced through this staffing structure.

Conclusions:

• The PC-DE collaborative staffing model is effective for managing complex, multi-site clinical trials.
• This model enhances operational efficiency and staff support in pediatric diabetes research.
• Mutual support and task sharing are key to successful clinical trial implementation.