Implementing Home Health Care Services for a Rare Disease Clinical Trial

Background

During COVID pandemic, a rare disease study with a pediatric population, needed to adapt so patients could have assessments completed at home. A home health care (HHC) team was put in place so sites, patients, and caregivers were supported and the study could continue with minimal disruption

Challenge
HOW TO SEAMLESSLY IMPLEMENT A HOME HEALTH CARE VENDOR MID-STUDY

The prospect of HHC services supporting the sites caused the PIs/sites to be apprehensive about signing the DOA log if the HHC staff was listed on the log because the PI did not want to take responsibility for individuals with whom they had to relationship, authority, or knowledge of the qualifications and training.

Solution
BUILDING RELATIONSHIPS OF TRUST

Stiris’ biggest roles here were: listening, bringing groups together to collaborate, fostering open communication and collaboration, getting everyone to work to the same goal, and problem solving

The Stiris team worked closely to foster an environment where the sites and the HHC teams could develop a relationship and get to know each other.  First step in this process was to coordinate a kick-off meeting so that the investigators and their teams and the HHC team could have a dedicated arena to speak openly, get to know each other, and build a rapport that would encourage teamwork and collaboration.

Direct communication between site team and the HHC laid the foundation for relationship building and allowed them to set up processes that worked for their combined teams.

To further build familiarity, Stiris had the HHC team provide the site with:

  • All CVs and relevant licenses for team members who would be working on the study
  • Training logs and details around training content as required
Results

  • Stiris project team took two groups who had no accountability to each other, brought them together and developed a strong team that successfully collaborated and drove the process so the service to the patients and caregivers experienced minimal interruption
  • When it came to solving challenges, Stiris didn’t mandate what had to be done, we listened and designed solutions that were unique and satisfied people’s needs.