Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia
University of Texas Southwestern Medical Center
Summary
The purpose and objective of this study is to improve cholesterol treatment among blood donors with FH (Familial Hypercholesterolemia).
Description
This is a single center randomized, two arm trial. The two study arms include usual care (standard notification) and implementation bundle intervention. UT Southwestern Medical Center will be the main study site and Carter Blood Care will serve as the recruitment site. Screening/Baseline visit: Donors agreeing to participate in the study will be informed of study procedures and will provide informed consent. A 20 mL blood sample as well as a urine sample will be obtained for eligibility screening laboratories and baseline LDL-C. Follow-up phone call: At 3 months post-randomization, participa…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria * Age 18 to 75 years Exclusion Criteria: * Currently taking medication to lower cholesterol * Taking any medication that can interact with statins * Pregnancy * Identified secondary cause of elevated lipids * Chronic liver disease or significantly elevated liver function tests (\> 3 times upper limit)
Interventions
- BehavioralImplementation Strategy Bundle
Bundle includes multimodal communications to notify donors about high cholesterol and its treatment, website with resources, and an optional care navigator. Resources for their primary care provider will also be disseminated.
- OtherUsual care notification
Carter BloodCare will notify participants of their high cholesterol, potential for genetic causes, and recommendation to see their care provider by sending its routine, standard notification letter. These participants will also be eligible to receive the intervention bundle at the end of the study.
Location
- UT Southwestern Medical CenterDallas, Texas