Can Biochemistry Interpretive Comments on Elevated Cholesterol Levels Increase Referrals to Lipid Clinics and Detection of Familial Hypercholesterolemia? A Step Wedge Cluster Randomized Controlled Trial

What this Trial Is About

Familial hypercholesterolemia (FH) is a common inherited disorder affecting lipid metabolism, yet it remains largely underdiagnosed, with only about 15% of an estimated 30,000 patients identified in Denmark. This study aims to evaluate whether adding a biochemistry interpretive comment on elevated LDL cholesterol levels can increase referrals to lipid clinics and improve the detection rate of FH. The study uses a step wedge cluster randomized controlled trial design across the Region of Southern Denmark to test this approach. The intervention involves implementing an interpretive comment on LDL-C levels that encourages healthcare providers to investigate secondary causes of dyslipidemia and refer patients to lipid clinics when FH is suspected. This comment will be introduced stepwise in four clusters of general practitioners and hospital wards based on their laboratory providers. The LDL-C thresholds for triggering the comment are 4 mmol/L for people under 40 years old and 5 mmol/L for those 40 or older. The intervention period lasts 52 weeks with clusters adopting the comment at 12-week intervals. Participants are patients referred to lipid clinics in Southern Denmark with elevated LDL-C levels meeting the study criteria. Researchers will collect data from electronic patient records to measure the number of referrals and confirmed FH diagnoses, along with laboratory values like HbA1c, TSH, and lipid profiles. Outcomes include changes in LDL-C from referral to first clinic contact and the rate of new FH diagnoses. The study will also assess how many referrals are needed to identify one FH patient, with a total duration of 52 weeks including buffer periods.

Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.