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Substudy: Familial interpretive comment nudging to detection

Project: Research

Project Details

Description

Background
Familial hypercholesterolemia (FH) is the most common inherited disease of the lipid metabolism with 1/200. FH patients are at high risk of premature ischemic heart disease, and it is paramount to initiate lipid-lowering treatment to achieve low-density lipoprotein cholesterol (LDL-C) treatment goals. The diagnosis is made by clinical criteria and genetic test. However, only 15 % of 30.000 possible FH patients remains found in Denmark. Interpretive comment on LDL-C > 6,5 mmol/L is shown to increase referral to lipid clinic by 10 %. FH should be suspected in patients with premature cardiovascular disease, or LDL-C > 4 mmol/L in patients < 40 years, or with LDL-C > 5 mmol/L in patients > 40 years.
We hypothesize that an interpretive comment on LDL-C, meeting these criterions, will increase referrals to lipid clinics, and increase detection of FH.

Methods/Design
We plan to conduct a stepwedge cluster randomized trial, evaluating implementation of an interpretive comment on LDL-C. The comment will be attached if a LDL-C measurement meets the abovementioned criteria. If secondary dyslipidemia can be ruled out, the comment encourages to referral to lipid clinic.
Implementation of the comment will be done stepwise in four clusters, defined by hospitals and general practitioners serviced by the four laboratories in Southern Denmark with three months interval between implementation. The study will evaluate number of referred patients and number of patients diagnosed with clinical FH or positive genetic test, before and after implementation of the comment in each cluster and between the clusters. The stepwedge cluster design allows to adjust for and overall awareness on FH in the Region of Southern Denmark in the evaluation of the interpretive comment.

Conclusion
we currently await data collection and results
AcronymFIND
StatusNot started

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