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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Familial hypercholesterolemia is the most common inherited disease of the lipid metabolism, however it remains underdiagnosed. Only 15 % of 30.000 possible patients have been found in Denmark. This quality assessing project will through a step wedge cluster randomized controlled trial evaluate establishment of a biochemistry interpretive comment on elevated LDL-C levels. The study will test if the comment results in an increase in referred patients to the lipid clinics of Southern Denmark as the primary endpoint, and as the secondary endpoint in more patients diagnosed with familial hypercholesterolemia. The project will run in totally 52 weeks and will in steps initiate the comment from the different laboratories in the Region of Southern Denmark.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• All referred patients to the lipid clinics of Southern Denmark

• LDL-C \< 4 mmol/L in persons under the age of 40.

• LDL-C \> 5 mmol/L in persons over the age of 40.

Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense
Departement of Cardiology, Odense University Hospital
RECRUITING
Odense C
Contact Information
Primary
Jakob Knold, MD
jakobknold@rsyd.dk
004541278928
Backup
Finn Lund Henriksen, Ph.d.
finn.l.henriksen@rsyd.dk
29679722
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 2000
Treatments
Experimental: Biochemistry interpretive comment on LDL-C levels
The general practitioners and hospital wards will be allocated in cluster according to their providing lab, and stepwise implement the comment on LDL-C \> 4 mmol/L in persons under the age of 40 and over 5 mmol/L in persons over the age of 40 years. Raising awareness on familial hypercholesterolemia an encouraging to referral.~Cluster 1. Will from the 01.12.2022 implement comment on LDL-C Cluster 2. Will from the 01.03.2023 implement comment on LDL-C Cluster 3. Will from the 01.06.2023 implement comment on LDL-C Cluster 4.Will from the 01.09.2023 implement comment on LDL-C
No_intervention: Control
The clusters will act as their own controls, due to the stepwise implementation of the comment.~Cluster 2: Will not implement the comment before the 01.03.2023 Cluster 3: Will not implement the comment before the 01.06.2023 Cluster 4: Will not implement the comment before the 01.09.2023
Sponsors
Leads: Odense University Hospital

This content was sourced from clinicaltrials.gov