Actively Recruiting
Clinical Decision Support for Familial Hypercholesterolemia A Cluster Randomized Trial in Primary Care
Led by University Hospital, Linkoeping · Updated on 2024-11-26
460000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a computer-based clinical decision support system to improve the identification and management of patients with Familial Hypercholesterolemia (FH), a genetic disorder that causes high cholesterol and increases the risk of early coronary artery disease. This cluster randomized trial involves primary care clinics in the county of Östergötland, Sweden, aiming to diagnose more patients with FH by 36 months after starting the study. FH is often underdiagnosed, and this study aims to support physicians in recognizing affected patients earlier. The study compares two groups of primary care clinics: one with access to the clinical decision support (CDS) tool integrated into their electronic health records and one receiving standard care. The CDS activates when a physician reviews a patient's cholesterol test showing high levels, providing alerts and recommendations for referral and treatment steps. Physicians can choose to act on or postpone the alerts. Referrals and patient data are collected and followed for up to 36 months, with new patient inclusion stopping after 30 months. Participants are primary care clinics and their patients in Östergötland. Physicians use the CDS tool during patient visits, and patient diagnoses and referrals are tracked at a specialized FH clinic. Researchers monitor the number of patients diagnosed with FH, including those diagnosed by genetic testing and cascade screening of relatives. The study also evaluates cost-effectiveness and reasons for deviating from recommendations. The study period lasts 36 months, with ongoing data collection and follow-up throughout.
CONDITIONS
Brief Title
Clinical Decision Support for Familial Hypercholesterolemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary care centers in the county of Östergötland
- Patients aged 18 to 80 years
- Care at clinics using the Cambio Cosmic Electronic Health Record System
You will not qualify if you...
- Primary care centers not using the Cambio Cosmic Electronic Health Record System
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or electronic health record screening)
Duration - Up to 36 months after study initiation
Participants undergo evaluation through clinical decision support to identify high cholesterol levels and risk factors for familial hypercholesterolemia (FH). Physicians receive alerts and decide on further referrals or treatments based on the evaluation.
Visits occur as part of routine primary care when cholesterol lab results are reviewed
Duration - Up to 36 months after study initiation
Participants diagnosed with FH are followed to assess diagnosis rates, treatment adherence, and outcomes related to FH over the study period.
Monitoring occurs through routine healthcare visits and follow-up at the FH clinic
Trial Site Locations
Total: 1 location
1
Universitetssjukhuset i Linköping
Linköping, Sweden
Actively Recruiting
Research Team
L
Lars O Karlsson, MD, PhD
O
Olof Persson Lindell, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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