Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID03989167

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or electronic health record screening)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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