Clinical Decision Support for Familial Hypercholesterolemia

NCT03989167 | Recruiting

• 1 other identifier: LIO-793111
• Study Type: interventional
• Target: 460,000
• Locations: 1 country
• Sites: 1

Brief Summary

A cluster randomized study in the primary care setting to evaluate a computer-based clinical decision support system to aid in the identification and management of patients with FH. The primary outcome of the study is the number of patients diagnosed with FH thirty-six months after study initiation.

Conditions

Hypercholesterolemia, Familial; Clinical Decision Support

Keywords

Hypercholesterolemia, Familial; Primary care; Clinical decision support

Outcome Measures

Primary Outcomes (1)

• The number of patients diagnosed with FH (ICD E78.0A) at thirty-six months after study initiation

  The number of probands (index patients) diagnosed with FH (ICD E78.0A) at thirty-six months after study initiation.The diagnosis of FH will be based on the Dutch Lipid Clinic Network (DLCN) criteria. All patients found to have definite or probable FH according to the DLCN criteria will be diagnosed with FH. This endpoint excludes patients diagnosed secondary to cascade screening.

  36 months after study initiation

Secondary Outcomes (4)

• Number of patients diagnosed with FH (ICD E78.0A) based on genetic testing.

  36 months after study initiation

• Number of patients diagnosed with FH (ICD E78.0A) including cascade screening.

  36 months after study initiation

• Cost-effectiveness of using the Clinical decision support for Familial hypercholesterolemia

  36 months after study initiation

• Reasons for deviation

  36 months after study initiation

Study Arms (2)

Intervention group

EXPERIMENTAL

Group receiving the Clinical decision support

Other: Clinical decision support

Control group

NO INTERVENTION

Group receiving standard care

Interventions

Clinical decision support OTHER

Computer-based support tool for identification of patients with high levels of total cholesterol or LDL-C, at high risk of being affected by FH.

Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care centers in the county of Östergötland.

You may not qualify if:

• Primary care centers not using the Cambio Cosmic Electronic Health Record System.

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

Universitetssjukhuset i Linköping

Linköping, Sweden

RECRUITING

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lars O Karlsson, MD, PhD

  Linkoping University. Linkoping University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars O Karlsson, MD, PhD

CONTACT

+46708784690; lars.o.karlsson@regionostergotland.se

Olof Persson Lindell, MD

CONTACT

+46707410736; olof.persson.lindell@regionostergotland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Principal investigator

Model Details: Cluster randomized in the primary care setting

Study Record Dates

• First Submitted: June 15, 2019
• First Posted: June 18, 2019
• Study Start: December 6, 2022
• Primary Completion: December 6, 2025
• Study Completion: December 6, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)