Hypercholesterolemia, Familial Clinical Trial
— CDS-FHOfficial title:
Clinical Decision Support for Familial Hypercholesterolemia: A Cluster Randomized Trial in the Primary Care Setting
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 at thirty months after study initiation.
Status | Recruiting |
Enrollment | 460000 |
Est. completion date | June 6, 2025 |
Est. primary completion date | June 6, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria - Primary care centers in the county of Östergötland. Exclusion Criteria - Primary care centers not using the Cambio Cosmic Electronic Health Record System. |
Country | Name | City | State |
---|---|---|---|
Sweden | Universitetssjukhuset i Linköping | Linköping |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Linkoeping |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of patients diagnosed with FH (ICD E78.0A) at thirty months after study initiation | The number of probands (index patients) diagnosed with FH (ICD E78.0A) at thirty 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. | 30 months after study initiation | |
Secondary | Number of patients diagnosed with FH (ICD E78.0A) based on genetic testing. | We will investigate the number of patients diagnosed with FH based on the presence of a pathogenic FH-causing mutation and evaluate a possible difference between the CDS intervention group and the control group. | 30 months after study initiation | |
Secondary | Number of patients diagnosed with FH (ICD E78.0A) including cascade screening. | To evaluate the full effect of the intervention we will investigate the number of patients diagnosed with FH including any relatives to the proband that are diagnosed secondary to cascade screening. The cascade screening will continue in parallel with the inclusion of new probands throughout the study period. | 30 months after study initiation | |
Secondary | Cost-effectiveness of using the Clinical decision support for Familial hypercholesterolemia | We will calculate the cost of implementation and usage of the CDS-FH as well as annual fees and costs related to administration of the CDS-FH. The costs-effectiveness will then be calculated in relation to the potential cost-reducing long-term effects of improvements in the identification and management of FH patients. | 30 months after study initiation | |
Secondary | Reasons for deviation | We will investigate the main reasons for not sending a referral to the FH-clinic when recommended to do so by the CDS. The mandatory question in the CDS system regarding the reason for refraining from sending the referral will be analysed to identify the main reasons stated by the physicians. | 30 months after study initiation |
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