Clinical Decision Support for Familial Hypercholesterolemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Linkoeping
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary care centers in the county of Östergötland.
Disqualifiers
Primary care centers not using the Cambio Cosmic Electronic Health Record System.
Trial design
Design model
Parallel
Treatments tested in this trial
Clinical decision support
Other interventionComputer-based support tool for identification of patients with high levels of total cholesterol or LDL-C, at high risk of being affected by FH.
Treatment groups
460,000 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
36 months after study initiationSecondary outcomes
1
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.
Time frame
36 months after study initiation2
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.
Time frame
36 months after study initiation3
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.
Time frame
36 months after study initiation4
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.
Time frame
36 months after study initiationSponsors and contacts
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Source ClinicalTrials.gov