Clinical Decision Support for Familial Hypercholesterolemia (CDS-FH)
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|ClinicalTrials.gov Identifier: NCT03989167|
Recruitment Status : Not yet recruiting
First Posted : June 18, 2019
Last Update Posted : June 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia, Familial Clinical Decision Support||Other: Clinical decision support||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Cluster randomized in the primary care setting|
|Masking:||None (Open Label)|
|Official Title:||Clinical Decision Support for Familial Hypercholesterolemia: A Cluster Randomized Trial in the Primary Care Setting|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2022|
Experimental: Intervention group
Group receiving the Clinical decision support
Other: Clinical decision support
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.
|No Intervention: Control group|
- The number of patients diagnosed with FH (ICD E78.0A) at twenty-four months after study initiation [ Time Frame: 24 months after study initiation ]The number of patients diagnosed with FH (ICD E78.0A) at twenty-four months after study initiation
- LDL-cholesterol treatment target [ Time Frame: Twenty-four months after study initiation ]An analysis will be conducted to investigate any difference between the groups in the number of patients reaching the LDL-cholesterol targets in accordance with recent ESC/EAS guidelines.
- Cost-effectiveness of using the Clinical decision support for Familial hypercholesterolemia [ Time Frame: 24 months after study initiation ]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.
- Reasons for deviation [ Time Frame: 24 months after study initiation ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989167
|Contact: Lars O Karlsson, MD, PhDfirstname.lastname@example.org|
|Contact: Olof Persson Lindell, MDemail@example.com|