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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
Sponsor:
Information provided by (Responsible Party):
Lars Karlsson, University Hospital, Linkoeping

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 at twenty-four months after study initiation.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia, Familial Clinical Decision Support Other: Clinical decision support Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized in the primary care setting
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Primary care centers in the county of Östergötland and the county of Uppsala, Sweden.

Exclusion Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Lars O Karlsson, MD, PhD +46708784690 lars.o.karlsson@regionostergotland.se
Contact: Olof Persson Lindell, MD +46707410736 olof.persson.lindell@regionostergotland.se

Sponsors and Collaborators
University Hospital, Linkoeping

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Responsible Party: Lars Karlsson, Deputy Head of Cardiology Department, Senior Consultant, Principal investigator, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT03989167     History of Changes
Other Study ID Numbers: LIO-793111
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lars Karlsson, University Hospital, Linkoeping:
Hypercholesterolemia, Familial
Primary care
Clinical decision support
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias