Computerized Decision Support for Identification and Management of Familial Hypercholesterolemia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBrigham and Women's Hospital

About this trial

The goal of this clinical trial is to learn if a computer alert can aid clinicians in identifying patients with a genetic type of high cholesterol, called Familial Hypercholesterolemia. The main question it aims to answer is whether the computer alert increases recognition of this high cholesterol disorder.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years old

seen in the BWH Endocrinology, Cardiovascular Medicine, and Primary Care Clinics

Dutch Lipid Clinic Network score of at least 3 points

Disqualifiers

a Familial Hypercholesterolemia diagnosis already documented in the EHR medical history, visit history, or problem list

Trial design

Design model

Sequential

Treatments tested in this trial

  • Alert-based computerized decision support

    Device

    A program will be designed to run within the Electronic Health Record (EHR) that will identify outpatients with "definite," "probable," or "possible" diagnosis of FH. The BPA will calculate the Dutch Lipid Clinic Network score using the following EHR data: 1. Maximum LDL-C level in the laboratory results 2. Abnormal genetic testing for FH in the laboratory results 3. Medical history or problem list entry for tendinous xanthomata or arcus cornealis 4. Medical history, visit diagnosis, or problem list entry of premature CAD, cerebrovascular disease, or PAD 5. Family history of premature CAD, cerebrovascular disease, or PAD In the Alert phase, an on-screen alert will notify the ambulatory care clinician of record that the patient has a "definite," "probable," or "possible" diagnosis of FH. ambulatory care clinician will have the opportunity to proceed to an order template through which a referral for specialty care focused on evaluation and management of FH can be made.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: Pre-AlertNo intervention 0 interventions
Group B: AlertExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of documented FH diagnosis

We will review the medical history, visit diagnosis, and problem list sections of the Electronic Health Record (EPIC) to make this determination of diagnosis of Familial Hypercholesterolemia.

Time frame
6 Months

Secondary outcomes

1

Mean Change in LDL-C

Mean change in LDL-C levels within 6 months following triggering of the BPA compared with the most recent LDL-C prior to the clinic visit in outpatients with presentations consistent with FH ("definite," "probable," or "possible" Dutch Lipid Clinic Network score).

Time frame
6 Months

Other outcomes

Sponsors and contacts

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