Familial Hypercholesterolaemia
Conditions
Keywords
Familial Hypercholesterolemia, Computerized Decision Support, Electronic Alerts, High Cholesterol
Brief summary
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.
Detailed description
FH-ALERT is a single-center, time-series trial of a patient- and provider-facing EPIC BPA (alert-based CDS tool) to increase diagnosis, LDL-C lowering, and guideline-based therapy of outpatients with presentations consistent with FH. For the first 6 months, the BPA will run in silent mode, identifying patients with presentations consistent with FH, but not alerting the clinician of record. Following this initial pre-alert 6-month period, the BPA will switch to alert mode for 18 months, which will provide the on-screen notification to the clinician of record. In other words, consecutive outpatients with presentations consistent with FH will be enrolled over two years: pre-alert (silent mode) for 6 months and alert mode for 18 months.
Interventions
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.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
During the first 6 months, the BPA will run in silent mode and will not provide notification to the clinician of record about the potential diagnosis of FH. For the following 18 months, the BPA will run in alert mode during which an on-screen alert will notify the ambulatory care clinician of record that the patient has a definite, probable, or possible diagnosis of FH but has not been recognized as such.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years old * seen in the BWH Endocrinology, Cardiovascular Medicine, and Primary Care Clinics * Dutch Lipid Clinic Network score of at least 3 points
Exclusion criteria
* a Familial Hypercholesterolemia diagnosis already documented in the EHR medical history, visit history, or problem list
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of documented FH diagnosis | 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in LDL-C | 6 Months | 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). |
Countries
United States
Contacts
Primary ContactGregory Piazza, MD, MS
Outcome results
None listed