A quasi-experimental study to assess the effectiveness of an educational intervention for improving identification and management of familial hypercholesterolemia in general practice

Study type
Protocol
Date of Approval
Study reference ID
18_099
Lay Summary

Familial hypercholesterolaemia (FH) is a common inherited cause of raised cholesterol affecting about 320,000 people in the UK. However, over 80% of individuals are not identified, leading to many avoidable heart attacks and early deaths.
An educational programme to help general practitioners (GPs) identify people with FH was carried out in 6 general practices in England. This study will use electronic patient heart records from 24 different general practices in England sourced from CPRD to show the impact of the educational programme on identifying and managing individuals with FH in general practice.
The findings from this study will possibly inform a policy decision on the possible implementation of the educational intervention to more general practices. This will help in early identification and management of individuals with FH thereby reducing or avoiding heart attacks and early death in these individuals.

Technical Summary

Background: Familial hypercholesterolaemia (FH) is a common inherited cause of raised cholesterol which puts an individual at risk of premature coronary heart disease and myocardial infarction. Under-diagnosis and mis-identification of patients with familial hypercholesterolemia is, therefore, an important issue. The Simon Broome criteria, however, informs general practitioners of risk factors which should prompt further investigation and possible referral to familial hypercholesterolemia specialists.

Objective: The aim of the study is to assess the effectiveness of an educational intervention for general practitioners in the identification and management of familial hypercholesterolemia in primary care.

Study Design: Quasi-experimental

Setting: UK General Practices in England: 6 general practices using EMIS system in East Midlands where FH identification and management intervention was carried out and 24 comparison general practices using VISION system from across England

Participants: Patients aged 18 years and over, with a record of cholesterol at a level > 7.5mmol/L and without a confirmed diagnosis of FH

Exposure/Intervention: Educational intervention informing general practitioners of the Simon Broome criteria and NICE guidelines on diagnosis and management of familial hypercholesterolemia; alert-system on the computer system informing GPs of eligible patients; and provision of laminated sheets outlining the Simon Broome criteria.

Comparator: No education intervention for the diagnosis and management of familial hypercholesterolemia.

Outcomes: Primary outcome – number of patients diagnosed with FH; Secondary outcomes – indicators related to a change in identification and management of patients with FH at the general practice level.

Methods: Retrospective records for eligible patients from the 24 randomly selected general practices will be obtained from the Clinical Practice Research Datalink from 2013 and 2015. A differences-in-differences analysis will be conducted, to compare changes in outcomes between the 6 intervention general practices which were given an education intervention with 24 comparison general practices which were not given the intervention.

Outputs: Quantify the effect of the educational intervention on patient identification and management; determine the significance of any differences. Findings to inform the possibility of rolling-out the educational intervention to more general practices.

Health Outcomes to be Measured

Primary outcome:
• Number of patients diagnosed with familial hypercholesterolaemia (FH)

Secondary Outcomes:
• Indicators related to change in identification and management of familial hypercholesterolaemia
- Number of patients diagnosed with possible FH, arcus senilis/xanthalasma, secondary cause of FH;
- Proportion of patients with the following assessed: any family history of heart disease, complete family history of coronary heart disease, thyroid stimulating hormone, glycated haemoglobin, serum creatinine, bilirubin, ALP, gamma GT, repeat cholesterol test.

Collaborators

Ralph Kwame Akyea - Chief Investigator - University of Nottingham
Ralph Kwame Akyea - Corresponding Applicant - University of Nottingham
Emily Wallbanks - Collaborator - University of Nottingham
Jo Leonardi-Bee - Collaborator - University of Nottingham
Joe Kai - Collaborator - University of Nottingham
Nadeem Qureshi - Collaborator - University of Nottingham
Stephen Weng - Collaborator - University of Nottingham

Linkages

Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation