Hypercholesterolaemia Nutritional, Metabolic, Endocrine
Conditions
Interventions
This pragmatic study will employ an open-labelled, randomised controlled trial design, using cluster randomisation at the practice level. GP practices (representing clusters of individual patients) wi
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Practice inclusion criteria: 1. List size of over 6,000 2. A principal investigator (PI), on behalf of the practice, is willing and able to sign the Remote Access Agreement and Organisation Information Document with the University of Leicester for the sharing of pseudonymised patient data, and provide informed consent on behalf of the practice 3. The GP Practice is willing for PRIMIS to carry out a remote database search and data extractions (at 0, 7.5 and 15 months), on behalf of the lead study team at the University of Leicester and in line with the Remote Access Agreement (see Section 8.2) 4. The PI and corresponding GP practice is able and willing (in the investigator’s opinion) to comply with all study requirements, including allowing practice staff to attend and complete study-related training 5. The GP practice is already using an automated text mailing system as part of their routine care 6. The GP practice is using either the EMIS Web or SystmOne clinical database systems. 7. The GP practice is not participating in any cluster trials involving medication adherence Patient inclusion criteria: 1. Male or female, aged between 18 and 75 years at study initiation 2. Enrolled at an eligible and participating practice 3. Receiving a prescription for any type of statin for at least the last 12 months 4. Displaying hypercholesterolaemia, defined in this instance as a most recent (within the last 24 months) LDL-C result of >3.0 mmol/l 5. Diagnosed with at least one of the following conditions: type 2 diabetes; diagnosed hypertension (coded in their healthcare records); chronic kidney disease (stage 3 onwards – eGFR <60 ml/min/1.73m²), or cardiovascular disease (comprising ischaemic heart disease, previous myocardial infarction, previous stroke, previous transient ischaemic attack)
Exclusion criteria
Exclusion criteria: Practice exclusion criteria: 1. The PI is not willing and able to give informed consent 2. The GP practice is not willing and able to sign the OID or Remote Access Agreement 3. The GP practice is not willing to let PRIMIS remotely install electronic software on their system to carry out the database search and data extractions 4. The GP practice is not willing to have clinical staff participate in the training 5. The GP practice is not able and willing (in the chief investigator’s opinion) to comply with all other study requirements 6. The GP practice is not using either EMIS Web or SystmOne clinical database systems 7. The GP practice is currently participating in any cluster trials involving medication adherence Patient exclusion criteria: 1. Aged under 18 years or over 75 years at study initiation 2. Most recent LDL-C result of < 3.0 mmol/l 3. Most recent LDL-C result of < 3.0 mmol/l 4. Receiving prescriptions via electronic repeat dispensing (this invalidates the use of PDC, as prescriptions are automatically ‘filled’ without input from the patient, therefore invaliding the use of PDC as a surrogate measure of adherence) or routinely using ‘dosset box’ prescriptions (this also impacts adherence and makes adherence difficult to approximate) 5. Receiving end of life or palliative care 6. Patient has opted out of sharing their personal data as part of the national data opt-out policy 7. Patients still on the GP system who have died or left the practice prior to the first data extraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low-density lipoprotein-cholesterol (LDL-C) measured via extraction of routine test results from healthcare records at 0, 7.5 and 15 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Statin adherence measured by the proportion of days covered (PDC) at 15 months post-baseline assessment 2. Statin prescriptions measured by extraction of routine prescriptions from healthcare records at 15 months post-baseline assessment 3. Total cholesterol levels measured by extraction of routine prescriptions from healthcare records at 15 months post-baseline assessment at 15 months post-baseline assessment 4. Adherence to other cardiovascular medications, such as anti-hypertensive medication, measured by the proportion of days covered (PDC) at 15 months post-baseline assessment 5. LDL-C levels in those with vs without co-morbidities (hypertension, chronic kidney disease (CKD), cardiovascular disease (CVD), type 2 diabetes mellitus (T2DM), multimorbidity) measured by extraction of routine prescriptions from healthcare records at 15 months post-baseline assessment 6. Consultation rates measured using audit feedback at 15 months post-baseline assessment | — |
Countries
England, United Kingdom
Outcome results
None listed