A Randomised Clinical Trial for OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals and Evaluation of Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Leeds
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- The proportion of patients with any of the following therapeutic intervention to optimise cardio-renal-metabolic-pulmonary risk factor management
Study Overview
Brief Summary
Cardiovascular disease (CVD) causes a quarter of all deaths in the United Kingdom (UK). This is the single biggest area where the National Health Service (NHS) can save lives by detecting and treating risk factors early.
Improvements in control of blood pressure, cholesterol, diabetes, kidney disease, as well as weight loss in individuals who are obese, have been shown to reduce the risk of CVD and death. The NHS has guidelines for investigations and treatments for risk factors recommended by the National Institute for Health and Care Excellence (NICE).
Though it is known that better control of risk factors will reduce the risk of CVD the investigators do not know whether having extra appointments in primary care with heart specialists can lead to better treatment and better control of risk factors.
The OPTIMISE trial (OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals) will compare patients who have consultations at a local General Practitioner (GP) practice by a cardiology professional to optimise the treatment of their risk factors (OPTIMISE) with those patients who receive standard care (Standard care). Standard care is patients being seen by their GP at routine care appointments.
Participants in the OPTIMISE arm will be reviewed by the cardiology professional and recommended treatment in line with current NICE guidance. They will be seen at 3 months to review their treatment and potentially adjusted to ensure it meets NICE guidelines.
Participants in the standard arm will have data related to their cardiovascular, renal, metabolic and pulmonary risk factors collected through their Electronic Health Record (EHR).
At 6 months, all participants will be seen to find out changes to their prescribed medication and the effect of this on their blood pressure, cholesterol, blood sugar level, and body mass index (BMI).
All participants will also complete a quality of life questionnaire prior to randomisation study and at 6 months to identify any differences between the arms and time points.
Detailed Description
Cardiovascular disease (CVD) causes a quarter of all deaths in the UK and is the largest cause of premature mortality in deprived areas. The National Health Service (NHS) Long Term Plan emphasises that this is the single biggest area where the NHS can save lives and that better detection and treatment of cardiovascular, renal, metabolic and pulmonary risk factors is a priority.
Treatment of blood pressure, cholesterol, diabetes, kidney disease, as well as weight loss in individuals who are obese, have been shown in randomised clinical trials (RCT) to reduce the risk of CVD and cardiovascular death.
Many risk factors for patients with CVD do not occur in isolation, but often co-exist in clusters and increase the risk of other risk factors such as obesity, high blood pressure and diabetes.
In the NHS CVD risk factors identification and improvement is through contact with a healthcare professional in primary care. It is from primary care that the prescription of medications and monitoring to control cardio-renal-metabolic-pulmonary risk factors is delivered.
Research has demonstrated that, especially during the Coronavirus disease 2019 (COVID-19) pandemic, the management of cardio-renal-metabolic-pulmonary risk factors, through monitoring of observations and blood tests and prescription of medications, deteriorated. That is, patients in the community may not be receiving the full extent of NICE guideline directed care and prescriptions of medications for cardiovascular, renal, metabolic and pulmonary risk factors to reduce their risk of future cardiovascular events like heart attack, stroke and death.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
An endpoint adjudication committee, blinded to allocation, will review observations, laboratory measures and GP medical records data for the participant to establish adherence of care to guidelines.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Consented participants in the FIND-AF study
- •Higher predicted FIND-AF risk according to the FIND-AF score
Exclusion Criteria
- •Unable to give written informed consent for participation in the study
- •Unable to adhere to the study requirements
Arms & Interventions
Standard care
The participant will complete a questionnaire (EQ-5D-5L) at both baseline and six months. Their baseline information will be collected from their electronic health records. They will be advised to see their GP as part of their routine care. At six months they will attend a visit where their clinical observations will be recorded.
Optimisation arm
Participants in the intervention arm will attend a baseline visit and two further research appointments at three months and six months from time of randomisation, For baseline assessment, the research cardiology doctor will review the participant's GP records with relation to previous cardiovascular disease, hypertension, dyslipidaemia, chronic kidney disease, diabetes, BMI, COPD and smoking history. They will conduct observations and blood tests that are recommended in NICE guidance if the results are not already available. They will carry out an ambulatory lung test (to screen for risk of pulmonary diseases). They will recommend changes to treatment if the treatment the patient is currently on does not adhere to guidelines. The research team will provide a letter and verbal communication with the participant's GP of the recommendations. For the second visit at three months after randomisation, the research team doctor will conduct the same review as undertaken at the first visit.
Intervention: NICE guidance (Other)
Outcomes
Primary Outcomes
The proportion of patients with any of the following therapeutic intervention to optimise cardio-renal-metabolic-pulmonary risk factor management
Time Frame: 6 months
The proportion of patients with any of the following therapeutic intervention to optimise cardio-renal-metabolic-pulmonary risk factor management including initiation or increase in dose regimen of: * Angiotensin converting enzyme inhibitor / angiotensin 2 receptor blocker * Calcium channel blocker / thiazide-like diuretic / spironolactone / alpha blocker / beta blocker * SGLT2 inhibitor * Glucagon-like peptide (GLP) -1 receptor agonist * Metformin / Dipeptidyl peptidase 4 (DPP4) inhibitor / pioglitazone / sulphonylurea / insulin * Statin / ezetimibe / icosapent ethyl / bempedoic acid / PCSK9 inhibitor * Orlistat * Nicotine replacement therapy / bupropion * Inhaler therapy
Secondary Outcomes
- Number of participants developing a new cardio-renal-metabolic-pulmonary risk factor(6 months)
- Time to diagnosis of a new cardio-renal-metabolic-pulmonary risk factor(6 months)
- Change in EuroQol five dimensional descriptive system (EQ-5D-5L) questionnaire score(6 months)
- Components of primary endpoint(6 months)
- Time to primary endpoint(6 months)
- Number of participants with a new uptake of guideline directed risk factor management(6 months)
Investigators
Prof Christopher Gale
Professor of Cardiovascular Medicine
University of Leeds