Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444711
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-23
Brief Title:
OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals
Sponsor:
University of Leeds
Organization:
University of Leeds
Study Overview
Official Title:
A Randomised Clinical Trial for OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals and Evaluation of Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMISE
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
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
The investigators research has demonstrated that individuals identified as at higher predicted risk of Atrial Fibrillation AF are also at increased risk of other conditions such as chronic kidney disease heart failure diabetes mellitus stroketransient ischaemic attack myocardial infarction and peripheral vascular disease The investigators have also shown in their study Future Innovations in Novel Detection of Atrial Fibrillation FIND AF that high FIND-AF predicted risk individuals are also at higher risk of death the majority of which are of cardiovascular cause during 10 years of follow up Accordingly individuals at higher FIND-AF predicted risk may have comorbidities and cardiovascular risk factors that are undiagnosed or under-treated during routine practice that may be potential targets for guideline directed treatment to reduce the risk of future adverse events
The study will take advantage of the FIND AF Primary Care network and processes by recruiting from the FIND AF participants who have already been identified as having a high FIND AF predicted risk score OPTIMISE OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals will compare General Practitioner GP based clinic appointments with a cardiovascular healthcare professional compared to usual care on therapeutic interventions for cardio-renal-metabolic-pulmonary disease and risk factors It will determine the effect of the differing approaches over a follow up of six months to find out if GP based clinic appointments with a cardiovascular healthcare provides better outcomes for patients than standard care
OPTIMISE is a multicentre pragmatic prospective randomised open-label blinded-endpoint strategy trial PROBE
Eligible patients will have consented to take part in the FIND AF pilot study and be assessed as at high risk of developing Atrial Fibrillation in the next 6 months by the FIND AF algorithm
For patients who have consented to the optional follow up visit for the FIND AF pilot study prior to their visit they will be posted the OPTIMISE patient information sheet At the visit the patient will have the opportunity to ask questions provide consent and complete a questionnaire They will then undergo randomisation into either the standard care arm or the Optimisation arm The aim is to recruit 11 between the two arms If the participant is randomised to the Optimisation arm the patient will undergo the Optimise baseline appointment at the same time as the FIND AF pilot study optional visit Combining the visits will reduce the overall time required by the participant as it will avoid duplication of any clinical observations
For patients who have consented to further contact from the research team and have either already undergone the FIND AF pilot study optional visit or have declined to attend the visit they will be sent the patient information sheet consent questionnaire and a reply paid envelope They will be supplied with the study teams contact information so if they have any questions they can contact the team Upon receipt of the consent and questionnaire the study team will randomise the participant The study team will then contact the participant with the results of the randomisation and if the patient has been randomised to the Optimisation arm arrange the baseline appointment
It will be clearly stated that the participant has the right to refuse participation without giving a reason and can withdraw from the study at any time without prejudicing their further treatment or their legal rights The participant will be allowed as much time as wished to consider the information and the opportunity to question the research team their GP or family and friends to decide whether they will participate in the study
For the baseline assessment the research team cardiology doctor will review the data stored in the participants GP records with relation to previous cardiovascular disease hypertension dyslipidaemia chronic kidney disease diabetes Body Mass Index BMI Chronic obstructive pulmonary disease COPD and smoking history At the baseline appointment they will conduct observations and blood tests that are recommended in National Institute for Health and Care Excellence NICE guidance if the results are not already available in the GP medical records They will also carry out an ambulatory lung test to screen for risk of pulmonary diseases
For patients in the Optimisation arm the research team cardiology doctor will recommend changes to treatment if the treatment the patient is currently on does not adhere to NICE guidelines The research team will not directly initiate treatment but will provide a letter and verbal communication with the participants GP of the recommendations
Patients in the standard arm will have consented to their data being reviewed in their GPs record as per the Optimisation arm however they will not undergo an appointment with the research team cardiology doctor and no recommendations for changes to treatment will be identified
For patients in the Optimisation arm at three months following their baseline appointment they will attend their second visit and undergo the same tests as at the baseline appointment and again will recommend changes in line with NICE guidance
At six months both participants in the Optimisation arm and the standard arm will have their observations eg blood pressure BMI and an ambulatory lung test taken during an appointment by a research team suitably qualified health professional as well as any blood tests that are indicated by the patients known comorbidities eg HBA1c if known to have diabetes as well as completing a patient-reported outcome measure EQ-5D-5L
All visits will take place at the participants primary care site
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
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
The investigators research has demonstrated that individuals identified as at higher predicted risk of Atrial Fibrillation AF are also at increased risk of other conditions such as chronic kidney disease heart failure diabetes mellitus stroketransient ischaemic attack myocardial infarction and peripheral vascular disease The investigators have also shown in their study Future Innovations in Novel Detection of Atrial Fibrillation FIND AF that high FIND-AF predicted risk individuals are also at higher risk of death the majority of which are of cardiovascular cause during 10 years of follow up Accordingly individuals at higher FIND-AF predicted risk may have comorbidities and cardiovascular risk factors that are undiagnosed or under-treated during routine practice that may be potential targets for guideline directed treatment to reduce the risk of future adverse events
The study will take advantage of the FIND AF Primary Care network and processes by recruiting from the FIND AF participants who have already been identified as having a high FIND AF predicted risk score OPTIMISE OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals will compare General Practitioner GP based clinic appointments with a cardiovascular healthcare professional compared to usual care on therapeutic interventions for cardio-renal-metabolic-pulmonary disease and risk factors It will determine the effect of the differing approaches over a follow up of six months to find out if GP based clinic appointments with a cardiovascular healthcare provides better outcomes for patients than standard care
OPTIMISE is a multicentre pragmatic prospective randomised open-label blinded-endpoint strategy trial PROBE
Eligible patients will have consented to take part in the FIND AF pilot study and be assessed as at high risk of developing Atrial Fibrillation in the next 6 months by the FIND AF algorithm
For patients who have consented to the optional follow up visit for the FIND AF pilot study prior to their visit they will be posted the OPTIMISE patient information sheet At the visit the patient will have the opportunity to ask questions provide consent and complete a questionnaire They will then undergo randomisation into either the standard care arm or the Optimisation arm The aim is to recruit 11 between the two arms If the participant is randomised to the Optimisation arm the patient will undergo the Optimise baseline appointment at the same time as the FIND AF pilot study optional visit Combining the visits will reduce the overall time required by the participant as it will avoid duplication of any clinical observations
For patients who have consented to further contact from the research team and have either already undergone the FIND AF pilot study optional visit or have declined to attend the visit they will be sent the patient information sheet consent questionnaire and a reply paid envelope They will be supplied with the study teams contact information so if they have any questions they can contact the team Upon receipt of the consent and questionnaire the study team will randomise the participant The study team will then contact the participant with the results of the randomisation and if the patient has been randomised to the Optimisation arm arrange the baseline appointment
It will be clearly stated that the participant has the right to refuse participation without giving a reason and can withdraw from the study at any time without prejudicing their further treatment or their legal rights The participant will be allowed as much time as wished to consider the information and the opportunity to question the research team their GP or family and friends to decide whether they will participate in the study
For the baseline assessment the research team cardiology doctor will review the data stored in the participants GP records with relation to previous cardiovascular disease hypertension dyslipidaemia chronic kidney disease diabetes Body Mass Index BMI Chronic obstructive pulmonary disease COPD and smoking history At the baseline appointment they will conduct observations and blood tests that are recommended in National Institute for Health and Care Excellence NICE guidance if the results are not already available in the GP medical records They will also carry out an ambulatory lung test to screen for risk of pulmonary diseases
For patients in the Optimisation arm the research team cardiology doctor will recommend changes to treatment if the treatment the patient is currently on does not adhere to NICE guidelines The research team will not directly initiate treatment but will provide a letter and verbal communication with the participants GP of the recommendations
Patients in the standard arm will have consented to their data being reviewed in their GPs record as per the Optimisation arm however they will not undergo an appointment with the research team cardiology doctor and no recommendations for changes to treatment will be identified
For patients in the Optimisation arm at three months following their baseline appointment they will attend their second visit and undergo the same tests as at the baseline appointment and again will recommend changes in line with NICE guidance
At six months both participants in the Optimisation arm and the standard arm will have their observations eg blood pressure BMI and an ambulatory lung test taken during an appointment by a research team suitably qualified health professional as well as any blood tests that are indicated by the patients known comorbidities eg HBA1c if known to have diabetes as well as completing a patient-reported outcome measure EQ-5D-5L
All visits will take place at the participants primary care site
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None