OPTIMISE 2
Summary
More than one in three adults aged 75+ years are prescrived five or more drugs to treat their long-term conditions. people who take lots of drugs are more likely to end up with reduced independece and quality of life as they get older. They are also more likely to end up in hospital due to drug side effects. One solution is to stop of "deprescribe" drugs which no longer provide benefit, or could be potentially harmful. The most commonly prescribed drugs in older people are those used to lower blood pressure, which reduce the risk of stroke and heart attack. However, in some frail, older people they may be harmful, which could cancel out any potential benefits of treatment. Very little research has been done in this area.
The aim is to establish whether deprescribing common drugs that lower BP is safe in older people:
What are the effects on hospital admissions and death?
Are there any effects on health-related quality of life?
Is deprescribing offer value for money for the NHS?
For more information please click HERE for the full summary.
Sponsor - University of Oxford
Recruitment End Date - 30/06/2025
Type of Study - Recruiting
RSI Points - 350 CRN/400 Practice Nurse
Practice Involvement
Set up visit with study team.
Database searches and mail out. Opportunistic recruitment also possible.
medication check and reduction plan.
basline visit: trial discussion and informed consent (30 minutes), eligibility check, randomisation & collection of baseline data/collection of eCRF: BP; weight; height; patient questionnaires; collect data from pateint notes (1 hour).
Ongoing review/reportiong of any AE/SAEs as required.
Safety follow up at 4 weeks: BP check/AE check.
If more than 1 medication is deprescribed, carry out additional follow up visit. Safety visits continue at 4-weekly intervals per medication reduced.
Eligibility Criteria
Inclusion
Participant is willing and able to give informed consent for participation in the trial (or with designated consultee consent).
Registered at either a practice contributing to or willing to contribute to ORCHID or running the EMIS/SystemOne electronic health records system.
Aged 75 years or above at recruitment.
Controlled clinic systolic blood pressure defined (in accordance with NICE 2019 guidelines) as less than 140 mmHg (if aged 75-79 years) or less than 150 mmHg (if 80 years or above). Systolic blood pressure level will be based on screening measurements taken at baseline (mean of the 2nd and 3rd readings taken in a standarised manner).
Prescribed two or more antihypertensive medications for at least 12 months prior to trial entry. Antihpertensive medications defined as any ACE inhibitor, angiotensin II receptor blocker, calcium channel blocker, thiazide and thiazide-like diuretic, potassium-sparing diuretic, alpha-blocker, beta-blocker, vasodilator antihypertensives, centrally acting antihypertensives, direct renin inhibitors, adrenergic neurone blocking drugs.
Stable dose of antihypertensive medications for at least four weeks prior to trial entry.
Moderate or severe frailty (defined by an eFI score >0.20) and/or high risk (>5%) of hypotension, syncope, or falls in the next 5 years, based on STRATIFY risk prediction algorithms applied to an individual's electronic health record.
Exclusion
Heart failure due to left ventricular systolic dysfunction (LVSD) prescribed only ACE inhibitors/angiotensin II receptor blockers and/or beta-blockers and/or spironolactone (removing any of which would be contraindicted).
Heart failure diagnoses without a coded echocardiogram (might have undiagnosed LVSD and a compelling need for ACEI/angiotensin II receptor blocker and beta-blockers).
Suffered a myocardial infarction or stroke within the past 6 months.
Secondary hypertension or previous accelerated or malignant hypertension.
Lacking capacity to give consent and without a consultee present at the point of screening.
Participating in any other randomised controlled trial of drug treatment or interventional medical devices in the past 4 weeks (can be re-invited subsequently).
***To express an interest for the OPTIMISE 2 study please use the form provided and a member of the team will be in touch***