OPTIMISE2
Research type
Research Study
Full title
Optimising Prescription of Treatment In older patients with Mild hypertension at Increased risk of Serious adverse Events
IRAS ID
1006598
Contact name
Richard McManus
Contact email
Sponsor organisation
University of Oxford
Research summary
This trial will establish whether deprescribing common drugs that lower blood pressure is safe in older people. We will answer:
1. What is the effect of deprescribing blood pressure lowering drugs on hospital admissions and death?
2. Does deprescribing improve quality of life and/or save money for the NHS?
Building on our previous trial of 569 people, we will aim to enrol 3,014 participants aged 75 years or older and taking blood pressure lowering drugs, but not have raised blood pressure readings. We will actively follow them up for one year. We will focus on those who are frail and/or with a higher risk of serious drug related side-effects. We will examine whether deprescribing is safe in this group by measuring how many people are admitted to hospital or die the year after having blood pressure lowering drugs withdrawn compared to those who continued with them. If the numbers are similar, deprescribing will be viewed as safe. If safe, we will continue the trial and passively follow-up participants using their electronic health records for up to 10 years (subject to further funding). We will also check if deprescribing affects quality of life and/or costs for the NHS.
Participants will be enrolled at participating practices in England by their own GP and be required to attend a minimum of 2 appointments - a baseline assessment and one follow-up after 4 weeks. If further medications are to be stopped then another follow-up appointment would be required. After one year participants will be sent a questionnaire to complete remotely and the trial team will follow-up participants passively using their electronic health records for an average of 3 years (dependent on funding).REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
23/EM/0054
Date of REC Opinion
15 Sep 2023
REC opinion
Further Information Favourable Opinion