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OPtimising Treatment for MIld Systolic hypertension in the Elderly (OPTiMISE): protocol for a randomised controlled non-inferiority trial
  1. James P Sheppard1,
  2. Jenni Burt2,
  3. Mark Lown3,
  4. Eleanor Temple1,
  5. John Benson4,
  6. Gary A Ford1,
  7. Carl Heneghan1,
  8. F D Richard Hobbs1,
  9. Sue Jowett5,
  10. Paul Little3,
  11. Jonathan Mant4,
  12. Jill Mollison1,
  13. Alecia Nickless1,
  14. Emma Ogburn1,
  15. Rupert Payne6,
  16. Marney Williams7,
  17. Ly-Mee Yu1,
  18. Richard J McManus1
  1. 1 Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  2. 2 The Healthcare Improvement Studies Institute, University of Cambridge, Cambridge, UK
  3. 3 Primary Care Research Group, University of Southampton, Southampton, UK
  4. 4 Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
  5. 5 Institute of Applied Health Research, University of Birmingham, Birmingham, UK
  6. 6 Centre for Academic Primary Care, University of Bristol, Bristol, UK
  7. 7 Patient and Public Involvement Representative, London, UK
  1. Correspondence to Dr James P Sheppard; james.sheppard{at}phc.ox.ac.uk

Abstract

Introduction Recent evidence suggests that larger blood pressure reductions and multiple antihypertensive drugs may be harmful in older people, particularly frail individuals with polypharmacy and multimorbidity. However, there is a lack of evidence to support deprescribing of antihypertensives, which limits the practice of medication reduction in routine clinical care. The aim of this trial is to examine whether antihypertensive medication reduction is possible in older patients without significant changes in blood pressure control at follow-up.

Methods and analysis This trial will use a primary care-based, open-label, randomised controlled trial design. A total of 540 participants will be recruited, aged ≥80 years, with systolic blood pressure <150 mm Hg and receiving ≥2 antihypertensive medications. Participants will have no compelling indication for medication continuation and will be considered to potentially benefit from medication reduction due to existing polypharmacy, comorbidity and frailty. Following a baseline appointment, individuals will be randomised to a strategy of medication reduction (intervention) with optional self-monitoring or usual care (control). Those in the intervention group will have one antihypertensive medication stopped. The primary outcome will be to determine if a reduction in medication can achieve a proportion of participants with clinically safe blood pressure levels at 12-week follow-up (defined as a systolic blood pressure <150 mm Hg), which is non-inferior (within 10%) to that achieved by the usual care group. Qualitative interviews will be used to understand the barriers and facilitators to medication reduction. The study will use economic modelling to predict the long-term effects of any observed changes in blood pressure and quality of life.

Ethics and dissemination The protocol, informed consent form, participant information sheet and all other participant facing material have been approved by the Research Ethics Committee (South Central—Oxford A; ref 16/SC/0628), Medicines and Healthcare products Regulatory Agency (ref 21584/0371/001–0001), host institution(s) and Health Research Authority. All research outputs will be published in peer-reviewed journals and presented at national and international conferences.

Trial registration number EudraCT 2016-004236-38; ISRCTN97503221; Pre-results.

  • multi-morbidity
  • cardiovascular disease
  • frailty
  • antihypertensive
  • de-prescribing

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Contributors JPS conceived, designed and secured funding for the study with JBu, ML, JBe, GAF, CH, FDRH, SJ, PL, JM, EO, RP, MW, L-MY and RJM. JPS wrote the first draft. AN, JMo and L-MY provided the sample size calculations and statistical analysis section. JBu provided the qualitative section. SJ provided the health economic section. All authors reviewed and edited the manuscript. ET is the trial manager. JPS and RJM are co-chief investigators and will act as guarantors for this work.

  • Funding This work receives joint funding from the National Institute for Health Research (NIHR) Oxford Collaboration for Leadership in Applied Health Research and Care (CLAHRC) at Oxford Health NHS Foundation Trust (ref: P2-501) and the NIHR School for Primary Care Research (SPCR; ref 335). JS and RJMcM have been funded by an NIHR Professorship (NIHR-RP-R2-12-015). FDRH acknowledges part support from the NIHR SPCR, the NIHR CLAHRC Oxford, and the NIHR Oxford Biomedical Research Centre (BRC). CH receives support from the NIHR SPCR and NIHR Oxford BRC. Trial Sponsor: University of Oxford.

  • Disclaimer The views and opinions expressed are those of the authors and do not necessarily reflect those of the NHS, NIHR or the Department of Health. The sponsor and funder had no role in the study design, writing of the paper; or the decision to submit this protocol for publication, which was made jointly by the authors who have all approved the final manuscript.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval The protocol, informed consent form, participant information sheet and all other participant facing material have been approved by the Research Ethics Committee (South Central—Oxford A; ref 16/SC/0628), Medicines and Healthcare products Regulatory Agency (ref 21584/0371/001–0001), host institution(s) and Health Research Authority.

  • Provenance and peer review Not commissioned; externally peer reviewed.