Trials (Nov 2021)

Deprescribing to reduce polypharmacy: study protocol for a randomised controlled trial assessing deprescribing of anticholinergic and sedative drugs in a cohort of frail older people living in the community

  • Ulrich Bergler,
  • Nagham J. Ailabouni,
  • John W. Pickering,
  • Sarah N. Hilmer,
  • Dee Mangin,
  • Prasad S. Nishtala,
  • Hamish Jamieson,
  • Sponsor-investigator

DOI
https://doi.org/10.1186/s13063-021-05711-w
Journal volume & issue
Vol. 22, no. 1
pp. 1 – 12

Abstract

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Abstract Background Targeted deprescribing of anticholinergic and sedative medications in older people may improve their health outcomes. This trial will determine if pharmacist-led reviews lead to general practitioners deprescribing anticholinergic and sedative medications in older people living in the community. Methods and analysis The standard protocol items: Recommendations for Interventional Trials (SPIRIT) checklist was used to develop and report the protocol. The trial will involve older adults stratified by frailty (low, medium, and high). This will be a pragmatic two-arm randomized controlled trial to test general practitioner uptake of pharmacist recommendations to deprescribe anticholinergic and sedative medications that are causing adverse side effects in patients. Study population Community-dwelling frail adults, 65 years or older, living in the Canterbury region of New Zealand, seeking publicly funded home support services or admission to aged residential care and taking at least one anticholinergic or sedative medication regularly. Intervention New Zealand registered pharmacists using peer-reviewed deprescribing guidelines will visit participants at home in the community, review their medications, and recommend anticholinergic and sedative medications that could be deprescribed to the participant’s general practitioner. The total use of anticholinergic and sedative medications will be quantified using the Drug Burden Index (DBI). Outcomes The primary outcome will be the change in total DBI between baseline and 6-month follow-up. Secondary outcomes will include entry into aged residential care, prolonged hospitalization, and death. Data collection points Data will be collected at the time of interRAI assessments (T0), at the time of the baseline review (T1), at 6 months following the baseline review (T2), and at the end of the study period, or end of study participation for participants admitted into aged residential care, or who died (T3). Ethics and dissemination Ethical approval has been obtained from the Human, Disability and Ethics Committee: ethical number (17CEN265). Trial registration ClinicalTrials.gov ACTRN12618000729224 . Registered on May 2, 2018, with the Australian New Zealand Clinical Trials Registry

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