REGENERATE feasibility study

• Research type

  Research Study

• Full title

  Intervention to REduce anticholinerGic burdEN in oldER pATiEnts (REGENERATE) aged 65 years and older: A non-randomised feasibility study

• IRAS ID

  289526

• Contact name

  Phyo Myint

• Contact email

  phyo.myint@abdn.ac.uk

• Sponsor organisation

  University of Aberdeen

• Clinicaltrials.gov Identifier

  NCT04660838

• Duration of Study in the UK

  0 years, 6 months, 16 days

• Research summary

  Research Summary

  Medications with anticholinergic properties are frequently prescribed for several conditions in older age; for example cardiovascular drugs (e.g. digoxin, furosemide), urologicals (e.g. darifenacin, oxybutynin) and anti-parkinsonism drugs (e.g. benztropine, trihexyphenadyl). It has been shown that increasing anticholinergic burden (ACB) can cause poor health-related outcomes, but there are still uncertainties around whether it is possible or acceptable to stop medication with high ACB and/or switching to another medication with no or low anticholinergic burden, the effect on health-related outcomes of such an approach, the most appropriate person to deliver this intervention or the health care setting in which it should take place.
  The term ‘deprescribing’ is the process of intentionally stopping a medication or reducing its dose to improve the person's health or reduce the risk of adverse side effects (Olasehinde-williams 2020). There is, however, limited research regarding deprescribing. Previously, Scott et al. (2017) have suggested deprescribing is a systematic process of identifying and discontinuing drugs in instances in which existing or potential harms outweigh existing or potential benefits within the context of an individual patient’s care goals, current level of functioning, life expectancy, values, and preferences. However, there are not many studies about implementation of appropriate interventions to reduce ACB in older patients (aged 65 year and over).
  The aim of this non-randomised study is to explore the feasibility of delivering an intervention to reduce the ACB in older patients by deprescribing or switching to inform a future definitive clinical trial. This is a single-arm, open feasibility study conducted in primary and secondary care involving older patients. Mixed method (routine data, questionnaires and interviews) will be used in this study.
  
  Summary of Results

  The study could not be conducted in secondary care setting due to the COVID-19 pandemic. The ward pharmacists were not able to accommodate the individual interviews with patients, as mentioned in the PIL. The ward pharmacists were only allowed to see patients at the point of discharge, and as a result by that time, changes to medication already been made.
  The study was conducted in one primary care setting (one primary care is located in west of Aberdeen, Scotland) that registered population has 8,231 people from July 2021 to February 2022. A total of 200 patients were screened and 41 patients were identified from a computer database and assessed for eligibility by the clinician. The clinician decided not to invite nine patients due to their severe mental illness and hearing difficulties. Twenty patients were asked to take part in the study, however, four patients did not respond to the invitation and two patients declined to participate because one had problems with understanding in the study process and one was on operation during the study period. Fourteen patients gave their formal consent and received the initial consultation with a primary care pharmacist. Nevertheless, one patient was excluded due to a prior attempt to switch was not agreeable to the patient. Thirteen baseline, 6 weeks and 3 months follow up questionnaires were sent to patients and all of them were returned to research team within one or two weeks. The number of patients in each step presented in CONSORT flow diagram. The response rate of participants is 80% (16 of 20), recruitment rate is 87.50% (14 of 16) and retention rate is 92.85% (13 of 14).
  The majority of patients were male. The age of patients was between 65 and 79 years old (65-69y [n = 3], 70-74y [N=3], 75-79y [N=3]). The mean (SD) number of medications is 7.62 (±3.18) and the majority of patients have Anticholinergic Cognitive Burden score equal 3. The median time for the initial consultation with the primary care pharmacist is 15 minutes (12.5- 20 minutes). All patients thought the duration of the consultation was appropriate, and they appreciated and were satisfied with the pharmacist’s consultation and medication review. Patients’ views on the intervention and the acceptability of the intervention by Likert rating scale. The quality of life in all patients during the study period was measured by EQ-5D-5L. The utility of EQ-5D-5L was calculated. The values [median (IQR)] are 0.592 (-0.515, 0.859), 0.667 (-0.402, -1.411) and 0.655 (-1.411, 1.000) at baseline, six weeks and 3 months follow up respectively. The ACB medication changes for individual patient were summarised. The majority of patient was happy to be randomised in future study. Finally, seven interviews were conducted among 5 patients, one primary care pharmacist, and one GP. Themes and sub-themes are illustrated by verbatim quotes identified by participant ID, gender, and age.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  21/ES/0031

• Date of REC Opinion

  8 Apr 2021

• REC opinion

  Further Information Favourable Opinion