Clinical trial NCT04660838: Intervention to REduce anticholinerGic burdEN in oldER pATiEnts (REGENERATE) Aged 65 Years and Older
Official title: Intervention to REduce anticholinerGic burdEN in oldER pATiEnts (REGENERATE) Aged 65 Years and Older: A Non-randomised Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anticholinergic Adverse Reaction
Keywords: Anticholinergic burden
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. There is, however, limited research regarding deprescribing. Previously, researchers 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.


Eligibility criteria: Inclusion Criteria for stopping and/or switching medications

Patients who are:

* aged 65 and over
* able to provide informed consent.
* on one or more long-term drugs (have been prescribed a minimum 6 weeks) with ACB potential (Anticholinergic Cognitive Burden scale ≥3) (defined according to Boustani et al (Boustani, Campbell et al. 2008)

Exclusion Criteria for stopping and/or switching medications

Patients who:

* are without capacity to provide informed consent.
* have severe mental illness \[such as diagnosis of severe anxiety, severe depression, severe dementia etc.\].
* are terminally ill (life expectancy less than 6 months).
* in opinion of responsible clinician are not suitable.
* are taking part in another study.

Health care professional inclusion criteria for interviews

- Professionals: doctors (consultants, GPs), pharmacist in primary and secondary care involved in the care of patients aged 65 and over on polypharmacy regimes/likely to have anticholinergic burden and have taken part in the study by delivering the intervention

Patients inclusion criteria for interviews

- Patients: patients aged 65 years and over who met eligible criteria and have taken part in the REGENERATE study will be selected.

Exclusion criteria for interviews

- Participants who cannot understand English fluently

Primary outcomes:
measure: Recruitment of patients from GP practices and hospitals
timeFrame: 3 months
measure: The completion rate of baseline and follow up data
timeFrame: 3 months
measure: The number of medication changes recommended and the number implemented
timeFrame: 3 months
measure: The sustainability of intervention (i.e. those remained on same drugs at 6 week and 3 months post intervention)
timeFrame: 3 months
measure: The acceptability of intervention to patients and health care professional stakeholders
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Peterculter Medical Practice
Study officials:
References:
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citation: OLASEHINDE-WILLIAMS, O., July, 2020-last update, Deprescribing guide. Available: https://southendccg.nhs.uk/your-health-services/healthcare-professionals/medicines-management/medicines-management-resources/2308-deprescribing-guide/file [April/03, 2020].
citation: Reeve E, Shakib S, Hendrix I, Roberts MS, Wiese MD. The benefits and harms of deprescribing. Med J Aust. 2014 Oct 6;201(7):386-9. doi: 10.5694/mja13.00200.