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Deprescribing anticholinergic and sedative medicines: A feasibility study in residential aged care facilities

Deprescribing anticholinergic and sedative medicines: A Feasibility Trial (DEFEAT-polypharmacy) in residential aged care facilities

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000721404
Acronym
DEFEAT-polypharmacy
Enrollment
150
Registered
2016-06-01
Start date
2016-06-01
Completion date
2017-01-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Optimising medicine use in older people is important to reduce their risk of developing negative health outcomes, such as a poorer quality of life, due to increased adverse effects (e.g. falls, impaired cognition, increased muscle pains, poorer nutrition), medicine interactions and reduced medication adherence. One way to achieve medicine optimisation is through deprescribing. Deprescribing is the process of reducing or discontinuing medicines that are un-necessary, harmful or inappropriately prescribed. Medicines with sedative and anticholinergic effects, such as antipyschotics and hypnotics, have been shown to be widely prescribed inappropriately in older people worldwide and in New Zealand. These medicines are particularly harmful as they are associated with a wide variety of adverse drug events (ADEs) including falls/fractures, drug-dependance, poor cognitive function and functional impairment. We hypothesise that anticholinergic and sedative medicines can be safely deprescribed in residents living in residential aged care facilities (RACFs) using a systematic, evidence based, pharmacist-led approach. We hypothesize that this will have a positive effect on quality of life of residents. Our specific study’s objectives are therefore to: 1. Reduce the participants’ anticholinergic and sedative medication drug burden, quantified by the change in drug burden index (DBI, a validated measure of an individuals anticholinergic-sedative drug burden) after 6 months of implementing the deprescribing intervention 2. Examine the participants’ quality of life 3. Monitor participants’ adverse effects thought to be caused by the prescribed medicines 4. Observe participants and monitor adverse effects thought to be attributable to deprescribing, such as withdrawal adverse effects etc.

Interventions

A collaborative pharmacist-led medication review with the GP will be employed, as this model has shown to improve success of implementing deprescribing in this setting. General practitioners (GPs) who prescribe for the residents across the three RACFs will receive a personalised invitation letter prior to the study initiation date. Participating GPs will be provided with a list of residents who are under their medical care and who have consented to participate in the study. Reasons for GP non-pa

A collaborative pharmacist-led medication review with the GP will be employed, as this model has shown to improve success of implementing deprescribing in this setting. General practitioners (GPs) who prescribe for the residents across the three RACFs will receive a personalised invitation letter prior to the study initiation date. Participating GPs will be provided with a list of residents who are under their medical care and who have consented to participate in the study. Reasons for GP non-participation will be formally documented and the residents under their care will be excluded from the study sample. Study participants will receive a pharmacist-led medication review intervention, initiated by the study pharmacist. The medication review will be based on the Medication Therapy Assessment (MTA) Framework endorsed by the Pharmaceutical Society of New Zealand (PSNZ). Step 1: Medical history The InteRAI-Long term Care Facilities (InteRAI-LTCF) is a comprehensive assessment database system, utilised in residential aged care facilities internationally and in New Zealand to improve the quality of life of vulnerable people. It comprises of a wide array of cognitive performance, activities of daily living and health quality assessments. The reliability of the inteRAI suite of assessment instruments has been tested and has been shown that all items tested met or exceeded standard cut-offs for acceptable reliability, and a substantial proportion of items showed excellent reliability. It is a versatile, viable way of recording health information from routine practice in a way that permits aggregation of accurate, reliable, valid data, safe for use in health services research and pragmatic studies where randomised controlled trials are impossible. Step 2: Intitial consultation Participants will have an initial face to face consultation with the study pharmacist about their medicines and their medical conditions. The duration of this will be approximatey 30 minutes to an hour. The participant may invite their representative/relative to attend this consultation. In this study, anticholinergic and sedative medicines will be specifically targeted for deprescribing. Any potential anticholinergic and/or sedative medicine(s) that can be targeted for deprescribing will be flagged and any patient concerns around these medications will be noted. Step 3: Deprescribing Medication Review A detailed medication review will be carried out by the study pharmacist and this will focus on reducing the burden of these medications. The review will utilise peer-reviewed deprescribing guidelines for anticholinergic and sedative medicines developed for the intervention. The drug classes include benzodiazepines, antidepressants, and antipsychotics. These protocols were developed as part of the pharmacist’s doctoral studies and were peer reviewed by an international advisory group including geriatricians, pharmacists, general practitioners and critical appraisal experts. They are designed to serve as guidance for prescribers and clinical pharmacists involved in the process of deprescribing. The protocols appraise the evidence-based literature regarding the appropriateness of anticholinergic and sedative medicines in older people. They also provide guidance on when it may be appropriate for the prescriber to consider reviewing, reducing or stopping a targeted medicine. If a prescribed anticholinergic or sedative medicine is not included in these drug-specific deprescribing protocols, deprescribing recommendations will be based on the most recent clinical evidence available alongside appropriate clinical judgement. The deprescribing medication review plan will list the medicine(s) that can be targeted for deprescribing, the reasons as to why these medicines would be appropriate for deprescribing, and suggestions for tapering and monitoring if indicated. When anticholinergic and/or sedative medicines are reduced or discontinued, adverse drug withdrawal effects (ADWEs) may develop. Therefore, it is important to slowly taper the dose of the medicine(s) and monitor the participants regularly. It is also important to determine the order in which the medicines will be deprescribed before deprescribing is initiated. The report will be provided to the GP who will endorse or reject the recommendations. Reasons for rejection will be recorded. Step 4: Medication management plan A medication management plan (MMP) will be formulated by the study pharmacist based on the endorsed list of recommendations and including the detailed tapering and monitoring recommendations. This information will be communicated clearly to the participant and/or their relative/representative, the participant’s GP and nurse. The MMP report will ensure that all recommendations and concerns are communicated clearly to all parties and will help ensure that deprescribing occurs in a safe manner. The MMP will specifically include the following: 1) Medicines to be deprescribed (i.e. reduced or discontinued) 2) The recommended order in which medicines are to be deprescribed, accompanied by appropriate reasoning if necessary 3) Specific tapering or stopping guidance for each targeted medicine 4) Anticipated adverse drug withdrawal effects (ADWEs) 5) Monitoring and appropriate management options if withdrawal effects are to occur The participant and/or the participant’s relative/representative will be provided with a copy of the MMP along with the participant’s GP and will explain to them the recommendations contained in the report. The study pharmacist will discuss the recommendations with the GP face-to-face, via telephone or at the 3 monthly resident clinical review meeting. If the participant, the GP and the participants’ nurse agree to the recommendations listed in the MMP, the GP will initiate deprescribing for the resident at the next GP visit. Step 5: Monitoring and follow-up Participants will be reviewed twice weekly by the study pharmacist for adverse drug withdrawal effects (ADWEs) after the cessation or the dose reduction of the first target medicine. These would be brief meetings of 15 minute duration. If symptoms are stable according to pre-defined criteria and no ADWEs are reported after two weeks, the dose will be further reduced or the next target medicine will be withdrawn. The participant will continue to be reviewed twice weekly for a further two weeks and, if symptoms are stable, the dose of the next target medication will be reduced or ceased. This will continue until all target medicines are withdrawn and the participants are stable. The participant will be monitored on a weekly basis for two more visits and, if stable, no additional visits will be conducted. Monitoring for ADWEs will also occur independently by nursing staff and participating GPs who will observe withdrawal symptoms or recurrence of disease. Details of this will be documented on the MMP form, and the staff will be encouraged to contact the pharmacist at any time the resident develops ADWEs. The GP will then be notified in a timely fashion, and an appropriate course of action, such as a GP visit and/or conducting necessary tests, will be undertaken in order to ensure the safety of the participant. Multi-disciplinary clinical review meetings are usually held for each resident every three months in the recruited RACFs. The residents’ GP, nurses, caregivers, the resident, and/or the residents’ representative/relative usually attend these meetings. The study pharmacist will attend each multi-disciplinary clinical review meeting when feasibly possible. Any concerns regarding deprescribing and the health of the resident will be discussed and the study pharmacist will address these concerns. At these meetings, the resident’s willingness to remain enrolled in the study will be discussed. If the resident or the resident’s representative/relative expresses their wishes to withdraw from the study, the resident will be excluded. All reasons for withdrawal or dropout will be recorded in the study. Deprescribed medication status and intentions will be recorded at the time the patient exists. All dropouts with no information will be assumed to not have a change in their DBI.

Sponsors

Professor Steve Duffull, Dean of the Pharmacy school
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Aged 65 years or older 2. A drug burden index (DBI) of 0.5 or greater 3. Taking at least one anticholinergic medication from the reference anticholinergic list published by Salahudeen et al. or one sedative medicine as listed by Hilmer et al.

Exclusion criteria

1. Limited life expectancy: resident is receiving palliative care or their life expectancy is 3 months or less, based on Holmes life expectancy calculator 2. Residents admitted for hospice care (short-duration of stay of less than 4 weeks) 3. Severe dementia: residents’ with a score on the Mini-mental State Examination test (MMSE) < 10 4. Resident’s not prescribed any anticholinergic medicines.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 27, 2026