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Deprescribing in frail older people: a randomised controlled trial

A randomised controlled trial in frail older people living in residential aged care facilities in Western Australia designed to test the effect of deprescribing on medication burden at one year.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000370909
Enrollment
100
Registered
2011-04-11
Start date
2011-07-24
Completion date
2013-11-16
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

Older people are at high risk of adverse drug reactions and many medications cause confusion and falls in older patients. In addition, evidence for the benefit of preventative and symptomatic therapies in frail older people is limited, as most clinical trials specifically exclude these patients. Although polypharmacy is widely recognised as a serious problem in frail older people, data on the effects of active medication withdrawal ("deprescribing") are scarce. Our primary aim is to determine whether we can safely reduce the total number of medications prescribed to older people living in residential aged care facilities (RACF). Secondary aims are to estimate the effect of deprescribing on mortality, falls and fractures, sleep quality, cognitive function, and independence.

Interventions

Withdrawal of multiple medications according to a structured deprescribing protocol. We will record a detailed medical history and conduct a clinical examination of each participant. We will record the generic name, indication, dosage, and frequency of all medications taken by the participant, including all prescribed and over-the-counter medications and any herbal or mineral supplements. We will determine the indication for each medication by discussion with the participant, the participant’

Withdrawal of multiple medications according to a structured deprescribing protocol. We will record a detailed medical history and conduct a clinical examination of each participant. We will record the generic name, indication, dosage, and frequency of all medications taken by the participant, including all prescribed and over-the-counter medications and any herbal or mineral supplements. We will determine the indication for each medication by discussion with the participant, the participant’s doctor, and, if necessary, by accessing the participant’s medical records. Two investigators will independently review the medication lists and indications and identify target drugs for withdrawal in each participant. Target drugs will be identified using previously published lists of medications considered potentially inappropriate in older people. The list of medications considered for withdrawal will include, but not necessarily be limited to, benzodiazepines, antipsychotics, tricyclic antidepressants, long-acting sulphonylureas, non-steroidal anti-inflammatory drugs, antispasmodics, anticholinergic antihistamines, short-acting calcium channel blockers, stimulant laxatives, muscle relaxants, dipyridamole, nitrofurantoin, ditropan, amiodarone, antihypertensives, statins, potassium supplements, mineral supplements, vitamins, opioid analgesics, inhaled and oral corticosteroids, diuretics, antiemetics, oral and topical oestrogens, digoxin, nitrates, antacids, antireflux medications, iron supplements, herbal remedies, cough suppressants, and nasal decongestants. Each potentially inappropriate medication will be checked against four criteria and if any of the criteria are met in a participant, the medication will be targeted for withdrawal in that participant. The criteria are as follows: 1. Inappropriate prescription (no indication for drug OR clear contraindication) 2. Adverse effects (adverse effects or interactions outweigh any symptomatic benefit OR any future potential benefit) 3. Drug taken for symptom relief AND symptoms stable or absent (determined by reference to a table of pre-defined criteria for assessing symptom stability) 4. Drug taken to prevent future serious events AND patient is experiencing serious adverse effects OR potential future benefit unlikely to be realised due to limited life expectancy. Both investigators will independently determine the order of drug withdrawal. Drugs least likely to cause an adverse drug withdrawal event (ADWE) will be ceased before drugs most likely to cause an ADWE. The investigators will resolve by consensus any differences in the target drugs and withdrawal order. Dose reductions will be made at two weekly intervals by the investigator or the participant's usual treating doctor. Participants will be monitored twice weekly for adverse drug withdrawal effects. If no adverse effects or symptom recurrence are noted, dose reduction and target drug cessation will continue until all target drugs are ceased.

Sponsors

Kathleen Potter
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

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

Inclusion criteria

People aged 65 years and older living in resdential aged care facilities in Western Australia who consent to be randomised

Exclusion criteria

Not taking any regular medication In the final terminal stages of cancer or other serious disease Not competent to consent (MMSE score <24) AND their next of kin does not agree to their participation Usual doctor does not agree to their participation in the study

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 2, 2026