Frail Elderly Syndrome Clinical Trial
Official title:
Medication Rationalization for Older People Awaiting Long-term Nursing Home Care: a Randomized Controlled Trial Using the STOPPfrail Criteria
Older people often have several chronic diseases requiring several medications all at once.
Taking several medications all at once is called polypharmacy. Polypharmacy is common in
nursing home residents. When people take the same medication long term, the original reason
for prescribing the medication may no longer be important or a priority. Polypharmacy is
associated with an increased risk of harmful side effects.
STOPPfrail is a tool, designed for doctors, that highlights situations where medications may
be inappropriate or harmful to frail older people. When these situations are identified,
reducing or stopping the inappropriate medication should be considered. The STOPPfrail tool
was developed by an expert group specializing in geriatric pharmacotherapy.
In the present research study, the investigators wish to examine whether medications can be
safely reduced and stopped using the STOPPfrail tool in hospitalized frail older people who
are awaiting transfer to a nursing home. The investigators will assess this method by
comparing its effects with those of the current standard practice of medication management.
In the trial, participants are allocated to one of two groups. One group will have their
medications evaluated using the STOPPfrail tool (intervention group). The other group will
have their medications reviewed in the standard way (control group). The allocation of
participants into these two groups will be done randomly to avoid any bias in the study. When
participants are allocated to the intervention group, their physician will receive written
advice designed to help him/her to adjust medications so as to minimize the risk of
withdrawal reactions. The advice will be based on the STOPPfrail tool.
The hospital case notes and discharge summaries of the participants taking part in the trial
will be reviewed at the time of discharge from hospital. Three months after recruitment, the
participant's nursing home will be contacted. Information about the number and type of
medications prescribed will be requested as well as details about hospitalizations, falls and
the participant's well general well-being.
The main aim is to examine whether it is possible to significantly reduce the number of
medications that an older frail person takes using the STOPPfrail tool. The investigators
will also examine whether reducing the number of medications in this way has an effect on
quality of life, unscheduled medical care, falls and the cost of medications.
STUDY TITLE Medication Rationalization for Older People awaiting long-term nursing home care:
a randomized controlled trial using the STOPPfrail criteria.
AIMS Our primary aim is to test the feasibility of applying explicit deprescribing criteria
(STOPPfrail) to the medication regimens of a cohort of older, frail hospitalized patients for
whom long-term care is considered necessary and compare this intervention with usual care.
Secondary aims are to estimate the effect of medication rationalization on mortality, acute
hospital transfers, unscheduled medical reviews, falls and non vertebral fractures,
prescription of neuroleptic antipsychotic medications and cost of medications.
BACKGROUND The majority of people transferring to nursing home care are frail and highly
dependent. The average survival following admission to a nursing home in Ireland is 1.9
years.1 Despite frailty and shortened life expectancy, these patients are among the highest
consumers of prescription medications. The SHELTER study reports the rate of polypharmacy
(5-9 drugs) and excessive polypharmacy (≥10 drugs) in nursing home residents to be 48.7 and
24.3%, respectively.2 This is important because the number of drugs that a patient is taking
is the most important predictor of adverse drug reactions (ADRs).3 ADRs are associated with
ill health,4 hospitalization,5 and higher mortality.6
Transfer to a nursing home is major life event for older people and medication review in
hospital prior to transfer is appropriate. Medication rationalization or deprescribing is the
process of tapering and stopping medications. The goal is to prevent adverse drug reactions
and to appropriately match medications to the goals of care and prognosis of the patient.
Deprescribing trials have been promising to date. Garfinkel8 discontinued 332 different drugs
in 119 nursing home residents (2.8 per person) and reported successful cessation of all
target drugs in 82% of patients. The one-year mortality rate was 45% in the control group and
21% in the intervention group. Overall, deprescribing of medications resulted in a 53%
reduction in mortality(p<0.001). Potter et al9 successfully deprescribed 207 medications in
47 residents (4.4 per patient) and while there was a trend towards improved survival in the
intervention group, this did not reach statistical significance. Both trials use a similar
deprescribing algorithm that requires the user to answer a series of questions about each
medication before a deprescribing decision can be made. Expertise in geriatric
pharmacotherapy as well as clinical judgement is required, and these factors, along with time
constraints, may limit the use of these algorithms in everyday clinical practice.
STOPPfrail is a validated explicit list of 27 drugs and drug classes that are potentially
inappropriate in older adults with high morbidity burden and poor 1 year survival
prognosis.10 The criteria were developed by Delphi consensus survey of an expert panel
comprising academic geriatricians, clinical pharmacologists, palliative care physicians, old
age psychiatrists, general practitioners and clinical pharmacists. The criteria are explicit
and concise and therefore easy-to-use and time efficient. Observational work by our group,
led by Dr. Amanda Lavan, has shown that 90% of people awaiting transfer to a nursing home bed
are prescribed at least one potentially inappropriate medication (PIM) according to the
STOPPfrail criteria and the median number of PIMs per person is three. Of those people deemed
suitable for long-term care in a nursing home, 64.3% were eligible for the STOPPfrail
intervention.
In theory, the deprescribing of unnecessary, ineffective, potentially inappropriate
medications should reduce medication burden as well as exposure to adverse drug events.
Recent deprescribing trials have suggested a trend towards improved survival in patients who
have their medications deprescribed. Deprescribing using the STOPPfrail criteria has not yet
been evaluated in a randomized controlled trial.
Recruitment Hospitalized patients applying for the Nursing Home Support Scheme undergo a
multidisciplinary team assessment and the report of this assessment is compiled in the Common
Summary Assessment Report (CSAR) form. At the Local Placement Forum (LPF), which takes place
fortnightly in Cork University Hospital (CUH), city-wide applications are reviewed and
suitability for long-term care (LTC) is determined.
Potential participants will be identified at the Local Placement Forum (LPF) in CUH.
Inpatients in CUH, the Mercy University Hospital and St. Finbarr's Hospital (Cork City
Hospitals) who are transitioning to long-term care will be considered potentially eligible
for recruitment. The CSAR form, which includes information about medical history as well as
cognitive and functional status will be used to screen participants for eligibility.
Prior to approaching potential participants, a senior physician (consultant, registrar
overseeing the patient's care in hospital or the patient's own GP), will be contacted and
requested to answer the 'surprise question'(SQ). If the physician indicates he or she "would
not be surprised if the participant died in the next year" (SQ+), permission will be
requested to review the patient's chart.
Establishing informed consent (figure 2) The unblinded researcher will approach potential
participants directly, explain the study aims and provide a participant information form
(PIF). Any patient who declines to participate will not be enrolled in the study. Cognition
will be assessed using the Mini-Mental Status Examination (MMSE) in individuals who agree to
participate. Participants with a MMSE ≥24 will be considered competent to formally consent to
inclusion in the study. If these participants agree, the unblinded researcher will also
inform the nominated next-of-kin (NOK) of the participant's desire to participate in the
trial and provide the NOK with a study information sheet. If a participant wishes to
participate in the study, but is not competent to formally consent (MMSE <24), the unblinded
researcher will request written agreement from the participant's nominated NOK.
Baseline data A detailed medical history of each participant will be documented. The
unblinded researcher 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. The unblinded researcher will determine
the indication for each medication by discussion with the participant, the participant's
doctor and by reviewing the participant's medical records. The unblinded researcher will
determine medication compliance as well as challenges associated with administrating
individual medications by communicating with nursing staff and reviewing the medication
kardex. Cognitive status (MMSE) and functional status (Barthel index) as well as weight and
blood pressure will be recorded. Quality of life will be measured using the ICECAP-O (proxy
version) and, for those with a diagnosis of dementia, the QUALIDEM.
Randomization:
Each participant will be randomized to the intervention arm (STOPPfrail tool) or to the
control arm receiving routine care on a 1:1 ratio using block randomization.
Intervention group:
The unblinded researcher will advise intervention group participants' doctors that their
patient has been randomised to the intervention group. The unblinded researcher (an
experienced Specialist Registrar in geriatric medicine) will offer medication advice based on
the STOPPfrail criteria. Where there is a risk of an adverse drug withdrawal event, it will
be recommended that that particular medication be withdrawn slowly according to an evidence
based protocol .Prior to recommending the dose reduction or cessation of a medication, the
unblinded researcher will inform the participant, NOK and nursing staff of potential adverse
withdrawal effects associated with that drug. The nurse manager and medical team will have
the mobile phone number of the primary researcher and will be encouraged to make contact if
there are any concerns about adverse withdrawal effects in the participant.
If the participant is discharged to a nursing home during the period of drug withdrawal, a
written drug withdrawal plan will be sent to the nursing home director of nursing as well as
to the medical officer overseeing the care of patients in that nursing home. The mobile phone
number of the unblinded researcher will be included in this written plan and the unblinded
researcher will be available to respond to queries or concerns.
Follow-up data In order to minimize the risk of ascertainment bias, a different researcher,
who is blinded to the group allocation of participants will provide follow-up and obtain
outcome measurements. Follow-up will take place at the time of discharge from hospital and at
3- months post-enrolment. All medications, falls and non-vertebral fractures, emergency
transfers to hospital, unscheduled medical reviews and deaths will be recorded. Quality of
life will be reassessed, and weight and sitting blood pressure will be measured.
Serious Adverse Events (SAEs) SAEs are defined as death, emergency hospital admission, fall,
non-vertebral fracture, non-fatal vascular event (MI or CVA), and an unscheduled medical
review. The nurse managers overseeing the care of the participants will be asked to advise
the unblinded researcher as soon as practical if any of these events occur in study
participants. All SAEs are to be reported to the principle investigator (PI) within 24 hours
upon becoming aware of the event.
The principal investigator will evaluate whether the SAE is related to the deprescribing
intervention. It is the PIs responsibility to report SAEs that are related or possibly
related to the intervention within 7 days to the local ethics committee.
Sample Size Calculation
The investigators plan to enrol 160 participants (80 participants in each group). This allows
for an anticipated attrition rate (deaths and dropouts) of 30%. This will allow a power to
detect a difference of 2 in the mean number of medications between the groups (α = .05 and
1-β =0.8, population variance 14). Of note, Garfinkel and Potter achieved a mean reduction of
2.8 and 4.4 medications per subject respectively.
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