Frail Elderly Syndrome Clinical Trial
— STOPPFrailOfficial 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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility |
Inclusion Criteria: - Poor one-year survival prognosis as a result of irreversible pathology - A senior physician (consultant, registrar, or general practitioner) indicating that he or she "would not be surprised if the participant died in the next year" ('surprise question'(SQ)) and - Severe functional impairment (Clinical frailty Scale score = 7) - Symptom control is the priority rather than prevention of disease progression (e.g. stringent control of blood pressure or diabetes is not a priority) - Prescribed =5 long-term medications Exclusion Criteria: - Not taking any regular medication - Actively dying - Not competent to consent AND their next of kin does not agree to their participation - Prescribed <5 long-term medications |
Country | Name | City | State |
---|---|---|---|
Ireland | Cork University Hospital | Cork | Munster |
Lead Sponsor | Collaborator |
---|---|
University College Cork |
Ireland,
Anathhanam S, Powis RA, Cracknell AL, Robson J. Impact of prescribed medications on patient safety in older people. Ther Adv Drug Saf. 2012 Aug;3(4):165-74. doi: 10.1177/2042098612443848. Review. — View Citation
Garfinkel D, Zur-Gil S, Ben-Israel J. The war against polypharmacy: a new cost-effective geriatric-palliative approach for improving drug therapy in disabled elderly people. Isr Med Assoc J. 2007 Jun;9(6):430-4. — View Citation
Jyrkkä J, Enlund H, Korhonen MJ, Sulkava R, Hartikainen S. Polypharmacy status as an indicator of mortality in an elderly population. Drugs Aging. 2009;26(12):1039-48. doi: 10.2165/11319530-000000000-00000. — View Citation
Kalisch LM, Caughey GE, Barratt JD, Ramsay EN, Killer G, Gilbert AL, Roughead EE. Prevalence of preventable medication-related hospitalizations in Australia: an opportunity to reduce harm. Int J Qual Health Care. 2012 Jun;24(3):239-49. doi: 10.1093/intqhc/mzs015. Epub 2012 Apr 11. — View Citation
Lavan AH, Gallagher P, Parsons C, O'Mahony D. STOPPFrail (Screening Tool of Older Persons Prescriptions in Frail adults with limited life expectancy): consensus validation. Age Ageing. 2017 Jul 1;46(4):600-607. doi: 10.1093/ageing/afx005. — View Citation
Onder G, Liperoti R, Fialova D, Topinkova E, Tosato M, Danese P, Gallo PF, Carpenter I, Finne-Soveri H, Gindin J, Bernabei R, Landi F; SHELTER Project. Polypharmacy in nursing home in Europe: results from the SHELTER study. J Gerontol A Biol Sci Med Sci. 2012 Jun;67(6):698-704. doi: 10.1093/gerona/glr233. Epub 2012 Jan 4. — View Citation
Potter K, Flicker L, Page A, Etherton-Beer C. Deprescribing in Frail Older People: A Randomised Controlled Trial. PLoS One. 2016 Mar 4;11(3):e0149984. doi: 10.1371/journal.pone.0149984. eCollection 2016. — View Citation
Steinman MA, Miao Y, Boscardin WJ, Komaiko KD, Schwartz JB. Prescribing quality in older veterans: a multifocal approach. J Gen Intern Med. 2014 Oct;29(10):1379-86. doi: 10.1007/s11606-014-2924-8. Epub 2014 Jul 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the Number of medications taken by participants from randomization to 3 months post- randomization | Total whole number | At 3 months post-randomization. | |
Secondary | Change in the number of patients prescribed neuroleptic antipsychotic medications from randomization to 3 months post randomization | total whole number | At 3 months post-randomization. | |
Secondary | Number of patients transferred to emergency department since randomization | Total whole number | At 3 months post-randomization. | |
Secondary | Number of patients that have undergone unscheduled medical reviews since randomization | Total whole number | At 3 months post-randomization. | |
Secondary | Number of patients who have had a fall since randomization | Total whole number | At 3 months post-randomization. | |
Secondary | Monthly medication cost | Total number in euros | At 3 months post-randomization. | |
Secondary | Mortality | Number of patients who have died since randomization | At 3 months post-randomization. | |
Secondary | Number of patients who have had a non-vertebral fracture since randomization | Total whole number | At 3 months post-randomization | |
Secondary | Change in Dementia-specific Quality of life from randomization to 3 months post randomization | QUALIDEM -dementia specific quality of life instrument. Higher scores indicate higher levels of quality of life | At 3 months post randomization | |
Secondary | Change in Quality of life from randomization to 3 months post randomization | ICECAP-O quality of life instrument for older people. Higher scores indicate greater quality of life | At 3 months post randomization |
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