Discontinuation of Long-term Medications in Older People Entering Nursing Home Care

NCT03501108 | Unknown DMC

• 1 other identifier: 1767
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polypharmacy; Frail Elderly Syndrome; Inappropriate Prescribing; Drug-Related Side Effects and Adverse Reactions

Keywords

Polypharmacy; Multi-morbidity; Deprescribing; Older people; Elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in the number of patients prescribed neuroleptic antipsychotic medications from randomization to 3 months post randomization

  At 3 months post-randomization.

• Number of patients transferred to emergency department since randomization

  At 3 months post-randomization.

• Number of patients that have undergone unscheduled medical reviews since randomization

  At 3 months post-randomization.

• Number of patients who have had a fall since randomization

  At 3 months post-randomization.

• Monthly medication cost

  At 3 months post-randomization.

Study Arms (2)

Control

NO INTERVENTION

Patients in the control arm receive usual pharmaceutical care in hospital i.e. daily medication review by the attending physicians and ward-assigned pharmacist.

Intervention

EXPERIMENTAL

Patients in the intervention arm receive usual pharmaceutical care as per the control group plus application of STOPPFrail deprescribing criteria advice points on their medication list at a single time point i.e. within 24 hours of randomization. The bespoke STOPPFrail advice report is presented to the patient's attending physician who then adjusts the patient's prescriptions according to the STOPPFrail advice points. The attending physician can implement as few or as many STOPPFrail advice points as he/she sees appropriate.

Other: STOPPFrail deprescribing criteria

Interventions

STOPPFrail deprescribing criteria OTHER

STOPPFrail is a recently validated set of explicit deprescribing criteria devised specifically for use in older patients with advanced physical and /or mental morbidity such that the 1-year survival prognosis is likely to be poor. STOPPFrail-defined medications that appear on the patient's medication list are highlighted to the attending physician for his/her consideration for deprescribing i.e. removal from the medication list immediately or gradually as appropriate.

Intervention

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Cork University Hospital

Cork, Munster, Ireland

RECRUITING

Related Publications (8)

• 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.

  PMID: 22219520 BACKGROUND

• 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.

  PMID: 25002159 BACKGROUND

• 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.

  PMID: 25083234 BACKGROUND

• 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.

  PMID: 22495574 BACKGROUND

• Jyrkka 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.

  PMID: 19929031 BACKGROUND

• 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.

  PMID: 17642388 BACKGROUND

• 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.

  PMID: 26942907 BACKGROUND

• 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.

  PMID: 28119312 BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Denis O'Mahony

  University College Cork

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denis Curtin, MB

CONTACT

00353-87-7541099; deniscurtin@hotmail.com

DENIS O'MAHONY

CONTACT

00353872480133; denis.omahony@ucc.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher obtaining outcome measurements will be blinded to the group allocation of patient participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine

Model Details: Comparison of application of explicit deprescribing criteria (STOPPFrail) with standard pharmaceutical care versus standard pharmaceutical care alone. The intervention is applied randomly at a single time point in hospitalized older people who will undergo a transition of care from the community to nursing home. The primary outcome measure is total number of daily prescription drugs.

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: April 18, 2018
• Study Start: March 27, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

IE (1)