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

NCT03501108 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2018-04-18

No results posted yet for this study

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

Interventions

OTHER

STOPPFrail deprescribing criteria

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.

Sponsors & Collaborators

  • University College Cork

    lead OTHER

Principal Investigators

  • Denis O'Mahony · University College Cork

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-27
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03501108 on ClinicalTrials.gov