Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2026-01-12 @ 2:30 AM
Study NCT ID:
NCT01932632
Status:
WITHDRAWN
Last Update Posted:
2017-05-09
First Post:
2013-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medication Minimization for Long-term Care Residents
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
The Effect of Medication Minimization on Mortality and Hospitalization in Long-Term Care Residents: The WiseMed RCT
Status:
WITHDRAWN
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to recruit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WiseMed
Brief Summary:
The purpose of this experiment is to test the effect of medication minimization on mortality and hospitalization in long-term care residents.
Detailed Description:
People living in residential care are typically elderly and often have complex co-morbid illnesses that are not expected to improve and which they are unable to manage on their own at home. Many of these patients have been prescribed multiple medications to:
1. treat individual conditions
2. theoretically prevent unwanted sequelae of chronic conditions and/or
3. treat side effects of medications given for a) and b).
Advancing age has been found to be a significant factor in adverse drug events and polypharmacy has been found to be a stand alone risk factor for higher mortality and morbidity. However, in British Columbia, the average number of medications taken by patients in residential care is 9, with a range of 0-55 (hospital reporting data, specific reference pending).
Frail elders are often being treated for chronic diseases using published guidelines for both symptom modification and prevention despite the fact that very few of these guidelines are able to include convincing evidence about efficacy in the frail elder population.
Despite the available knowledge of the possible harm of adverse effects in the aged, polypharmacy and a lack of appropriate population-specific evidence, many residential care patients do not have medications stopped or tapered. The lack of change may be explained by the admitting physicians' belief that there is appropriate evidence or a reluctance to stop a medication that was started by a specialist. Other research has also suggested that there is little or no experience/education for many physicians about which medications to address and exactly how to stop/taper medications, and/or a concern/belief that patients or families will fear that the care provider is "giving up" on a patient or relegating her/him to a quicker death.
Medication reviews at point of admission to residential care facilities typically do not result in a significant reduction in the number of medications nor dose reductions.
However, there have been some promising initial studies looking at more formalized approaches to medication discontinuation and minimization as well as a review of the ethics of such programs(23). In a 2007 prospective cohort study, Garfinkel et al were able to demonstrate a reduction in 1-year mortality (45% in control and 21% in study group, p\<0.001, chi-square test), fewer transfers to acute care (30 % in control and 11.8% in study group, p\<0.002) as well as a reduction in costs of medication.
I propose to do a randomized control study of medication minimization for residential care patients. I will use a modified version of the "GP-GP protocol" developed by Garfinkel, et al and randomly assign patients to either "medication prescribing as usual" or the medication minimization protocol.
To see if reducing polypharmacy (i.e. the number and dosage of medications) for elders living in residential care increases time between admission and death (i.e. improves mortality) and reduces the number of transfers to acute care (i.e. improves morbidity).
1. treat individual conditions
2. theoretically prevent unwanted sequelae of chronic conditions and/or
3. treat side effects of medications given for a) and b).
Advancing age has been found to be a significant factor in adverse drug events and polypharmacy has been found to be a stand alone risk factor for higher mortality and morbidity. However, in British Columbia, the average number of medications taken by patients in residential care is 9, with a range of 0-55 (hospital reporting data, specific reference pending).
Frail elders are often being treated for chronic diseases using published guidelines for both symptom modification and prevention despite the fact that very few of these guidelines are able to include convincing evidence about efficacy in the frail elder population.
Despite the available knowledge of the possible harm of adverse effects in the aged, polypharmacy and a lack of appropriate population-specific evidence, many residential care patients do not have medications stopped or tapered. The lack of change may be explained by the admitting physicians' belief that there is appropriate evidence or a reluctance to stop a medication that was started by a specialist. Other research has also suggested that there is little or no experience/education for many physicians about which medications to address and exactly how to stop/taper medications, and/or a concern/belief that patients or families will fear that the care provider is "giving up" on a patient or relegating her/him to a quicker death.
Medication reviews at point of admission to residential care facilities typically do not result in a significant reduction in the number of medications nor dose reductions.
However, there have been some promising initial studies looking at more formalized approaches to medication discontinuation and minimization as well as a review of the ethics of such programs(23). In a 2007 prospective cohort study, Garfinkel et al were able to demonstrate a reduction in 1-year mortality (45% in control and 21% in study group, p\<0.001, chi-square test), fewer transfers to acute care (30 % in control and 11.8% in study group, p\<0.002) as well as a reduction in costs of medication.
I propose to do a randomized control study of medication minimization for residential care patients. I will use a modified version of the "GP-GP protocol" developed by Garfinkel, et al and randomly assign patients to either "medication prescribing as usual" or the medication minimization protocol.
To see if reducing polypharmacy (i.e. the number and dosage of medications) for elders living in residential care increases time between admission and death (i.e. improves mortality) and reduces the number of transfers to acute care (i.e. improves morbidity).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: