Clinical trial NCT01932632: Medication Minimization for Long-term Care Residents
Official title: The Effect of Medication Minimization on Mortality and Hospitalization in Long-Term Care Residents: The WiseMed RCT
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Polypharmacy
Keywords: Polypharmacy
De-prescribing
Frailty
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* age\>70
* Living in one of the 6 participating residential care facilities:

  1. Youville Residence, PHC, 4950 Heather Street, Vancouver, BC, V5Z 3L9
  2. Brock Fahrni Residence, 4650 Oak Street, Vancouver, BC, V6H 4J4
  3. Mount St. Joseph's LTC, PHC, 3080 Prince Edward Street, Vancouver, BC, V5T 3N4
  4. Holy Family Hospital, PHC, 7801 Argyle Street, Vancouver, BC, V5P 3L6
  5. St. Vincent's Langara, PHC, 255 West 62nd Avenue, BC, V5X 4V4
  6. Minoru Residence, VCH, 6111 Minoru Boulevard, Richmond, BC V6Y 1Y4
* Attending GP has agreed to participate in study
* Taking more that 5 medications
* If unable to provide consent (due to cognitive impairment, aphasia or any other barrier), that there is a family member or designated decision maker able and willing to sign consent

  1. Cognitive impairment will be identified by the attending GP. Any participant who is deemed unable to consent as a result of cognitive impairment will be offered a chance to participate by the research team contacting the alternate decision maker identified in the patient's chart. If appropriate, an assent form will be made available to those participants who agree to sign the consent form for their loved one

Exclusion Criteria:

* On hemodialysis (due to multiple active prescribing MD's at anyone time)
* If cognitively impaired, but family member, (or designated decision maker) cannot be contacted to discuss and sign consent

Primary outcomes:
measure: Mortality Rate Compared Between Control and Intervention Group
timeFrame: Up to 2 years
Secondary outcomes:
measure: Survival Analysis Compared Between Control and Intervention Group
timeFrame: Up to 2 years
measure: Difference in Acute Care Transfers Between Control and Intervention Group
timeFrame: Up to 2 years
measure: Number of Attending MD emergency facility visits and nurse to physician phone calls billed by the attending physician (captures significant medical issues not requiring transfer to acute care problems)
timeFrame: Up to 2 years
measure: Comparison of Total Cost of Care Between Control and Intervention Group
timeFrame: Up to 2 years
Other outcomes:
measure: Proportion of Drugs Reduced in Experimental Group
timeFrame: Up to 2 years
measure: Proportion of Drugs Discontinued in Experimental Group
timeFrame: Up to 2 years
measure: Proportion of Drugs With No Identified Indication at the Time of Enrolment Into the Study
timeFrame: Up to 2 years
measure: Number of Hip Fractures in Experimental Group
timeFrame: Up to 2 years
measure: Number of Strokes in Experimental Group
timeFrame: Up to 2 years
Locations:
city: Vancouver
country: Canada
facility: Holy Family Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Mount St. Joseph's
state: British Columbia
city: Vancouver
country: Canada
facility: St. Vincent's Langara
state: British Columbia
city: Vancouver
country: Canada
facility: Youville Residence
state: British Columbia
city: Vancouver
country: Canada
facility: Brock Fahrni Residence
state: British Columbia
city: Vancouver
country: Canada
facility: Minoru Residence
state: British Columbia
Study officials:
affiliation: UBC
name: Rita McCracken, MD, PhD (student)
role: PRINCIPAL_INVESTIGATOR
References: