Medication Minimization for Long-term Care Residents (WiseMed)
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|ClinicalTrials.gov Identifier: NCT01932632|
Recruitment Status : Withdrawn (unable to recruit)
First Posted : August 30, 2013
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Polypharmacy||Other: Medication Minimization||Not Applicable|
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:
- treat individual conditions
- theoretically prevent unwanted sequelae of chronic conditions and/or
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Medication Minimization on Mortality and Hospitalization in Long-Term Care Residents: The WiseMed RCT|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
No Intervention: Usual Care
This group will receive care as similar as possible to care that they received prior to the study beginning. Their attending MDs will be instructed and reminded to avoid making parallel changes in the prescribing for the control patients unless there is a specific medical indication to which they would normally respond with a medication reduction. No other reminders or prompts about the study will be provided for these patients.
Experimental: Medication Minimization
Other: Medication Minimization
Series of specific medication reviews done by attending MD using standardized study protocol forms and MD's clinical assessment.
- Mortality Rate Compared Between Control and Intervention Group [ Time Frame: Up to 2 years ]This information will be gathered from acute care and facility electronic health records and where needed validated using participant paper chart. A request will be made to facilities for this information every three months during the study.
- Survival Analysis Compared Between Control and Intervention Group [ Time Frame: Up to 2 years ]Survival Analysis and Acute Care Transfers will be calculated every 3 months from the same data collected for the primary outcome.
- Difference in Acute Care Transfers Between Control and Intervention Group [ Time Frame: Up to 2 years ]Lengths of stay for each transfer, measured in days. Survival Analysis and Acute Care Transfers will be calculated every 3 months from the same data collected for the primary outcome.
- 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) [ Time Frame: Up to 2 years ]Number of unscheduled MD visits + phone calls billed(this data will be collected as an encrypted file from participating GP's billing data, only the number of 00115, 00118 and 13005 Medical Services Plan billing codes will be requested, no additional data will be contained in this file) A request will be made for this information every three months during the study.
- Comparison of Total Cost of Care Between Control and Intervention Group [ Time Frame: Up to 2 years ]This will be estimated from medication costs, number of acute care inpatient days, and number of family physician telephone and emergency visit billings. This will be calculated at the termination of the study from the data collected above.
- Proportion of Drugs Reduced in Experimental Group [ Time Frame: Up to 2 years ]
Broken down by drug classes:
- Cognitively Acting
- Proportion of Drugs Discontinued in Experimental Group [ Time Frame: Up to 2 years ]
Broken down by drug classes:
- Cognitively Acting
- Proportion of Drugs With No Identified Indication at the Time of Enrolment Into the Study [ Time Frame: Up to 2 years ]
- Number of Hip Fractures in Experimental Group [ Time Frame: Up to 2 years ]This will be measured every 3 months according to hospital records obtained for primary outcome, ICD9 codes 820.x or 78.5.
- Number of Strokes in Experimental Group [ Time Frame: Up to 2 years ]This will be assessed every 3 months according to physician billing codes secondary outcome #3 with ICD9 431,432,433,434,435 or 436.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932632
|Canada, British Columbia|
|Holy Family Hospital|
|Vancouver, British Columbia, Canada, V5P 3L6|
|Mount St. Joseph's|
|Vancouver, British Columbia, Canada, V5T 3N4|
|St. Vincent's Langara|
|Vancouver, British Columbia, Canada, V5X 4V4|
|Vancouver, British Columbia, Canada, V5Z 3L9|
|Brock Fahrni Residence|
|Vancouver, British Columbia, Canada, V6H 4J4|
|Vancouver, British Columbia, Canada, V6Y 1Y4|
|Principal Investigator:||Rita McCracken, MD, PhD (student)||UBC|