Polypharmacy Clinical Trial
— WiseMedOfficial title:
The Effect of Medication Minimization on Mortality and Hospitalization in Long-Term Care Residents: The WiseMed RCT
Verified date | May 2017 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this experiment is to test the effect of medication minimization on mortality and hospitalization in long-term care residents.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 70 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Brock Fahrni Residence | Vancouver | British Columbia |
Canada | Holy Family Hospital | Vancouver | British Columbia |
Canada | Minoru Residence | Vancouver | British Columbia |
Canada | Mount St. Joseph's | Vancouver | British Columbia |
Canada | St. Vincent's Langara | Vancouver | British Columbia |
Canada | Youville Residence | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Proportion of Drugs Reduced in Experimental Group | Broken down by drug classes: Cardiovascular Cognitively Acting Gastrointestinal Hyperglycemics Pain Respiratory Other |
Up to 2 years | |
Other | Proportion of Drugs Discontinued in Experimental Group | Broken down by drug classes: Cardiovascular Cognitively Acting Gastrointestinal Hyperglycemics Pain Respiratory Other |
Up to 2 years | |
Other | Proportion of Drugs With No Identified Indication at the Time of Enrolment Into the Study | Up to 2 years | ||
Other | Number of Hip Fractures in Experimental Group | This will be measured every 3 months according to hospital records obtained for primary outcome, ICD9 codes 820.x or 78.5. | Up to 2 years | |
Other | Number of Strokes in Experimental Group | This will be assessed every 3 months according to physician billing codes secondary outcome #3 with ICD9 431,432,433,434,435 or 436. | Up to 2 years | |
Primary | Mortality Rate Compared Between Control and Intervention Group | 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. | Up to 2 years | |
Secondary | Survival Analysis Compared Between Control and Intervention Group | Survival Analysis and Acute Care Transfers will be calculated every 3 months from the same data collected for the primary outcome. | Up to 2 years | |
Secondary | Difference in Acute Care Transfers Between Control and Intervention Group | 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. | Up to 2 years | |
Secondary | 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) | 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. | Up to 2 years | |
Secondary | Comparison of Total Cost of Care Between Control and Intervention Group | 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. | Up to 2 years |
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