Medication Minimization for Long-term Care Residents

NCT01932632 | Withdrawn DMC

• 1 other identifier: H12-03169
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this experiment is to test the effect of medication minimization on mortality and hospitalization in long-term care residents.

Conditions

Polypharmacy

Keywords

Polypharmacy; De-prescribing; Frailty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Survival Analysis Compared Between Control and Intervention Group

  Up to 2 years

• Difference in Acute Care Transfers Between Control and Intervention Group

  Up to 2 years

• 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)

  Up to 2 years

• Comparison of Total Cost of Care Between Control and Intervention Group

  Up to 2 years

Other Outcomes (5)

• Proportion of Drugs Reduced in Experimental Group

  Up to 2 years

• Proportion of Drugs Discontinued in Experimental Group

  Up to 2 years

• Proportion of Drugs With No Identified Indication at the Time of Enrolment Into the Study

  Up to 2 years

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Medication Minimization

EXPERIMENTAL

1. Initial Medication Review (IMR) Completed by Attending MD and identifies potential medications to be considered for minimization as well as those UNSUITABLE (as per usual MD opinion) 2. Orders-Medication Update (OMU) (ref form) The attending MD will have identified one or more medications to be considered for minimization and in the IMR suggested a time when a reduced dose will be reviewed (recommended every 4 weeks). Each review will generate an OMU. This process will be repeated for every participant in the Medication Minimization arm until all medications are marked as having no further changes, ie no need for further OMU. At that time a participant's record will be marked as having completed medication minimization.

Other: Medication Minimization

Interventions

Medication Minimization OTHER

Series of specific medication reviews done by attending MD using standardized study protocol forms and MD's clinical assessment.

Medication Minimization

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• age\>70
• Living in one of the 6 participating residential care facilities:
• Youville Residence, PHC, 4950 Heather Street, Vancouver, BC, V5Z 3L9
• Brock Fahrni Residence, 4650 Oak Street, Vancouver, BC, V6H 4J4
• Mount St. Joseph's LTC, PHC, 3080 Prince Edward Street, Vancouver, BC, V5T 3N4
• Holy Family Hospital, PHC, 7801 Argyle Street, Vancouver, BC, V5P 3L6
• St. Vincent's Langara, PHC, 255 West 62nd Avenue, BC, V5X 4V4
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (6)

Holy Family Hospital

Vancouver, British Columbia, V5P 3L6, Canada

Location

Mount St. Joseph's

Vancouver, British Columbia, V5T 3N4, Canada

Location

St. Vincent's Langara

Vancouver, British Columbia, V5X 4V4, Canada

Location

Youville Residence

Vancouver, British Columbia, V5Z 3L9, Canada

Location

Brock Fahrni Residence

Vancouver, British Columbia, V6H 4J4, Canada

Location

Minoru Residence

Vancouver, British Columbia, V6Y 1Y4, Canada

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rita McCracken, MD, PhD (student)

  UBC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Rita McCracken

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: August 30, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

CA (6)