Potentially Inappropriate Prescribing (PIP) in Long-Term Care (LTC) Patients
NCT ID: NCT02523482
Last Updated: 2015-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
275 participants
OBSERVATIONAL
2014-06-30
2016-03-31
Brief Summary
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Detailed Description
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The overall aim of this study is to validate medication appropriateness criteria applicable to HAD by comparing their performance when applied to clinical data. The present study has two main and three secondary objectives (see Figure 1 for details):
A. Main objectives:
Objective 1: To validate subsets of the STOPP/START and Beers criteria defined by their applicability to HAD, by comparing their performance in detecting PIP when applied to HAD with that of the full set of criteria applied to clinical data for the same residents (with the clinical data providing the "gold standard").
Objective 2: To compare the detection rates of the full STOPP/START and full Beers criteria with one another when applied to clinical data.
B. Secondary objectives:
Objective 3: To assess the number and proportion of unidentified PIP when using the subset of STOPP/START and Beers criteria with HAD when compared with the full set of criteria, when applied to clinical data.
Objective 4: To compare the performance of the subset of the STOPP/START and Beers criteria applied to the HAD in detecting PIP when compared to clinical data for the same residents.
Objective 5: To compare the performance of the subset of STOPP/START and Beers criteria applicable to HAD with one another when applied to HAD.
To achieve these objectives, the investigators will conduct a cross-sectional study of linked HAD and clinical data. Eligible patients will be 66 years and over and recently admitted to one of six LTC facilities in Ottawa, Ontario, beginning June 1st, 2014. The target sample size is 275, but recruitment may stop if interim analyses demonstrate statistical significance can be achieved with fewer patients. Medication, diagnostic and clinical data will be collected after admission by a pharmacist not otherwise involved in the patient's care. The main outcome measure is the proportion of PIP missed by the subset of STOPP/START criteria applied to HAD when compared to clinical data (the gold standard).
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* Newly admitted to LTC or convalescent care at the participating care facilities
* Consent to participate
Exclusion Criteria
* Residents will be excluded if they do not have a valid Ontario Health Insurance Plan (OHIP) number.
* Residents residing in Ontario whose health care is covered through other plans, and are therefore not captured through ICES data, such as First Nations people living on reserve, members of the Armed Forces, and refugee claimants, will also be excluded.
* A resident will also be excluded if he or she has no prescribed medications.
66 Years
ALL
Yes
Sponsors
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Bruyere Centre for Learning, Research and Innovation in Long-Term Care (CLRI)
UNKNOWN
Ontario Ministry of Health and Long Term Care
OTHER_GOV
Bruyère Health Research Institute.
OTHER
Responsible Party
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Lise Bjerre
Principal Investigator
Principal Investigators
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Lise Bjerre, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinician Investigator, Bruyere Research Institute
Locations
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Residence St. Louis
Ottawa, Ontario, Canada
Centre d'accueil Champlain
Ottawa, Ontario, Canada
Residence Elisabeth Bruyere
Ottawa, Ontario, Canada
Garry J Armstrong
Ottawa, Ontario, Canada
Carleton Lodge
Ottawa, Ontario, Canada
Peter D Clark
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Melissa Donskov
Role: primary
France Galipeau
Role: primary
Melissa Donskov
Role: primary
Kerri-Ann Ede
Role: primary
Judy Miller
Role: primary
Karen Currie
Role: primary
References
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Bjerre LM, Halil R, Catley C, Farrell B, Hogel M, Black CD, Williams M, Ryan C, Manuel DG. Potentially inappropriate prescribing (PIP) in long-term care (LTC) patients: validation of the 2014 STOPP-START and 2012 Beers criteria in a LTC population--a protocol for a cross-sectional comparison of clinical and health administrative data. BMJ Open. 2015 Oct 9;5(10):e009715. doi: 10.1136/bmjopen-2015-009715.
Other Identifiers
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CLRI - PIP in LTC
Identifier Type: -
Identifier Source: org_study_id
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