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Clinical Trials/NCT02570945
NCT02570945
Completed
Phase 4

Randomized Controlled Trial of a Pharmacist-physician Intervention Model to Reduce High-risk Drug Use by Elderly Inpatients

Centre de recherche du Centre hospitalier universitaire de Sherbrooke0 sites321 target enrollmentSeptember 2015

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Potentially Inappropriate Medication Use
Sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Enrollment
321
Primary Endpoint
Change rate in medication
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The study population will consist of all elderly (65 and older) patients hospitalized at the Centre hospitalier universitaire de Sherbrooke. The patients who present a pharmacotherapeutic problem will be randomly allocated between intervention and control groups. Practically, the relevant data will be extracted from the Electronic Medical Record (EMR) on a daily basis and analysed by a Computerized Alert System (CAS) to identify pharmacotherapeutic problems. These problems will be analysed a pharmacist specialised in geriatrics to determine their clinical relevance and the modifications that can be made. Clinically relevant pharmacotherapeutic problems will be discussed by the pharmacist and treating physician to establish the changes needed to optimize drug therapy. A geriatrician will also be available to assist the pharmacist in his initial assessment for particularly complex cases. For control patients, a CAS analysis will be conducted to identify patients with a pharmacotherapeutic problem but there will not be a formal discussion amongst the health care providers (usual care) and the physicians of the control group will provide usual care to their patients. The investigators believe that it is ethical to provide usual care to the control group since the beneficial impact on patients outcomes of the investigators' intervention has not been demonstrated.

Pharmacotherapeutic problems were prioritized by the CHUS Elderly Adapted Care-medication committee and are based on the Beers criteria with an emphasis on drugs involved in the development of delirium. Selected pharmacotherapeutic problems are: 1) For patients 75 and older: i) taking a PIM; ii) concomitant use of 4 or more drugs from a list of drugs active at the CNS; iii) positive test for delirium with a PIM; 2) For patients 65 years and older: i) taking levodopa (Parkinson indicator) with a PIM; ii) taking cholinesterase inhibitor or memantine (indicators of dementia) with a PIM. The use of levodopa, a cholinesterase inhibitor or memantine are frailty indicators.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
December 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Responsible Party
Principal Investigator
Principal Investigator

Benoit Cossette

Principal investigator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Eligibility Criteria

Inclusion Criteria

  • Patients 65 and older admitted at the Centre hospitalier universitaire de Sherbrooke

Exclusion Criteria

  • Patients admitted in psychiatry and intensive care
  • Patients seen only in the emergency room

Outcomes

Primary Outcomes

Change rate in medication

Time Frame: 48 hours

The main outcome was the change rate in medications, defined as the number of patient-days with a change in at least one medication out of the total number of patient-days with a pharmacist intervention with the treating physician.

Secondary Outcomes

  • Clinical relevance of the Computerized Alert System alerts(1 day)
  • Number of falls(From randomisation to the end of the hospitalisation, an average of 12 days)
  • Death(From randomisation to the end of the hospitalisation, an average of 12 days)
  • Delirium(From randomisation to the end of the hospitalisation, an average of 12 days)
  • Readmission within 30 days of hospital discharge(30 days after hospital discharge)

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