Clinical trial NCT02570945: Trial of a Pharmacist-physician Intervention Model to Reduce High-risk Drug Use by Hospitalised Elderly Patients
Official title: Randomized Controlled Trial of a Pharmacist-physician Intervention Model to Reduce High-risk Drug Use by Elderly Inpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Potentially Inappropriate Medication Use
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 321
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change rate in medication
timeFrame: 48 hours
Secondary outcomes:
measure: Clinical relevance of the Computerized Alert System alerts
timeFrame: 1 day
measure: Number of falls
timeFrame: From randomisation to the end of the hospitalisation, an average of 12 days
measure: Delirium
timeFrame: From randomisation to the end of the hospitalisation, an average of 12 days
measure: Death
timeFrame: From randomisation to the end of the hospitalisation, an average of 12 days
measure: Readmission within 30 days of hospital discharge
timeFrame: 30 days after hospital discharge
Other outcomes:
Locations:
Study officials:
References: