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Trial of a Pharmacist-physician Intervention Model to Reduce High-risk Drug Use by Hospitalised Elderly Patients

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02570945
Enrollment
321
Registered
2015-10-07
Start date
2015-09-30
Completion date
2015-12-31
Last updated
2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Potentially Inappropriate Medication Use

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.

Interventions

PROCEDUREPharmacist-physician intervention to reduce high-risk medication use by elderly inpatients

Sponsors

Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change rate in medication48 hoursThe 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

MeasureTime frameDescription
Clinical relevance of the Computerized Alert System alerts1 dayThe clinical relevance of the CAS alerts is defined as the proportion of alerts requiring an intervention (as assessed by the pharmacist) out of the total number of alerts.
Number of fallsFrom randomisation to the end of the hospitalisation, an average of 12 daysFalls documented in the discharge summary and in the incident reports will be included
DeliriumFrom randomisation to the end of the hospitalisation, an average of 12 daysDelirium will be assessed with the Confusion assessment Method (CAM) questionnaire
DeathFrom randomisation to the end of the hospitalisation, an average of 12 daysDeath
Readmission within 30 days of hospital discharge30 days after hospital discharge

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026