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

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.

Study Overview

• Status: Completed
• Conditions: Potentially Inappropriate Medication Use
• Intervention / Treatment: Procedure: Pharmacist-physician intervention to reduce high-risk medication use by elderly inpatients

• Study Type: Interventional
• Enrollment (Actual): 321
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Intervention; Pharmacist-physician medication review	Procedure: Pharmacist-physician intervention to reduce high-risk medication use by elderly inpatients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change rate in medication	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.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical relevance of the Computerized Alert System alerts	The 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.	1 day
Number of falls	Falls documented in the discharge summary and in the incident reports will be included	From randomisation to the end of the hospitalisation, an average of 12 days
Delirium	Delirium will be assessed with the Confusion assessment Method (CAM) questionnaire	From randomisation to the end of the hospitalisation, an average of 12 days
Death	Death	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

Collaborators and Investigators

• Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: September 25, 2015
• First Submitted That Met QC Criteria: October 6, 2015
• First Posted (ESTIMATE): October 7, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2015-965