NCT Number: NCT02570945
Trial of a Pharmacist-physician Intervention Model to Reduce High-risk Drug Use by Hospitalised Elderly Patients
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.
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Notify MeKey information
Conditions
Age range
65 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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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
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Clinical relevance of the Computerized Alert System alerts
Time frame: 1 day
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.
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Number of falls
Time frame: From randomisation to the end of the hospitalisation, an average of 12 days
Falls documented in the discharge summary and in the incident reports will be included
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Delirium
Time frame: From randomisation to the end of the hospitalisation, an average of 12 days
Delirium will be assessed with the Confusion assessment Method (CAM) questionnaire
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Death
Time frame: From randomisation to the end of the hospitalisation, an average of 12 days
Death
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Readmission within 30 days of hospital discharge
Time frame: 30 days after hospital discharge
Sponsors and collaborators
Lead sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Other
Registry information
Official study title
Randomized Controlled Trial of a Pharmacist-physician Intervention Model to Reduce High-risk Drug Use by Elderly Inpatients
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Oct 7, 2015
- Registry last updated
- Feb 3, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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