Clinical Trial: Adverse Drug Event Prevention Using Structured Pharmacist Review
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Title of Study: Adverse Drug Event (ADE) Incidence in Older Patients Following Hospital Admission and Pharmacist Review to Older Persons' Prescriptions and Its' Effect on
Brief Summary:
The next four decades will see a marked expansion of the elderly population in Ireland, in particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of prescription medicines in Ireland and have the highest prevalence rates of major polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and consequent major morbidity and mortality. Epidemiological data from the Unites States indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that effective evidence based interventions can be applied to this major public health problem.
A recently described approach to hospitalised older patients' medication optimisation is that of Spinewine and colleagues at Louvain University, Belgium. In this model, a pharmacist with expertise in geriatric pharmacotherapy routinely reviews the prescriptions of older patients from admission to discharge. The pharmacist provides a detailed pharmaceutical care plan for older patients and their carers where appropriate as well as feedback information to prescribers in the event of detecting instances of probable medication inappropriateness. Whenever an opportunity for medication optimisation is identified, the pharmacist discusses the opportunity with the prescriber who can accept or reject the intervention. At discharge from hospital, the pharmacist also provides written and verbal information on treatment changes to the patient / caregiver and GP. The intervention therefore represents a comprehensive pharmaceutical care approach that is based upon careful review and subsequent consensus on individualised pharmacotherapy. In an RCT comparison of this approach with standard care, older patients in the intervention arm of the study had significant improvements in medication appropriateness (medication appropriateness index (MAI), Beers' criteria, and Assessing Care
Detailed Summary:
Sponsor: University College Cork
Current Primary Outcome: Number of patients with definite and possible adverse drug events during their hospital admission [ Time Frame: From point of randomization to Day 14 ]
Original Primary Outcome: Number of patients with definite and possible adverse drug events during their hospital admission [ Time Frame: From point of randomization to discharge from hospital ]
Current Secondary Outcome:
- Drug ingredient cost at hospital discharge [ Time Frame: Up to Day 14 ]
- Medication Appropriateness Index score [ Time Frame: measured at Day 14 and again at three months post hospital discharge. ]
- Composite health resource utilization including hospital admissions and primary care consultations [ Time Frame: Measured at 3 months post hospital discharge ]
Original Secondary Outcome:
- Drug ingredient cost at hospital discharge [ Time Frame: Discharge from hospital ]
- Medication Appropriateness Index score [ Time Frame: measured at discharge from hospital and again at three months post hospital discharge. ]
- Composite health resource utilization including hospital admissions and primary care consultations [ Time Frame: Measured at 3 months post hospital discharge ]
Information By: University College Cork
Dates:
Date Received: September 2, 2011
Date Started: June 2011
Date Completion:
Last Updated: June 5, 2012
Last Verified: June 2012
