Clinical Trial: Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients Using STOPP/START Criteria
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 United 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.
Recent research data indicate a cause-and-effect relationship between inappropriate prescription medicines and serious ADEs in older people in hospital. To date, Beers' criteria have been the dominant set of criteria for defining potentially inappropriate medicines (PIMs) in late life. Research data collected by this group show that the recently validated STOPP/START criteria (Screening Tool of Older Persons' Prescriptions and Screening Tool to Alert doctors to Right Treatment) identify ADEs that are causal or contributory to acute hospital admission in older people 2.7 times more frequently than Beers' criteria. Based on these findings, our hypothesis is that STOPP/START criteria have the potential to be used as a regular intervention for the purpose of ADE prevention in older people. A recent single centre randomised control trial (RCT) undertaken at Cork University Hospital showed that prospective application of STOPP/START criteria led to a highly significant improvement in medication appropriateness in older hospitalised patients compared with standard inpatient pharmaceutical care. Significantly, the improvement in medication appropriateness was maintained to the end of the study follow-up i.e. 6 months post-discharge. However, the ability of STOPP/START crit
Detailed Summary:
Sponsor: University College Cork
Current Primary Outcome: Number of patients with probable and definite adverse drug events in hospital [ Time Frame: Up to Day 14 of hospital admission ]
Original Primary Outcome: Number of patients with probable and definite adverse drug events in hospital [ Time Frame: From time of randomization to hospital discharge ]
Current Secondary Outcome:
- drug ingredient cost at hospital discharge [ Time Frame: Up to day 14 ]
- Composite health resource utilization including hospital readmissions and primary care consultations [ Time Frame: At 3 months post discharge from hospital ]
Original Secondary Outcome:
- drug ingredient cost at hospital discharge [ Time Frame: at time of discharge from hospital ]
- Composite health resource utilization including hospital readmissions and primary care consultations [ Time Frame: At 3 months post discharge from hospital ]
Information By: University College Cork
Dates:
Date Received: August 31, 2011
Date Started: June 2011
Date Completion:
Last Updated: June 5, 2012
Last Verified: June 2012
