Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients
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|ClinicalTrials.gov Identifier: NCT01467050|
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : June 6, 2012
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 criteria to significantly reduce ADEs in a prospective RCT has yet to be demonstrated.
|Condition or disease||Intervention/treatment||Phase|
|Adverse Drug Reaction||Other: Application of STOPP/START criteria Other: Normal pharmaceutical care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||732 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients Using STOPP/START Criteria|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
|Active Comparator: Application of STOPP/START criteria||
Other: Application of STOPP/START criteria
The researcher will apply the STOPP/START criteria to the cases randomised to this intervention. This will occur at the point of recruitment into the study and consists of applying STOPP/START criteria to the list of prescribed medications the patient is taking at that time point.
Where potentially inappropriate medications (PIM's) are identified using the intervention, these are highlighted to the medical team with primary responsibility for the patient both verbally and in writing. The relevant registrar will be contacted in person or via telephone by the researcher and informed of the PIM's in addition to a standard medication advice form inserted into the patients' notes also highlighting the PIM's.
Other Name: STOPP/START criteria for potentially inappropriate medications in older people.
|No Intervention: Control||
Other: Normal pharmaceutical care
The normal process of medication prescription and review by the attending medical team.
- Number of patients with probable and definite adverse drug events in hospital [ Time Frame: Up to Day 14 of hospital admission ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467050
|Cork University Hospital|
|Cork, Munster, Ireland|
|Principal Investigator:||Denis O'Mahony, MD||University College Cork, Ireland|