Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients

University College Cork (UCC)

Status and phase

Completed

Phase 4

Conditions

Adverse Drug Reaction

Treatments

Other: Application of STOPP/START criteria

Other: Normal pharmaceutical care

Study type

Interventional

Funder types

Other

Identifiers

NCT01467050

HRA_HSR/2010/14

Details and patient eligibility

About

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.

Enrollment

732 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients aged 65 years and over presenting to CUH Accident and Emergency Departments with acute illness for admission under a medical or surgical team.

Exclusion criteria

Age less than 65 years.
Patient to be admitted under the care of a Geriatrician Psychiatrist of Old Age or Clinical Pharmacologist, or having been admitted under these services or attended their outpatient clinics in the previous 12 months. (These doctor groups are likely to minimise inappropriate medications in this population).
Terminally ill patient attended by palliative care team.
Critically ill patient e.g. admitted to Intensive Care Unit.
Patients who do not wish to participate in the study.
Patients whose hospital physician does not wish to participate in the study.