Skip to main content
OpenTrials
Completed

NCT Number: NCT01467050

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adverse Drug Reaction Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cork University Hospital

Cork, Munster, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Application of STOPP/START criteria

Other

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 names: STOPP/START criteria for potentially inappropriate medications in older people.

Normal pharmaceutical care

Other

The normal process of medication prescription and review by the attending medical team.

Primary outcomes

  1. Number of patients with probable and definite adverse drug events in hospital

    Time frame: Up to Day 14 of hospital admission

Secondary outcomes

  1. drug ingredient cost at hospital discharge

    Time frame: Up to day 14

  2. Composite health resource utilization including hospital readmissions and primary care consultations

    Time frame: At 3 months post discharge from hospital

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study title

Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients Using STOPP/START Criteria

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 8, 2011
Registry last updated
Jun 6, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.