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

June 5, 2012 updated by: Denis O'Mahony, University College Cork

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

732

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Munster
      • Cork, Munster, Ireland
        • Cork University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  1. Age less than 65 years.
  2. 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).
  3. Terminally ill patient attended by palliative care team.
  4. Critically ill patient e.g. admitted to Intensive Care Unit.
  5. Patients who do not wish to participate in the study.
  6. Patients whose hospital physician does not wish to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Other: Normal pharmaceutical care
The normal process of medication prescription and review by the attending medical team.
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 Names:
  • STOPP/START criteria for potentially inappropriate medications in older people.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with probable and definite adverse drug events in hospital
Time Frame: Up to Day 14 of hospital admission
Up to Day 14 of hospital admission

Secondary Outcome Measures

Outcome Measure
Time Frame
drug ingredient cost at hospital discharge
Time Frame: Up to day 14
Up to day 14
Composite health resource utilization including hospital readmissions and primary care consultations
Time Frame: At 3 months post discharge from hospital
At 3 months post discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Cork

Investigators

  • Principal Investigator: Denis O'Mahony, MD, University College Cork, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 31, 2011

First Submitted That Met QC Criteria

November 3, 2011

First Posted (Estimate)

November 8, 2011

Study Record Updates

Last Update Posted (Estimate)

June 6, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRA_HSR/2010/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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