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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Denis O'Mahony, University College Cork
ClinicalTrials.gov Identifier:
NCT01467050
First received: August 31, 2011
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Adverse Drug Reaction
Other: Application of STOPP/START criteria
Other: Normal pharmaceutical care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients Using STOPP/START Criteria

Resource links provided by NLM:


Further study details as provided by University College Cork:

Primary Outcome Measures:
  • Number of patients with probable and definite adverse drug events in hospital [ Time Frame: Up to Day 14 of hospital admission ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • drug ingredient cost at hospital discharge [ Time Frame: Up to day 14 ] [ Designated as safety issue: No ]
  • Composite health resource utilization including hospital readmissions and primary care consultations [ Time Frame: At 3 months post discharge from hospital ] [ Designated as safety issue: No ]

Enrollment: 732
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01467050

Locations
Ireland
Cork University Hospital
Cork, Munster, Ireland
Sponsors and Collaborators
University College Cork
Investigators
Principal Investigator: Denis O'Mahony, MD University College Cork, Ireland
  More Information

Publications:
Responsible Party: Denis O'Mahony, Senior Lecturer, Department of Medicine, University College Cork
ClinicalTrials.gov Identifier: NCT01467050     History of Changes
Other Study ID Numbers: HRA_HSR/2010/14
Study First Received: August 31, 2011
Last Updated: June 5, 2012
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Cork:
Adverse drug event
Adverse drug reaction
Inappropriate prescribing
Elderly
Hospital-acquired

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on October 19, 2014