Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients
Primary Purpose
Adverse Drug Reaction
Status
Completed
Phase
Phase 4
Locations
Ireland
Study Type
Interventional
Intervention
Application of STOPP/START criteria
Normal pharmaceutical care
Sponsored by
About this trial
This is an interventional prevention trial for Adverse Drug Reaction focused on measuring Adverse drug event, Adverse drug reaction, Inappropriate prescribing, Elderly, Hospital-acquired
Eligibility 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:
- 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.
Sites / Locations
- Cork University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Application of STOPP/START criteria
Control
Arm Description
Outcomes
Primary Outcome Measures
Number of patients with probable and definite adverse drug events in hospital
Secondary Outcome Measures
drug ingredient cost at hospital discharge
Composite health resource utilization including hospital readmissions and primary care consultations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01467050
Brief Title
Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients
Official Title
Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients Using STOPP/START Criteria
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Cork
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Reaction
Keywords
Adverse drug event, Adverse drug reaction, Inappropriate prescribing, Elderly, Hospital-acquired
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
732 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Application of STOPP/START criteria
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Application of STOPP/START criteria
Other Intervention Name(s)
STOPP/START criteria for potentially inappropriate medications in older people.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Normal pharmaceutical care
Intervention Description
The normal process of medication prescription and review by the attending medical team.
Primary Outcome Measure Information:
Title
Number of patients with probable and definite adverse drug events in hospital
Time Frame
Up to Day 14 of hospital admission
Secondary Outcome Measure Information:
Title
drug ingredient cost at hospital discharge
Time Frame
Up to day 14
Title
Composite health resource utilization including hospital readmissions and primary care consultations
Time Frame
At 3 months post discharge from hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis O'Mahony, MD
Organizational Affiliation
University College Cork, Ireland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cork University Hospital
City
Cork
State/Province
Munster
Country
Ireland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21508941
Citation
Gallagher PF, O'Connor MN, O'Mahony D. Prevention of potentially inappropriate prescribing for elderly patients: a randomized controlled trial using STOPP/START criteria. Clin Pharmacol Ther. 2011 Jun;89(6):845-54. doi: 10.1038/clpt.2011.44. Epub 2011 Apr 20.
Results Reference
background
PubMed Identifier
18349010
Citation
O'Mahony D, Gallagher PF. Inappropriate prescribing in the older population: need for new criteria. Age Ageing. 2008 Mar;37(2):138-41. doi: 10.1093/ageing/afm189.
Results Reference
background
PubMed Identifier
21670370
Citation
Hamilton H, Gallagher P, Ryan C, Byrne S, O'Mahony D. Potentially inappropriate medications defined by STOPP criteria and the risk of adverse drug events in older hospitalized patients. Arch Intern Med. 2011 Jun 13;171(11):1013-9. doi: 10.1001/archinternmed.2011.215.
Results Reference
background
PubMed Identifier
18218287
Citation
Gallagher P, Ryan C, Byrne S, Kennedy J, O'Mahony D. STOPP (Screening Tool of Older Person's Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment). Consensus validation. Int J Clin Pharmacol Ther. 2008 Feb;46(2):72-83. doi: 10.5414/cpp46072.
Results Reference
background
PubMed Identifier
30003429
Citation
O'Brien GL, O'Mahony D, Gillespie P, Mulcahy M, Walshe V, O'Connor MN, O'Sullivan D, Gallagher J, Byrne S. Cost-Effectiveness Analysis of a Physician-Implemented Medication Screening Tool in Older Hospitalised Patients in Ireland. Drugs Aging. 2018 Aug;35(8):751-762. doi: 10.1007/s40266-018-0564-0.
Results Reference
derived
Links:
URL
http://hrb.ie
Description
Health Research Board of Ireland website
Learn more about this trial
Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients
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