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

NCT01467050 | Completed Phase 4

• 1 other identifier: HRA_HSR/2010/14
• Study Type: interventional
• Target: 732
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Drug Reaction

Keywords

Adverse drug event; Adverse drug reaction; Inappropriate prescribing; Elderly; Hospital-acquired

Outcome Measures

Primary Outcomes (1)

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

  Up to Day 14 of hospital admission

Secondary Outcomes (2)

• drug ingredient cost at hospital discharge

  Up to day 14

• Composite health resource utilization including hospital readmissions and primary care consultations

  At 3 months post discharge from hospital

Study Arms (2)

Application of STOPP/START criteria

ACTIVE COMPARATOR

Other: Application of STOPP/START criteria

Control

NO INTERVENTION

Other: Normal pharmaceutical care

Interventions

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.

Also known as: STOPP/START criteria for potentially inappropriate medications in older people.

Application of STOPP/START criteria

Normal pharmaceutical care OTHER

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

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Cork University Hospital

Cork, Munster, Ireland

Location

Related Publications (5)

• 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.

  PMID: 21508941 BACKGROUND

• 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.

  PMID: 18349010 BACKGROUND

• 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.

  PMID: 21670370 BACKGROUND

• 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.

  PMID: 18218287 BACKGROUND

• 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.

  PMID: 30003429 DERIVED

Related Links

• Health Research Board of Ireland website

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Potentially Inappropriate Medication List

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Denis O'Mahony, MD

  University College Cork, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer, Department of Medicine

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: November 8, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

IE (1)