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

Sponsor

University College Cork (Other)

Overall Status

Completed

CT.gov ID

NCT01467050

Collaborator

(none)

732

Enrollment

Location

Arms

Duration (Months)

60.9

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

732 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Control	Other: Normal pharmaceutical care The normal process of medication prescription and review by the attending medical team.

Arm

Intervention/Treatment

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.

No Intervention: Control

Other: Normal pharmaceutical care

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

Outcome Measures

Primary Outcome Measures

Number of patients with probable and definite adverse drug events in hospital [Up to Day 14 of hospital admission]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.