Overview

This trial is active, not recruiting.

Condition healthy
Treatment stopp/start criteria
Phase phase 4
Sponsor Cork University Hospital
Start date November 2007
End date June 2009
Trial size 400 participants
Trial identifier NCT00915824, CRT2006029

Summary

Potentially inappropriate prescribing is common in older patients and encompasses overuse, misuse and underuse of medications. Potentially inappropriate prescribing is associated with negative outcomes including adverse drug events and hospitalization.

STOPP (Screening Tool of Older Person's potentially inappropriate Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment) is a new screening tool designed to detect instances of potentially inappropriate medication use and under-prescribing of clinically indicated medications in older patients. The purpose of this study is to determine whether clinical implementation of STOPP/START criteria in hospitalized older patients is effective in improving prescribing quality.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
STOPP/START intervention group
stopp/start criteria
Application of STOPP/START criteria to the patient's prescription and diagnostic information with subsequent written recommendation on pharmaceutical care to the patient's medical team

Primary Outcomes

Measure
Appropriateness of prescribing using the Medication Appropriateness Index and the Assessment of Underutilization of Medication Tool
time frame: Measured on admission, discharge and at 2, 4 and 6 months post-discharge

Secondary Outcomes

Measure
Composite health resource utilization including hospital readmission and primary care consultations
time frame: at 2, 4 and 6 months post-discharge

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: - All patients aged 65 years and older admitted to the general medical services of Cork University Hospital, Cork, Ireland Exclusion Criteria: - Patient admitted to a geriatric medicine service, psychiatry of old age service or clinical pharmacology service, or under review of these services during the previous 12 months - Critically ill patient (admitted to the intensive care unit) - Terminally ill patient - Refusal of patient or hospital physician to participate - No time for the research physician to enrol the patient within 3 days of admission

Additional Information

Official title Prevention of Potentially Inappropriate Prescribing in Late Life Using STOPP (Screening Tool of Older Persons' Potentially Inappropriate Prescriptions) and START (Screening Tool to Alert Doctors to Right i.e. Appropriate Indicated Treatment): A Randomized Controlled Trial.
Principal investigator Paul Gallagher, MB MRCPI
Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by Cork University Hospital.