Prevention of Potentially Inappropriate Prescribing in Late Life Using Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) and Screening Tool to Alert Doctors to Right Treatment (START) Criteria

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Healthy	Other: STOPP/START criteria	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	400 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
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.
Study Start Date :	November 2007
Actual Primary Completion Date :	June 2009
Estimated Study Completion Date :	June 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: STOPP/START intervention; STOPP/START intervention group	Other: 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

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. Composite health resource utilization including hospital readmission and primary care consultations [ Time Frame: at 2, 4 and 6 months post-discharge ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	65 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Ireland
Cork University Hospital
Cork, Ireland

Sponsors and Collaborators

Cork University Hospital

Investigators

Principal Investigator:	Paul Gallagher, MB MRCPI	Cork University Hospital
Study Director:	Denis O'Mahony, MD FRCPI	Cork University Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr. Paul Gallagher, Clinical Research Fellow, Department of Geriatric Medicine, Cork University Hospital
ClinicalTrials.gov Identifier:	NCT00915824 History of Changes
Other Study ID Numbers:	CRT2006029
First Posted:	June 8, 2009
Last Update Posted:	October 29, 2009
Last Verified:	October 2009

Keywords provided by Cork University Hospital:

Drug therapy; Prescribing; Appropriateness; Randomized controlled trial	STOPP/START criteria; Appropriateness of prescribing in older patients; Prescription Drugs