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

October 28, 2009 updated by: Cork University Hospital

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Cork, Ireland
        • Cork University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measured on admission, discharge and at 2, 4 and 6 months post-discharge

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cork University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 8, 2009

Study Record Updates

Last Update Posted (Estimate)

October 29, 2009

Last Update Submitted That Met QC Criteria

October 28, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRT2006029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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