NCT00915824

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4 healthy

Timeline
Completed

Started Nov 2007

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
Last Updated

October 29, 2009

Status Verified

October 1, 2009

Enrollment Period

1.6 years

First QC Date

June 4, 2009

Last Update Submit

October 28, 2009

Conditions

Keywords

Drug therapyPrescribingAppropriatenessRandomized controlled trialSTOPP/START criteriaAppropriateness of prescribing in older patientsPrescription Drugs

Outcome Measures

Primary Outcomes (1)

  • Appropriateness of prescribing using the Medication Appropriateness Index and the Assessment of Underutilization of Medication Tool

    Measured on admission, discharge and at 2, 4 and 6 months post-discharge

Secondary Outcomes (1)

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

    at 2, 4 and 6 months post-discharge

Study Arms (1)

STOPP/START intervention

EXPERIMENTAL

STOPP/START intervention group

Other: STOPP/START criteria

Interventions

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

STOPP/START intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • All patients aged 65 years and older admitted to the general medical services of Cork University Hospital, Cork, Ireland

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cork University Hospital

Cork, Ireland

Location

MeSH Terms

Interventions

Potentially Inappropriate Medication List

Intervention Hierarchy (Ancestors)

Quality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Paul Gallagher, MB MRCPI

    Cork University Hospital

    PRINCIPAL INVESTIGATOR
  • Denis O'Mahony, MD FRCPI

    Cork University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 8, 2009

Study Start

November 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

October 29, 2009

Record last verified: 2009-10

Locations