Tool for Inappropriate Prescription Evaluation: The TaIPE Study (TaIPE)

July 22, 2019 updated by: Chantal Csajka, Centre Hospitalier Universitaire Vaudois
A mono-center, randomized controlled trial will be conducted at the University Hospital of Lausanne. Hospitalized patients will be randomly assigned from the emergency department to two sub-units composing the acute care for elders (ACE) unit. In one subunit, potentially inappropriate prescriptions will be detected and treatment optimized according PIM-Check. In the other, STOPP/START criteria will be independently applied.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

464

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Recruiting
        • Centre Hospitalier Universitaire Vaudois
        • Contact:
        • Principal Investigator:
          • Chantal Csajka, PharmD, PhD
        • Sub-Investigator:
          • Pierre-Olivier Lang, MPH, PhD
        • Sub-Investigator:
          • Akram FARHAT, PharmD, MPH, PhD

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 meeting the admission criteria of the acute care for elders (ACE) unit will be eligible.

Exclusion Criteria:

  • none

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PIM-Check group
Other: PIM-Check
In the PIM-Check group, a medication review will be conducted using PIM-Check within 72 hours of patient's admittance to the unit. The physician will decide whether to accept these recommendations or not and implement prescribing changes if agreed.
ACTIVE_COMPARATOR: STOPP/START group
Other: STOPP/START
In the STOPP/START group, medication lists will be analyzed within 72 hours of patient's admittance and optimized according to STOPP/START criteria. The second physician will decide whether to accept these recommendations or not and implement prescribing changes if agreed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Potentially Inappropriate Prescriptions (PIPs) reduction in the PIM-Check group compared to STOPP/START
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and type of PIPs detected by each tool
Time Frame: 18 months
18 months
Rate of acceptability
Time Frame: 18 months
18 months
Number of treatment (mean and median) modification by clinicians
Time Frame: 18 months
18 months
Number of drugs at discharge
Time Frame: 18 months
18 months
Incidence rate of falls
Time Frame: 18 months
18 months
Activities of daily living (ADL) score
Time Frame: 18 months
Activities of daily living are routine activities people do every day without assistance (6 basic activities) : eating, bathing, getting dressed, toileting, transferring, and continence. The score is the number of activities performed without assistance. Score ranges : from 0/6 (minimum) to 6/6 (maximum). Higher values represent a better outcome of activities of daily living.
18 months
Confusion Assessment Method (CAM)
Time Frame: 18 months
Result ranges : [negative result (-) = no confusion] ; [positive result (+) = confusion].
18 months
Length of stay
Time Frame: 18 months
18 months
Number of unplanned readmission
Time Frame: up to 3 months after discharge
up to 3 months after discharge
Association between the number and type of PIPs at discharge with rate of re-admission
Time Frame: up to 3 months after discharge
up to 3 months after discharge

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

February 26, 2018

Primary Completion (ACTUAL)

April 30, 2019

Study Completion (ANTICIPATED)

August 4, 2019

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (ACTUAL)

July 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TaIPE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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