Tool for Inappropriate Prescription Evaluation: The TaIPE Study

Inappropriate Prescribing Clinical Trial

— TaIPE  

Official title:

Tool for Inappropriate Prescription Evaluation: The TaIPE Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04028583
• Other study ID #: TaIPE
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: August 4, 2019

Study information

• Verified date: July 2019
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Chantal Csajka, PharmD, PhD
• Phone: +41 21 314 42 63
• Email: chantal.csajka[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 464
• Est. completion date: August 4, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Inappropriate Prescribing

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Potentially Inappropriate Prescriptions (PIPs) reduction in the PIM-Check group compared to STOPP/START		18 months
Secondary	Number and type of PIPs detected by each tool		18 months
Secondary	Rate of acceptability		18 months
Secondary	Number of treatment (mean and median) modification by clinicians		18 months
Secondary	Number of drugs at discharge		18 months
Secondary	Incidence rate of falls		18 months
Secondary	Activities of daily living (ADL) score	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
Secondary	Confusion Assessment Method (CAM)	Result ranges : [negative result (-) = no confusion] ; [positive result (+) = confusion].	18 months
Secondary	Length of stay		18 months
Secondary	Number of unplanned readmission		up to 3 months after discharge
Secondary	Association between the number and type of PIPs at discharge with rate of re-admission		up to 3 months after discharge