Tool for Inappropriate Prescription Evaluation: The TaIPE Study

Not Applicable

• Conditions: Inappropriate Prescribing
• Interventions: Other: STOPP/START; Other: PIM-Check

• Registration Number: NCT04028583
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-26
• Primary Completion: 2019-04-30
• Status Verified: 2019-07
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-22
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23
• Study Completion: 2019-08-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 464

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STOPP/START group	STOPP/START	-
PIM-Check group	PIM-Check	-

Primary Outcome Measures

Name	Time	Method
Rate of Potentially Inappropriate Prescriptions (PIPs) reduction in the PIM-Check group compared to STOPP/START	18 months

Secondary Outcome Measures

Name	Time	Method
Number and type of PIPs detected by each tool	18 months
Rate of acceptability	18 months
Activities of daily living (ADL) score	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.
Confusion Assessment Method (CAM)	18 months	Result ranges : \[negative result (-) = no confusion\] ; \[positive result (+) = confusion\].
Number of unplanned readmission	up to 3 months after discharge
Incidence rate of falls	18 months
Association between the number and type of PIPs at discharge with rate of re-admission	up to 3 months after discharge
Number of treatment (mean and median) modification by clinicians	18 months
Number of drugs at discharge	18 months
Length of stay	18 months

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland