Tool for Inappropriate Prescription Evaluation: The TaIPE Study

Study Overview
=================
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.

Official Title
-----------------
Tool for Inappropriate Prescription Evaluation: The TaIPE Study

Conditions
-----------------
Inappropriate Prescribing

Intervention / Treatment
-----------------
* Other: PIM-Check
* Other: STOPP/START


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients meeting the admission criteria of the acute care for elders (ACE) unit will be eligible. Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PIM-Check group<br> | Other: PIM-Check<br>* 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.<br>|
| Active Comparator: STOPP/START group<br> | Other: STOPP/START<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inappropriate Prescribing, Potentially Inappropriate Medication List, Aged, Practice Guideline, Education, Medical