NCT04028583

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.

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
464

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

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

February 26, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

July 17, 2019

Last Update Submit

July 22, 2019

Conditions

Keywords

Inappropriate PrescribingPotentially Inappropriate Medication ListAgedPractice GuidelineEducation, Medical

Outcome Measures

Primary Outcomes (1)

  • Rate of Potentially Inappropriate Prescriptions (PIPs) reduction in the PIM-Check group compared to STOPP/START

    18 months

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

PIM-Check group

EXPERIMENTAL
Other: PIM-Check

STOPP/START group

ACTIVE COMPARATOR
Other: STOPP/START

Interventions

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.

PIM-Check group

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.

STOPP/START group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (1)

  • Farhat A, Al-Hajje A, Lang PO, Csajka C. Impact of Pharmaceutical Interventions with STOPP/START and PIM-Check in Older Hospitalized Patients: A Randomized Controlled Trial. Drugs Aging. 2022 Nov;39(11):899-910. doi: 10.1007/s40266-022-00974-7. Epub 2022 Sep 30.

MeSH Terms

Interventions

Potentially Inappropriate Medication List

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Chantal Csajka, PharmD, PhD

CONTACT

Akram FARHAT, PharmD, MPH, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 22, 2019

Study Start

February 26, 2018

Primary Completion

April 30, 2019

Study Completion

August 4, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations