NCT03688542

Brief Summary

Older people residing in nursing homes (NH) are frequently polymedicated and often prescribed potentially inappropriate medications. Deprescribing has been proposed as a way to reduce the number of drugs they receive and their exposure to harmful treatments. The objectives of this study are 1) To evaluate the effect of a deprescribing-specific interdisciplinary quality circle module on the use of potentially inappropriate medication in nursing-home residents. 2) To determine the effective strategies to reach and implement deprescribing consensus resulting of said quality circle module.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 25, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
10 months until next milestone

Results Posted

Study results publicly available

April 21, 2021

Completed
Last Updated

April 21, 2021

Status Verified

March 1, 2021

Enrollment Period

2.8 years

First QC Date

September 26, 2018

Results QC Date

November 10, 2020

Last Update Submit

March 24, 2021

Conditions

Keywords

DeprescribingInappropriate MedicationNursing Homes

Outcome Measures

Primary Outcomes (2)

  • Percentage of Potentially Inappropriate Galenic Units

    The primary outcome is the percentage, at follow-up, of potentially inappropriate galenic units at follow-up, relative to the total number of galenic units used in the nursing home.

    12 months

  • Number of Potentially Inappropriate Defined Daily Doses (DDDs) Per Average Resident and Per Day

    Sum of Defined Daily Doses identified as potentially inappropriate (PIM, see protocol for assessement method), divided by the total number of days spent in the NH

    12 months

Secondary Outcomes (6)

  • Number of Potentially Inappropriate DDD to Avoid

    12 months

  • Number of Potentially Inappropriate DDD to Reevaluate

    12 months

  • Number of Hospital Days

    12 months

  • Mortality Rate

    12 months

  • Number of Falls Per Average Resident and Per Year

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Nursing Homes allocated to the Intervention arm will enact the Quality Circle Deprescribing Module and create a local deprescribing consensus and implementation strategy.

Other: Quality Circle Deprescribing Module

Control

NO INTERVENTION

Nursing Homes allocated to the Control arm will not enact the intervention.

Interventions

The Quality Circle Deprescribing Module consist of a discussion bringing together nurses, physicians and responsible pharmacist to create a local deprescribing consensus for frequently used drug classes, as well as implementation strategies for the consensus..

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nursing homes taking part in the study must have
  • a geriatric of psycho-geriatric mission;
  • been part of their cantonal pharmaceutical assistance program for at least a year.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Pharamacie Communautaire

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (4)

  • Mena S, Moullin JC, Schneider M, Niquille A. Implementation of interprofessional quality circles on deprescribing in Swiss nursing homes: an observational study. BMC Geriatr. 2023 Oct 3;23(1):620. doi: 10.1186/s12877-023-04335-w.

  • Cateau D, Ballabeni P, Niquille A. Effects of an interprofessional deprescribing intervention in Swiss nursing homes: the Individual Deprescribing Intervention (IDeI) randomised controlled trial. BMC Geriatr. 2021 Nov 19;21(1):655. doi: 10.1186/s12877-021-02465-7.

  • Cateau D, Ballabeni P, Niquille A. Effects of an interprofessional Quality Circle-Deprescribing Module (QC-DeMo) in Swiss nursing homes: a randomised controlled trial. BMC Geriatr. 2021 May 1;21(1):289. doi: 10.1186/s12877-021-02220-y.

  • Cateau D, Ballabeni P, Mena S, Bugnon O, Niquille A. Deprescribing in nursing homes: Protocol for nested, randomised controlled hybrid trials of deprescribing interventions. Res Social Adm Pharm. 2021 Apr;17(4):786-794. doi: 10.1016/j.sapharm.2020.05.026. Epub 2020 May 27.

Related Links

Results Point of Contact

Title
Dr Anne Niquille
Organization
Community Pharmacy, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland

Study Officials

  • Olivier Bugnon, Prof

    University of Geneva

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 26, 2018

First Posted

September 28, 2018

Study Start

September 25, 2017

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

April 21, 2021

Results First Posted

April 21, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations