Opportunities and Limits to Deprescribing in Nursing Homes:Quality Circle Deprescribing Module (OLD-NH-QC-DeMo)

March 24, 2021 updated by: Anne Niquille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Centre de Pharamacie Communautaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
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..
No Intervention: Control
Nursing Homes allocated to the Control arm will not enact the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Potentially Inappropriate Galenic Units
Time Frame: 12 months
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
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Potentially Inappropriate DDD to Avoid
Time Frame: 12 months
Sum of Defined Daily Doses identified as "to avoid" (see protocol for assessement method), divided by the total number of days spent in the NH.
12 months
Number of Potentially Inappropriate DDD to Reevaluate
Time Frame: 12 months
Sum of Defined Daily Doses identified as "to reevaluate" (see protocol for assessement method), divided by the total number of days spent in the NH.
12 months
Number of Hospital Days
Time Frame: 12 months
The number of days spent in the hospital by average resident
12 months
Mortality Rate
Time Frame: 12 months
Number of residents of the nursing home having died during the considered year, divided by the total number of residents having stayed in the nursing home.
12 months
Number of Falls Per Average Resident and Per Year
Time Frame: 12 months
Number of falls per average resident and per year
12 months
Percentage of Residents With at Least One Day of Physical Restraints Use
Time Frame: 12 months
Number of residents of the nursing home with at least one day of physical restraints use during the considered year, divided by the total number of residents having stayed in the nursing home.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anne Niquille

Investigators

  • Study Director: Olivier Bugnon, Prof, University of Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2017

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

April 21, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OLD-NH-QC-DeMo-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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