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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688542
Recruitment Status : Active, not recruiting
First Posted : September 28, 2018
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Anne Niquille, University of Geneva, Switzerland

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.


Condition or disease Intervention/treatment Phase
Polypharmacy Inappropriate Prescribing Other: Quality Circle Deprescribing Module Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Opportunities and Limits to Deprescribing in Nursing Homes:Quality Circle Deprescribing Module
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

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.



Primary Outcome Measures :
  1. Change in the proportion of PIMs use [ Time Frame: 12 months ]
    The primary outcome is the change at 12 months, relative to baseline, in the proportion of Potentially Inappropriate medication (PIMs) used in the NHs relative to their total drug consumption


Secondary Outcome Measures :
  1. Difference in proportion of probably inappropriate galenic units and of possibly inappropriate galenic units [ Time Frame: 12 months ]
  2. Difference in proportion of probably inappropriate Defined Daily Doses (DDDs) and of possibly inappropriate DDDs: [ Time Frame: 12 months ]
  3. Number of hospital days [ Time Frame: 12 months ]
    The number of days spent in the hospital by residents in the nursing home

  4. Mortality rate [ Time Frame: 12 months ]
    The proportion of residents of the nursing home having died

  5. Number of falls per mean resident and per month [ Time Frame: 12 months ]
  6. Number of restraints measures per mean resident and per month [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688542


Locations
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Switzerland
Centre de Pharamacie Communautaire
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Anne Niquille
Investigators
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Study Director: Olivier Bugnon, Prof University of Geneva
  Study Documents (Full-Text)

Documents provided by Anne Niquille, University of Geneva, Switzerland:
Study Protocol  [PDF] December 21, 2017


Additional Information:
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Responsible Party: Anne Niquille, Dr, University of Geneva, Switzerland
ClinicalTrials.gov Identifier: NCT03688542    
Other Study ID Numbers: OLD-NH-QC-DeMo-2017
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anne Niquille, University of Geneva, Switzerland:
Deprescribing
Inappropriate Medication
Nursing Homes