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Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents (OLD-NH-IDeI)

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: NCT03655405
Recruitment Status : Completed
First Posted : August 31, 2018
Results First Posted : May 19, 2021
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Anne Niquille, University of Geneva, Switzerland

Study Description
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Brief Summary:
This study will evaluate the effects of a pharmacist-led, deprescribing-focused medication review on the use of inappropriate medications by nursing home residents

Condition or disease Intervention/treatment Phase
Polypharmacy Inappropriate Prescribing Other: Individual Deprescribing Intervention Not Applicable

Detailed Description:

Nursing home residents are often prescribed inappropriate medication, drugs whose negative effects outweigh potential benefits or which are not useful anymore. Inappropriate medication have been linked with worse health outcomes, hospitalisations and death. Deprescribing, the structured process of withdrawing or tapering inappropriate medications, has been studied as a potential solution to this problem.

In this study, nursing home residents living in institution which are already engaged in a deprescribing process will be randomly allocated to receive a medication review or usual care. The medication review will be performed by the nursing home pharmacist an its results will be discussed with the responsible physicians and nurses to create a deprescribing plan specifically tailored to the needs of the resident.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Opportunities and Limits to Deprescribing in Nursing Homes: Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents.
Actual Study Start Date : October 30, 2018
Actual Primary Completion Date : August 22, 2019
Actual Study Completion Date : August 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

Arms and Interventions
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Arm Intervention/treatment
Experimental: Individual Deprescribing Intervention
Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).
 Other: Individual Deprescribing Intervention
The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.
No Intervention: Control
Participants allocated to the control group will receive usual care.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Inappropriate Medication at Follow-up [ Time Frame: 4 months ]
    Number of inappropriate medications prescribed at follow-up, assessed using the French translation of STOPP v2.


Secondary Outcome Measures :
  1. Number of Potentially Inappropriate DDDs Prescribed to Participants at Follow-up [ Time Frame: 4 months ]
    Appropriateness assessed using the French translation of STOPP v2; DDD defined by WHO.

  2. Number of Chronic Drugs Prescribed to Participants [ Time Frame: 4 months ]
    Number of Chronic Drugs Prescribed to Participants

  3. Number of Chronic DDDs Prescribed to Participants [ Time Frame: 4 months ]
    Number of chronic DDDs prescribed to participants

  4. Number of New Drugs Prescribed as a Result of the Intervention [ Time Frame: 4 months ]
    This outcome was not analysed

  5. Health-related Quality of Life [ Time Frame: 4 months ]

    The EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) tool was used to assess quality of life; this tool includes

    • a visual analog scale, ranging from 0 to 100, 100 indicating "the best health you can imagine" and 0 "the worst health you can imagine". Higher results indicate an higher quality of life.
    • 5 questions, each with 5 possible answers. Using a valuation set, the answers to individual questions were transformed in a numeric index value for each participants, with a maximum of 1 and an infinitely low minimum. Higher values indicates higher perceived health-related quality of life.

  6. Number of Common Drug-related Complaints at Follow-up [ Time Frame: 4 months ]
    Number of common drug-related complaints at follow-up


Other Outcome Measures:
  1. Number of Deaths [ Time Frame: 4 months ]
    Number of deaths

  2. Number of Participants Hospitalized [ Time Frame: 4 months ]
    Number of participants hospitalized at any time during the study

  3. Days Spent in Hospital [ Time Frame: 4 months ]
    Average number of days spent in hospital during the study period

  4. Number of Falls Per Participant [ Time Frame: 4 months ]
    Average number of falls during the study period

  5. Number of Participants Who Fell [ Time Frame: 4 months ]
    Number of participants who fell at least once during the study period

  6. Number of Falls in Participants That Fell at Least Once [ Time Frame: 4 months ]
  7. Number of Days Spent With Physical Restraints [ Time Frame: 4 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Take 5 or more prescribed drugs daily;
  • Reside in the Nursing Home since at least 4 months.

Exclusion Criteria:

  • Physician judges that discussing deprescribing with them risks destabilising them.
Contacts and Locations
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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): NCT03655405


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

Documents provided by Anne Niquille, University of Geneva, Switzerland:
Study Protocol and Statistical Analysis Plan  [PDF] August 27, 2018

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Anne Niquille, Doctor, University of Geneva, Switzerland
ClinicalTrials.gov Identifier: NCT03655405    
Other Study ID Numbers: OLD-NH-IDeI-2018
First Posted: August 31, 2018    Key Record Dates
Results First Posted: May 19, 2021
Last Update Posted: May 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data are available from the investigators upon reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 10-year availability
Access Criteria: Data are available from the investigators upon reasonable request.

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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
Nursing Home
Potentially Inappropriate Medication