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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03655405
Other study ID # OLD-NH-IDeI-2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2018
Est. completion date August 22, 2019

Study information

Verified date April 2021
Source University of Geneva, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date August 22, 2019
Est. primary completion date August 22, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Switzerland Centre de Pharmacie Communautaire Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
Anne Niquille

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Deaths Number of deaths 4 months
Other Number of Participants Hospitalized Number of participants hospitalized at any time during the study 4 months
Other Days Spent in Hospital Average number of days spent in hospital during the study period 4 months
Other Number of Falls Per Participant Average number of falls during the study period 4 months
Other Number of Participants Who Fell Number of participants who fell at least once during the study period 4 months
Other Number of Falls in Participants That Fell at Least Once 4 months
Other Number of Days Spent With Physical Restraints 4 months
Primary Number of Inappropriate Medication at Follow-up Number of inappropriate medications prescribed at follow-up, assessed using the French translation of STOPP v2. 4 months
Secondary Number of Potentially Inappropriate DDDs Prescribed to Participants at Follow-up Appropriateness assessed using the French translation of STOPP v2; DDD defined by WHO. 4 months
Secondary Number of Chronic Drugs Prescribed to Participants Number of Chronic Drugs Prescribed to Participants 4 months
Secondary Number of Chronic DDDs Prescribed to Participants Number of chronic DDDs prescribed to participants 4 months
Secondary Number of New Drugs Prescribed as a Result of the Intervention This outcome was not analysed 4 months
Secondary Health-related Quality of Life 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.
4 months
Secondary Number of Common Drug-related Complaints at Follow-up Number of common drug-related complaints at follow-up 4 months
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