Clinical trial NCT03655405: Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents
Official title: Opportunities and Limits to Deprescribing in Nursing Homes: Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Inappropriate Prescribing
Keywords: Deprescribing
Nursing Home
Potentially Inappropriate Medication
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 62
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Number of Inappropriate Medication at Follow-up
timeFrame: 4 months
Secondary outcomes:
measure: Number of Potentially Inappropriate DDDs Prescribed to Participants at Follow-up
timeFrame: 4 months
measure: Number of Chronic Drugs Prescribed to Participants
timeFrame: 4 months
measure: Number of Chronic DDDs Prescribed to Participants
timeFrame: 4 months
measure: Number of New Drugs Prescribed as a Result of the Intervention
timeFrame: 4 months
measure: Health-related Quality of Life
timeFrame: 4 months
measure: Number of Common Drug-related Complaints at Follow-up
timeFrame: 4 months
Other outcomes:
measure: Number of Deaths
timeFrame: 4 months
measure: Number of Participants Hospitalized
timeFrame: 4 months
measure: Days Spent in Hospital
timeFrame: 4 months
measure: Number of Falls Per Participant
timeFrame: 4 months
measure: Number of Participants Who Fell
timeFrame: 4 months
measure: Number of Falls in Participants That Fell at Least Once
timeFrame: 4 months
measure: Number of Days Spent With Physical Restraints
timeFrame: 4 months
Locations:
city: Lausanne
country: Switzerland
facility: Centre de Pharmacie Communautaire
state: Vaud
Study officials:
affiliation: ISPSO, Universties of Geneva and Lausanne, Switzerland
name: Olivier Bugnon, Prof
role: STUDY_DIRECTOR
References:
citation: 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.