Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents

Polypharmacy Clinical Trial

— OLD-NH-IDeI  

Official title:

Opportunities and Limits to Deprescribing in Nursing Homes: Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03655405
• Other study ID #: OLD-NH-IDeI-2018
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Inappropriate Prescribing
• Polypharmacy

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

External Links

•   Project description on the funding body website