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

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

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

Study Overview

• Status: Completed
• Conditions: Polypharmacy; Inappropriate Prescribing
• Intervention / Treatment: Other: Individual Deprescribing Intervention

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre de Pharmacie Communautaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Chronic Drugs Prescribed to Participants	Number of Chronic Drugs Prescribed to Participants	4 months
Number of Chronic DDDs Prescribed to Participants	Number of chronic DDDs prescribed to participants	4 months
Number of New Drugs Prescribed as a Result of the Intervention	This outcome was not analysed	4 months
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
Number of Common Drug-related Complaints at Follow-up	Number of common drug-related complaints at follow-up	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Deaths	Number of deaths	4 months
Number of Participants Hospitalized	Number of participants hospitalized at any time during the study	4 months
Days Spent in Hospital	Average number of days spent in hospital during the study period	4 months
Number of Falls Per Participant	Average number of falls during the study period	4 months
Number of Participants Who Fell	Number of participants who fell at least once during the study period	4 months
Number of Falls in Participants That Fell at Least Once		4 months
Number of Days Spent With Physical Restraints		4 months

Collaborators and Investigators

• Sponsor: Anne Niquille
• Investigators: Study Director: Olivier Bugnon, Prof, ISPSO, Universties of Geneva and Lausanne, Switzerland

Publications and helpful links

General Publications

• 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.

Helpful Links

• Project description on the funding body website

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): August 22, 2019
• Study Completion (Actual): August 22, 2019

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Nursing Home; Deprescribing; Potentially Inappropriate Medication
• Other Study ID Numbers: OLD-NH-IDeI-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data are available from the investigators upon reasonable request.
• IPD Sharing Time Frame: 10-year availability
• IPD Sharing Access Criteria: Data are available from the investigators upon reasonable request.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No