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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polypharmacy, Inappropriate Prescribing

Intervention / Treatment
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* Other: Individual Deprescribing Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual Deprescribing Intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>Participants allocated to the control group will receive usual care. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deprescribing, Nursing Home, Potentially Inappropriate Medication