Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents (OLD-NH-IDeI)
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|ClinicalTrials.gov Identifier: NCT03655405|
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : October 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Polypharmacy Inappropriate Prescribing||Other: Individual Deprescribing Intervention||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Opportunities and Limits to Deprescribing in Nursing Homes: Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents.|
|Actual Study Start Date :||October 30, 2018|
|Actual Primary Completion Date :||August 22, 2019|
|Actual Study Completion Date :||August 22, 2019|
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.
- Change in the number of inappropriate medication between baseline and 4 months [ Time Frame: 4 months ]
- Change between baseline and 4 months in the number of potentially inappropriate Defined Daily Doses (DDDs) prescribed to participants. [ Time Frame: 4 months ]
- Change between baseline and 4 months in the number of regular drugs prescribed to participants [ Time Frame: 4 months ]
- Change between baseline and 4 months in the number of regular DDDs prescribed to participants [ Time Frame: 4 months ]
- Number of new drugs prescribed as a result of the intervention [ Time Frame: 4 months ]
- Change in health-related quality of life between baseline and follow-up, measured with EQ-5D-5L [ Time Frame: 4 months ]The EQ-5D-5L (EuroQol 5-Dimension 5-Level) quality of life scale uses a questionnaire (5 questions) and a visual analog scale (0-100, higher score indicates better quality of life) to evaluate simply the respondent's perceived quality of life.
- Change in the number of common drug-related complaints presented by the participant between baseline and follow-up [ Time Frame: 4 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655405
|Centre de Pharmacie Communautaire|
|Lausanne, Vaud, Switzerland, 1011|
|Study Director:||Olivier Bugnon, Prof||ISPSO, Universties of Geneva and Lausanne, Switzerland|