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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual Deprescribing Intervention | Experimental | 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). |
|
| Control | No Intervention | Participants allocated to the control group will receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual Deprescribing Intervention | Other | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Bugnon, Prof | ISPSO, Universties of Geneva and Lausanne, Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Pharmacie Communautaire | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32622774 | Derived | 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. |
| Label | URL |
|---|---|
| Project description on the funding body website | View source |
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Data are available from the investigators upon reasonable request.
10-year availability
Data are available from the investigators upon reasonable request.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). 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. |
| FG001 | Control | Participants allocated to the control group will receive usual care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intervention: 1 participant excluded, died before initial data collection; Control: 3 participants excluded: 2 died before initial data collection, no data was collected on one.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Inappropriate Medication at Follow-up | Number of inappropriate medications prescribed at follow-up, assessed using the French translation of STOPP v2. | Posted | Mean | Standard Deviation | drugs | 4 months |
|
4 months
Adverse events were collected for the intervention group only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.911 0.911 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). 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Anne Niquille | a. Community Pharmacy, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland | +41213144845 | anne.niquille@unisante.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2018 | Oct 14, 2019 | Prot_SAP_000.pdf |
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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
| 4 months |
| Number of Common Drug-related Complaints at Follow-up | Number of common drug-related complaints at follow-up | 4 months |
| 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 |
| Protocol Violation |
|
| BG001 | Control | Participants allocated to the control group will receive usual care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of stay in years | Mean | Standard Deviation | years |
|
| Number of drugs prescribed | Median | Inter-Quartile Range | drugs |
|
| Number of chronic drugs | Median | Inter-Quartile Range | drugs |
|
| Number of PIMs | Number of Potentially Inappropriate Medications (PIMs); appropriateness is assessed using the French translation of the Screening Tool of Older People's Prescription (STOPP) v2. | Median | Inter-Quartile Range | potentially inappropriate medications |
|
| Number of chronic DDDs | Number of chronic Defined Daily Dose (DDD); chronicity is defined as the absence of a planned cessation date in the participant's record. DDDs are assigned according the the World Health Organization's (WHO) DDD set. | Mean | Standard Deviation | chronic DDD |
|
| Number of PIM DDDs | Sum of potentially inappropriate DDDs; appropriateness is assessed using the French translation of STOPP v2; DDDs are assigned according to the WHO's DDD set. | Mean | Standard Deviation | PIM DDD |
|
| Quality of life: EQ-5D-5L analog scale | 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. | Mean | Standard Deviation | analog scale units |
|
| Quality of life: EQ-5D-5L index | The quality of life was assessed using EQ-5D-5L; this tool includes 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. | Mean | Standard Deviation | index |
|
| OG001 | Control | Participants allocated to the control group will receive usual care. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | DDD | 4 months |
|
|
|
|
| Secondary | Number of Chronic Drugs Prescribed to Participants | Number of Chronic Drugs Prescribed to Participants | Posted | Mean | Standard Deviation | drugs | 4 months |
|
|
|
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| Secondary | Number of Chronic DDDs Prescribed to Participants | Number of chronic DDDs prescribed to participants | Posted | Mean | Standard Deviation | DDD | 4 months |
|
|
|
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| Secondary | Number of New Drugs Prescribed as a Result of the Intervention | This outcome was not analysed | This outcome was not analyzed, as the drugs newly prescribed as a result of the intervention could not be distinguished from the other drugs newly prescribed. | Posted | 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
| Data on this outcome were missing for some participants | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
|
|
|
| Secondary | Number of Common Drug-related Complaints at Follow-up | Number of common drug-related complaints at follow-up | Data on this outcome at follow-up were missing for some participants, because of death or hospitalisation. | Posted | Mean | Standard Deviation | Number of complaints | 4 months |
|
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| Other Pre-specified | Number of Deaths | Number of deaths | Posted | Count of Participants | Participants | 4 months |
|
|
|
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| Other Pre-specified | Number of Participants Hospitalized | Number of participants hospitalized at any time during the study | Posted | Count of Participants | Participants | 4 months |
|
|
|
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| Other Pre-specified | Days Spent in Hospital | Average number of days spent in hospital during the study period | Posted | Mean | Standard Deviation | Number of days | 4 months |
|
|
|
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| Other Pre-specified | Number of Falls Per Participant | Average number of falls during the study period | Posted | Mean | Standard Deviation | falls | 4 months |
|
|
|
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| Other Pre-specified | Number of Participants Who Fell | Number of participants who fell at least once during the study period | Posted | Count of Participants | Participants | 4 months |
|
|
|
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| Other Pre-specified | Number of Falls in Participants That Fell at Least Once | Only the participants who fell at least once were included in this analysis | Posted | Mean | Standard Deviation | Number of falls | 4 months |
|
|
|
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| Other Pre-specified | Number of Days Spent With Physical Restraints | Posted | Mean | Standard Deviation | days | 4 months |
|
|
|
|
| 5 |
| 32 |
| 4 |
| 31 |
| 0 |
| 31 |
| EG001 | Control | Participants allocated to the control group will receive usual care. | 4 | 30 | 0 | 0 | 0 | 0 |
| Hematemesis | Gastrointestinal disorders | Non-systematic Assessment |
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| Gout crisis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Oedema | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| Regression, Linear |
Scale value at follow-up, adjusted for baseline value |
| 0.075 |
| Slope |
| -0.096 |
| 2-Sided |
| 95 |
| -0.202 |
| 0.01 |
| Superiority |