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Older people residing in nursing homes (NH) are frequently polymedicated and often prescribed potentially inappropriate medications. Deprescribing has been proposed as a way to reduce the number of drugs they receive and their exposure to harmful treatments.
The objectives of this study are 1) To evaluate the effect of a deprescribing-specific interdisciplinary quality circle module on the use of potentially inappropriate medication in nursing-home residents. 2) To determine the effective strategies to reach and implement deprescribing consensus resulting of said quality circle module.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Nursing Homes allocated to the Intervention arm will enact the Quality Circle Deprescribing Module and create a local deprescribing consensus and implementation strategy. |
|
| Control | No Intervention | Nursing Homes allocated to the Control arm will not enact the intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality Circle Deprescribing Module | Other | The Quality Circle Deprescribing Module consist of a discussion bringing together nurses, physicians and responsible pharmacist to create a local deprescribing consensus for frequently used drug classes, as well as implementation strategies for the consensus.. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Potentially Inappropriate Galenic Units | The primary outcome is the percentage, at follow-up, of potentially inappropriate galenic units at follow-up, relative to the total number of galenic units used in the nursing home. | 12 months |
| Number of Potentially Inappropriate Defined Daily Doses (DDDs) Per Average Resident and Per Day | Sum of Defined Daily Doses identified as potentially inappropriate (PIM, see protocol for assessement method), divided by the total number of days spent in the NH | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Potentially Inappropriate DDD to Avoid | Sum of Defined Daily Doses identified as "to avoid" (see protocol for assessement method), divided by the total number of days spent in the NH. | 12 months |
| Number of Potentially Inappropriate DDD to Reevaluate |
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Inclusion Criteria:
Nursing homes taking part in the study must have
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Bugnon, Prof | University of Geneva, Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Pharamacie Communautaire | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37789286 | Derived | Mena S, Moullin JC, Schneider M, Niquille A. Implementation of interprofessional quality circles on deprescribing in Swiss nursing homes: an observational study. BMC Geriatr. 2023 Oct 3;23(1):620. doi: 10.1186/s12877-023-04335-w. | |
| 34798826 | Derived | Cateau D, Ballabeni P, Niquille A. Effects of an interprofessional deprescribing intervention in Swiss nursing homes: the Individual Deprescribing Intervention (IDeI) randomised controlled trial. BMC Geriatr. 2021 Nov 19;21(1):655. doi: 10.1186/s12877-021-02465-7. |
| Label | URL |
|---|---|
| Website of funding body | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Nursing Homes allocated to the Intervention arm will enact the Quality Circle Deprescribing Module and create a local deprescribing consensus and implementation strategy. Quality Circle Deprescribing Module: The Quality Circle Deprescribing Module consist of a discussion bringing together nurses, physicians and responsible pharmacist to create a local deprescribing consensus for frequently used drug classes, as well as implementation strategies for the consensus.. |
| FG001 | Control | Nursing Homes allocated to the Control arm will not enact the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The unit of analysis for the trial is the nursing home (NH); no individual NH residents were enroled. Therefore, no data on age and gender can be provided.
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Nursing Homes allocated to the Intervention arm will enact the Quality Circle Deprescribing Module and create a local deprescribing consensus and implementation strategy. Quality Circle Deprescribing Module: The Quality Circle Deprescribing Module consist of a discussion bringing together nurses, physicians and responsible pharmacist to create a local deprescribing consensus for frequently used drug classes, as well as implementation strategies for the consensus.. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Units |
| 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 | Percentage of Potentially Inappropriate Galenic Units | The primary outcome is the percentage, at follow-up, of potentially inappropriate galenic units at follow-up, relative to the total number of galenic units used in the nursing home. | The analysis level is the nursing home; no data on individual residents were collected | Posted | Mean | Standard Deviation | percent | 12 months | Nursing homes | Nursing homes |
|
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Individual adverse events were not collected for this study; safety outcomes are included in the Outcomes section
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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 | Intervention | Nursing Homes allocated to the Intervention arm will enact the Quality Circle Deprescribing Module and create a local deprescribing consensus and implementation strategy. Quality Circle Deprescribing Module: The Quality Circle Deprescribing Module consist of a discussion bringing together nurses, physicians and responsible pharmacist to create a local deprescribing consensus for frequently used drug classes, as well as implementation strategies for the consensus.. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Anne Niquille | 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 | Yes | No | No | Study Protocol | Feb 5, 2020 | Mar 31, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2018 | Mar 3, 2021 | SAP_002.pdf |
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|
Sum of Defined Daily Doses identified as "to reevaluate" (see protocol for assessement method), divided by the total number of days spent in the NH. |
| 12 months |
| Number of Hospital Days | The number of days spent in the hospital by average resident | 12 months |
| Mortality Rate | Number of residents of the nursing home having died during the considered year, divided by the total number of residents having stayed in the nursing home. | 12 months |
| Number of Falls Per Average Resident and Per Year | Number of falls per average resident and per year | 12 months |
| Percentage of Residents With at Least One Day of Physical Restraints Use | Number of residents of the nursing home with at least one day of physical restraints use during the considered year, divided by the total number of residents having stayed in the nursing home. | 12 months |
| 33933030 | Derived | Cateau D, Ballabeni P, Niquille A. Effects of an interprofessional Quality Circle-Deprescribing Module (QC-DeMo) in Swiss nursing homes: a randomised controlled trial. BMC Geriatr. 2021 May 1;21(1):289. doi: 10.1186/s12877-021-02220-y. |
| 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. |
| BG001 | Control | Nursing Homes allocated to the Control arm will not enact the intervention. |
| BG002 | Total | Total of all reporting groups |
| Nursing home |
|
| Nursing home |
| Nursing home |
|
| Sex/Gender, Customized | Count of Units | Nursing home | Nursing home |
|
| Race/Ethnicity, Customized | Count of Units | Nursing home | Nursing home |
|
| Region of Enrollment | Number | participants | Nursing home |
|
| NH mission | Psycho-geriatric mission include NHs with mixed mission (both geriatric and psycho-geriatric) | Count of Units | Nursing home | Nursing home |
|
| Number of average residents | Total number of days spent in the nursing home (NH) by all residents in a year, divided by 365. Roughly equivalent to the number of beds in the NH, but accounting for "empty beds". NOT equivalent to the average number of residents, as this measure would require the knowledge of individual residents, which was not collected for this study. Only data at the NH level (e.g. total number of days spent in the H) were collected. | Median | Inter-Quartile Range | Number of average residents | Nursing home |
|
| Percentage of potentially inappropriate galenic units | Percentage of potentially inappropriate galenic units, relative to the total number of galenic units used in the nursing home in a year. | Median | Inter-Quartile Range | percent | Nursing home |
|
| Overall number of potentially inappropriate DDD | Potentially inappropriate medications are classified as "to avoid" (indicating that inappropriate use is more likely) or "to reevaluate". The overall number is the sum of these two categories. | Median | Inter-Quartile Range | DDD per average resident and per day | Nursing home |
|
| Number of potentially inappropriate DDD to avoid | Potentially inappropriate medications are classified as "to avoid" (indicating that inappropriate use is more likely) or "to reevaluate". | Median | Inter-Quartile Range | DDD per average resident and per day | Nursing home |
|
| Number of potentially inappropriate DDD to reevaluate | Potentially inappropriate medications are classified as "to avoid" (indicating that inappropriate use is more likely) or "to reevaluate". | Median | Inter-Quartile Range | DDD per average resident and per day | Nursing home |
|
| Mortality rate | Percentage of residents in the nursing home (NH) having died in the considered year, relative to the total number of residents having stayed at the NH during this year. | Median | Inter-Quartile Range | percent | Nursing home |
|
| Days in hospital | Total number of days spent in the hospital by all nursing residents in the considered year, divided by the number of average residents. | Median | Inter-Quartile Range | Days | Nursing home |
|
| Number of falls | Total number of falls that occured in the nursing home during the considered year, divided by the number of average residents. | Median | Inter-Quartile Range | Falls per avg. resident and per year | Nursing home |
|
| Rate of physical restraints use | Percentage of residents in the nursing home (NH) with at least one day with physical restraints during the considered year, relative to the total number of residents having stayed at the NH during this year. | Median | Inter-Quartile Range | Percent | Nursing home |
|
| OG001 | Control | Nursing Homes allocated to the Control arm will not enact the intervention. |
|
|
|
| Primary | Number of Potentially Inappropriate Defined Daily Doses (DDDs) Per Average Resident and Per Day | Sum of Defined Daily Doses identified as potentially inappropriate (PIM, see protocol for assessement method), divided by the total number of days spent in the NH | The analysis level is the nursing home; no data on individual residents were collected | Posted | Mean | Standard Deviation | PIM DDD per avg resident per day | 12 months | Nursing homes | Nursing homes |
|
|
|
|
| Secondary | Number of Potentially Inappropriate DDD to Avoid | Sum of Defined Daily Doses identified as "to avoid" (see protocol for assessement method), divided by the total number of days spent in the NH. | The analysis level is the nursing home; no data on individual residents were collected | Posted | Mean | Standard Deviation | Number of PIM DDD per avg resident | 12 months | Nursing homes | Nursing homes |
|
|
|
|
| Secondary | Number of Potentially Inappropriate DDD to Reevaluate | Sum of Defined Daily Doses identified as "to reevaluate" (see protocol for assessement method), divided by the total number of days spent in the NH. | The analysis level is the nursing home; no data on individual residents were collected | Posted | Mean | Standard Deviation | Number of PIM DDD per avg resident | 12 months | Nursing homes | Nursing homes |
|
|
|
|
| Secondary | Number of Hospital Days | The number of days spent in the hospital by average resident | The analysis level is the nursing home; no data on individual residents were collected | Posted | Mean | Standard Deviation | Days per avg resident and per year | 12 months | Nursing homes | Nursing homes |
|
|
|
|
| Secondary | Mortality Rate | Number of residents of the nursing home having died during the considered year, divided by the total number of residents having stayed in the nursing home. | The analysis level is the nursing home; no data on individual residents were collected | Posted | Mean | Standard Deviation | Percent of residents having died | 12 months | Nursing homes | Nursing homes |
|
|
|
|
| Secondary | Number of Falls Per Average Resident and Per Year | Number of falls per average resident and per year | The analysis level is the nursing home; no data on individual residents were collected. | Posted | Mean | Standard Deviation | Falls per avg resident and per year | 12 months | Nursing homes | Nursing homes |
|
|
|
|
| Secondary | Percentage of Residents With at Least One Day of Physical Restraints Use | Number of residents of the nursing home with at least one day of physical restraints use during the considered year, divided by the total number of residents having stayed in the nursing home. | The analysis level is the nursing home; no data on individual residents were collected. | Posted | Mean | Standard Deviation | Proportion of res with phys restraints | 12 months | Nursing homes | Nursing homes |
|
|
|
|
| 921 |
| 2,899 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control | Nursing Homes allocated to the Control arm will not enact the intervention. | 717 | 2,113 | 0 | 0 | 0 | 0 |
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