Trial Outcomes & Findings for Opportunities and Limits to Deprescribing in Nursing Homes:Quality Circle Deprescribing Module (NCT NCT03688542)
NCT ID: NCT03688542
Last Updated: 2021-04-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
12 months
Results posted on
2021-04-21
Participant Flow
Unit of analysis: Nursing home
Participant milestones
| Measure |
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..
|
Control
Nursing Homes allocated to the Control arm will not enact the intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
0 27
|
0 29
|
|
Overall Study
COMPLETED
|
0 27
|
0 28
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Opportunities and Limits to Deprescribing in Nursing Homes:Quality Circle Deprescribing Module
Baseline characteristics by cohort
| Measure |
Intervention
n=27 Nursing home
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..
|
Control
n=29 Nursing home
Nursing Homes allocated to the Control arm will not enact the intervention.
|
Total
n=56 Nursing home
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
n/a
|
NA Nursing home
n=64 Nursing home
|
NA Nursing home
n=62 Nursing home
|
NA Nursing home
n=126 Nursing home
|
|
Sex/Gender, Customized
n/a
|
NA Nursing home
n=64 Nursing home
|
NA Nursing home
n=62 Nursing home
|
NA Nursing home
n=126 Nursing home
|
|
Race/Ethnicity, Customized
n/a
|
NA Nursing home
n=64 Nursing home
|
NA Nursing home
n=62 Nursing home
|
NA Nursing home
n=126 Nursing home
|
|
Region of Enrollment
Switzerland
|
27 participants
n=64 Nursing home
|
29 participants
n=62 Nursing home
|
56 participants
n=126 Nursing home
|
|
NH mission
Geriatric
|
16 Nursing home
n=64 Nursing home
|
20 Nursing home
n=62 Nursing home
|
36 Nursing home
n=126 Nursing home
|
|
NH mission
Psycho-geriatric
|
11 Nursing home
n=64 Nursing home
|
9 Nursing home
n=62 Nursing home
|
20 Nursing home
n=126 Nursing home
|
|
Number of average residents
|
48 Number of average residents
n=64 Nursing home
|
35 Number of average residents
n=62 Nursing home
|
43 Number of average residents
n=126 Nursing home
|
|
Percentage of potentially inappropriate galenic units
|
26 percent
n=64 Nursing home
|
22 percent
n=62 Nursing home
|
24 percent
n=126 Nursing home
|
|
Overall number of potentially inappropriate DDD
|
2.4 DDD per average resident and per day
n=64 Nursing home
|
2.4 DDD per average resident and per day
n=62 Nursing home
|
2.4 DDD per average resident and per day
n=126 Nursing home
|
|
Number of potentially inappropriate DDD to avoid
|
0.3 DDD per average resident and per day
n=64 Nursing home
|
0.4 DDD per average resident and per day
n=62 Nursing home
|
0.4 DDD per average resident and per day
n=126 Nursing home
|
|
Number of potentially inappropriate DDD to reevaluate
|
1.9 DDD per average resident and per day
n=64 Nursing home
|
2.1 DDD per average resident and per day
n=62 Nursing home
|
2.0 DDD per average resident and per day
n=126 Nursing home
|
|
Mortality rate
|
32 percent
n=64 Nursing home
|
34 percent
n=62 Nursing home
|
34 percent
n=126 Nursing home
|
|
Days in hospital
|
2.7 Days
n=64 Nursing home
|
2.5 Days
n=62 Nursing home
|
2.5 Days
n=126 Nursing home
|
|
Number of falls
|
2.3 Falls per avg. resident and per year
n=64 Nursing home
|
2.3 Falls per avg. resident and per year
n=62 Nursing home
|
2.3 Falls per avg. resident and per year
n=126 Nursing home
|
|
Rate of physical restraints use
|
23 Percent
n=64 Nursing home
|
27 Percent
n=62 Nursing home
|
24 Percent
n=126 Nursing home
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The analysis level is the nursing home; no data on individual residents were collected
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.
Outcome measures
| Measure |
Intervention
n=27 Nursing homes
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..
|
Control
n=28 Nursing homes
Nursing Homes allocated to the Control arm will not enact the intervention.
|
|---|---|---|
|
Percentage of Potentially Inappropriate Galenic Units
|
24 percent
Standard Deviation 7
|
23 percent
Standard Deviation 9
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The analysis level is the nursing home; no data on individual residents were collected
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
Outcome measures
| Measure |
Intervention
n=27 Nursing homes
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..
|
Control
n=28 Nursing homes
Nursing Homes allocated to the Control arm will not enact the intervention.
|
|---|---|---|
|
Number of Potentially Inappropriate Defined Daily Doses (DDDs) Per Average Resident and Per Day
|
2.1 PIM DDD per avg resident per day
Standard Deviation 0.5
|
2.3 PIM DDD per avg resident per day
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The analysis level is the nursing home; no data on individual residents were collected
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.
Outcome measures
| Measure |
Intervention
n=27 Nursing homes
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..
|
Control
n=28 Nursing homes
Nursing Homes allocated to the Control arm will not enact the intervention.
|
|---|---|---|
|
Number of Potentially Inappropriate DDD to Avoid
|
0.3 Number of PIM DDD per avg resident
Standard Deviation 0.2
|
0.3 Number of PIM DDD per avg resident
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The analysis level is the nursing home; no data on individual residents were collected
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.
Outcome measures
| Measure |
Intervention
n=27 Nursing homes
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..
|
Control
n=28 Nursing homes
Nursing Homes allocated to the Control arm will not enact the intervention.
|
|---|---|---|
|
Number of Potentially Inappropriate DDD to Reevaluate
|
1.8 Number of PIM DDD per avg resident
Standard Deviation 0.5
|
2.0 Number of PIM DDD per avg resident
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The analysis level is the nursing home; no data on individual residents were collected
The number of days spent in the hospital by average resident
Outcome measures
| Measure |
Intervention
n=24 Nursing homes
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..
|
Control
n=27 Nursing homes
Nursing Homes allocated to the Control arm will not enact the intervention.
|
|---|---|---|
|
Number of Hospital Days
|
3.1 Days per avg resident and per year
Standard Deviation 1.5
|
2.5 Days per avg resident and per year
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The analysis level is the nursing home; no data on individual residents were collected
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.
Outcome measures
| Measure |
Intervention
n=25 Nursing homes
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..
|
Control
n=26 Nursing homes
Nursing Homes allocated to the Control arm will not enact the intervention.
|
|---|---|---|
|
Mortality Rate
|
31 Percent of residents having died
Standard Deviation 14
|
38 Percent of residents having died
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The analysis level is the nursing home; no data on individual residents were collected.
Number of falls per average resident and per year
Outcome measures
| Measure |
Intervention
n=25 Nursing homes
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..
|
Control
n=27 Nursing homes
Nursing Homes allocated to the Control arm will not enact the intervention.
|
|---|---|---|
|
Number of Falls Per Average Resident and Per Year
|
3.0 Falls per avg resident and per year
Standard Deviation 1.9
|
2.6 Falls per avg resident and per year
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The analysis level is the nursing home; no data on individual residents were collected.
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.
Outcome measures
| Measure |
Intervention
n=25 Nursing homes
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..
|
Control
n=27 Nursing homes
Nursing Homes allocated to the Control arm will not enact the intervention.
|
|---|---|---|
|
Percentage of Residents With at Least One Day of Physical Restraints Use
|
33 Proportion of res with phys restraints
Standard Deviation 27
|
37 Proportion of res with phys restraints
Standard Deviation 23
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 921 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 717 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Anne Niquille
Community Pharmacy, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland
Phone: +41213144845
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place