OLD-NH-QC-DeMo: Opportunities and Limits to Deprescribing in Nursing Homes:Quality Circle Deprescribing Module

• Sponsor: Anne Niquille (Other)
• Overall Status: Completed
• CT.gov ID: NCT03688542
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 33.2
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Polypharmacy; Inappropriate Prescribing	Other: Quality Circle Deprescribing Module	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Opportunities and Limits to Deprescribing in Nursing Homes:Quality Circle Deprescribing Module
• Actual Study Start Date: Sep 25, 2017
• Actual Primary Completion Date: Jul 1, 2020
• Actual Study Completion Date: Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Nursing Homes allocated to the Intervention arm will enact the Quality Circle Deprescribing Module and create a local deprescribing consensus and implementation strategy.	Other: 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..
No Intervention: Control Nursing Homes allocated to the Control arm will not enact the intervention.

Outcome Measures

Primary Outcome Measures

1. Percentage of Potentially Inappropriate Galenic Units [12 months]

   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.

2. Number of Potentially Inappropriate Defined Daily Doses (DDDs) Per Average Resident and Per Day [12 months]

   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

Secondary Outcome Measures

1. Number of Potentially Inappropriate DDD to Avoid [12 months]

   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.

2. Number of Potentially Inappropriate DDD to Reevaluate [12 months]

   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.

3. Number of Hospital Days [12 months]

   The number of days spent in the hospital by average resident

4. Mortality Rate [12 months]

   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.

5. Number of Falls Per Average Resident and Per Year [12 months]

   Number of falls per average resident and per year

6. Percentage of Residents With at Least One Day of Physical Restraints Use [12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Nursing homes taking part in the study must have

• a geriatric of psycho-geriatric mission;

• been part of their cantonal pharmaceutical assistance program for at least a year.

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de Pharamacie Communautaire	Lausanne	Vaud	Switzerland	1011

Sponsors and Collaborators

• Anne Niquille

Investigators

• Study Director: Olivier Bugnon, Prof, University of Geneva

Study Documents (Full-Text)

• Study Protocol - Feb 5, 2020
• Statistical Analysis Plan - Aug 7, 2018

More Information

Additional Information:

• Website of funding body

Publications

None provided.

• Responsible Party: Anne Niquille, Dr, University of Geneva, Switzerland
• ClinicalTrials.gov Identifier: NCT03688542
• Other Study ID Numbers: OLD-NH-QC-DeMo-2017
• First Posted: Sep 28, 2018
• Last Update Posted: Apr 21, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Anne Niquille, Dr, University of Geneva, Switzerland: Deprescribing; Inappropriate Medication; Nursing Homes

Study Results

Participant Flow

Arm/Group Title	Intervention	Control
Arm/Group Description	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..	Nursing Homes allocated to the Control arm will not enact the intervention.
Period Title: Overall Study
STARTED	NA	NA
COMPLETED	NA	NA
NOT COMPLETED	NA	NA

Baseline Characteristics

Arm/Group Title	Intervention	Control	Total
Arm/Group Description	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..	Nursing Homes allocated to the Control arm will not enact the intervention.	Total of all reporting groups
Overall Participants	NA	NA	NA
Overall Nursing home	27	29	56
Age, Customized (Nursing home) [Count of Units]
n/a	NA	NA	NA
Sex/Gender, Customized (Nursing home) [Count of Units]
n/a	NA	NA	NA
Race/Ethnicity, Customized (Nursing home) [Count of Units]
n/a	NA	NA	NA
Region of Enrollment (participants) [Number]
Switzerland	27 NaN	29 NaN	56 NaN
NH mission (Nursing home) [Count of Units]
Geriatric	16	20	36
Psycho-geriatric	11	9	20
Number of average residents (Number of average residents) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Number of average residents]	48	35	43
Percentage of potentially inappropriate galenic units (percent) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [percent]	26	22	24
Overall number of potentially inappropriate DDD (DDD per average resident and per day) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [DDD per average resident and per day]	2.4	2.4	2.4
Number of potentially inappropriate DDD to avoid (DDD per average resident and per day) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [DDD per average resident and per day]	0.3	0.4	0.4
Number of potentially inappropriate DDD to reevaluate (DDD per average resident and per day) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [DDD per average resident and per day]	1.9	2.1	2.0
Mortality rate (percent) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [percent]	32	34	34
Days in hospital (Days) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Days]	2.7	2.5	2.5
Number of falls (Falls per avg. resident and per year) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Falls per avg. resident and per year]	2.3	2.3	2.3
Rate of physical restraints use (Percent) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Percent]	23	27	24

Outcome Measures

1. Primary Outcome

Title	Percentage of Potentially Inappropriate Galenic Units
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The analysis level is the nursing home; no data on individual residents were collected

Arm/Group Title	Intervention	Control
Arm/Group Description	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..	Nursing Homes allocated to the Control arm will not enact the intervention.
Measure Participants	NA	NA
Measure Nursing homes	27	28
Mean (Standard Deviation) [percent]	24 (7)	23 (9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Regression, Linear
	Comments	Dependant variable = follow-up value; adjusted for baseline value, canton, avg number of residents, mission
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-1.4
	Confidence Interval	(2-Sided) 95%; -3.8 to 1.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Number of Potentially Inappropriate Defined Daily Doses (DDDs) Per Average Resident and Per Day
Description	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
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The analysis level is the nursing home; no data on individual residents were collected

Arm/Group Title	Intervention	Control
Arm/Group Description	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..	Nursing Homes allocated to the Control arm will not enact the intervention.
Measure Participants	NA	NA
Measure Nursing homes	27	28
Mean (Standard Deviation) [PIM DDD per avg resident per day]	2.1 (0.5)	2.3 (0.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Regression, Linear
	Comments	Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -0.39 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Number of Potentially Inappropriate DDD to Avoid
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The analysis level is the nursing home; no data on individual residents were collected

Arm/Group Title	Intervention	Control
Arm/Group Description	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..	Nursing Homes allocated to the Control arm will not enact the intervention.
Measure Participants	NA	NA
Measure Nursing homes	27	28
Mean (Standard Deviation) [Number of PIM DDD per avg resident]	0.3 (0.2)	0.3 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Regression, Linear
	Comments	Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.035
	Confidence Interval	(2-Sided) 95%; -0.095 to 0.025
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Number of Potentially Inappropriate DDD to Reevaluate
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The analysis level is the nursing home; no data on individual residents were collected

Arm/Group Title	Intervention	Control
Arm/Group Description	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..	Nursing Homes allocated to the Control arm will not enact the intervention.
Measure Participants	NA	NA
Measure Nursing homes	27	28
Mean (Standard Deviation) [Number of PIM DDD per avg resident]	1.8 (0.5)	2.0 (0.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Regression, Linear
	Comments	Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.237
	Confidence Interval	(2-Sided) 95%; -0.435 to -0.040
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Number of Hospital Days
Description	The number of days spent in the hospital by average resident
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The analysis level is the nursing home; no data on individual residents were collected

Arm/Group Title	Intervention	Control
Arm/Group Description	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..	Nursing Homes allocated to the Control arm will not enact the intervention.
Measure Participants	NA	NA
Measure Nursing homes	24	27
Mean (Standard Deviation) [Days per avg resident and per year]	3.1 (1.5)	2.5 (1.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Regression, Linear
	Comments	Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents, interaction between mission and group.
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.55
	Confidence Interval	(2-Sided) 95%; 0.164 to 2.938
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Mortality Rate
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The analysis level is the nursing home; no data on individual residents were collected

Arm/Group Title	Intervention	Control
Arm/Group Description	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..	Nursing Homes allocated to the Control arm will not enact the intervention.
Measure Participants	NA	NA
Measure Nursing homes	25	26
Mean (Standard Deviation) [Percent of residents having died]	31 (14)	38 (8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Regression, Linear
	Comments	Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents, interaction between mission and group.
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-12.7
	Confidence Interval	(2-Sided) 95%; -21.5 to -4.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Number of Falls Per Average Resident and Per Year
Description	Number of falls per average resident and per year
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The analysis level is the nursing home; no data on individual residents were collected.

Arm/Group Title	Intervention	Control
Arm/Group Description	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..	Nursing Homes allocated to the Control arm will not enact the intervention.
Measure Participants	NA	NA
Measure Nursing homes	25	27
Mean (Standard Deviation) [Falls per avg resident and per year]	3.0 (1.9)	2.6 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Regression, Linear
	Comments	Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.165
	Confidence Interval	(2-Sided) 95%; -0.754 to 0.424
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Percentage of Residents With at Least One Day of Physical Restraints Use
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The analysis level is the nursing home; no data on individual residents were collected.

Arm/Group Title	Intervention	Control
Arm/Group Description	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..	Nursing Homes allocated to the Control arm will not enact the intervention.
Measure Participants	NA	NA
Measure Nursing homes	25	27
Mean (Standard Deviation) [Proportion of res with phys restraints]	33 (27)	37 (23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Regression, Linear
	Comments	Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-4.2
	Confidence Interval	(2-Sided) 95%; -16.0 to 7.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	Individual adverse events were not collected for this study; safety outcomes are included in the Outcomes section
Arm/Group Title	Intervention		Control
Arm/Group Description	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..		Nursing Homes allocated to the Control arm will not enact the intervention.
All Cause Mortality
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	921/2899 (31.8%)		717/2113 (33.9%)
Serious Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.