PolypharmacyOLD-NH-QC-DeMoNCT03688542
Opportunities and Limits to Deprescribing in Nursing Homes:Quality Circle Deprescribing Module
A study testing Quality Circle Deprescribing Module in people with Polypharmacy and Inappropriate Prescribing, run by Anne Niquille at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Polypharmacy, Inappropriate Prescribing
- What is being tested?
- Quality Circle Deprescribing Module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Sep 2017to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre de Pharamacie Communautaire
Lausanne, Canton of Vaud, 1011
About this study
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.
- Conditions
- Polypharmacy, Inappropriate Prescribing
- Being tested
- Quality Circle Deprescribing Module
- Keywords
- Deprescribing, Inappropriate Medication, Nursing Homes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Circle Deprescribing ModuleOther
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..
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Quality Circle Deprescribing Module |
| Control | No intervention | Nursing Homes allocated to the Control arm will not enact the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
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.
Measured: 12 months
Number of Hospital Days
The number of days spent in the hospital by average resident
Measured: 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.
Measured: 12 months
Number of Falls Per Average Resident and Per Year
Number of falls per average resident and per year
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start25 Sep 2017
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne Niquille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anne Niquille, University of Geneva, Switzerland
- Investigators
- Olivier Bugnon, Prof, Study director, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688542
- Sponsor's protocol ID
- OLD-NH-QC-DeMo-2017
- Acronym
- OLD-NH-QC-DeMo
- Status last verified
- Mar 2021
- First submitted
- 26 Sep 2018
- Last updated
- 21 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37789286Cateau 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.
PubMed 34798826Cateau 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.
PubMed 33933030Cateau 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.
PubMed 32622774
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunities and Limits to Deprescribing in Nursing Homes:Quality Circle Deprescribing Module
- ClinicalTrials.gov ID
- NCT03688542
- Acronym / sponsor ID
- OLD-NH-QC-DeMo / OLD-NH-QC-DeMo-2017
- Conditions
- Polypharmacy, Inappropriate Prescribing
- Keywords
- Deprescribing, Inappropriate Medication, Nursing Homes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Anne NiquilleUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Posted 21 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Quality Circle Deprescribing ModuleNursing 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality Circle Deprescribing ModuleThe 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.. | Other | Intervention |
Primary outcome
Percentage of Potentially Inappropriate Galenic Units
Time frame: 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.
Number of Potentially Inappropriate Defined Daily Doses (DDDs) Per Average Resident and Per Day
Time frame: 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
6 secondary outcomes
Number of Potentially Inappropriate DDD to Avoid
Time frame: 12 months
Number of Potentially Inappropriate DDD to Reevaluate
Time frame: 12 months
Number of Hospital Days
Time frame: 12 months
Mortality Rate
Time frame: 12 months
Number of Falls Per Average Resident and Per Year
Time frame: 12 months
Percentage of Residents With at Least One Day of Physical Restraints Use
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37789286Mena 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.
- Derived from this study: PubMed 34798826Cateau 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.
- Derived from this study: PubMed 33933030Cateau 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.
- Derived from this study: PubMed 32622774Cateau 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.
- Website of funding bodyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Bugnon, Prof study director
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Circle Deprescribing Module in people with Polypharmacy and Inappropriate Prescribing, run by Anne Niquille at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Potentially Inappropriate Galenic Units (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03688542, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.