PolypharmacyOLD-NH-IDeINCT03655405
Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents
A study testing Individual Deprescribing Intervention in people with Polypharmacy and Inappropriate Prescribing, run by Anne Niquille at 1 site in Switzerland.
Trial summary
This study will evaluate the effects of a pharmacist-led, deprescribing-focused medication review on the use of inappropriate medications by nursing home residents Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Polypharmacy, Inappropriate Prescribing
- What is being tested?
- Individual Deprescribing Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Oct 2018to 22 Aug 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Take 5 or more prescribed drugs daily;
- Reside in the Nursing Home since at least 4 months.
Who cannot join
- Physician judges that discussing deprescribing with them risks destabilising them.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre de Pharmacie Communautaire
Lausanne, Canton of Vaud, 1011
About this study
Official title: Opportunities and Limits to Deprescribing in Nursing Homes: Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents.
This study will evaluate the effects of a pharmacist-led, deprescribing-focused medication review on the use of inappropriate medications by nursing home residents
Read the detailed description
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.
- Conditions
- Polypharmacy, Inappropriate Prescribing
- Being tested
- Individual Deprescribing Intervention
- Keywords
- Deprescribing, Nursing Home, Potentially Inappropriate Medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Deprescribing InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Individual Deprescribing Intervention |
| Control | No intervention | Participants allocated to the control group will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Inappropriate Medication at Follow-up
Number of inappropriate medications prescribed at follow-up, assessed using the French translation of STOPP v2.
Measured: 4 months
Secondary outcomes (6)
Number of Potentially Inappropriate DDDs Prescribed to Participants at Follow-up
Appropriateness assessed using the French translation of STOPP v2; DDD defined by WHO.
Measured: 4 months
Number of Chronic Drugs Prescribed to Participants
Number of Chronic Drugs Prescribed to Participants
Measured: 4 months
Number of Chronic DDDs Prescribed to Participants
Number of chronic DDDs prescribed to participants
Measured: 4 months
Number of New Drugs Prescribed as a Result of the Intervention
This outcome was not analysed
Measured: 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
- 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.
- 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.
Measured: 4 months
Number of Common Drug-related Complaints at Follow-up
Number of common drug-related complaints at follow-up
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start30 Oct 2018
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
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 (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 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, ISPSO, Universties of Geneva and Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655405
- Sponsor's protocol ID
- OLD-NH-IDeI-2018
- Acronym
- OLD-NH-IDeI
- Status last verified
- Apr 2021
- First submitted
- 30 Aug 2018
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available from the investigators upon reasonable request.
Publications
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.
PubMed 32622774
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunities and Limits to Deprescribing in Nursing Homes: Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents.
- ClinicalTrials.gov ID
- NCT03655405
- Acronym / sponsor ID
- OLD-NH-IDeI / OLD-NH-IDeI-2018
- Conditions
- Polypharmacy, Inappropriate Prescribing
- Keywords
- Deprescribing, Nursing Home, Potentially Inappropriate Medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Anne NiquilleUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Posted 19 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effects of a pharmacist-led, deprescribing-focused medication review on the use of inappropriate medications by nursing home residents
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Deprescribing Intervention | Experimental | Other: Individual Deprescribing InterventionParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Take 5 or more prescribed drugs daily;
- Reside in the Nursing Home since at least 4 months.
Key exclusion criteria (1 listed)
- Physician judges that discussing deprescribing with them risks destabilising them.
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 |
|---|---|---|
| Individual Deprescribing InterventionThe 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. | Other | Individual Deprescribing Intervention |
Primary outcome
Number of Inappropriate Medication at Follow-up
Time frame: 4 months
Number of inappropriate medications prescribed at follow-up, assessed using the French translation of STOPP v2.
6 secondary outcomes
Number of Potentially Inappropriate DDDs Prescribed to Participants at Follow-up
Time frame: 4 months
Number of Chronic Drugs Prescribed to Participants
Time frame: 4 months
Number of Chronic DDDs Prescribed to Participants
Time frame: 4 months
Number of New Drugs Prescribed as a Result of the Intervention
Time frame: 4 months
Health-related Quality of Life
Time frame: 4 months
Number of Common Drug-related Complaints at Follow-up
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Project description on the funding body websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data are available from the investigators upon reasonable request.
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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
ISPSO, Universties of Geneva and Lausanne, 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 Individual Deprescribing Intervention 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 2 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 19 May 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 19 May 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?
Number of Inappropriate Medication at Follow-up (time frame: 4 months). 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 NCT03655405, which also lists 1 linked publication.
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 19 May 2021.