PolypharmacyFeDeS+PNCT04204590
Feasibility Study of a Systematic Approach for Deprescribing of Statins and PPI's.
A study testing Deprescribing algorithm in people with Polypharmacy, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
Deprescribing, the process of safely reducing or discontinuing unnecessary or harmful medication, has the potential to decrease polypharmacy and improve health outcomes. In this study a structured implicit algorithm, focusing on both extrinsic medication factors (eg change in disease) and intrinsic patient factors… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Polypharmacy
- What is being tested?
- Deprescribing algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Apr 2018to 3 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant uses a statin and/or a proton pump inhibitor.
- Participant signs informed consent.
- Participant is a nursing home resident.
Who cannot join
- Participant is there for short term nursing home admission (<3 months)
- Participant is there for hospice admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of a Systematic Approach for Deprescribing of Statins and Proton Pump Inhibitors in Nursing Home Residents
Deprescribing, the process of safely reducing or discontinuing unnecessary or harmful medication, has the potential to decrease polypharmacy and improve health outcomes. In this study a structured implicit algorithm, focusing on both extrinsic medication factors (eg change in disease) and intrinsic patient factors (eg. pill burden) will be used.
- Conditions
- Polypharmacy
- Being tested
- Deprescribing algorithm
- Keywords
- Deprescribing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deprescribing algorithmOther
For this study an implicit, evidence-supported and patient-centred algorithm has been developed. The outcome of the algorithm is an advice to the doctor to deprescribe or not deprescribe the statin and/or PPI.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Other | The aim of this study is to test the feasibility of this algorithm as an intervention to carry out deprescribing a targeted medication group, proton pump inhibitors (PPI's) and statins, among nursing home residents. Receives: Other: Deprescribing algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in pill burden (the number of statins and PPI's)
On T0 (intervention) and on T1 + T2 (3 and 6 months after intervention), we will measure the number of PPI's and statins on the medication list of every participant. These are provided by the pharmacist.
Measured: 3 and 6 months after intervention.
Decrease in pill burden (the dose of statins and PPI's)
On T0 (intervention) and on T1 + T2 (3 and 6 months after intervention), we will measure the dose of PPI's and statins on the medication list of every participant. These are provided by the pharmacist.
Measured: 3 and 6 months after intervention.
Secondary outcomes (2)
All possible negative side effects of deprescribing (e.g. nausea, symptom recurrence)
All possible negative effects of deprescribing as recognised by the doctor involved, e.g. symptom recurrence.
Measured: From intervention to six months after intervention
Feasibility to use this algorithm.
Three and six months after intervention we will ask the participating doctors the next questions (per included participant):
- What did the algorithm advice you?
- Did you follow the advice?
- Why dit you follow/deny the advice?
Measured: 3 and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start2 Apr 2018
- Primary completion3 Jul 2019
- Study completion3 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- A multicentre, unblinded, single group (pre-comparison and post-comparison) feasibility study.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jos Schols, Prof. Dr., Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204590
- Sponsor's protocol ID
- Z2018001
- Acronym
- FeDeS+P
- Status last verified
- Dec 2019
- First submitted
- 1 May 2018
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Systematic Approach for Deprescribing of Statins and Proton Pump Inhibitors in Nursing Home Residents
- ClinicalTrials.gov ID
- NCT04204590
- Acronym / sponsor ID
- FeDeS+P / Z2018001
- Conditions
- Polypharmacy
- Keywords
- Deprescribing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Deprescribing, the process of safely reducing or discontinuing unnecessary or harmful medication, has the potential to decrease polypharmacy and improve health outcomes. In this study a structured implicit algorithm, focusing on both extrinsic medication factors (eg change in disease) and intrinsic patient factors (eg. pill burden) will be used.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A multicentre, unblinded, single group (pre-comparison and post-comparison) feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Participants | Other | Other: Deprescribing algorithmThe aim of this study is to test the feasibility of this algorithm as an intervention to carry out deprescribing a targeted medication group, proton pump inhibitors (PPI's) and statins, among nursing home residents. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participant uses a statin and/or a proton pump inhibitor.
- Participant signs informed consent.
- Participant is a nursing home resident.
Key exclusion criteria (2 listed)
- Participant is there for short term nursing home admission (<3 months)
- Participant is there for hospice admission.
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 |
|---|---|---|
| Deprescribing algorithmFor this study an implicit, evidence-supported and patient-centred algorithm has been developed. The outcome of the algorithm is an advice to the doctor to deprescribe or not deprescribe the statin and/or PPI. | Other | Participants |
Primary outcome
Decrease in pill burden (the number of statins and PPI's)
Time frame: 3 and 6 months after intervention.
On T0 (intervention) and on T1 + T2 (3 and 6 months after intervention), we will measure the number of PPI's and statins on the medication list of every participant. These are provided by the pharmacist.
Decrease in pill burden (the dose of statins and PPI's)
Time frame: 3 and 6 months after intervention.
On T0 (intervention) and on T1 + T2 (3 and 6 months after intervention), we will measure the dose of PPI's and statins on the medication list of every participant. These are provided by the pharmacist.
2 secondary outcomes
All possible negative side effects of deprescribing (e.g. nausea, symptom recurrence)
Time frame: From intervention to six months after intervention
Feasibility to use this algorithm.
Time frame: 3 and 6 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- 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.
Jos Schols, Prof. Dr. principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deprescribing algorithm in people with Polypharmacy, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
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 2 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 Dec 2019. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decrease in pill burden (the number of statins and PPI's) (time frame: 3 and 6 months after intervention.). 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?
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 Dec 2019.