Proton Pump InhibitorsDeprescrIPPNCT04255823
Efficacy of a Multi-faceted Intervention to Deprescribe Proton Pump Inhibitors (PPI) in Primary Care: a Population-based, Pragmatic, Cluster-randomized Controlled Trial.
A study testing General practitioner and Patient receive informations related to PPI deprescribing. and Only General practitioner receive informations related to PPI deprescribing. in people with Proton Pump Inhibitors and Deprescription, run by Nantes University Hospital at 1 site in France.
Trial summary
Deprescribing is defined as "the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing the polypharmacy and improving outcomes". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proton Pump Inhibitors, Deprescription
- What is being tested?
- General practitioner and Patient receive informations related to PPI deprescribing. and Only General practitioner receive informations related to PPI deprescribing.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34,000 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2020to 15 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General practitioners (GPs):
- All GPs settled in the 2 departments of Loire-Atlantique and Vendée with more than 100 patients in the year before baseline, will be eligible.
- Patients:
- aged over 18 years
- affiliated to the French health insurance system (CPAM)
- treated with PPI with more than 300 DDD/year in the year before baseline, estimated with reimbursement databases.
- whose GP is included in the study
Who cannot join
- General practitioners (GPs):
- Participation refusal
- Patients :
- Participation refusal
- Patients at risk of gastroduodenal lesions i.e. treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and over 65 years old or treated with either corticosteroids or anticoagulants or platelet aggregation inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Deprescribing is defined as "the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing the polypharmacy and improving outcomes". Inappropriate use of proton pump inhibitors (PPI) is associated with severe adverse drug reactions and a major economic impact. Deprescribing should be considered when inappropriate prescription of PPI is identified.
DeprescrIPP is a pragmatic population-based cluster-randomized trial conducted in primary care. It will assess the efficacy and effectiveness of a multi-faceted intervention (on patients and general practitioners) to deprescribe PPI.
- Conditions
- Proton Pump Inhibitors, Deprescription
- Being tested
- General practitioner and Patient receive informations related to PPI deprescribing., Only General practitioner receive informations related to PPI deprescribing.
- Keywords
- Proton pump inhibitors, Deprescription, Multi-faceted intervention, Patient-centered, Primary health care, Pharmacoepidemiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General practitioner and Patient receive informations related to PPI deprescribing.Other
General practitioner will receive a sensibilization and an algorithm related to PPI deprescribing.
Their patients will receive any informations (patient information material on PPI deprescribing)
Only General practitioner receive informations related to PPI deprescribing.Other
General practitioner will receive the sensibilization and an algorithm related to PPI deprescribing.
Their patients will not receive any informations.
| Study group | Role | What they receive |
|---|---|---|
| Multi-faceted intervention | Experimental | A patient education material on PPI deprescribing will be send to patients with long-term treatment with PPI (>300DDD/patient/year).
Their general practitioner (GP) will receive a "dear doctor" letter with an algorithm related to PPI deprescribing. Receives: Other: General practitioner and Patient receive informations related to PPI deprescribing. |
| "Dear doctor" letter of the GP | Experimental | Only the GP will receive the "dear doctor" letter with the algorithm.
Their patients will not receive any patient education material. Receives: Other: Only General practitioner receive informations related to PPI deprescribing. |
| Control | No intervention | Neither the patients nor their GP will receive information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPI deprescribing
Proportion of patients achieving a 50% decrease in their reimbursement of PPI (Defined Daily Dose (DDD)/year) at the end of the intervention compared to baseline.
Measured: 12 months
Secondary outcomes (3)
Cost-utility analysis
Incremental cost-utility ratio (cost by quality-adjusted life-years, QALY) of control group compared to the intervention.
Measured: 12 months
GERD symptoms recurrence
A short-form REFLUX-QUAL questionnaire will be assessed to a 10% patient sample in each arm (baseline and 12 months)
Measured: 12 months
Attitudes of patients towards deprescribing
Revised patients' attitudes toward deprescribing questionnaire will be assigned to a 10% patient sample in each arm (baseline and 12 months)
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 posted5 Feb 2020
- Study start29 Sep 2020
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Proton Pump InhibitorsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255823
- Sponsor's protocol ID
- RC19_0460
- Acronym
- DeprescrIPP
- Status last verified
- Apr 2024
- First submitted
- 3 Feb 2020
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fournier JP, Gaultier A, Riche VP, Tessier P, Rat C, Nguyen-Soenen J. Deprescribing Intervention and Reduction of Proton Pump Inhibitor Use in Primary Care: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2026 Jun 1;186(6):668-676. doi: 10.1001/jamainternmed.2026.0584.
PubMed 41973459Nguyen-Soenen J, Rat C, Gaultier A, Schirr-Bonnans S, Tessier P, Fournier JP. Effectiveness of a multi-faceted intervention to deprescribe proton pump inhibitors in primary care: protocol for a population-based, pragmatic, cluster-randomized controlled trial. BMC Health Serv Res. 2022 Feb 17;22(1):219. doi: 10.1186/s12913-022-07496-3.
PubMed 35177042
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Multi-faceted Intervention to Deprescribe Proton Pump Inhibitors (PPI) in Primary Care: a Population-based, Pragmatic, Cluster-randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04255823
- Acronym / sponsor ID
- DeprescrIPP / RC19_0460
- Conditions
- Proton Pump Inhibitors, Deprescription
- Keywords
- Proton pump inhibitors, Deprescription, Multi-faceted intervention, Patient-centered, Primary health care, Pharmacoepidemiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34,000 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 5 Feb 2020 (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 is defined as "the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing the polypharmacy and improving outcomes". Inappropriate use of proton pump inhibitors (PPI) is associated with severe adverse drug reactions and a major economic impact. Deprescribing should be considered when inappropriate prescription of PPI is identified.
DeprescrIPP is a pragmatic population-based cluster-randomized trial conducted in primary care. It will assess the efficacy and effectiveness of a multi-faceted intervention (on patients and general practitioners) to deprescribe PPI.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multi-faceted intervention | Experimental | Other: General practitioner and Patient receive informations related to PPI deprescribing.A patient education material on PPI deprescribing will be send to patients with long-term treatment with PPI (>300DDD/patient/year). Their general practitioner (GP) will receive a "dear doctor" letter with an algorithm related to PPI deprescribing. |
| "Dear doctor" letter of the GP | Experimental | Other: Only General practitioner receive informations related to PPI deprescribing.Only the GP will receive the "dear doctor" letter with the algorithm. Their patients will not receive any patient education material. |
| Control | No intervention | –Neither the patients nor their GP will receive information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- General practitioners (GPs):
- Patients:
Key exclusion criteria (5 listed)
- General practitioners (GPs):
- Patients :
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 |
|---|---|---|
| General practitioner and Patient receive informations related to PPI deprescribing.General practitioner will receive a sensibilization and an algorithm related to PPI deprescribing. Their patients will receive any informations (patient information material on PPI deprescribing) | Other | Multi-faceted intervention |
| Only General practitioner receive informations related to PPI deprescribing.General practitioner will receive the sensibilization and an algorithm related to PPI deprescribing. Their patients will not receive any informations. | Other | "Dear doctor" letter of the GP |
Primary outcome
PPI deprescribing
Time frame: 12 months
Proportion of patients achieving a 50% decrease in their reimbursement of PPI (Defined Daily Dose (DDD)/year) at the end of the intervention compared to baseline.
3 secondary outcomes
Cost-utility analysis
Time frame: 12 months
GERD symptoms recurrence
Time frame: 12 months
Attitudes of patients towards deprescribing
Time frame: 12 months
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 22 Apr 2024.
- Derived from this study: PubMed 41973459Fournier JP, Gaultier A, Riche VP, Tessier P, Rat C, Nguyen-Soenen J. Deprescribing Intervention and Reduction of Proton Pump Inhibitor Use in Primary Care: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2026 Jun 1;186(6):668-676. doi: 10.1001/jamainternmed.2026.0584.
- Derived from this study: PubMed 35177042Nguyen-Soenen J, Rat C, Gaultier A, Schirr-Bonnans S, Tessier P, Fournier JP. Effectiveness of a multi-faceted intervention to deprescribe proton pump inhibitors in primary care: protocol for a population-based, pragmatic, cluster-randomized controlled trial. BMC Health Serv Res. 2022 Feb 17;22(1):219. doi: 10.1186/s12913-022-07496-3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General practitioner and Patient receive informations related to PPI deprescribing. and Only General practitioner receive informations related to PPI deprescribing. in people with Proton Pump Inhibitors and Deprescription, run by Nantes University Hospital at 1 site in France.
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 7 inclusion and 5 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 22 Apr 2024. 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 France. 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?
PPI deprescribing (time frame: 12 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 NCT04255823, which also lists 2 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 22 Apr 2024.