Proton Pump InhibitorsDeprescrIPPDAMNCT04513834
Efficacy of a Multi-faceted Intervention Combining an Educational Outreach Visit to General Practitioners and Patient Education Material to Deprescribe Proton Pump Inhibitors (PPI): a Population-based, Pragmatic, Cluster-randomized Controlled Trial
A study testing GP will receive the educational outreach visit by a DAM (healthcare representative). and Patient education material on PPI deprescribing will be sent to the patients 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?
- GP will receive the educational outreach visit by a DAM (healthcare representative). and Patient education material on PPI deprescribing will be sent to the patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25,000 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2022to 19 Dec 2023
- 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 (GP)
- All GP settled in the French region Pays-de-la-Loire having seen more than 100 different patients in the year before baseline, will be eligible.
- Patients
- Aged more than 18 years old
- Affiliated to the French health insurance CPAM
- Treated with PPI> 300DDD/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
- Patients under legal protection
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 DAM is a pragmatic trial, population-based, designed in clusters. It wil assess the efficacy of a multi-faceted intervention (an educational outreach visit to general practitioners associated with the sending of patient education material to their patients) to deprescribe PPI.
- Conditions
- Proton Pump Inhibitors, Deprescription
- Being tested
- GP will receive the educational outreach visit by a DAM (healthcare representative)., Patient education material on PPI deprescribing will be sent to the patients
- 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.
GP will receive the educational outreach visit by a DAM (healthcare representative).Other
GP will receive the educational outreach visit by a DAM (healthcare representative).
Patient education material on PPI deprescribing will be sent to the patientsOther
Patient education material on PPI deprescribing will be sent to the patients
| Study group | Role | What they receive |
|---|---|---|
| Multi-faceted intervention | Experimental | Patient education material on PPI deprescribing will be sent to the patients and their general practitioner (GP) will receive an educational outreach visit by a Delegue d'Assurance Maladie (DAM, healthcare representative ) Receives: Other: GP will receive the educational outreach visit by a DAM (healthcare representative).; Other: Patient education material on PPI deprescribing will be sent to the patients |
| Educational outreach visit to GPs | Active comparator | GP will receive the educational outreach visit by a DAM (healthcare representative). Their patients will not receive any patient education material. Receives: Other: GP will receive the educational outreach visit by a DAM (healthcare representative). |
| Control | No intervention | Neither the patients nor their GP will receive any 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 (estimated with reimbursement databases)
Measured: 12 months
Secondary outcomes (1)
Characteristics of patients engaging in the deprescription process
Sex, age, long-term illness, universal health insurance, complementary health insurance, medication
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 posted14 Aug 2020
- Study start19 Sep 2022
- Primary completion19 Sep 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 25,000 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
- NCT04513834
- Sponsor's protocol ID
- RC20_0339
- Acronym
- DeprescrIPPDAM
- Status last verified
- Apr 2024
- First submitted
- 12 Aug 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
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 Combining an Educational Outreach Visit to General Practitioners and Patient Education Material to Deprescribe Proton Pump Inhibitors (PPI): a Population-based, Pragmatic, Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04513834
- Acronym / sponsor ID
- DeprescrIPPDAM / RC20_0339
- 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
- 25,000 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 14 Aug 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 DAM is a pragmatic trial, population-based, designed in clusters. It wil assess the efficacy of a multi-faceted intervention (an educational outreach visit to general practitioners associated with the sending of patient education material to their patients) 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: GP will receive the educational outreach visit by a DAM (healthcare representative)., Other: Patient education material on PPI deprescribing will be sent to the patientsPatient education material on PPI deprescribing will be sent to the patients and their general practitioner (GP) will receive an educational outreach visit by a Delegue d'Assurance Maladie (DAM, healthcare representative ) |
| Educational outreach visit to GPs | Active comparator | Other: GP will receive the educational outreach visit by a DAM (healthcare representative).GP will receive the educational outreach visit by a DAM (healthcare representative). Their patients will not receive any patient education material. |
| Control | No intervention | –Neither the patients nor their GP will receive any 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 (GP)
- Patients
Key exclusion criteria (6 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 |
|---|---|---|
| GP will receive the educational outreach visit by a DAM (healthcare representative).GP will receive the educational outreach visit by a DAM (healthcare representative). | Other | Educational outreach visit to GPs, Multi-faceted intervention |
| Patient education material on PPI deprescribing will be sent to the patientsPatient education material on PPI deprescribing will be sent to the patients | Other | Multi-faceted intervention |
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 (estimated with reimbursement databases)
1 secondary outcome
Characteristics of patients engaging in the deprescription process
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.
- 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 GP will receive the educational outreach visit by a DAM (healthcare representative). and Patient education material on PPI deprescribing will be sent to the patients 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 6 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?
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.