Drug OverdoseNCT03840018
Effectiveness of a Postal Intervention to Improve the Use of PPI
A study testing Letter by post to patients in people with Drug Overdose, run by Osakidetza at 1 site in Spain.
Trial summary
It was a randomised intervention study, with before-and-after outcome measures and a control group, in patients who had an active long-term prescription for PPIs at high doses for at least 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Overdose
- What is being tested?
- Letter by post to patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteSpain
- Study dates
- 10 May 2017to 18 Apr 2018
- 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
- Patients under the care of our organisation who in May 2017 had an active long-term prescription for PPIs at high doses for at least 6 months.
Who cannot join
- Patients whose GPs declined to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial to Assess the Effectiveness of a Postal Intervention for Reducing the Chronic Use of Highe Doses of Proton Pump Inhibitors
It was a randomised intervention study, with before-and-after outcome measures and a control group, in patients who had an active long-term prescription for PPIs at high doses for at least 6 months.
Read the detailed description
The intervention consisted of sending patients an informative letter by post, in which their doctor invited them to seek an appointment for a medication review. Control group patients did not receive such a letter, and they were treated as usual (their doctors received a list of identifiers of patients on high doses).
The main outcome variable was the number of active prescriptions of each PPI dose (high dose/standard dose/treatment cessation) at 6 months after the intervention.
- Conditions
- Drug Overdose
- Being tested
- Letter by post to patients
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letter by post to patientsOther
Patients received an informative letter by post, in which their doctor invited them to seek an appointment for a medication review
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Sending doctors the lists of patients that meet the inclusion criteria to have their treatment reviewed |
| Letter by post to patients | Other | Patients were sent a letter explaining the risks of using PPIs at long-term high doses and encouraging them to visit their doctor Receives: Other: Letter by post to patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active prescriptions of each proton pump inhibitors dose after the intervention
Number of active prescriptions of each proton pump inhibitors dose (high dose/standard dose/treatment cessation) at 6 months after the intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start10 May 2017
- Primary completion10 Dec 2017
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug OverdoseStudies 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
- Care provider
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osakidetza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Valverde, Osakidetza
- Investigators
- Elena Valverde, Principal investigator, Osakidetza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840018
- Sponsor's protocol ID
- EVB-IBP-2017-01
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 15 Feb 2019
- 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 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Assess the Effectiveness of a Postal Intervention for Reducing the Chronic Use of Highe Doses of Proton Pump Inhibitors
- ClinicalTrials.gov ID
- NCT03840018
- Acronym / sponsor ID
- EVB-IBP-2017-01
- Conditions
- Drug Overdose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- OsakidetzaUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 10 Dec 2017 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 15 Feb 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.
It was a randomised intervention study, with before-and-after outcome measures and a control group, in patients who had an active long-term prescription for PPIs at high doses for at least 6 months.
Detailed description
The intervention consisted of sending patients an informative letter by post, in which their doctor invited them to seek an appointment for a medication review. Control group patients did not receive such a letter, and they were treated as usual (their doctors received a list of identifiers of patients on high doses).
The main outcome variable was the number of active prescriptions of each PPI dose (high dose/standard dose/treatment cessation) at 6 months after the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Sending doctors the lists of patients that meet the inclusion criteria to have their treatment reviewed |
| Letter by post to patients | Other | Other: Letter by post to patientsPatients were sent a letter explaining the risks of using PPIs at long-term high doses and encouraging them to visit their doctor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients under the care of our organisation who in May 2017 had an active long-term prescription for PPIs at high doses for at least 6 months.
Key exclusion criteria (1 listed)
- Patients whose GPs declined to participate
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 |
|---|---|---|
| Letter by post to patientsPatients received an informative letter by post, in which their doctor invited them to seek an appointment for a medication review | Other | Letter by post to patients |
Primary outcome
Active prescriptions of each proton pump inhibitors dose after the intervention
Time frame: 6 months
Number of active prescriptions of each proton pump inhibitors dose (high dose/standard dose/treatment cessation) at 6 months after the 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 15 Feb 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.
Elena Valverde principal investigator
Osakidetza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letter by post to patients in people with Drug Overdose, run by Osakidetza at 1 site in Spain.
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 1 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 15 Feb 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 Spain. 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?
Active prescriptions of each proton pump inhibitors dose after the intervention (time frame: 6 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 15 Feb 2019.