Back to resultsEffectiveness of a Postal Intervention to Improve the Use of PPI
Primary Purpose
Drug Overdose
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Letter by post to patients
Sponsored by
About this trial
This is an interventional other trial for Drug Overdose
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients whose GPs declined to participate
Sites / Locations
- Bidasoa Integrated Health Organization
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Control
Letter by post to patients
Arm Description
Sending doctors the lists of patients that meet the inclusion criteria to have their treatment reviewed
Patients were sent a letter explaining the risks of using PPIs at long-term high doses and encouraging them to visit their doctor
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03840018
Brief Title
Effectiveness of a Postal Intervention to Improve the Use of PPI
Official Title
Randomized Trial to Assess the Effectiveness of a Postal Intervention for Reducing the Chronic Use of Highe Doses of Proton Pump Inhibitors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
December 10, 2017 (Actual)
Study Completion Date
April 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Osakidetza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Overdose
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
401 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Sending doctors the lists of patients that meet the inclusion criteria to have their treatment reviewed
Arm Title
Letter by post to patients
Arm Type
Other
Arm Description
Patients were sent a letter explaining the risks of using PPIs at long-term high doses and encouraging them to visit their doctor
Intervention Type
Other
Intervention Name(s)
Letter by post to patients
Intervention Description
Patients received an informative letter by post, in which their doctor invited them to seek an appointment for a medication review
Primary Outcome Measure Information:
Title
Active prescriptions of each proton pump inhibitors dose after the intervention
Description
Number of active prescriptions of each proton pump inhibitors dose (high dose/standard dose/treatment cessation) at 6 months after the intervention
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Patients whose GPs declined to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Valverde
Organizational Affiliation
Osakidetza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bidasoa Integrated Health Organization
City
Hondarribia
State/Province
Gipuzkoa
ZIP/Postal Code
20270
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of a Postal Intervention to Improve the Use of PPI
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