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NCT03840018 Clinical Trial

Effectiveness of a Postal Intervention to Improve the Use of PPI

Drug Overdose Clinical Trial

Official title:
Randomized Trial to Assess the Effectiveness of a Postal Intervention for Reducing the Chronic Use of Highe Doses of Proton Pump Inhibitors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03840018
Other study ID # EVB-IBP-2017-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2017
Est. completion date April 18, 2018

Study information
Verified date February 2019
Source Osakidetza
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 401
Est. completion date April 18, 2018
Est. primary completion date December 10, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Letter by post to patients
Patients received an informative letter by post, in which their doctor invited them to seek an appointment for a medication review

Locations
Country Name City State
Spain Bidasoa Integrated Health Organization Hondarribia Gipuzkoa

Sponsors (1)
Lead Sponsor Collaborator
Osakidetza

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 6 months
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