Effectiveness of a Postal Intervention to Improve the Use of PPI

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.

Study Overview

• Status: Completed
• Conditions: Drug Overdose
• Intervention / Treatment: Other: Letter by post to patients

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 Type: Interventional
• Enrollment (Actual): 401
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Gipuzkoa
    • Hondarribia, Gipuzkoa, Spain, 20270
      • Bidasoa Integrated Health Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Sending doctors the lists of patients that meet the inclusion criteria to have their treatment reviewed
Other: Letter by post to patients; Patients were sent a letter explaining the risks of using PPIs at long-term high doses and encouraging them to visit their doctor	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Osakidetza
• Investigators: Principal Investigator: Elena Valverde, Osakidetza

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Actual): December 10, 2017
• Study Completion (Actual): April 18, 2018

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Drug Overdose
• Other Study ID Numbers: EVB-IBP-2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No