NCT03840018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

February 11, 2019

Last Update Submit

February 13, 2019

Conditions

Drug Overdose

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Other: Letter by post to patients

Interventions

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

Letter by post to patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients whose GPs declined to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bidasoa Integrated Health Organization

Hondarribia, Gipuzkoa, 20270, Spain

Location

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Elena Valverde

    Osakidetza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary care pharmacist

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 15, 2019

Study Start

May 10, 2017

Primary Completion

December 10, 2017

Study Completion

April 18, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)