Effectiveness of a Postal Intervention to Improve the Use of PPI

NCT ID: NCT03840018

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-10

Study Completion Date

2018-04-18

Brief Summary

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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

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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

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Drug Overdose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Control

Sending doctors the lists of patients that meet the inclusion criteria to have their treatment reviewed

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type OTHER

Letter by post to patients

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Osakidetza

OTHER

Sponsor Role lead

Responsible Party

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Elena Valverde

Primary care pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elena Valverde

Role: PRINCIPAL_INVESTIGATOR

Osakidetza

Locations

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Bidasoa Integrated Health Organization

Hondarribia, Gipuzkoa, Spain

Site Status

Countries

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Spain

Other Identifiers

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EVB-IBP-2017-01

Identifier Type: -

Identifier Source: org_study_id

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