NCT06108817

Brief Summary

Dyspepsia is a commonly encountered clinical condition in Dutch general practice, which is often treated through the prescription of acid-reducing medication (ARM). However, recent studies indicate that the majority of chronic ARM users lack an indication for their use and that their long-term use is associated with adverse outcomes. A patient-focussed educational intervention was developed aiming to reduce low-value (chronic) use of ARM. This study is a randomized controlled study, evaluating its effect on the low-value chronic prescription of ARM using data from a subset of practices from the Nivel Primary Care Database. The intervention involves distributing an educational waiting room posters and flyers informing both patients and general practitioners (GPs) regarding the appropriate indications for prescription of an ARM for dyspepsia, which also referred to an online decision aid. The interventions' effect is evaluated through calculation of the odds ratio of a patient receiving a low-value chronic ARM prescription over the second half of 2021 and 2022 (i.e. pre-intervention vs. post-intervention).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

October 19, 2023

Last Update Submit

October 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • patients receiving a low-value chronic ARM prescription

    the incidence rate of (inappropriate) chronic ARM prescriptions in the same 6 months before and after the intervention

    4 months

Study Arms (2)

Information material

EXPERIMENTAL

The intervention involved distributing an educational waiting room poster and flyers informing patients regarding the appropriate indications for prescription of an ARM for dyspepsia, which also referred to an online decision aid.

Other: Information material

No information material

ACTIVE COMPARATOR

No intervention

Other: No Intervention

Interventions

The intervention consists of the distribution of a poster for the waiting room and flyers to be given to patients aiming to inform both patients and GPs with respect to the correct indications for treatment of dyspepsia. After signing up, practices assigned to the intervention group received a package containing 60 flyers and one waiting room poster to use during consultations. The flyer and poster provide a short description of the correct indications for treatment of dyspepsia. Additionally, both the flyers and posters contained a QR-code linking to a decision aid explaining the correct indications and causes of dyspepsia.

Information material

These practices do not receive information material

No information material

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • the pool of practices that provide their registration data to the Nivel

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre, IQ healthcare

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

  • Muskens JLJM, van Dulmen SA, Hek K, Westert GP, Kool RB. Low-value chronic prescription of acid reducing medication among Dutch general practitioners: impact of a patient education intervention. BMC Prim Care. 2024 Apr 4;25(1):106. doi: 10.1186/s12875-024-02351-2.

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: randomized controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 31, 2023

Study Start

July 1, 2022

Primary Completion

October 31, 2022

Study Completion

October 1, 2023

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations