Trial to Reduce Inappropriate Oesophagogastroduodenoscopies for Dyspepsia

NCT ID: NCT03205319

Last Updated: 2019-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-20
• Study Completion Date: 2019-03-01

Brief Summary

Indigestion or dyspepsia is highly prevalent worldwide. Often these symptoms are of benign nature and subside without treatment, or with lifestyle interventions like dietary modifications. Too often, gastroscopy is performed because of dyspepsia. Although this is indicated when malignancy is suspected, in a substantial part of the cases the gastroscopy is not indicated and will not achieve clinically relevant results. It is suspected that gastroscopy is often used for reassurance of patients or as a 'last resort'.

Our hypothesis is that adequate education of patients can replace this need for invasive measures. The aim of this study was therefore to reduce the volume of gastroscopies for dyspepsia, by offering patients an e-learning containing educational material on dyspepsia.

During the trial, 119 dyspeptic patients, referred for gastroscopy by the GP, will randomly be divided into two groups: One group will receive the e-learning instead of gastroscopy (intervention), the other group will receive the gastroscopy (control).

After a twelve week follow-up, change in symptom severity, disease specific quality of life and fear of disease will be compared between the two groups.

Detailed Description

Rationale: Upper gastrointestinal (GI) symptoms, such as dyspepsia without alarm symptoms, are highly prevalent in the general population. Lifestyle modifications and medication can reduce symptoms in most patients. Guidelines state that oesophagogastroduodenoscopy (OGD) is only indicated in a selected high risk group. In spite of these guidelines, OGD referrals for dyspepsia without alarm symptoms are still substantial, subjecting patients to unnecessary risks and causing a burden on healthcare costs and endoscopic capacity. Therefore a strategy is needed to reduce the volume of OGDs in dyspepsia without alarm symptoms.

Objective: To evaluate the clinical use of a patient-centred, education based, clinical strategy to reduce the volume of endoscopies for dyspepsia in patients over 18 years of age without alarm symptoms, referred for OGD through open-access endoscopy compared to usual care.

Study design: A multicentre, randomised, controlled superiority trial, with two parallel arms and a primary endpoint of the percentage of patients receiving OGD. Intervention and usual care will be compared.

Study population: 119 Patients, aged 18 years or above, with upper GI symptoms without alarm symptoms, referred for open-access OGD.

Intervention: Patients will be offered e-learning instead of endoscopy. The e-learning will contain educational material and questionnaires. Questionnaire data will be extracted from the e-learning.

Main study endpoints: The main study endpoint is the difference in proportion of patients receiving OGD between both arms and Patient Reported Outcomes (PROMS), after a follow-up of 12 weeks.

Conditions

Dyspepsia; Indigestion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention arm / e-learning

Patients will receive e-learning instead of upper GI endoscopy.

Group Type: EXPERIMENTAL

e-learning

Intervention Type: DEVICE

The e-learning for patients is a user friendly, audiovisual based, online-accessible program, designed especially for this study. The e-learning will contain information on dyspepsia and advice on lifestyle interventions

Control arm / upper GI endoscopy

Patients will receive the upper GI endoscopy, i.e. standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

e-learning

The e-learning for patients is a user friendly, audiovisual based, online-accessible program, designed especially for this study. The e-learning will contain information on dyspepsia and advice on lifestyle interventions

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Reported upper gastrointestinal symptoms in the past 6 months
• Referred for OGD
• Guidelines for referral not met
• Signed informed consent

Exclusion Criteria

Patients who fulfil the criteria for OGD according to the Dutch college of General Practitioners (NHG) guidelines and NICE guidelines on 'Upper gastrointestinal tract cancers'.

In addition, patients with:

• A family history of gastric- or oesophageal cancer (at least one first or second grade family member with a malignancy at the age of 50 or younger)
• Diseases or circumstances that will most likely impair understanding of the e-learning
• Any argument provided by a patient's own GP stating the urge of OGD, notwithstanding the guidelines

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: collaborator

Canisius-Wilhelmina Hospital

OTHER

Sponsor Role: collaborator

VieCuri Medical Centre

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Dr. Drenth, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Prof. Dr. Masclee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Ziekenhuis Gelderse Vallei

Ede, Gelderland, Netherlands

Canisius-Wilhelmina Hospital

Nijmegen, Gelderland, Netherlands

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

VieCuri Medical Center

Venlo, Limburg, Netherlands

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, Netherlands

Countries

Netherlands

References

de Jong JJ, Lantinga MA, Tan ACITL, Aquarius M, Scheffer RCH, Uil JJ, de Reuver PR, Keszthelyi D, Westert GP, Masclee AAM, Drenth JPH. Web-Based Educational Intervention for Patients With Uninvestigated Dyspepsia Referred for Upper Gastrointestinal Tract Endoscopy: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jun 1;181(6):825-833. doi: 10.1001/jamainternmed.2021.1408.

Reference Type: DERIVED

PMID: 33900373 (View on PubMed)

Other Identifiers

NL.60056.091.17

Identifier Type: OTHER

Identifier Source: secondary_id

2016-3079

Identifier Type: -

Identifier Source: org_study_id