Trial to Reduce Inappropriate Oesophagogastroduodenoscopies for Dyspepsia

NCT03205319 | Completed

• 2 other identifiers: 2016-3079NL.60056.091.17
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 5

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.

Conditions

Dyspepsia; Indigestion

Keywords

Oesophagoduodenoscopy; E-learning; Appropriate use of healthcare; Deimplementation

Outcome Measures

Primary Outcomes (1)

• The difference in proportion performed OGDs between groups

  The difference between the two study arms in proportion of patients that have received OGD, measured 12 weeks after the initial visit to the endoscopy clinic, out of the total number of patients referred for open-access endoscopy

  12 weeks

Secondary Outcomes (4)

• The influence of the intervention on health-related anxiety

  12 weeks

• The influence of the intervention on severity of upper GI symptoms

  12 weeks

• The influence of the intervention on dyspepsia-related quality of life

  12 weeks

• The ability of the e-learning to improve knowledge

  15 minutes

Study Arms (2)

Intervention arm / e-learning

EXPERIMENTAL

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

Device: e-learning

Control arm / upper GI endoscopy

NO INTERVENTION

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

Interventions

e-learning 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

Intervention arm / e-learning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Maastricht University Medical Center: collaborator
• Canisius-Wilhelmina Hospital: collaborator
• VieCuri Medical Centre: collaborator

Study Sites (5)

Ziekenhuis Gelderse Vallei

Ede, Gelderland, 7616RP, Netherlands

Location

Canisius-Wilhelmina Hospital

Nijmegen, Gelderland, Netherlands

Location

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Location

VieCuri Medical Center

Venlo, Limburg, Netherlands

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, 5223GZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 33900373 DERIVED

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Dr. Drenth, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Prof. Dr. Masclee, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking will be impossible in this study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, randomised controlled, open label

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 2, 2017
• Study Start: November 20, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: June 26, 2019

Record last verified: 2018-10

Locations

NL (5)