Trial to Reduce Inappropriate Oesophagogastroduodenoscopies for Dyspepsia (TRIODe)

To Scope or Not to Scope: Trial to Reduce Inappropriate Oesophagogastroduodenoscopies for Dyspepsia; a Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Dyspepsia; Indigestion
• Intervention / Treatment: Device: e-learning

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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Brabant
    • 's-Hertogenbosch, Brabant, Netherlands, 5223GZ
      • Jeroen Bosch ziekenhuis
  • Gelderland
    • Ede, Gelderland, Netherlands, 7616RP
      • Ziekenhuis Gelderse Vallei
    • Nijmegen, Gelderland, Netherlands
      • Canisius-Wilhelmina Hospital
  • Limburg
    • Maastricht, Limburg, Netherlands
      • Maastricht University Medical Center
    • Venlo, Limburg, Netherlands
      • VieCuri Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention arm / e-learning; Patients will receive e-learning instead of upper GI endoscopy.	Device: 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
NO_INTERVENTION: Control arm / upper GI endoscopy; Patients will receive the upper GI endoscopy, i.e. standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The influence of the intervention on health-related anxiety	The difference between the change scores of the two study arms concerning health-related anxiety, measured by the total score on the validated Short Health Anxiety Inventory	12 weeks
The influence of the intervention on severity of upper GI symptoms	The difference between the change scores of the two study arms concerning severity of upper GI symptoms, measured by the mean on the subscale scores of the validated PAGI-SYM questionnaire	12 weeks
The influence of the intervention on dyspepsia-related quality of life	The difference between the change scores of the two study arms concerning dyspepsia-related quality of life, measured by the sum of the subscale scores of the validated Nepean Dyspepsia Index	12 weeks
The ability of the e-learning to improve knowledge	Using a knowledge test integrated in the e-learning and administered before and after the e-learning, the difference in correctly answered questions will be measured	15 minutes

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Maastricht University Medical Center; ZonMw: The Netherlands Organisation for Health Research and Development; VieCuri Medical Centre; Canisius-Wilhelmina Hospital
• Investigators: Principal Investigator: Prof. Dr. Drenth, MD, PhD, Radboud University Medical Center; Principal Investigator: Prof. Dr. Masclee, MD, PhD, Maastricht University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2017
• Primary Completion (ACTUAL): March 1, 2019
• Study Completion (ACTUAL): March 1, 2019

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (ACTUAL): July 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: E-learning; Deimplementation; Oesophagoduodenoscopy; Appropriate use of healthcare
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: 2016-3079; NL.60056.091.17 (OTHER: ToetsingOnline)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No