Clinical trial NCT03205319: Trial to Reduce Inappropriate Oesophagogastroduodenoscopies for Dyspepsia
Official title: To Scope or Not to Scope: Trial to Reduce Inappropriate Oesophagogastroduodenoscopies for Dyspepsia; a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspepsia
Indigestion
Keywords: Oesophagoduodenoscopy
E-learning
Appropriate use of healthcare
Deimplementation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Maastricht University Medical Center
name: Canisius-Wilhelmina Hospital
name: VieCuri Medical Centre
First posted: 2017-07-02
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomised controlled, open label
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: The difference in proportion performed OGDs between groups
timeFrame: 12 weeks
Secondary outcomes:
measure: The influence of the intervention on health-related anxiety
timeFrame: 12 weeks
measure: The influence of the intervention on severity of upper GI symptoms
timeFrame: 12 weeks
measure: The influence of the intervention on dyspepsia-related quality of life
timeFrame: 12 weeks
measure: The ability of the e-learning to improve knowledge
timeFrame: 15 minutes
Other outcomes:
Locations:
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
state: Brabant
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Hospital
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
city: Venlo
country: Netherlands
facility: VieCuri Medical Center
state: Limburg
Study officials:
affiliation: Radboud University Medical Center
name: Prof. Dr. Drenth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Prof. Dr. Masclee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.