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Trial to Reduce Inappropriate Oesophagogastroduodenoscopies for Dyspepsia (TRIODe)

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ClinicalTrials.gov Identifier: NCT03205319
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : June 26, 2019
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University Medical Center
Canisius-Wilhelmina Hospital
VieCuri Medical Centre
Information provided by (Responsible Party):
Radboud University

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.


Condition or disease Intervention/treatment Phase
Dyspepsia Indigestion Device: e-learning Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, randomised controlled, open label
Masking: None (Open Label)
Masking Description: Masking will be impossible in this study
Primary Purpose: Other
Official Title: To Scope or Not to Scope: Trial to Reduce Inappropriate Oesophagogastroduodenoscopies for Dyspepsia; a Randomised Controlled Trial
Actual Study Start Date : November 20, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

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



Primary Outcome Measures :
  1. The difference in proportion performed OGDs between groups [ Time Frame: 12 weeks ]
    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


Secondary Outcome Measures :
  1. The influence of the intervention on health-related anxiety [ Time Frame: 12 weeks ]
    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

  2. The influence of the intervention on severity of upper GI symptoms [ Time Frame: 12 weeks ]
    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

  3. The influence of the intervention on dyspepsia-related quality of life [ Time Frame: 12 weeks ]
    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

  4. The ability of the e-learning to improve knowledge [ Time Frame: 15 minutes ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205319


Locations
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Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Brabant, Netherlands, 5223GZ
Ziekenhuis Gelderse Vallei
Ede, Gelderland, Netherlands, 7616RP
Canisius-Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
VieCuri Medical Center
Venlo, Limburg, Netherlands
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University Medical Center
Canisius-Wilhelmina Hospital
VieCuri Medical Centre
Investigators
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Principal Investigator: Prof. Dr. Drenth, MD, PhD Radboud University
Principal Investigator: Prof. Dr. Masclee, MD, PhD Maastricht University Medical Center

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03205319     History of Changes
Other Study ID Numbers: 2016-3079
NL.60056.091.17 ( Other Identifier: ToetsingOnline )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
Oesophagoduodenoscopy
E-learning
Appropriate use of healthcare
Deimplementation
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms