Web-Based Educational Intervention for Patients With Uninvestigated Dyspepsia Referred for Upper Gastrointestinal Tract Endoscopy: A Randomized Clinical Trial

Abstract

Importance: Diagnostic yield of upper gastrointestinal (GI) tract endoscopy for uninvestigated dyspepsia is low, and its clinical implications are limited. There is an unmet need for better strategies to reduce the volume of upper GI tract endoscopic procedures for dyspepsia.

Objective: To study the effectiveness of a web-based educational intervention as a tool to reduce upper GI tract endoscopy in uninvestigated dyspepsia.

Design, setting, and participants: This open-label, multicenter, randomized clinical trial enrolled participants between November 1, 2017, and March 31, 2019, with follow-up 52 weeks after randomization, at 4 teaching hospitals in the Netherlands. Participants included patients with uninvestigated dyspeptic symptoms who were referred for upper GI tract endoscopy by their general health care clinician without prior consultation of a gastroenterologist. A total of 119 patients, aged 18 to 69 years, were included. Patients were excluded if any of the following red flag symptoms were present: (indirect) signs of upper GI tract hemorrhage (hematemesis, melena, hematochezia, or anemia), unintentional weight loss of 5% or higher of normal body weight during a period of 6 to 12 months, persistent vomiting, dysphagia, or jaundice.

Interventions: Patients were randomly assigned (1:1) to education (intervention) or upper GI tract endoscopy (control). Education consisted of a self-managed web-based educational intervention, containing information on gastric function, dyspepsia, and upper GI tract endoscopy.

Main outcomes and measures: Difference in the proportion of upper GI tract endoscopy procedures between those who received access to the web-based educational intervention and those who did not at 12 weeks and 52 weeks after randomization, analyzed in the intention-to-treat population. Secondary outcomes included quality of life (Nepean Dyspepsia Index) and symptom severity (Patient Assessment of Gastrointestinal Disorders Symptom Severity Index) measured at baseline and 12 weeks.

Results: Of 119 patients included (median age, 48 years [interquartile range, 37-56 years]; 48 men [40%]), 62 were randomized to web-based education (intervention) and 57 to upper GI tract endoscopy (control). Significantly fewer patients compared with controls underwent upper GI tract endoscopy after using the web-based educational intervention: 24 (39%) vs 47 (82%) (relative risk, 0.46; 95% CI, 0.33-0.64; P < .001). Symptom severity and quality of life improved equivalently in both groups. One additional patient in the intervention group required upper GI tract endoscopy during follow-up.

Conclusions and relevance: Findings of this study indicate that web-based patient education is an effective tool to decrease the need for upper GI tract endoscopy in uninvestigated dyspepsia.

Trial registration: ClinicalTrials.gov Identifier: NCT03205319.

Conflict of interest statement

Conflict of Interest Disclosures: Dr de Jong reported receiving a grant from ZonMw through her institution during the conduct of the study. Dr Lantinga reported receiving grants from the National Health Care Institute (Zorginstituut Nederland) and grants from Jeroen Bosch Hospital outside the submitted work. Dr Keszthelyi reported receiving grants from Allergan, Grünenthal, MLDS, United European Gastroenterology, Will Pharma, and ZonMw outside the submitted work. Dr Masclee reported receiving grants from Bioactor, the Dutch Cancer Society, the Netherlands Organization for Health Research and Development, Pentax GmbH, Will Pharma, and ZonMw; and receiving personal fees from Bayer, Kyowa Kirin, and Takeda outside the submitted work. Dr Drenth reported receiving grants from the Dutch Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport; “Doen of laten? Terugdringen van onnodige zorg”) during the conduct of the study; receiving personal fees or research grants through Radboudumc from AbbVie, Gilead, Ipsen, Novartis, and Otsuka; and serving as member of the advisory board for AbbVie, Bristol Myers Squibb, Janssen, Gilead, Norgine, and Otsuka. No other disclosures were reported.

Figures

Figure 1.. Study Flow Diagram

GI represents gastrointestinal.

Figure 2.. Time to Endoscopy Curve

Kaplan-Meier curve of the proportion of patients who underwent upper gastrointestinal tract endoscopy in the educational (intervention) and control groups. Relative risk (RR) is the risk of undergoing upper gastrointestinal tract endoscopy within 12 weeks after perusing the web-based educational information compared with receiving no relevant education.