Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)

AstraZeneca

Status: Completed

Conditions: Esophagitis; Heartburn; Regurgitation; Reflux

Study type: Observational

Funder types: Industry

Identifiers

NCT00842387

NIS-GEU-DUM-2008/1

Details and patient eligibility

About

The aim of this project is to compare the GERD clinical outcomes in patients where a structured pathway using the GerdQ questionnaire is implemented compared with the clinical outcomes of those treated without this implementation.

This is a European project with 5 participating countries (Austria, Italy, Norway, Spain and Sweden). Due to different characteristics regarding the actual management of this disease in the 5 countries, each country had the flexibility to introduce design differences and changes in the study protocol.

Full description

In Norway, it is developed as a clinical trial where a new structured pathway in the diagnosis and treatment of GERD is compared to the ordinary clinical pathway consisting of the endoscopic/pH-metry approach in patients referred from primary care to GI specialists.

In Italy, it is a PCP-level, cluster randomized, controlled trial comparing a structured clinical pathway versus usual care in patients with GERD. The implementation consists of training sessions on the clinical pathway with the selected PCPs (Implementation Group).

In Sweden, it is a cluster-randomised interventional study performed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway in patients identified as having GERD. The participating PCCs will be randomised (1:1) to implement the structured clinical pathway or handling the patients according to local clinical routines.

In Austria and Spain, it is a cluster-randomized study to be developed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway on GERD patients . The evaluation study will take place subsequent to a prior implementation of a clinical pathway. The implementation consists of a detailed explanation by training-materials about the clinical pathway in a selected randomized pool of PCCs. The implementation that will be evaluated is outside of the study procedures; it is the physician's decision whether to apply it or not.

Enrollment: 2,370 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting with symptoms suggestive of GERD (heartburn or regurgitation as prevailing symptoms) of any severity
• Patient able to understand and complete the questionnaires

Exclusion criteria

• Alarm symptoms (Dysphagia/odynophagia, anorexia, anaemia, unintentional weight loss, abdominal mass, upper GI bleeding)
• If the patient is participating in any clinical trial, he/she cannot take part on this study
• Any condition that, in the investigator's opinion, makes the patient's participation in the study difficult

Trial design

2,370 participants in 2 patient groups

1

Description:

Patients with symptoms suggestive of GERD, managed according to a new structured and implemented pathway

2

Description:

Patients with symptoms suggestive of GERD, managed according to usual clinical practice.