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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Reflux, Heartburn, Regurgitation, Esophagitis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with symptoms suggestive of GERD, managed according to a new structured and implemented pathway | |
| 2<br>Patients with symptoms suggestive of GERD, managed according to usual clinical practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of symptoms based on results of GerdQ, need of treatment change and % of patients requiring referral to a specialist (Austria and Italy). |  | up to 8 weeks | 
| Treatment response and symptomatic control (Norway) |  | up to 8 weeks | 
| Symptom relief and patient satisfaction with treatment (Spain) |  | up to 8 weeks | 
| Symptom relief measured by RDQ (Sweden) |  | 5 months +/- 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use and consumption of healthcare resources (all countries). Physicians adherence to the clinical pathway (Austria, Spain) and intrinsic characteristics of the physicians/PCC that may affect this adherence (Austria) |  | Up to 8 weeks, except for Sweden: 5 months +/- 4 weeks | 
| Percentage of patients referred to specialists (Spain). Health status based on EQ-5D measure (Norway, Sweden). Work productivity based on the WPAI-GERD questionnaire (Norway, Sweden) |  | Up to 8 weeks, except for Sweden: 5 months +/- 4 weeks | 
| Sweden: Persisting symptoms according to GerdQ, Treatment changes, Reason(s) for the patient consultation at visit 1. To explore other GERD related symptoms, To describe patients' experience of treatment/care given during the study. |  | 5 months +/- 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastroesophageal reflux disease, reflux, heartburn, regurgitation, acid control, PPI, antiacid, primary care, esophagitis