Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Patients with symptoms suggestive of GERD, managed according to a new structured and implemented pathway |
|
| 2 Patients with symptoms suggestive of GERD, managed according to usual clinical practice. |
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients presenting with symptoms suggestive of GERD (heartburn or regurgitation as prevailing symptoms) of any severity
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Patient able to understand and complete the questionnaires
Exclusion Criteria:
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Alarm symptoms (Dysphagia/odynophagia, anorexia, anaemia, unintentional weight loss, abdominal mass, upper GI bleeding)
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If the patient is participating in any clinical trial, he/she cannot take part on this study
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Any condition that, in the investigator's opinion, makes the patient's participation in the study difficult
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Amstetten | Austria | ||
| 2 | Research Site | Baden | Austria | ||
| 3 | Research Site | Bludenz | Austria | ||
| 4 | Research Site | Bregenz | Austria | ||
| 5 | Research Site | Feldbach | Austria | ||
| 6 | Research Site | Gmunden | Austria | ||
| 7 | Research Site | Graz | Austria | ||
| 8 | Research Site | Gross Gerungs | Austria | ||
| 9 | Research Site | Innsbruck | Austria | ||
| 10 | Research Site | Kitzbuhel | Austria | ||
| 11 | Research Site | Klagenfurt | Austria | ||
| 12 | Research Site | Krems | Austria | ||
| 13 | Research Site | Kufstein | Austria | ||
| 14 | Research Site | Leibnitz | Austria | ||
| 15 | Research Site | Leoben | Austria | ||
| 16 | Research Site | Linz | Austria | ||
| 17 | Research Site | Mattersburg | Austria | ||
| 18 | Research Site | Mistelbach | Austria | ||
| 19 | Research Site | Murzzuschlag | Austria | ||
| 20 | Research Site | Neunkirchen | Austria | ||
| 21 | Research Site | Neusiedl | Austria | ||
| 22 | Research Site | Perg | Austria | ||
| 23 | Research Site | Schwaz | Austria | ||
| 24 | Research Site | St. Veit | Austria | ||
| 25 | Research Site | Steyr | Austria | ||
| 26 | Research Site | Villach | Austria | ||
| 27 | Research Site | Vocklabruck | Austria | ||
| 28 | Research Site | Volkermarkt | Austria | ||
| 29 | Research Site | Wels | Austria | ||
| 30 | Research Site | Zell | Austria | ||
| 31 | Research Site | Brescia | Italy | ||
| 32 | Research Site | Aalesund | Norway | ||
| 33 | Research Site | Arendal | Norway | ||
| 34 | Research Site | Bergen | Norway | ||
| 35 | Research Site | Bodo | Norway | ||
| 36 | Research Site | Haugesund | Norway | ||
| 37 | Research Site | Kristiansund | Norway | ||
| 38 | Research Site | Levanger | Norway | ||
| 39 | Research Site | Molde | Norway | ||
| 40 | Research Site | Mosjoen | Norway | ||
| 41 | Research Site | Orkdal | Norway | ||
| 42 | Research Site | Oslo | Norway | ||
| 43 | Research Site | Tynset | Norway | ||
| 44 | Research Site | Valencia | Spain | ||
| 45 | Research Site | Arlov | Sweden | ||
| 46 | Research Site | Dalby | Sweden | ||
| 47 | Research Site | Falkoping | Sweden | ||
| 48 | Research Site | Farsta | Sweden | ||
| 49 | Research Site | Goteborg | Sweden | ||
| 50 | Research Site | Helsingborg | Sweden | ||
| 51 | Research Site | Karlshamn | Sweden | ||
| 52 | Research Site | Kristianstad | Sweden | ||
| 53 | Research Site | Kungsangen | Sweden | ||
| 54 | Research Site | Lulea | Sweden | ||
| 55 | Research Site | Lund | Sweden | ||
| 56 | Research Site | Malmo | Sweden | ||
| 57 | Research Site | Munkedal | Sweden | ||
| 58 | Research Site | Nordstan(Goteborg) | Sweden | ||
| 59 | Research Site | Partille | Sweden | ||
| 60 | Research Site | Pitea | Sweden | ||
| 61 | Research Site | Skanor | Sweden | ||
| 62 | Research Site | Sodertalje | Sweden | ||
| 63 | Research Site | Solna | Sweden | ||
| 64 | Research Site | Stockholm | Sweden | ||
| 65 | Research Site | Trollhattan | Sweden | ||
| 66 | Research Site | Vannas | Sweden |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Mónica Tafalla, MD, Medical DepartmentAstraZeneca Spain
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NIS-GEU-DUM-2008/1