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. 2022 Aug 24;17(8):e0273115.
doi: 10.1371/journal.pone.0273115. eCollection 2022.

The Abdominal Pain Unit (APU). Study protocol of a standardized and structured care pathway for patients with atraumatic abdominal pain in the emergency department: A stepped wedged cluster randomized controlled trial

Maria B Altendorf  1 , Martin Möckel  2 , Liane Schenk  1 , Antje Fischer-Rosinsky  3 , Johann Frick  1 , Lukas Helbig  2 , Dirk Horenkamp-Sonntag  4 , Dörte Huscher  5 , Luisa Lichtenberg  4 , Thomas Reinhold  6 , Daniel Schindel  1 , Britta Stier  2 , Hanna Sydow  6 , Yves-Noel Wu  3 , Grit Zimmermann  7 , Anna Slagman  6
Affiliations

The Abdominal Pain Unit (APU). Study protocol of a standardized and structured care pathway for patients with atraumatic abdominal pain in the emergency department: A stepped wedged cluster randomized controlled trial

Maria B Altendorf et al. PLoS One. .

Abstract

This study aims to improve emergency department (ED) care for patients suffering from atraumatic abdominal pain. An application-supported pathway for the ED will be implemented, which supports quick, evidence-based, and standardized diagnosis and treatment steps for patients with atraumatic abdominal pain at the ED. A mixed-methods multicentre cluster randomized controlled stepped wedge trial design will be applied. A total of 10 hospitals with EDs (expected n = 2.000 atraumatic abdominal pain patients) will consecutively (every 4 months) be randomized to apply the intervention. Inclusion criteria for patients are a minimum age of 18 years, suffering from atraumatic abdominal pain and being insured with a German statutory health insurance. Primary outcomes: acute pain score at time of discharge from ED, duration of treatment at the ED, patient-reported satisfaction. Secondary endpoints include patient safety and quality of care parameters, process evaluation parameters, and costs and cost-effectiveness parameters. Quantitative data will be gathered from patient-surveys, clinical records, and routine data from hospital information systems as well as from a participating German statutory health insurance. Descriptive and analytic statistical analysis will be performed to provide summaries and associations for primary patient-reported outcomes, process measures, quality measures, and costs. Qualitative data collection consists of participatory patient observations and semi-structured expert interviews, which will be inductively analysed. Findings will be disseminated in publications in peer-reviewed journals, on conferences, as well as via a project website. To ensure data protection, appropriate technical and organisational measures will be taken. Trial registration: DRKS00021052.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Schedule of enrolment, intervention, and assessments.
Fig 2
Fig 2. Stepped wedge trial design.
Fig 3
Fig 3. Flow chart of patients admitted to the participating 10 emergency departments in Germany and resulting study population with atraumatic abdominal pain.
Fig 4
Fig 4. Evaluation modules.
See this image and copyright information in PMC

References

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