Use Case 1 – Alerting in Care

IT Support for Patient Recruitment

Clinical studies often fail due to the insufficient number of suitable study participants. In the use case “Alerting in Care – IT Support for Patient Recruitment” the consortium MIRACUM integrates recruitment platforms into the Hospital Information System environments at each of its participating university hospitals. This will support recruitment processes with innovative IT solutions applying existing routine data.

New therapeutic options, whether drugs, treatment methods or other medical products, are subject to complex testing procedures, including the conduct of studies. For pursuing such studies those responsible for the studies often face one major challenge: identifying and recruiting sufficient participants in a timely manner. In a university hospital´s busy daily routine with many studies running at the same time, today efficient tools are missing, which would easily identify patients who are eligible for the respective studies. Therefore, Use Case 1 of the MIRACUM consortium is developing a digital recruitment platform that is designed to automatically check who is suitable for a study based on existing patient data.

 

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As a first step, all MIRACUM sites have harmonized their study description criteria and consented on a joined information model for a FHIR-based study description. Based on this all MIRACUM sites have established local study registries and initiated processes to continuously enter and maintain study descriptions of all clinical trials pursued at their sites. As early as the second half of 2019, the local study registries at the MIRACUM sites began to enter study data in a standardized manner. The study information from these local implementations is also recorded in a MIRACUM-wide central study registry, in which information on the individual studies can be searched across all sites. The central registry uses a FHIR-based interface to receive study information from all local registries. A web interface allows keyword searches and filtering by participating centers and study category. The website of the central registry is available at  studien.miracum.org. Up-to-date information is guaranteed by automated exports from the local registries.

The FHIR standard is also used for the implementation of IT-supported patient recruitment: An FHIR server serves as a central integration and communication platform. A search module is based on the central databases of the data integration centers at the MIRACUM sites to determine which of the patients currently enrolled are potential subjects for a study. These patients are placed on a screening list, which doctors can view as a clinic-internal web application. At the same time, a notification tool informs them about current recruitment proposals by e-mail. The physician then has the opportunity to check the respective patient file and recommend the patient to participate in the respective study. The procedure is now to be examined in an evaluation study in order to derive further optimization options.

Publications

Gulden C, Blasini R, Nassirian A, Stein A, Altun F, Kirchner M, Prokosch H, Boeker M. Prototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study. JMIR Med Inform 2021; 9:e20470. Doi: 10.2196/20470.

Reinecke I, Gulden C, Kümmel M, Nassirian A, Blasini R, Sedlmayr M. Design for a Modular Clinical Trial Recruitment Support System Based on FHIR and OMOP. Stud Health Technol Inform. 2020;270:158-162. Doi: 10.3233/SHTI200142. PMID: 32570366.

Becker L, Ganslandt T, Prokosch HU, Newe A. Applied practice and possible leverage points for information technology support for the screening for clinical trials: A qualitative study. JMIR Med Inform. 2020;8:e15749. Doi: 10.2196/15749. PMID: 32442156.

Gulden C, Kirchner M, Schüttler C, Hinderer M, Kampf M, Prokosch HUP, Toddenroth D. Extractive summarization of clinical trial descriptions. Int J Med Inform. 2019;129:114-121. Doi: 10.1016/j.ijmedinf.2019.05.019. PMID: 31445245.

Gulden C, Landerer I, Nassirian A, Altun FB, Andrae J. Extraction and Prevalence of Structured Data Elements in Free-Text Clinical Trial Eligibility Criteria. Stud Health Technol Inform. 2019;258:226-230. Doi: 10.2196/15749. PMID: 30942751.

Hasselblatt H, Andrae J, Tassoni A, Fitzer K, Bahls T, Prokosch HU, Boeker M. Establishing an Interoperable Clinical Trial Information System Within MIRACUM. Stud Health Technol Inform. 2019;258:216-220. Doi: 10.3233/978-1-61499-959-1-216. PMID: 30942749.

Sommer M, Kirchner M, Gulden C, Egloffstein S, Lux MP, Beckmann MW, Mackensen A, Prokosch HU. Design and Implementation of a Single Source Multipurpose Hospital-Wide Clinical Trial Registry. Stud Health Technol Inform. 2019;258:164-168. Doi: 10.3233/978-1-61499-959-1-164. PMID: 30942738.

Gulden C, Mate S, Prokosch HU, Kraus S. Investigating the Capabilities of FHIR Search for Clinical Trial Phenotyping. Stud Health Technol Inform. 2018;253:3-7. Doi: 10.3233/978-1-61499-896-9-3. PMID: 30147028.