The University of Birmingham has partnered with Cegedim Health Data for the RADIANT trial, a study exploring a data-driven approach to randomized controlled trials in primary care. The study uses Cegedim Health Data’s Health Improvement Network database and Outcomes Manager to identify eligible patients and electronically follow them up. The trial will focus on testing for diabetes in women who developed gestational diabetes during pregnancy and encouraging them to have yearly diabetes tests. The trial’s data-driven approach aims to improve the validity of clinical trials while minimizing the burden on patients and general practitioners.
In an outstanding study on the application and assessment of a revolutionary “dAta-DrIven rANdomised clinical Trial platform” (RADIANT) in primary care, the University of Birmingham and Cegedim Health Data have teamed up. The National Institute for Health and Care Research (NIHR) has provided funding for the RADIANT trial as a part of its Research for Patient Benefit Program. The study aims to investigate whether a data-driven approach to randomized controlled trials (RCTs) within electronic medical records could improve the validity of clinical trials while minimizing the burden on both patients and general practitioners (GPs). The RADIANT trial will use Cegedim Health Data’s anonymized patient database, The Health Improvement Network (THIN®), and Outcomes Manager in a data-driven approach at the HCP level to select a data set by gender and clinical criteria in a cohort for a randomized controlled trial on Gestational Diabetes Mellitus (GDM).
The Health Problem
The researchers found a current health problem: a lack of testing for diabetes in women who developed diabetes during pregnancy, or gestational diabetes mellitus (GDM). Each year, 30,000 women in the UK develop GDM, which is common in ethnic minority women. Often, GDM goes away after giving birth, but women who had GDM are more likely to develop diabetes in the next few years. Therefore, women are advised to have yearly diabetes tests to detect and manage diabetes early before problems occur. Unfortunately, many women are not tested annually.
Collaboration with Patients
In collaboration with patients, the University of Birmingham will develop a short animation explaining why it is important for women who had GDM to have yearly diabetes tests. The trial will send a text message with a link to the animation to women who had GDM, encouraging them to book a diabetes test with their GP. This way, they can inform and empower women to request a test.
Data-Driven Solutions
The RADIANT trial will make use of the Dexter Software, an automated Data Extractor for the Epidemiological Research Platform developed by the University of Birmingham Institute of Applied Health Research, which uses standardized methods to select eligible cohorts and electronically follow them up.
In addition, the trial will use Cegedim’s Outcomes Manager software to check eligibility criteria, randomize women to the intervention or control group, and send a text message reminder to women in the intervention group. This trial will reduce the burden of taking part for both patients and health workers by using data recorded in usual clinical practice to find out whether the intervention works.
Cegedim Health Data’s THIN® UK database is a proprietary anonymized clinical data repository, including patient characteristics and clinical outcomes, representative of 6% of the UK Population. Cegedim’s Outcomes Manager is agnostic and can integrate/plug into other GP Clinical Systems, including EMIS and System One, as well as Cegedim’s Clinical GP System (Vision). It will enable the GP to automatically read and write to the anonymized data set, accessing the key clinical information within the patient data/population.
The solution also utilizes ‘Patient App Integrations’ to facilitate the enrollment of prospective patients/participants via text message. This will also support communication for participants enrolled in the trial for notifications and monitoring such as blood test follow-ups and other communication to support engagement.
Finally, using data tagging and specific codes for the trial, data connected via the THIN® database and other GP Clinical Systems supports the anonymous tracking of trial participants. It facilitates live progress monitoring, whereas typically in clinical trials this can only be done retrospectively, thereby saving clinical time and resources.
