Clinical trials play a crucial role in the development of new treatments and therapies, helping to uncover potential risks as well as benefits that can improve the lives of patients with specific health conditions. Identifying eligible patients and recruiting them in adequate numbers is critical to the success of clinical trials, but not always easy to accomplish.
Not only can it be difficult to recruit patients to participate in clinical studies, but it also can be challenging to ensure their ongoing engagement to deliver successful outcomes. Traditional recruitment methods are slow and yield low participation due to the lack of efficient mechanisms to identify a sufficiently large pool of eligible patients, routinely recruit patients at clinical encounters, and enroll them as participants.
With these challenges in mind, the Louisiana Public Health Institute (LPHI) and its partners established the Research Action for Health Network (REACHnet) to increase the efficiency and effectiveness of patient-centered research. An innovation of REACHnet was to create an end-to-end patient recruitment and engagement mechanism to increase participation in pragmatic clinical trials.
REACHnet is part of the National Patient-Centered Clinical Research Network (PCORnet), which is designed to make it faster, easier, and less costly to conduct clinical research by harnessing the power of large amounts of health data nationwide. REACHnet houses data from participating healthcare organizations, including Ochsner Health System, Tulane University Medical Center, and Baylor Scott & White Health. It has compiled data on more than 5 million patients in Louisiana and Texas, and designed a recruitment strategy that would engage patients at the point-of-care during regular healthcare encounters.
Enabling end-to-end patient recruitment and engagement
LPHI worked with Persistent Systems to build a technology platform that would serve as an electronic patient engagement mechanism for REACHnet. The outcome was a tablet- and web-based tool for targeted study recruitment, registry building and survey collection, called the Pragmatic Trials App Suite (PTAS).
The initial concept was to use tablet computers to present patients with specific clinical trial opportunities and to leverage the clinical database to deliver the right study to the right patient, based on their eligibility. The tablets are located in exam rooms of participating clinics to provide sufficient privacy given that the technology is interactive, showing informational videos and collecting data from patients.
The strategy for placing tablets in exam rooms required careful implementation. Clinic staff have a limited amount of time, and adding an additional step to their workflow could be disruptive, so it was necessary that the solution be fully automated, secure, and not interfere with the clinic workflow.
The system uses HL7 interfaces between the REACHnet data center and the health systems to signal when a patient registers at a clinic. If the patient is eligible for any active trial, it sends a response that creates a link on the exam room workstation for the provider to activate the tablet. Once the medical assistant or nurse finishes rooming the patient, they click the link to activate the tablet with content specifically matched to the patient’s clinical eligibility. The tablet-based recruitment application is a self-directed workflow for the patient to complete while waiting for the doctor.
Accelerating recruitment through a patient network
To support patient recruitment and ongoing engagement in research, REACHnet created a patient network called Health in Our Hands (HiOH) to help involve patients in the design and implementation of research about their health as both stakeholders and participants. The network provides an opportunity to recruit members remotely to enroll in studies or help inform research initiatives, targeting eligible candidates based on their clinical characteristics.
To build the HiOH network, the PTAS was used to recruit patients 18 years and older at the point-of-care during regular clinic visits. With patients’ consent, they can be contacted directly by REACHnet outside of the clinic setting through web and mobile technologies to offer opportunities to participate in clinical trials. Within the first year, close to 5,000 patients were recruited into HiOH which is 30 times more efficient than traditional recruitment methods into patient registries. Given this success, LPHI is now developing a version to address the pediatrics segment.
In addition to HiOH recruitment, the PTAS has also been used to recruit for two interventional trials, collect patient-reported outcomes and patient satisfaction surveys, and screen for health risks with referral to interventions. The PTAS platform may also be customized to present targeted health information and research results to patients.
As researchers work to identify effective treatments for myriad health conditions through clinical studies, mobile technologies are fast becoming the vehicles for not only engaging with candidates and enrolling them in studies, but also for improved patient engagement in healthcare and health research.
This piece was written by Elizabeth Nauman, MPH, PhD, Director of Health Services Research with the Louisiana Public Health Institute, where she specializes in patient-centered research projects. To follow the organization on Twitter, click here.