The Value of Clinical Informatics In Every Stage of A Clinical Trial. Chapter 3: Recruiting and Screening

There is a site-centric approach to recruitment. In a clinical trial, you have to screen eligibility candidates somewhere in a physical place. Screening, consent, and enrollment happen during a clinical encounter at a hospital or doctor’s office. 

There are downsides to this approach. First, people living far from the trial location cannot participate. Second, you end up excluding people from an underserved geographic area. You can also limit the external validity of clinical trial findings. 

There is also a patient-centric approach to recruitment. You can apply mobile technologies to recruit patients and to use telemedicine. In the end, you set up a remote clinical trial.

There are networks of researchers who use similar, high-quality electronic health records (EHRs). These networks can help identify patients for extensive studies or observational registries. Some examples of these networks include InSite in Europe, CancerLinQ in the United States, and the National Patient-Centered Clinical Research Network (PCORnet).

How do EHR systems assist physicians?

One, you can ease patient searches for research and manage patient recruitment. For example, you can use software to identify patients eligible for the study based on specific criteria. Also, randomization can happen with a prompt that alerts about a potential candidate. 

Two, you can also use EHRs to ease the management of clinical trials on a day-to-day basis. You can digitize and code the study protocol within an EHR. It also improves communication between coordinators, regulatory staff, and finance staff. Everyone can access the information they need at any time. 

What should you pay attention to?

Data quality. The records may need to be completed or accurate. More and more hospitals are mapping their electronic health records to common data models to solve this problem.

Consistency in data collection. Even though there are some good examples, it is still hard to get people to use mHealth applications as part of a study. For example, less than 25% of people were still using the first five Apple ResearchKit applications after two months. However, more recent examples show that it is possible to get people to use mobile applications to get information and track results.

Usability. User-centered design involves users in the development of EHR systems. There have been many studies done recently concerning the usability and safety of EHRs. Workflow is a term often used in the clinical informatics field when discussing EHR design of EHRs, even if a formal workflow methodology is not employed. 

EHR Recruitment possibilities:

1. Using screening criteria for scheduling, reaching out, and recruiting of potential candidates;
2. Alerting about a candidate that could be eligible for the study;
3. Collecting feedback from the candidate to opt-in or out. 

EHR data are transforming how clinical trial protocols are planned and refined.

Why Should You Care? 

Clinical informatics has an important practical side because clinical computing operations have become critical as paper-based patient care processes are automated. Clinicians are more dependent on reliable, fast access to clinical computing systems.

It is essential to get clinical computing systems that work well and are easy to use, but once people start using them, it is even more critical that they always work. Once people are used to having them, they will be agitated if they stop working. Hospitals and clinics are busy and require computing systems to help them work better.

With each new clinical computing application or upgrade, things become more complicated, and the infrastructure these systems rely on becomes overloaded. When you look at these systems and talk to the people who maintain them, you realize how complex they are, and, amazingly, they work as well as they do. This is coupled with the impression that the only way to have the reliability we expect is through careful planning and systematic approaches. Yet there are no randomized controlled trials to guide us to the best way to select a clinical computing system, how to implement it, or how to maintain it.

Learn more on how we enable cutting edge clinical research at First Line Software.