Michael Benatar, at the University of Miami Miller School of Medicine in Florida, and Jonathan Katz, at California Pacific Medical Center in San Francisco, were awarded a clinical research network grant to support their work on Clinical Procedures To Support Research (CAPTURE) project, which aims to implement the “ALS Toolkit” within the Epic Electronic Health Record. The ALS Toolkit provides a mechanism to systematize the collection of clinical data so that it can be used for ALS (amyotrophic lateral sclerosis) research. The two-year award totaling $300,000 will support work conducted through Clinical Research in ALS and Related Disorders for Therapy Development (CReATe) aimed at lessening the burden on people with ALS to attend both clinical and research appointments. CReATe, a rare diseases clinical research consortium, is a member of the National Institutes of Health’s Rare Diseases Clinical Research Network.

Throughout the course of the disease, people with ALS require input and assistance from multiple health care professionals and, as a result, multidisciplinary clinics such as MDA ALS Care Centers are a key resource for ongoing medical management and care. Visits to care centers take several hours, and a substantial amount of clinical data (such as neurological examination results, quantification of respiratory muscle strength and motor function assessments) are routinely collected — much of it identical to the assessments performed at specialized research visits. However, data from these two types of visits are typically captured separately, necessitating separate appointments for people who, depending on the stage of their disease, may experience profound weakness, disability and difficulty associated with travel.

It has therefore been a longstanding goal of many ALS clinician-investigators to find ways to reduce the burden on patients by finding a way to regularly collect a standard data set at clinic appointments that can be used for research purposes as well.

With increasing penetration of the electronic medical record into academic medical centers, and the recently established collaboration between Benatar and Katz with Epic, a team will now develop and implement a novel ALS Toolkit (set of “smart forms”) within the electronic medical record system that will enable clinicians to collect standardized data that can serve both clinical and research purposes.

If successful, the work will support a fundamental change in practice that will provide people with ALS a simple and straightforward way to contribute to research that can accelerate progress towards treatments and cures.

What is the goal of this project?

The project is called CAPTURE, which stands for Clinical Procedures To Support Research.

The goal is to implement a module within the Epic Electronic Health Record (EHR) that will empower collection of clinical data in such a way that it can also be used for research. We call this module the “ALS Toolkit.”

Why is it important to integrate research with standard health care visits?

The clinic is the most important venue for regularly seeing and evaluating ALS patients. In addition, valuable data is routinely collected and entered into electronic health records (EHR) at every appointment, at every ALS center across the country.To date, no one has taken steps to structure this regular flow of data, or to combine them in a single database. Instead, we have costly research protocols that collect the same information, requiring an ongoing duplication of work, while attempts to transfer clinically collected data into a research database requires extra steps of duplicating data entry — once into the medical record/clinic note, and once into a research database. The ALS Toolkit aims to increase efficiency and reduce costs.

Integration of a mechanism to collect research-useful data through a clinical workflow within the EHR offers a huge opportunity not just to increase efficiency, but to transform the power of clinically collected data to support the engine of research.

What does success look like?

There are three phases to success: (1) complete development of the ALS Toolkit and make it available for use in Epic at University of Miami and CPMC; (2) obtain IRB approval for the CAPTURE protocol and use the ALS Toolkit to collect clinical data regularly at the bedside; and (3) retrieve the structured clinical data from both sites to combine into a single common data space. We will then be ready to make the Toolkit more broadly available for use in ALS clinics across the country.

What effect will this new system have on researchers and health care providers?

It will permit collection of real-world data in a structured manner. This will empower researchers to utilize this goldmine of clinical data for research purposes (for example, collection of phase 4 trial data).

Fundamentally, clinicians will be able to take part in a wider research community than the current situation, where they are essentially working in isolation within single centers.

There is a small activation energy required — to obtain IRB approval, to obtain consent from patients prospectively, and to learn to use the ALS Toolkit in Epic, but the effort should be minimal with little to no adverse impact on the clinical workflow.

The potential upside is huge, with clinicians able to use these data not only for research, but also for quality improvement projects

What will be gained from the successful completion of this work, and why should individuals and families affected by ALS be excited about this project?

The gain is enormous. Simply put, data will exist where it previously has not.This is a fundamental change in practice.

It means that every patient has a simple and straightforward opportunity to contribute to the research mission in some way.

More efficient collection of data means a better visibility of the disease in general. This opens new opportunities for seeing what individuals and families are going through, learning the real costs of the disease, and having better access to information that can lead to a cure.

To learn more about how you can #EndALSwithMDA, visit mda.org.