The Value Proposition for Clinical Research as Care, from a Healthcare CEO

What makes clinical research a priority to you, as a healthcare executive? 

Wilmington Health owns the largest physician-led Accountable Care Organization (ACO) in the country and is also the largest shareholder in Innovo Research, which is one of the largest clinically integrated, physician-led site management organizations in the United States. We are heavily steeped in value-based care, and research is embedded in all of our practices and fully integrated. Clinical research helps us in our pursuits and our triple aim aspirations.

In 2024 our ACO achieved gross savings of $156.5 million. We recognize the direct correlation to population health outcomes, including cost, quality (outcomes) and engagement. 

What would be your advice to community health centers or hospitals that are considering doing clinical research, but fear the additional cost or burden? 

Hospitals should look at research through the lens of their Clinically Integrated Networks (CIN) and value-based care, and from the perspective of the physician and the patients. 

If done right, the benefits for patient engagement, ACO performance, patient outcomes and diversification of physician revenue far outweigh any additional administrative burden it takes, particularly when partnering with physician-led site management organizations, like Innovo, that understand the operations of both ACOs and research. 

"We are heavily steeped in value-based care, and research is embedded in all of our practices and fully integrated."

How is clinical research presented as a care option in your organization?

Investigators will talk about trials with their patients or make their colleagues aware. Sub-investigators and physicians might refer, and research staff can do outreach. Patients can research and self-select, and we put out the information on the available trials, especially in areas of population health. Very occasionally, we might do advertising or social media, but we generally don’t need to. 

In addition, the EMRs of our sites are connected, so we can do centralized recruiting. Because we’re integrated, the patients get produced on one list, so if, for example, we have a study going in five states, one person might handle the patient outreach for all sites. To give a sense of the scope, we currently have 13 large, independent multispecialty physician practices in 9 states. We have nearly 2,500 providers and access to six million patients. All of our physician practice partners are focused on value-based care and population health.

How has that level of integration helped make clinical research more efficient? 

One example is when we had a project come up recently in which we needed to get patients in for their follow-up standard-of-care visit in conjunction with the research project. A number of patients were falling out of scope because they didn’t have a visit with their primary care physician at a time that fell within the timeline of the necessary follow-up visit. 

In that case, we simply reached out to all of the primary care providers and asked, “Do you mind if the research department schedules this for you?” We had the principal investigator put the orders for the standard-of-care into the EMR. Then, the research department scheduled the visits to make it easier for the primary care team and to ensure that the patients were kept in scope for this trial. 

What types of trials are the most interesting to your patient population? 

We focus on all trial types with the exception of Phase I. The most interesting trials to us are the ones that help us drive value-based care and the trials that allow us to engage more new investigators faster. One thing I have learned from watching other site networks is that diversification matters. 

Are there financial challenges with offering clinical research as care? 

There can be, but being fully integrated, having connected electronic medical records and the fact that we're fully electronic in both eSource and eReg make clinical research substantially more efficient. 

We have coordinators who are working shoulder-to-shoulder with the PIs, operating at the top of their license. That means that the amount of time and effort that the PIs have to spend is limited to really them operating at the top of their license, and we make it efficient for the investigators to see patients and oversee projects instead of doing things that others can do. 

"If done right, the benefits for patient engagement, ACO performance, patient outcomes and diversification of physician revenue far outweigh any additional administrative burden it takes."

Anything else you’re doing to make it easy to do research? 

We ask that the sites give us access to one of their mid-level managers for coordinating the things that we need to do research. For most of our physicians, PIs and sub-investigators, it's relatively painless. The fact that we are continuing to grow both sites and investigators probably lends itself to a level of efficiency that our provider partners don’t have that burden. 

What are the hurdles you’re facing in keeping clinical research a continuous engine at Wilmington Health? 

It can be challenging to plan for, in that you can never truly predict your volume. Studies you think will start may not. Ongoing studies may end sooner than anticipated. You may not get the studies you thought you would. Planning for that from a fiduciary perspective and managing growth are difficult in an uncertain environment. 

The legacy approach that many large pharma sponsors and CROs take doesn’t lend itself to efficiency, particularly when dealing with large, truly integrated networks. For example, if we have 10 locations, we have to fill out 10 feasibility assessments. I don’t think that sponsors and CROs are evolving fast enough to keep up with what we are able to do as large, multi-site networks or sophisticated multispecialty group practices, both in terms of the technologies we’re working with and our general attitude/approach to clinical research. 

What is one thing you’d like to see more flexibility with from sponsors? 

I would like the flexibility to decide which locations are best to run a study to access those patients. Oftentimes, a sponsor might only give permission to run a study at one address because they don’t want multiple sites in the same town with the same patient population. 

However, with an entity like Wilmington Health, we are one group accessing hundreds of thousands of patients. We know that, to maximize our contact, we could run the trial at, for example, three different locations. I would love to see that flexibility in the protocols, where it makes sense, to create real efficiencies in trials. 

The same point holds true at the network level. If the sponsor supplied parameters, such as diversity and geographic requirements, we could deploy those requirements across our network. Often sponsors choose sites that we know are not the best for recruiting into a particular type of study. They would be better off working with us collaboratively on how best to maximize for a particular study. 

What would the benefit be to gaining that level of flexibility? 

We might be able to recruit 50-60% more patients into the study when the locations are diversified under the same umbrella. Our network covers a relatively large geographic area and in each community our population of available patients is very dense. 

This holds true at the local level as well. On the map, two sites that we request might only be separated by a few miles, but we know our patients. For example, in Wilmington, we know that, if the patients are separated by the Cape Fear River from the site, we will lose some patients if we can’t open a site on both sides of the river. They don’t travel across the bridge, but they would go to another location on the other side of the river. They might not go to a location downtown because of the traffic, but that issue could be alleviated if we could direct them to another site. 

The point is, for national, multi-site/location networks, providing the flexibility to the networks to assign the physical addresses where they conduct the studies would change the game. 

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