Though mental healthcare has come a long way in recent years, patients with severe mental illness (SMI) are still at a higher risk of premature death when compared to the general population because of somatic illnesses that aren’t recognized in time or treated sufficiently.1 New interventions, developed and often deployed through clinical research, are often necessary to fix this problem.  

However, there are many barriers that stand between patients with SMI and clinical trial participation, including practical hurdles like location, transportation, and associated costs as well as reduced functioning, stigmatization, and discrimination in the healthcare system brought on by SMI. How can we bring more patients with SMI into clinical research to solve this care access gap?  

Elligo Health Research’s optimized clinical trials — trials that run through a combination of healthcare-first site visits and centralized virtual processes and are supported by HIPAA-compliant electronic health record (EHR) data and artificial intelligence (AI)-powered analytics — are an exciting solution.  

What Research Says about Optimized Trials and SMI Clinical Trial Enrollment 

A study in Denmark sought to understand the challenges of recruiting research participants with SMI by evaluating the use of general practitioners (GPs) as researchers in a clinical trial. It found that being familiar with the patient was important for successful recruitment. In fact, 95% of the SMI patients invited to participate in the trial by their general practitioners agreed!1 

This study underscores what Elligo Health Research® has already experienced: optimized trials are ideal for reaching previously underserved populations such as patients with SMI.  

Optimized trials are effective because they meet patients where they’re most comfortable. By bringing research to patients — in their communities with their trusted healthcare providers — optimized trials overcome practical barriers such as transportation, associated costs, and location as well as the delicate mental state and reduced functioning of such patients. Meeting patients where they’re comfortable also helps reduce the stigmatization and discrimination SMI patients regularly face in the healthcare system because they’re working with trusted providers who understand them and know their medical history.  

Optimized trials can also improve outcomes for patients with SMI beyond research, as continuity of care, such as participating in a clinical trial through a GP, has been shown to reduce acute hospitalization and mortality.1 

But What about EHR Data?  

The study in Denmark found that identifying possible trial participants using practice records was challenging, as GPs participating in the study reported that their record systems lacked the ability to isolate valid data. Because of misleading and/or missing data, more than 26% of patients eligible to participate in the trial were never contacted.1 

Elligo’s optimized trials have the solution: AI-powered analytics. Optimized trials use proprietary AI technology to turn unstructured EHR data into a research-grade registry of searchable records and subsequently match eligible patients with trials, resulting in rapid, accurate identification and enrollment.  

Patient Travel Services for When Healthcare-First Sites aren’t Available  

What happens when trials cannot be run by Healthcare-First sites in patients’ communities?  

In these cases, patient travel services are essential. This is especially true for patients with SMI, as travel can be incredibly challenging for clinical trial participants in delicate mental states. Travel services are essential because they go a long way toward easing the burden of trial-related travel, ensuring patients with SMI have the support they need to comfortably and safely get where they need to go.  

Optimize Your Psychiatry Clinical Trials with Elligo  

Not only does Elligo’s optimized trial model increase access to research as care for patients with SMI, but it also elevates trial execution. Healthcare-First sites in Elligo’s network operate under one contract and one budget, creating efficiencies that translate into cost and time savings. They’re also supported by Elligo investigators and central oversight, ensuring the highest quality research.  

Healthcare inequality for patients with SMI doesn’t have to be the status quo. Partner with Elligo for optimized trials that will break down research access barriers and ultimately improve mental healthcare outcomes.  


1 Tranberg, K., et al. Challenges in reaching patients with severe mental illness for trials in general practice—a convergent mixed methods study based on the SOFIA pilot trial. Pilot and Feasibility Studies. Published 2023 Oct. 31. 

When you need direct access to physicians and their known patients or research practice management solutions to accelerate your clinical trials, there’s Only Elligo.

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