So much has been written about the challenges experienced by medical teams, especially at clinical sites, working to advance clinical research. Of the many hurdles identified, some key ones continue to be:
- Recruiting patients: It is hard to identify, qualify, and maintain interest among patients considering joining a clinical trial. “Identifying” means matching patients to clinical trials based on inclusion and exclusion criteria, which are becoming more complex as science advances. It is not surprising that 80% of early-stage trials are halted due to low patient recruitment. Further complicating trial completion is that once enrolled, 30% of patients drop out of trials.
- Protocol management: Protocols are more complicated, with data coming from a variety of sources and protocol procedures up 44%. This adds a burden to physicians running the trials and explaining the procedures to their patients.
- IRB Compliance: Complying with the rules and regulations has become more exacting, and without efficient processes and a streamlined workflow, they can create bottlenecks for already overworked research teams.
- Clinical Site Staff Burnout: All of these pressures are resulting in overburdened staff and high turnover. Sage Publication reports turnover rates between 35 and 61%, depending on the institution. In their view, this shrinking pool has created a “war for talent.”
Managing these variables while delivering quality care led the University of California in San Diego (UCSD) to become a ClinOne adopter.
How to address the need: The UCSD ClinOne Experience
The world as we knew it
Listen to Karen Rapp, program manager for Stroke Research at the University of California in San Diego, discuss her involvement in clinical research for the last 30 years, and one can feel how the world has changed dramatically.
“In the good old days, we used pocket cards, which are laminated three-by-five-inch cards that keep all the relevant information. Imagine a doctor carrying the pocket cards on a ring in his white coat. There could be a lot of cards, too—one for each trial. The doctor would thumb through the ring until he found the right trial to consider.”
This “old-school” experience presented many problems, including:
- The cumbersome ring of cards: As the ring became filled with more cards, it was physically awkward to manage, review, and place this “portable” reference in a coat pocket, which also held other tools.
- Matching patients to the right trial was a slow, manual process: Physicians would review the cards and evaluate whether their patients fit the inclusion/exclusion criteria. If they believed there was a fit, they would locate and contact the trial manager.
- Updating the paper cards as information changed: The process of updating the trial information was manual, time-sensitive, and very necessary, as clinical decisions were being made based on the available data in hand. It took time for the trial managers to provide this up-to-date information, and it risked being unavailable when needed at the patient’s bedside. Automating the update reduced the risk and would save time for the clinical staff supporting the studies.
The UCSD team knew they needed to move away from paper, rework, and digitize their processes. A transformation team was put in place to survey the clinicians and conduct cross-functional process redesign workshops. Top priorities were identified as being ease of onboarding physicians in this teaching hospital setting, intuitive ease of use, and digitizing any manual artifacts. This enabled the concept of a “pocket e-reference” for physicians to use at the bedside in the acute setting.
ClinOne provided the technology platform foundation to implement these changes. From there, the UCSD team developed a new core set of processes to better manage the flow of clinical information as well as identify and implement new efficiencies. For example, UCSD integrated its log-in processes so that staff leveraged the UCSD single sign-on for all systems, including the ClinOne e-Reference companion.
As a result of these changes, the UCSD team has realized their goals where clinical staff rely on technology to facilitate a more efficient, automated process. UCSD has identified the following game-changers brought on by ClinOne:
- Quicker access to critical information: ClinOne estimates that single sign-on and a reduction of login hassles save between one to two minutes per interaction. “Single sign-on” is the ability to log in only once to access multiple applications versus logging into each application separately. UCSD has roughly 20 active ClinOne users in the Center, averaging 15 logins per week. Doing the math, ClinOne saves the research team five to ten hours per week from single sign-on alone, which is significant given the clinicians’ very tight schedules. Additionally, the team is spared user frustration when faced with managing several log-ins.
- Easier screening of potential participants: ClinOne provides an Inclusion and Exclusion module for reviewing a participant’s eligibility for a particular trial. Especially in acute settings where time is of the essence to evaluate criteria for those who are critically ill, it is estimated that the automated module saves 8 to 10 minutes per participant being considered. This translates to a significant amount of time back in the bank for an overburdened research staff to devote to care.
- A safety net on many fronts: ClinOne consolidates all the information needed for a participant to enroll, reducing the chance that something will be missed. Having a safety net of information and process control is important for the participant and the researcher.
Did the Initiative Meet the Mark?
Adopting ClinOne came with some very specific goals. The leadership at the Stroke Center was intent on finding an optimal way for physicians to manage their intake, triage, and assessment of patients to determine eligibility for their clinical trials. They also hoped that once a patient was determined to be eligible, the consent, enrollment, and dosing process could happen more quickly.
Physicians who are trying to do right by their patients and keep to a tight schedule can, if needed, conduct the full end-to-end assessment (qualification, enrollment, consent, and dosing) within a very short timeframe. This is convenient when a protocol requires a treatment window of two hours, but based on distance traveled and delays, physicians may find themselves having only 25 minutes. Speed of assessment and treatment is vital for patients who have suffered a stroke, but by leveraging the ClinOne platform, clinicians are able to meet the protocol requirements.
Finally, and maybe just as important as the digitization project itself, the ClinOne system is easily self-managed by UCSD. The team at UCSD has full control to make the timely, needed adjustments as protocols change. They have the ability to quickly onboard studies as needed. Physicians are trained on the tools and processes right from the start, helping to make the sought-after transformation complete.
With such high expectations, the question is: Did UCSD meet its goals?
The Stroke Center’s project manager, Karen Rapp, believes that while initially, the focus was on instant access to critical trial information so that “more acute patients could be enrolled into clinical trials,” a less articulated but extremely important benefit was to standardize their own protocol process. As Karen sees it,
“While accessing all the patient documents is key to our success for clinical trial enrollment, the big change for me is the one-stop-shop where all our clinical trial information is housed. With ClinOne, we can standardize our protocol process across studies and make it easy for clinicians to reference information to efficiently enroll new patients into research studies. This opens so many doors as we share more information.”
Dr Brett Meyer, Co-Director of UCSD Stroke Center, Department of Neurosciences, shared his thoughts on the benefits experienced a little differently.
“Simply put, ClinOne has made providers’ lives easier. It is a time-pressured world of acute stroke care; knowing the inclusion/exclusion criteria and having immediate access to protocol and contact information is valuable. It allows our team to focus on providing quality care and not focus on where we can find relevant clinical trial information. We want to make sure we continue to be a top-tier clinical research operation, and ClinOne has really helped our team.”
Conclusion
The UCSD/ClinOne partnership has delivered tangible results for some of the most persistent issues encountered today. Rapidly making information accessible and current to evaluate patients at the bedside is fundamental to offering the best treatments. In the words of Teri McQuaid, Stroke Research Coordinator,
“The tools ClinOne has provided make it much easier for me to do my job by providing access to study info promptly, making the screening and enrollment process more efficient.”
Enabling the UCSD team to manage their own requirements through easy-to-use tools – and in the exact terms of how they need them— saves time, removes frustration, and supports the clinician’s goal to focus on delivering quality clinical care.
