Speaker
Cynthia Hau, MPH
Statistician
Boston Cooperative Studies Program Coordinating Center
VA Boston Healthcare System
Keywords
Diuretic Comparison Project, VA Health System, Patient Recruitment, VA Point of Care Program
Key Points
- Diuretic Comparison Project (DCP) was one of the first full-scale studies for the VA Point of Care Program. It had a pragmatic recruitment model with an embedded design, multicenter study without local study investigators and management teams, and broad recruitment that included patients from all 50 states and Puerto Rico.
- DCP started to understand if chlorthalidone would be more effective at preventing cardiovascular (CV) outcomes compared to hydrochlorothiazide for thiazide-type diuretic. Both drugs have a well-established safety profile and would be a good fit for a pragmatic design. At the time, more than 95% of VA patients received hydrochlorothiazide for thiazide-type diuretic.
- The VA IRB determined DCP was a minimal risk study, with less restrictive eligibility criteria and EHR-based safety and outcome monitoring. The study started in June 2016 and ended in June 2022 and ultimately found no difference between the 2 drugs in preventing major CV outcomes and non-cancer death among hypertensive VA patients.
- DCP aimed to recruit 13,500 patients across the U.S. DCP developed an EHR-based workflows and integrated workflows within the local VA primary care setting.
- DCP planned to launch 5 sites in the first year starting with the Boston Healthcare System. DCP anticipated other customizations when expanding to regional settings. The study randomized 13,523 patients across the U.S. from 72 VA healthcare systems. Among study locations were sites in all 50 states including Alaska, Hawaii and Puerto Rico. 45% participants were from rural areas. 55% from urban residential areas.
- One key success factor was having a flexible EHR. DCP developed 3 electronic workflows with 6 major configurations including applications needed outside of the EHR system. DCP developed a patient tracking tool that nurses could use to make sure patients got through each step.
- Other key success factors were the creative thinking across the study team and the excellent study coordination and partnership within the health system.
- DCP learned that leveraging health systems for large-scale clinical trials is feasible. Key elements for successful implementation and execution were having a flexible EHR with systemwide collaboration, a supporting community and excellent study coordination, and aligned incentives.
Learn more
Read more in JAMA Network
Discussion Themes
-One real takeaway is the incredible amount of preparatory work that was required before a participant was randomized. How long did the start up for the trial take? The preparation work started with an idea in 2010, which led to selection of the pilot study in 2014 to test out the system for randomizing patients within the existing infrastructure. The actual startup was about 18 months. There was a lot of work that went into startup, making sure incentives were aligned across the VA system, meetings with primary care, cardiology, the VA ethics office, and ultimately with the central IRB. During that time the team was developing the best-case EHR modifications but quickly learned those were not the best modifications, so the first year was iterative where we were testing the forms as we were going. There was a lot of learning on our part for how to do this, and once we figured that out, we were more successful in our randomization rate.
–Regarding the critical importance of the health system as one of the take homes from your talk, do you encounter heterogeneity within the VA health system for “buy in” to participate in the trial or do all VA health systems cooperate equally? When people who are external to the VA view it as one homogeneous system, that is not the case. We did the study at 72 medical centers and encountered 72 different themes within the EHR. Centers did not engage in the same way or even the same way as their nearest neighbor. There were different reasons for not participating and it was interesting to see what was a main driver of participating. When people understood what we were trying to do, embed research into clinical care, people really engaged and a few regional directors made participation one of the drivers of research in their region and helped us get initial groundwork.
Tags
#pctGR, @Collaboratory1