Before the pandemic, Mayo Clinic was exploring ways to help patients get home sooner or avoid hospital admission all together. This work has continued, and one of Mayo's key initiatives in this arena is the Advanced Care at Home program, currently available in Mayo Clinic Health System in Eau Claire, Wisconsin; and at Mayo Clinic in Jacksonville, Florida; and in Phoenix. This program allows patients to receive, in their home, the level of Mayo Clinic care that would normally require an inpatient hospital stay. Plans are underway for expansion to other sites in early 2022.

This isn't simply a nice idea. Like everything else Mayo Clinic does for patients, Advanced Care at Home is being built and expanded based on evidence. This evidence is generated by research — both quantitative and qualitative — that ensures key objectives are being met.

From the earliest discussions of care for patients everywhere, the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery has been leading a number of research efforts for the Advanced Care at Home program and other related home care pilots and programs at Mayo.

For example, proof-of-concept pilots refine Mayo's understanding of what type of off-campus care models lead to higher patient satisfaction, lower costs and better outcomes. Another critical question the center researchers seek to answer with each project is whether the pilot solution is feasible at a larger scale, and if not, what modifications might lead to greater functionality.

"Now that we are seeing success and Advanced Care at Home is available for Mayo Clinic patients in growing numbers and multiple locations, we're able to move to the next step in the research," says Michael Maniaci, M.D., medical director of Care Anyplace, which includes Mayo Clinic Advanced Care at Home. "With a well-designed clinical trial, we can gather strong evidence."

A pragmatic, randomized controlled trial

In 2022, center researchers are leading a pragmatic, randomized controlled trial of Advanced Care at Home for acutely ill patients.

"A pragmatic trial is one in which we are investigating the intervention within the clinical practice," says Xiaoxi Yao, Ph.D., a health care delivery researcher in the center, and co-principal investigator for the Advanced Care at Home trial. "They differ from the better known 'explanatory' clinical trials in that the providers and patients who participate in a pragmatic trial are regular, everyday people, with no special qualifications to participate, and very little control of the setting."

"The information gleaned from real world comparisons of different care or treatment options is likely to be more generalizable than the rigidly controlled participation and outcomes found in an explanatory trial. Pragmatic trials are also important because they usually can be conducted more quickly, and trial attributes can be adjusted or other comparators added with minimal difficulty," she says.

On behalf of the Kern Center, Dr. Yao is partnering with the Mayo Clinic Center for Clinical and Translation Science in the development of resources to expand Mayo's ability to conduct pragmatic trials and implement practice transforming findings. She holds a similar role with Mayo Clinic Cancer Center.

In the current trial, the team is comparing whether the Advanced Care at Home option for acutely ill patients is equal to or better than traditional inpatient hospital care. Specifically, they will be looking at all-cause mortality and readmissions, as well as collecting information on medication errors, falls, costs and days spent at home instead of in the hospital.

Using mixed methods, the team will also investigate the experiences of patients, clinicians and other staff via interviews and surveys.

"The best practice transformations are those built on scientific evidence," says Dr. Maniaci, "and our Kern Center colleagues are helping us confirm our program's success through rigorous methodologies."

"We expect that our primary endpoints of all-cause mortality and readmissions will be equally or less likely to occur in the advanced care at home arm," says Sean Dowdy, M.D., Mayo Clinic's chief value officer, and the study's principal investigator.  "However, the trial is necessary for us to confirm, with scientific rigor, that the exceptionally high quality and value we expect of the Mayo Model of Care is effectively delivered through this new way of caring for patients."

"In addition, we want to understand how clinicians and other staff feel about this care option," he says. "It's also important to determine its effect on cost as well as other health and wellness concerns. Without the discipline created by the use of the pragmatic trial approach, we would be unable to provide an objective assessment and guide future expansions of this delivery model."

Over the next 12 months, the research team hopes to enroll 360 patients in the Advance Care at Home for Acutely Ill Patients trial, 180 patients receiving advanced care at home and 180 receiving traditional hospital inpatient care.

"The Advanced Care at Home program is a prime example of how Mayo Clinic is reaching the goals in the "Bold. Forward." strategic plan," says Dr. Dowdy. "It capitalizes on the concept of Mayo Clinic Platform while providing a new way to safely provide Mayo Clinic care to people who need it."

"Additionally, in this era of extremely high hospital census, it frees up beds for people too sick to qualify for advanced care at home. This allows hospital staff to focus on those with more critical needs, while ensuring program participants receive the level of care they need in a more comfortable environment."

Dr. Dowdy is also a gynecologic cancer surgeon and the Mayo Clinic Robert D. and Patricia E. Kern Associate Dean of Practice Transformation. The advanced care at home trial's other co-principal investigator is Elizabeth Habermann, Ph.D., who is the endowed Deputy Director of Research in the Mayo Clinic Kern Center for the Science of Health Care Delivery and directs the center's Surgical Outcomes Research program.

Advanced Care at Home is a key 2030 initiative of Mayo Clinic Platform, with technology enablement by the Center for Digital Health. The Mayo Clinic Kern Center for the Science of Health Care Delivery is fully embedded in Mayo's medical practice, and leads research — both quantitative and qualitative — to ensure that objectives are being met and evidence is gathered to support emerging and expanding programs. Center work enables new models of health care delivery to move rapidly from the earliest stages of research and discovery, through rigorous testing and refinement, and then be disseminated for widespread use in routine patient care.

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More information about Mayo Clinic's clinical trials can be found online.

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