Management of Heart Failure Patients Using Home Telehealth
New England Healthcare Institute and Atrius Health
The Home TeleHealth Project was conducted through a collaboration among NEHI, Atrius Health, Atrius Health Foundation, and the Massachusetts Technology Collaborative. Atrius Health is a large integrated delivery system providing multi-specialty care in 30 practice sites, serving nearly one million patients in eastern and central Massachusetts.
Goals of the Project were to assess the clinical, service utilization and financial impact of home TeleHealth (HT) technology among patients with heart failure (HF) at Atrius Health. Following a rigorous technology selection process, the project team selected the Philips TeleStation for use in this Project. Participants with HF were randomly selected for the intervention arm. They interacted daily with the HT technology, which provided continuous feedback to their care teams and created opportunities for ongoing monitoring and intervention as needed.
An overview of the Project’s results is as follows:
- In a controlled randomized study, patients using HT technology for monitoring and management of HF (the intervention group) had fewer all cause hospitalizations, fewer ED visits, and fewer urgent care visits than control group patients.
- Patient survey results also showed promising trends among the intervention group, including better HF symptom control, reduced emotional burden of illness, and increased satisfaction with physical capabilities.
The HT technology is innovative because of the opportunity for real-time monitoring of high-risk patients with HF (and other chronic conditions) in the home and community setting. Effective remote monitoring can lead to promising utilization and health outcomes as well as enable patients and caregivers to participate as members of the patient’s care management team.
WHO WAS INVOLVED
The RPM Project was accomplished through a collaboration among NEHI, Atrius Health, Atrius Health Foundation, and the Massachusetts Technology Collaborative.
WHAT THEY DID
Problem Addressed: The growing prevalence of HF and other chronic diseases, coupled with poor management of these conditions, have resulted in massive burdens of illness and costs to the health care system. Chronic diseases now account for more than 75 percent of the nation’s $2.6 trillion in total medical care costs. HT technology, a telehealth tool, has the potential to enhance chronic disease care and reduce re-hospitalizations, ED visits, and other medically unnecessary health care service utilization. Of all common chronic conditions, HF is reported to have the highest rate of preventable hospital readmissions.
The Project assessed the impact of HT technology on patient experience and on clinical, service utilization and financial outcomes in the treatment and management of patients with HF.
Patient Population: The patient population eligible for inclusion in this Project was Atrius Health patients discharged from a hospital with a primary diagnosis of HF within 12 months prior to enrollment. In most cases, patients were enrolled within three months of hospitalization for HF. In order to participate in the Project, patients had to be insured, able to speak and read English, and willing to consent to participation.
Description of the Program: All Atrius Health practice sites not already contracting with the Visiting Nurse Association (VNA) to provide in-home monitoring to patients with HF were eligible to enroll HF patients. At inception (January 2011), seven Atrius Health practice sites agreed to participate and enroll eligible patients. By the fall of 2011, 10 practice sites had joined the Project. All participating sites were located in the greater Boston area.
Atrius Health patients recently hospitalized with a primary diagnosis of HF and consenting to participation were randomly assigned to either an intervention arm or a control arm. Patients in the intervention arm of received a home TeleHealth device – the Philips TeleStation. Selected through a rigorous comparative assessment of available home TeleHealth products, use of the Philips TeleStation was approved by the project’s Clinical Advisory Committee. All patients participating in the Project continued their routine medical care for HF at Atrius Health, per current medical guidelines. In addition, the intervention group also used Philips HT technology to monitor and manage their HF condition.
Each patient in the intervention group received a TeleStation device equipped with digital scale, an automatic blood pressure cuff ,and a pulse oximeter. This device was used to transmit the patient’s daily weight, blood pressure, heart rate and information on key cardiac symptoms (e.g., increase in shortness of breath, edema, chest pain and palpitations) to a secure web portal through the patient’s home telephone line. The TeleStation also asked specific questions related to medication use on a daily basis and the patient’s input was sent to the web portal. Once the web portal received the daily data input, an automated computer algorithm checked the patient’s data with acceptable clinical ranges (i.e., answers previously set by the patient’s physician to identify potential problems that could indicate an impending hospitalization or need for physician-directed intervention). If patient readings were outside of the normal range, an alert notification (called a “Red Flag”) was sent to the designated clinical team member via the web portal.
For each patient, a Responsible Clinician at participating Atrius Health practice sites was assigned to monitor the patient data (Monday through Friday from 8:00 AM to 5:00 PM) and follow up with the patient as needed. Depending on the practice, the Responsible Clinician was either a physician, a nurse or an experienced medical assistant. The Responsible Clinician was determined once patients were enrolled in the Study, and depended on the patient’s physician team composition and workflow at each participating practice site. All clinical staff caring for enrolled patients were trained in:
- Their role in the Project and expectations;
- How to use the HT device (so they could understand the patient’s role);
- How to access HT data on the web site;
- How to incorporate daily monitoring of intervention group patients into their usual workflow;
- How to follow-up when a patient does not report data daily;
- Who to contact when a patient is having difficulty using the device or a device seems to have failed; and
- How to notify the covering clinician when out of the office.
Patients using HT technology were requested to transmit their data to their Responsible Clinician on a daily basis. The Responsible Clinician was expected to access patient information each day. After nine months of HT use, patients and physicians could determine whether the patient should continue with daily use of HT technology or whether the patient had internalized the self-management and monitoring behaviors prompted by this technology.
Results of the randomized controlled trial, shed light on the clinical, service utilization and financial impact of HT technology on patients with HF. Given the expansion of RPM within Atrius Health to all heart failure patients, the project halted recruitment into the RCT in March 2012. Early results were analyzed in February 2012. At that time, the intervention group had 21 HF patients using HT and the control group had 10 HF patients who had not used HT technology during the nine-month intervention period.
To examine differences within and between the groups over time, pre- and post-intervention analyses were performed using Atrius Health demographic and utilization data. Findings indicated that the intervention and control groups were not significantly different at baseline.
Primary utilization outcomes measured included the number of hospitalizations (for HF and for all causes); average length of stay (ALOS) for any hospitalization; and number of ED visits (for HF and all causes). Other outcomes measured included total number of outpatient visits; number of urgent care visits; number of outpatient cardiology visits; and number of home health visits. The results are presented below.
While there was no change and no difference in rates of hospitalization for HF between the two groups, other important differences were noted:
Differences within the Intervention Group (pre- vs. post-intervention) that were significant at the p <.10 level were as follows:
- A decline in all-cause hospitalizations among intervention group patients was observed following the use of HT technology (a mean of 1.5 hospitalizations per patient was observed in the 12-month period prior to the intervention versus a mean of 0.9 hospitalizations per patient during the intervention period).
- The number of ED visits declined for both groups during the Study period, but the decline in ED visits was greater in the intervention group.
- Among intervention group patients, declines in the number of urgent care visits, cardiology visits, and home health visits were also observed in the pre- and post-intervention periods.
The following between-group differences were also significant at the p <.10 level:
- Lower ALOS for all cause hospitalizations was observed among patients in the intervention group.
- Fewer total outpatient visits were observed in the intervention group.
- Fewer total urgent care visits were also observed in the intervention group.
Patient survey results (from the Kansas City Cardiomyopathy Questionnaire and the RAND Medical Outcomes Survey) also showed promising trends among patients in the intervention group over time and as compared to control group patients. Intervention group results indicated fewer HF symptoms, better HF symptom management, fewer physical limitations due to HF, improved quality of life, improved self-efficacy and improved confidence in managing chronic illness. Results from the Medical Outcomes Survey also showed greater reduction in the emotional burden of illness and increased satisfaction with physical capabilities among patients in the intervention group. Given the small size of the intervention and control groups, these findings signal large utilization and health outcomes effects attributable to the use of HT technology.
Conclusions and Implications: Results from this Project reinforced the value of HT technology at Atrius Health in managing high-risk patients with HF. In addition, growing published evidence supporting the efficacy of HT technology and increasing prevalence of the use of HT technology for monitoring and managing patients with HF also reinforced this Project. Supported by these promising results and trends, Atrius Health determined in March 2012 to expand the availability of HT technology to all patients with a diagnosis of HF. This expansion was accomplished primarily by outsourcing home-based care management of Atrius patients with HF to several VNA services. As in this Project, the VNAs use the Philips TeleStation for home monitoring of patients with HF. With this program, physicians can (at their discretion) enroll HF patients in the VNA home-based monitoring programs, formerly available to a only a few Atrius Health practice sites. Beginning in March 2012 the VNA programs became available to physicians and their patients at all Atrius Health sites. Rollout to all sites is now occurring over a 12-month period.
Atrius Health’s decision to outsource home monitoring of HF patients to the VNA was made in order to provide consistent home monitoring for all Atrius patients with HF, and to provide tighter system-wide management of patients with chronic conditions like HF. This decision also occurred partly in response to Atrius Health’s designation in 2012 as a Pioneer Medicare Accountable Care Organization (ACO). These and other organizational factors led Atrius to determine that the Project (as originally conceived) was no longer needed to make the case for remote patient monitoring for patients with HF. In less than two years, use of HT technology for remote patient monitoring had moved from “innovation” (demonstration status) to mainstream care throughout Atrius Health.
Remote patient monitoring through HT technology is now part of a larger home-based care initiative at Atrius Health. As a Pioneer ACO, incentives within Atrius Health elevate the importance of technologies that have been shown to control costs of care and achieve better outcomes through tighter monitoring and management of chronic conditions. The implication of these developments is that remote patient monitoring and the use of HT technology will be sustained at Atrius Health.
HOW THEY DID IT
Context of the Innovation: The Project occurred within Atrius Health, a large integrated delivery system serving nearly one million patients in eastern and central Massachusetts. Atrius Health provides primary and multi-specialty care in 30 practice sites. The varied practices have a significant number of heart failure patients, some of whom were being managed separately in a Complex Chronic Care (CCC) program that provided nurse case-management for the HF patients. Atrius Health was interested in finding an efficient, cost-effective, technology-based way to better manage their HF patients and expressed a willingness to participate with the other partners (NEHI, MTC, and BCBS of Massachusetts) in a rapid demonstration project.
Planning and Development Process: At the outset of the Project, staff from NEHI and the Atrius Health Foundation recruited and convened a Clinical Advisory Committee (CAC) to provide strategic guidance during Study development and operations.
CAC membership consisted of clinical, nurse, and administrative leaders from Atrius Health/Harvard Vanguard Medical Associates; Atrius clinical informatics leaders; project staff from NEHI, Atrius Health, and the Atrius Health Foundation; and representatives from Massachusetts Technology Collaborative; and Blue Cross Blue Shield of Massachusetts (the State’s largest health plan).
The CAC was charged with four main responsibilities:
- Determine the specific methodology required to ensure that the demonstration produced valid and significant outcomes;
- Determine the site selection criteria;
- Determine which home TeleHealth technology to employ in the demonstration based on NEHI’s analyses; and
- Provide ongoing oversight.
In addition to the CAC, a Project Advisory Committee (PAC) was formed and convened in May 2011. The PAC was an external group of local and national influencers who are well positioned to support dissemination of study findings and foster adoption of HT technology within (or through) their organizations following the demonstration. The PAC was an excellent forum for regional dialogue on the benefits, challenges and rate of adoption of HT and other remote patient monitoring technologies.
Resources Used and Skills Needed: Information on the staffing and financial costs of the innovation are as follows:
- Staffing: At Atrius Health, two salaried staff positions – a Research Manager and a Recruitment Coordinator – were hired to manage the program and recruit participants. The Research Manager was an RN who brought to the Study considerable experience managing clinical projects at Atrius Health/Harvard Vanguard Medical Associates. In addition to salaried staff support, other in-kind support was provided by Atrius Health Foundation President William Aikman, and by clinicians, nurses and data analytic staff at Atrius Health. NEHI staff provided support in Project design, management, documentation, analytic support, and convening and facilitation of the CAC and PAC oversight committees.
- Costs: The total cost to plan and implement this Project (over two years) is estimated at $575,000. This estimate includes in-kind and grant funded activities, plus HT technology costs.
Getting Started With This Innovation: Based on the team’s experience in the Project, important prerequisites to successful launch of a study of this nature include the need to:
- Translate clinical leaders’ consent to participate in the Project into organizational policies that facilitate and prioritize Project operations at the practice level. Ideally, this should occur at the outset of the project. For example, had the Project commenced with an “opt-out” recruitment policy for patients, patient enrollment would have occurred more rapidly. One year after the Project began, leaders at Atrius Health allowed the team to move to an “opt-out” patient recruitment strategy. With this change, busy physicians no longer needed to actively enroll their patients in the Project, and the rate of participant enrollment increased. This is just one example of how organizational policy can support a rapid demonstration study.
- Get the “buy-in” and support of clinical staff at participating practice sites before the project begins. Work with staff to ensure that study operations, recruitment and daily monitoring of HT feedback become part of the daily workflow at participating practice sites.
- Allow ample time in the project timeline for IRB documentation and review (if required).
Sustaining This Program: Use of HT technology for treatment and monitoring of HF has become routine practice in the organization and will be sustained at Atrius Health after the CTA grant cycle ends. In addition to remote patient monitoring through use of HT technology, home health nursing is now a component of Atrius’ home-based approach to monitoring and management of patients with HF.
Organizational leaders within Atrius Health and the Atrius Health Foundation support continuation and expansion of home-based monitoring and management for patients with HF through the use of HT technology. Atrius Health has budgeted to contract with four regional VNAs in eastern Massachusetts to provide home health nursing and remote patient monitoring through HT technology. These VNA services are now included in Atrius Health’s annual operating budget.
Incentives (financial and other) associated with Pioneer ACO status are important to sustaining the use of HT technology at Atrius Health. Strong leadership investment and a strategic focus on Atrius Health’s status as a Pioneer ACO are (and will be) important drivers of the sustainability of HT technology in the organization. Results of this Project (and others) suggest that use of HT technology for patient monitoring results in tighter management of HF, lower health care utilization, improved health outcomes, improved patient functioning, and lower cost of care. All of these are important outcomes for any ACO.
Other Considerations and Lessons: The program generated a number of important lessons for the field. First, while months of planning and stakeholder engagement activity generated support for the Project among Atrius Health and Atrius Health Foundation’s senior management (as evidenced by executive and clinical leader participation on the CAC and the important role of the CAC in overseeing Study operations), this support did not result in an organizational mandate or call for Project participation at the practice level. Participation among practice sites remained optional and voluntary, and within volunteering sites physicians were required to actively “opt-in” their patients for participation in the project. Eligible patients were introduced to the project at site-level clinicians’ discretion, and the possibility of follow-up and enrollment by project staff was then triggered.
This set of requirements (and the voluntary nature of all aspects of project enrollment) made site and participant recruitment processes challenging in the program. In order to successfully recruit participants, busy clinicians and staff at participating sites needed to have the Program “top of mind”, and they had to be willing to take the extra time necessary to discuss the Project with patients. Clinicians also had to be willing to conduct the daily management and monitoring activities required for participants’ use of HT technology. Further, the outsourced VNA alternative for home monitoring of Atrius Health’s HF patients emerged as the Project was in the field, and it offered another (more comprehensive) alternative for home-based monitoring that Atrius Health physicians could select for HF patients. Also, according to Atrius Health staff, a prior attempt at site-level use of HT technology within Atrius Health had been met with limited success. All of these factors slowed the pace of recruitment to the Study.
A second lesson learned is the benefit of using an “opt-out” participant recruitment strategy instead of the “opt-in” strategy applied in this program. Opt-out recruitment provides a much larger pool of eligible patients and facilitates enrollment because physicians must actively de-select eligible patients if they do not want patients to participate. In the opt-in scenario (as noted above), physicians must be aware and sufficiently interested in the program in order to actively enroll their patients. The opt-out approach removes administrative and other barriers to recruitment.
A third lesson from this project is the importance of a strong, visible and vocal physician champion with the time and enthusiasm to promote the program among clinicians and staff at the practice level. Innovation research efforts must have one or more dedicated physician champions in order to succeed. The program’s first director was an extremely busy clinical leader who was ultimately not able to devote the time necessary to champion the Study at the practice level.
A fourth lesson learned is that an IRB-driven, randomized controlled trial may have been too formal a structure and too slow a process for a rapid, one-year project. For example, whenever a change in patient care process or communication was needed to support the project, IRB review and approval was required. IRB oversight in this case was a rate limiting requirement for a rapid demonstration project.
A fifth lesson learned is that organizational and environmental factors can play a major role in the success or failure of a demonstration of this nature. For example, in the project, Atrius Health project staff determined that working with Atrius Health’s chronic care management program (led by the Project’s second PI) was the best way to identify and recruit patients with HF to the project. One year into the Project, Atrius announced that all home-based chronic care management and coordination of Atrius Health patients with HF would be outsourced to four VNA services. Further, the CAC had determined early on that this project would not operate side-by-side within practice sites where use of the VNA service for home-based monitoring and management of patients with HF was ongoing.
During this time, Atrius Health was awarded Pioneer ACO status by CMMI. ACO designation had the effect within Atrius Health of heightening the importance of improved chronic care management and increasing the financial incentive to monitor and manage high-risk patients using HT and other in-home support.
While these developments outpaced the project, they also simultaneously set the stage for highlighting the Project’s early findings that confirmed the benefits of HT technology in managing patients with HF.
A final lesson learned relates to the challenge of coordinating (and supporting) a research/program collaboration within a large, integrated delivery system. In this Project, NEHI had influence but ultimately limited control over how the project unfolded or whether it succeeded within Atrius practice sites. While the IRB process was cumbersome, and the ability to influence recruitment, site-level operations, and organizational policy were limited, fortunately for this Project, the partnership between NEHI and the Atrius Health Foundation was an excellent one, with the Foundation CEO being a knowledgeable, creative, thoughtful and important leader for the Project. In the end, the innovation (the use of HT technology for monitoring and managing patients with HF) was proven and sustained at Atrius Health.
Solid preliminary results from this Project, increasing evidence and environmental support for the benefits of remote patient monitoring through the use of HT, and strong policy and organizational incentives from Medicare all led to full-scale adoption of HT technology for patients with HF at Atrius Health.