Home Heart Failure (HF) Care: Comparing Patient-Driven Technology Models (Montana)

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Summary:

This study assessed the impact of health information technologies (health IT) on clinical and financial outcomes for patients with symptomatic heart failure (HF). Nearly 5 million Americans have HF (the leading cause of hospitalization) with an estimated $40 billion annual cost. The information technologies we used include remote monitoring (telemonitoring) of vital signs and symptoms, an electronic health record system and clinical decision support systems. We tested a reproducible model for technology-supported HF management and assist purchasers, payers and policy makers in selecting health IT to improve clinical and financial outcomes. Patients were recruited from rural and urban primary care practices. We evaluated two different configurations of health IT. One was Technology Supported Case Management, a combination of telemonitoring and telephone nurse case management. The other was Technology Supported Self Management, a novel combination of telemonitoring plus an expert system that assesses vital signs and symptoms for risk of decompensation and guides patients through an individually-tailored self-care algorithm. The study used a two-stage, randomized, open-label, multi-site, controlled trial design. In Stage 1, the incidence of hospitalization and/or ER visits with Standard Care were compared to the incidence with Case Management to test the hypothesis that Case Management will have a lower incidence of ER visits and/or hospitalization than Standard Care. In Phase 2, Case Management was compared to Self Management to test the hypothesis that both interventions are equivalent in reducing ER visits and/or hospitalization. Secondary outcomes included total cost of HF care, functional and psychosocial status and satisfaction with care.

Home Heart Failure (HF) Care: Comparing Patient-Driven Technology Models - 2008

Summary Highlights

  • Principal Investigator: 
  • Organization: 
  • Funding Mechanism: 
    RFA: HS04-012: Demonstrating the Value of Health Information Technology (THQIT)
  • Grant Number: 
    R01 HS 015459
  • Project Period: 
    09/04 – 09/08, Including No-Cost Extension
  • AHRQ Funding Amount: 
    $1,454,568
  • PDF Version: 
    (PDF, 50.42 KB)


Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to support patient-centered care, the coordination of care across transitions in care settings, and the use of electronic exchange of health information to improve quality of care.

Business Goal: Synthesis and Dissemination

Summary: Increasing prevalence, hospitalizations, and deaths have made heart failure (HF) a major chronic condition in the United States. HF is the most common diagnosis in hospital patients age 65 years and older. Although mortality for HF is declining, the growing number of older adults who require HF treatment will have a substantial impact on national health care resources and expenditures. As a result of complex clinical management problems, elders with HF have high hospital readmission rates, ranging from 29 to 47 percent; with more effective management, an estimated one-third to one-half of these readmissions would be preventable.

The objective of this concluded grant was to assess the impact of health information technologies (ITs) on clinical and financial outcomes for patients with symptomatic (New York Heart Association Class II – IV) HF. The health IT in this study included remote monitoring (or telemonitoring) of vital signs and symptoms, an electronic health record system, and clinical decision support systems. This study tested a scalable, reproducible model for technology-supported HF management, which was intended to assist purchasers, payers, and policymakers in selecting health IT to improve clinical and financial outcomes.

Two different configurations of health IT were evaluated. One was Technology Supported Case Management, a combination of telemonitoring and telephone nurse case management. The other was Technology Supported Self Management, which combined telemonitoring with an expert clinical decision support system that assessed vital signs and symptoms and guided patients through an individually-tailored self-care algorithm. These two interventions had many features in common; for clarity, they will be referred to as Case Management and Self Management. Patients were recruited from geographically, socially, and ethnically diverse settings: rural areas of southern Montana and northern Wyoming, including a Native American population; urban and suburban Philadelphia, where the study included African American, Caucasian, and Hispanic patients; and a third site in Charleston, South Carolina, which was added to the project in 2005.

Specific Aims

  • Demonstrate improvements in access to care. (Ongoing *)
  • Demonstrate improvements in quality of care. (Ongoing *)
  • Reduce costs, particularly costs related to hospital readmission. (Ongoing *)
  • Improve patient involvement and satisfaction. (Ongoing *)

2008 Activities: Data collection concluded in July 2008. At the end of the grant period, analysis and dissemination efforts were ongoing.

Impact and Findings: The study was placed on hold under Institutional Review Board (IRB) direction and approval in late March 2005. A pilot study was developed by the researchers and implemented under IRB approval on 14 healthy subjects in April 2005, using the device and care protocols planned for the HF patient trials. As the research staff and the IRB wanted to be thorough in testing the technology, this pilot required pushing the timetable for the HF study out by at least 6 months. The first subject was voluntarily consented and enrolled in the study in June 2005. There were additional administrative challenges during the first year, and several of those challenges extended well into year two of the award. Changes among tribal leadership as well as the research team staff at the Montana/Wyoming site delayed implementation of the study there. Challenges related to participant enrollment at all sites necessitated an abbreviated data collection period of 9 months of active participation plus 3 months of followup monitoring. Patient enrollment concluded in May 2007; active study participation thus concluded in March 2008, with 3 months of additional data collection afterward. At the end of the grant period, data were not yet available to verify the project’s research hypotheses.

Selected Outputs

Goldberg LR. Be Careful What You Wish For - Managing Devices and Data In Your Patient's Home. Presentation at the Annual Conference of the Agency for Healthcare Research and Quality; 2008 Sept 8; Bethesda, MD.

Farberow B, Hatton V, Leenknecht C, et al. Caveat emptor: the need for evidence, regulation, and certification of home telehealth systems for the management of chronic conditions. Am J Med Qual; 2008 May-Jun;23(3):208-14.

Grantee’s Most Recent Self-Reported Quarterly Status (as of September 2008): Grantee did not provide self-assessment for the most recent quarter.

Milestones: Grantee did not provide self-assessment.

Budget: Grantee did not provide self-assessment.

*All aims of the grant were not completed prior to the scheduled conclusion of the grant (September 2008), yet, as other sources of funding have been secured, these aims are still targeted for completion.

Home HF Care Comparing Patient-Driven Technology Models - Final Report

Citation:
Goldberg L. Home HF Care Comparing Patient-Driven Technology Models - Final Report. (Prepared by St. Vincent Healthcare under Grant No. R01 HS015459). Rockville, MD: Agency for Healthcare Research and Quality, 2009. (PDF, 74.16 KB)

The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
Principal Investigator: 
Document Type: 
Medical Condition: 
This project does not have any related resource.
This project does not have any related survey.
This project does not have any related project spotlight.
This project does not have any related survey.

Pioneering AHRQ-funded Project Is Helping Patients with Heart Failure Manage Their Condition

Lee Goldberg, MDEvery day, Joseph gets a check-up -- without even leaving his house. 

He is taking part in an important project funded by the Agency for Healthcare Research and Quality (AHRQ) aimed at evaluating how a new, cutting-edgetechnology can help patients with congestive heart failure (CHF) to better manage their condition.

Joseph records his vital signs, including weight, blood pressure, and blood sugar, and sends the data across phone lines with the simple touch of a button. He responds to a series of prompts generated by the data he enters, asking, for example, about his food and medication intake and activity during the previous day.

The data are monitored in real time at St. Vincent Hospital (SVH) in Billings, Mont., and if something is wrong -- if his readings are outside normal limits -- Joseph is immediately prompted to speak to his doctor. Often, these readings give him the first warning signs that he should see his doctor right away. Frequently, Joseph says, those warning signs were more difficult to observe before.  In addition, daily reports are faxed to Joseph's doctor.

"It's like having a doctor right there in your house!" he says.

Remote telemonitoring holds the potential to greatly improve the treatment and management of chronic conditions. Lee Goldberg, MD, and his colleagues at the St. Vincent Healthcare Foundation (SVHF) in Montana, the University of Pennsylvania (UPenn), Billings Area Indian Health Services and the University of Louisville are exploring that potential, comparing two types of telemonitoring with standard care.

Thanks to the AHRQ grant, SVHF and UPenn have launched a two-year project to evaluate whether this technology can improve clinical outcomes for patients with CHF, enhance clinical decision support, and prove a cost-effective aid in treating CHF, which costs the health care system $40 billion annually. The grant is part of AHRQ's Transforming Healthcare Quality through Health Information Technology initiative.

"The hope is that this project will help us educate patients about their conditions, to learn what some of the triggers are, and what some the barriers to better care are," says Goldberg, Assistant Professor of Medicine, at UPenn. Goldberg and his colleagues are also poised to examine potential cost efficiency of a new type of technology-enhanced case management. In their study, the cost to monitor patients hovers just below or above $2,000 per patient.  Contrast that to the costs of an emergency room visit and admission to an inpatient unit from CHF-related complications, which can loom into the tens of thousands of dollars.

CHF affects 5 million people in the United States. People living with CHF must actively manage their condition, or risk facing serious complications, frequent hospitalizations, or even death.

"This treatment gives me the details I need about how my body is doing," says Mona, an energetic grandmother who, following chemotherapy, was diagnosed with cardiomyopathy, a disease that often leads to heart failure. "I've seen how the things I used to do--like eating salt--affected my condition, even when I couldn't see any symptoms," she said. "It's really changed my behavior."

The study is comparing two types of disease management that use telemonitoring technology and clinical case management -- either by a nurse at the SVH call center or through an automated voice response system managed directly by the healthcare provider. Patients track and transmit their vitals -- using a small machine that connects to a home phone line. What's created is an electronic medical record for each patient that gets updated daily.

"We've developed a sophisticated system based on an algorithm tailored to each individual patient," says Goldberg. "To the patient on the other end of the phone, that algorithm translates to an automated series of questions that they answer. Any triggers or signs that there is a problem will result in immediate feedback, and an instant alert to the patient's physician."

"Mydoctor really likes the reports," Joseph says. Prior to treatment, his physician needed to see him every week to monitor him. Now, thanks to the daily updates he gets on Joseph's condition, he only needs to see Joseph every four to six weeks.

"And I don't get sick and end up at the emergency room as often," says Joseph. "I can know what's going on before I get sick."

Goldberg and his colleagues are quite encouraged by the data they've received so far. "With the support of the AHRQ, we're looking forward to moving closer to uncovering whether this emerging technology can make a real difference in improving the outcomes and lives of people with CHF," he says.  

This project does not have any related emerging lesson.