Appropriate, efficient, and cost-effective care for older adults remains an important objective for both patients and providers in healthcare. It is predicted that the number of adults older than age 65 will double in the next 20 years[4
]. These older adults are at higher risk for accidents and geriatric conditions such as urinary incontinence [12
]. The large post-World War II cohort will require changes in how healthcare is delivered as a result of both increased numbers and required intensity of care. The utilization of efficient systems may help to mitigate some of the potential shortages of staff and resources. Telemonitoring has emerged as one possible solution to help efficiently care for older adults[13
]. The potential advantages of telemonitoring are many; however, one must look at the potential costs involved with such a system.
The earliest methods of home monitoring were limited to periodic nurse telephone support, with or without other limited forms of data transmission such as cardiac rhythm monitoring. Telephone-based care has been used successfully, particularly in congestive heart failure (CHF), with a demonstrated 50% reduction in hospital readmissions through the use of nurse telephone support with remote cardiac rhythm monitoring[14
]. However, the clinical desire to provide more frequent and detailed monitoring of expanded physiologic parameters and to have a remote "face-to-face" interaction with the patient has lead to the development of more sophisticated telemonitoring equipment. This equipment provides direct visual and audio communication through video monitoring and expands the ability to frequently assess patient status via capabilities (e.g., oximetry, spirometry, direct vital sign measurement, remote auscultation, blood glucose measurement). It can be monitored in a synchronous fashion to facilitate early intervention. One might easily imagine this type of technology to have the greatest impact potential for older adults who may be challenged to collect their own physiologic data and communicate well solely over the telephone.
Telemonitoring using updated equipment has been quite successful for chronic disease management. The initial use of telemonitoring targeted patients who live long distances from medical or specialty care[15
]. Increasingly, telemonitoring has sought to help individuals with chronic illnesses (e.g., CHF, chronic obstructive pulmonary disease [COPD], diabetes) that require daily or frequent monitoring. The goal of telemonitoring is to identify and treat symptoms, functional decline, and other key changes in medical status before the patient requires acute care in an ED or hospital or long-term care in a skilled nursing facility. The results of many demonstration projects and pilot studies evaluating the effectiveness of telemonitoring have been favorable; however, the projects have been often limited to a single disease model. Diabetes has been widely studied in randomized controlled trials[16
]. In the diabetic population, using a meta-analysis, on aggregate, the patients favorably endorsed home telemonitoring and had lower hospital readmissions and improved hemoglobin A1c levels[3
]. In the CHF studies, all-cause mortality dropped by 40% and hospitalizations by 20%[3
]. Some of the CHF studies did not demonstrate a decrease in ED visits compared with usual care[19
Patients with mixed chronic diseases remain the most understudied group, yet many older adults have more than one chronic illness[20
]. In a randomized controlled trial of 53 patients with CHF, COPD, or a chronic wound, fewer patients were re-hospitalized in the telemonitoring group, which used a device capable of videoconferencing and physiologic monitoring of vital signs, spirometry, and pulse oximetry[21
]. In a similar study of 104 patients with CHF, COPD, and/or diabetes, Noel[22
] demonstrated reduced bed days and ED visits when patients at home used a device capable of measuring vital signs, blood glucose levels, three-lead electrocardiography, pulse oximetry, auscultation of heart and lungs, and pain assessment. However, cost analysis was limited to a previous 6-month comparison, making interpretation difficult. Videoconferencing was not available for this study. In a recent review for the Canadian government, this study was the only publication on elderly patients with mixed chronic disease given the quality score of B (good), with the remainder deemed to have significant shortcomings[3
The primary concern for many healthcare organizations undertaking telemonitoring is the cost justification for the clinical and capital investment. While the cost benefits of reduced utilization and functional decline are self-evident, the costs of telemonitoring have not been well-analyzed to date. In an example analysis of a single published work, the estimated annual cost for patients in the telemonitoring group was $14,678, compared with $10,161 for the usual care[3
]. However, remaining methodologic issues suggested lack of comprehensive cost accounting and validated staffing protocols. Moreover, the quality of the economic evaluations to date have been deemed poor, and the report called for more studies of higher methodologic quality to include more diverse patient populations with CHF, diabetes, and COPD to increase external validity[3
The proposed study will address the need for more rigorous study of the role of home telemonitoring in elderly patients with mixed chronic disease. We will use a unique, validated risk assessment index to systematically identify patients at high risk for hospitalization, ED visits, nursing home placement, and death. The study size will exceed the largest study to date for the mixed chronic disease population. We will provide a more robust analysis of key clinical outcomes and economic impacts not yet fully characterized and use these results in future studies comparing telemonitoring to care-transition programs. We will also use the results to define populations most suitable for these and similar interventions targeted to sustaining late-life independent living. This study may also provide a background for other monitoring devices.
The strengths of this study include the randomized trial approach, which will allow the groups to be randomly assigned and minimize the differences between the groups. The usual care group includes the standardized followup for patients, which is the standard of care for high-risk elderly patients in Rochester. The telemonitoring intervention group is based on cutting-edge technology for monitoring at home. The clinical group includes experienced midlevel nurse providers and RNs who oversee the management of home medical care. Patients also have a connection with their primary physician, who is informed of major clinical changes. Lastly, the group is maintained in a closed medical system of two major hospital groups in Olmsted County, with most care provided by the PCIM.
The major limitation is the lack of blinding inherent with two disparate groups of patients. This could lead to the Hawthorne Effect and lead to bias. It will not be practical to blind the providers or the patients receiving home equipment and constant monitoring at home. The limitations imposed will be mitigated despite the lack of blinding. Specifically, hospitalizations and ED visits as the primary outcome should occur regardless of arm or treatment and are not subjective measures. There is the potential for recall bias on self-reported outcomes; however, the primary outcomes should be captured by the medical record in nearly all cases.