Infection, Rejection, and Hospitalizations in Transplant Recipients Using Telehealth

By Leimig, Renata Gower, Gayle; Thompson, Denise A; Winsett, Rebecca P

Context-Telehealth technology serves individuals who live in geographical areas that prohibit easy access to specialized health care and can provide transplant recipients with access to transplant center personnel for adjunctive follow-up care. Objective-To compare infection, rejection, and hospitalization events in subjects randomized to telehealth or to standard posttransplant care.

Study Design, Study Participants, Setting and Research Procedure- This longitudinal prospective study compared transplant outcomes (infections, rejections, and hospitalizations) of 106 subjects who were randomized to either the telehealth (n = 53) or standard care (n = 53) group and met the 6-month study end point. Sex, race, and transplant type were evenly distributed within the 2 groups. Subjects received primary follow-up care from nurse practitioners. The telehealth visits were conducted via live interactive sessions with digitized equipment used to perform physical examinations.

Main Outcomes-Infections, rejections, and hospitalizations were summarized for each of the groups. Subgroup analyses were performed by sex, transplant type, and time since transplant.

Results-No differences were found between the telehealth and standard care groups for infections, rejections, or hospitalizations at the 6-month data end point. Overall, females had twice as many infections as males (P = .01). In this analysis, group assignment did not affect study outcomes.

Conclusions-The rates of infection, rejection, and hospitalization in a sample of primarily long-term transplant patients did not differ between patients who received telehealth follow-up and patients who received standard care, indicating that this delivery system can be used to provide follow-up care after transplant. (Progress in Transplantation. 2008;18:97-102)

Surveillance of organ dysfunction and detection of infection and rejection in transplant recipients is crucial for long-term survival of grafts and patients.1 Although the usual standard for visiting a health care provider is for treatment of an acute problem, in transplant recipients, the ongoing clinical follow-up is for prevention of acute complications. It is important for the recipient to return to a normal life; however, it is just as important for recipients to receive close followup care at their transplant center and from their local health-care provider. In a study of heart transplant recipients, attendance at clinic appointments was associated with better medication adherence,2 supporting the importance of ongoing clinical follow-up.

Appointments for transplant recipients are intended to help detect complications, monitor other comorbid diseases, and detect 2 major problems after solid-organ transplantation: the often subtle signs of infection and rejection.3 The down side to the increased number of visits to the health care provider or to the transplant center is that many transplant recipients travel outside of their home city to attend clinic. Ongoing long-term follow-up can be a double-edged sword. Although the transplant recipient needs and wants the appointment, the travel and the time waiting at the clinic office may serve as deterrents to attendance. Concurrently the transplant center continues to expand the number of patients it must follow, creating an overloaded clinic schedule. Given this situation, telehealth seems a reasonable delivery system to use; however, to date there have been no systematic investigations of the use of telehealth in transplant recipients.

Telehealth, defined as live, interactive, audio communications between health care provider and patient,4 is the focus of this study. Transplant recipients who live in areas distant from the study transplant center were randomized to either receive health care via telehealth or continue current standard care practices via in-person clinic attendance. The purpose of this analysis was to determine if infection, rejection, and hospitalization events were altered by using telehealth as compared with patients who received standard care. Thus, this study effectively tested the hypothesis that quality posttransplant care can be provided by using telehealth without additional risk of organ loss, hospitalization, or infection, while enabling the recipient to avoid undue travel for follow-up care. A brief overview of telehealth is provided, followed by a discussion of provider concerns regarding its reliability, patient and provider satisfaction with telehealth, and a review of studies focused on the outcomes of telehealth.

Literature Review

Overview of Telehealth

Technology in health care has been used since the telephone became universally available.5 With current advances in television, cable security, video streaming, and the Internet, use of technology in health care has advanced beyond simple follow-up phone contact with patients.5 Initial uses of advanced technology processes first emerged with professionals evaluating test results remotely from where the test was performed.6 This approach is known as store and forward technology; today it is used routinely in radiology,6,7 pathology,6,7 cardiology,7 and ultrasound.7 Access to health information (store and forward) and educational telehealth are the most useful forms of telehealth.7 Videoconferencing is rapidly replacing teleconsulting, which connected the health care professional and the patient in different locations via telephone.6 Patient visits via live videoconferencing are used in dermatology and psychiatry.7 Most published studies are limited to pilot projects and studies of short-term outcomes.8

Home health nurses use telehealth to monitor blood glucose values, with the ability to download data from blood glucose monitors as well as obtain blood pressure readings directly from home blood pressure monitors.9 Equipment is now available in the patient’s home to monitor physiological parameters of patients with chronic obstructive pulmonary disease and congestive heart failure.10 Home health agencies now use telehealth to follow up patients with mental illnesses,11 persons with acute infections,12 elderly patients with coronary artery bypass grafts,13 lung transplant patients,14 and hemodialysis patients.15

Reliability of Telehealth As a Delivery System

A significant concern for providers is the ability to recognize and treat illness appropriately, particularly when the provider and the patient are not in the same room. A study to evaluate the ability to diagnose and treat common acute illnesses was performed in a pediatric primary care center.16 Interrater reliability in diagnosis was tested with duplicate examinations performed on patients by both a telehealth physician and a regular treating physician. No significant differences were found in diagnosis between the 2 groups for all acute illnesses except for the discordance for acute otitis media. Poststudy evaluation of all study physicians indicated that the diagnosis of otitis media from the telehealth visit was more likely to be the correct one because the equipment provided in telehealth allowed the physician to make the diagnosis on the basis of evaluation of high-quality images of the tympanic membrane rather than on the basis of a glance as practiced in an in-person examination.16 Another study evaluated the feasibility and accuracy of cardiopulmonary examinations in 50 patients with heart failure by 2 cardiologists: one using an electronic stethoscope transmitting through a digital network line and the other using a conventional stethoscope. Investigators found that the remote examination was a feasible and reliable method of assessing patients.17 Other interrater agreement studies have been done with evaluation of cervical smears in telecytology,18 store- and-forward images in teledermatology,19 histologie specimens in telepathology,20 diagnostic reliability in telepsychiatry,21 and forensic evaluations22 with all results indicating that telehealth produces outcomes similar to outcomes achieved with conventional methods.

Satisfaction With Telehealth

Studies suggest that patients’ satisfaction with telehealth tends to be high. A focus group study12 to evaluate satisfaction and experiences of individuals transitioning from hospital to home telehealth showed that patients had an overall positive experience with telehealth. In another home telehealth study10 of patients with chronic obstructive pulmonary disease and congestive heart failure, researchers also found good satisfaction with telehealth among patients, although telehealth care was not a significant predictor of health and well-being. Patients’ satisfaction with teledermatology was significantly related to quality of life; patients reporting lower quality of life tended to prefer face-to- face rather than telehealth contact with their dermatologist.23 In a study24 conducted in the rural regions of northern Ontario, Canada, where patients experience unfavorable weather, geographic isolation, and significant costs to ensure delivery of care, home parenteral nutrition patients were generally satisfied with this alternative method of care. Satisfaction was also high in a school-based telehealth program where healthcare providers, children, and parents found telehealth in the school system an acceptable alternative to traditional health care.25 However, in a study26 that compared views on telehealth among health care professionals and patients, patients consistently demonstrated more positive perceptions of telehealth visits than did their health care providers, who demonstrated more discomfort with the telehealth system. Health Outcomes Studies

Few outcome studies have been focused on telehealth. A recent study27 compared outcomes in patients who were enrolled in the Cancer Care Coordination/ Home-Telehealth program from the Veterans Affairs with outcomes in veterans receiving standard care. Results indicated that patients in the telehealth program used fewer preventable services and had fewer noncancer clinic visits than did patients who received standard care.27 In another study” in Australia, researchers found that mental health patients enrolled in a telehealth program reported greater treatment adherence and compliance than did patients in the control group. In the Canadian parenteral nutrition study24 mentioned earlier, patients who were followed up via telehealth had catheter sepsis rates similar to rates reported in the literature. The infection rate, however, was not compared with the rate in a group followed within the traditional health care system, limiting the generalizability of the study results.24 To date, no telehealth studies exploring infection, rejection, or hospitalizations as outcomes in a transplant population have been reported.

Study Significance

Telehealth is emerging as an important delivery system with documented satisfaction among patients and diagnostic reliability. To facilitate widespread use of this technology, additional studies are needed to show that the health outcomes of patients followed up with telehealth and patients who receive standard care are equivalent. As we move toward patient-centered care, telehealth can provide alternative methods to help patients achieve their goals to remain healthy. Although the University Health Network of Toronto has not published their outcomes, telehealth has been successfully used in Canada with pretransplant evaluations, donor consultations, education, group support, and some posttransplant follow-up care (personal communication, Sharon McGonigle, MSN, August 29 and 31, 2007). No health outcome studies have been done in patients followed up with telehealth after transplant, which highlights the importance of this study, particularly for patients who live long distances from a transplant center. This study is a preliminary report of health outcomes of transplant recipients who received care via telehealth.

Methods

Study Design

This study was part of an ongoing longitudinal randomized control trial that examined the impact of care delivery via telehealth on health-related quality of life, adherence, and satisfaction between the 2 delivery systems (telehealth vs standard care) and transplant outcomes (infections, rejections, and hospitalizations). The university’s institutional review board approved this study.

Study Participants

To be included in the study, subjects were required to have received a transplant at the host center, be older than age 18, understand English, and be followed up primarily by a nurse practitioner at the time of recruitment. Subjects in this analysis were enrolled in the study between August 1, 2005, and October 31, 2006.

Setting

Within the transplant clinic, an examination room was set up to be the receiving site where 1 of the 3 posttransplant nurse practitioners visited with patients located in 1 of 3 available remote locations. Each site was equipped with a television monitor, a Polycom H.323 video-conference camera, an analog stethoscope with headphones for confidential auscultation, a hand-held close examination camera, and an otoscope. The telehealth infrastructure used dedicated point-topoint T-1 lines capable of transmission speeds of 1.544 Mbps. The equipment was connected to the University’s telehealth network via dedicated Cisco network switches and router for remote real-time diagnostic and preventive maintenance upgrades.

Research Procedure

Subjects were randomly assigned to either telehealth or standard care by a computer-generated concealed allocation sequence, after the informed consent process was completed and the signed written informed consent document was obtained. Telehealth subjects self- selected 1 of the 3 telehealth remote sites that were developed for this study. Telehealth subjects were expected to choose the site located geographically closest to their residence, although doing so was not required. Sites were located 19, 90, and 120 miles from the standard care clinic.

Patients assigned to standard health care were seen through the usual procedures in the transplant clinic. Laboratory results, review of medication, and physical assessment were performed by the nurse practitioner according to current transplant clinic policies. Telehealth visits were conducted in the same pattern as the standard care visit, but via a live interactive session. Transplant outcomes were collected from subjects’ medical records at study entry and at 6 and 12 months after entry. Infection was defined as any documented bacterial, viral, or fungal infection that necessitated treatment with antibiotic, antiviral, or antifungal medications. Rejection episodes were defined as health care provider documentation of rejection with biopsy verification. Hospitalizations were defined as inpatient admission for greater than 24 hours for any reason.

Telehealth Clinical Procedure

At the beginning of each visit, the trained telehealth nurse at the remote site obtained blood pressure, pulse, and weight and reviewed the patient’s medication list by intake, dose, and schedule. The nurse also took notes on any physical symptoms that needed to be addressed during the telehealth session. Medical record forms were faxed between sites before the nurse practitioner entered the room in the transplant clinic. Once the intake information was obtained, connection with the transplant clinic’s receiving unit was initiated. The telehealth system was operated by a telehealth coordinator present at the nurse practitioner’s receiving unit. The camera focused on the patient so that behavior, facial expressions, and body language were easily seen by the nurse practitioner. With picture-in-picture capability, the patient saw the nurse practitioner as well as himself in the TV monitor. Because adherence to antirejection medication is crucial for the survival of the transplanted graft, the nurse practitioner would also double-check the medication intake before reviewing laboratory results and completing the physical examination with the available digitized equipment. At the end of the visit, all orders (laboratory or otherwise) were faxed to the patient and a follow-up visit was scheduled. The telehealth nurse at the remote site would also review discharge instructions with the patient. In the event the patient had signs or symptoms that required urgent measures, arrangements for overnight hospital izations or same-day testing could be made. If deemed necessary by the nurse practitioner, patients with nonurgent problems could be scheduled to be seen in the standard care clinic.

All statistical analyses were conducted by using SAS version 9.1 statistical software (SAS Inc, Cary, NC). Chi-squared tests were used for univariate analysis between categorical variables. Poisson regression models were used for multivariate analysis to investigate associations between number of events (dependent variable) and race, sex, transplant type, and time since transplant (independent variables). The maximum likelihood method was used to estimate the odds ratio. Probability values were set at .05.

Results

Of the 121 subjects who entered the trial, 106 have met the 6- month data point and were included in this analysis. The telehealth group and the standard care group each had 53 subjects. The distribution of the 106 recipients by organ transplanted was as follows: 82 kidney transplants, 11 kidney-pancreas transplants, 2 pancreas alone, and 11 liver transplants. Patients were a mean of 5.6 years after transplant. Race, sex, and transplant type were evenly distributed between the 2 groups (Table 1).

During the first 6 months, the telehealth group (n=53) had 116 clinic visits. Of these visits, 59 (50.9%) were via the telehealth equipment and 57 (49.1%) were conducted in the regular clinic rather than via telehealth. The telehealth group had 32 documented infection events, 3 rejection episodes, and 10 hospitalizations. The standard care group (n = 53) had 139 visits during the 6-month period. A total of 31 documented infection events, 3 rejection episodes, and 10 hospitalizations occurred in the standard care group. No significant differences were found in the numbers of infections, rejections, or hospitalizations between the 2 groups (Table 2).

No differences between groups were found for subgroup analysis by sex, transplant type, or time from transplant. As the 2 groups did not differ in outcome, group assignment was subtracted from the model. When outcomes were evaluated without group assignment, sex of the patient was associated with infections. Females had significantly higher risk for infections than did males (P = .01), which was expected, because the incidence of infections females is twice as high in female than in male renal transplant recipients.28 No significant associations were found between the study outcomes and transplant type or time from transplant.

Discussion

In the analysis evaluating health outcomes (infection, rejection, and hospitalization events) between patients assigned to the telehealth group or the standard care group, no significant differences were found (Table 2). A significant association was found, however, between sex of the patient and infection episodes, with the odds for women higher than men.

Patients assigned to the telehealth group had a number of standard care visits in the transplant clinic. Healthcare delivery was not dictated by the study protocol, but the unusual number of standard care visits in the telehealth group was surprising and was considered a confounding variable. Review of the medical records did not show any new documented comorbid diseases, so that the number of standard care visits of patients in the telehealth group was most likely due to several factors such as hesitancy of the clinic personnel to use the telehealth equipment, patients’ hesitancy to lose face-to-face contact with the nurse practitioner, or patients wanting to see the practitioner or a physician in person. Further evaluation of the use of standard care in the telehealth group is ongoing. We were concerned that the transplant nurse practitioners were worried about both the loss of face-toface evaluation and the uncertainty of the ability to catch new diagnoses with telehealth. Hesitancy with new technology is common, and incorporating novel diagnostic equipment requires adequate time, orientation, and resources to adapt the new technology into practice. Findings from a study examining the adaptation of nurses to computer access from their workplace, a rural nursing home with a distant medical center,29 identified 3 major concerns for the staff. Two of the 3 major concerns identified were on-site staff knowledgeable and willing to provide immediate assistance and mentoring of individuals to build confidence with the new equipment. Acceptance of the computers was more likely if exposure to technology had occurred outside the facility so that encouragement of the staff to use the equipment for other purposes facilitated adaptation.29 Using these 3 identified outcomes guided our orientation and ongoing support for the nurse practitioners. The preliminary findings of our study indicated that we still need to focus on adaptation of nurse practitioners to the specialized diagnostic equipment.

Implications for Clinical Practice

Our initial findings are quite promising, but must be viewed as preliminary because of the study’s small sample size. Subjects had received their transplanted organs a mean of 5 years earlier. Thus, major concerns during health-care visits focused on review of chronic comorbid conditions rather than on the transplanted organ. As a result, the relevance of these findings in recent transplant recipients is unclear. Continued evaluation of the diagnostic capabilities of telehealth equipment as well as continued focus on adaptation of nurse practitioners to the technology is required. These adjustments will allow telehealth to be used during all phases of posttransplant follow-up.

Conclusion

Preliminary data show that it is possible to maintain the same level of adequate surveillance to prevent infections and organ dysfunction in long-term organ transplant recipients. Implementation of a telehealth program in the transplant clinic may include a combination of telehealth and standard care visits depending on time from transplant or the complexity of the posttransplant course. Diagnostic confidence is key to incorporating telehealth into the transplant clinic. Further evaluation will help clarify the issues surrounding adaptation to telehealth in the transplant setting.

Acknowledgment

The authors thank Dr Mona Wicks for content review and Ms Gail Spake for editorial revisions made in this manuscript.

Financial Disclosures

This study was supported by a grant from the National Institutes of Nursing Research, R01 NR-008917.

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Renata Leimig, BA, Gayle Gower, RN, BSN, Denise A. Thompson, PhD, Rebecca P. Winsett, PhD

University of Tennessee Health Science Center

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