Moore, Shirley M. PhD, RN, FAAN; Primm, Tonia AA, AS
The computer penetration rate has grown significantly over the past decade. Between 1994 and 1997 alone, personal computer ownership increased by 52%, modem ownership increased by 139%, and e-mail access grew by 397%.1 Data on the effectiveness of telehealth interventions that provide monitoring,2,3 information,4-6 support from professionals and peers,5-7 decision-making support,5,7,8 and behavioral change9-11 are appearing in the literature with greater frequency. These studies suggest that telehealth-assisted care can help patients adhere to a variety of health regimens by providing information, prompting, and feedback. Some of these telehealth interventions were designed specifically for persons with cardiovascular diseases. For example, Friedman9 found that computer-controlled telephone counseling improved adherence to medication, diet, and exercise in hypertensive patients. Artinian et al2 demonstrated that computer-based assistance for blood pressure control in community-based studies of inner city women is effective.
In the last few years, commercial Internet sites have become available to assist people in making cardiac-related lifestyle changes. In addition to Web sites designed to facilitate smoking cessation,12 3 electronic sites that address cardiac risk factor modification are the Interxvent,11 Stanford Heart Network (SCRIP),13,14 and HeartLinks10 programs. The Interxvent program is a telephone and computer information system for multifactor risk factor reduction in cardiac patients. The Stanford Heart Network exists primarily to assist professionals in using a multifactor cardiac risk factor reduction program based on the SCRIP face-to-face nurse-managed intervention with telephonic follow-up of patients. HeartLinks is a recent addition to the market, which offers communication with a clinician, discussion among patients, and tailored messages for health behavior change. Each of these projects is in the evaluation stage, however. Furthermore, most are using observational rather than randomized trials for evaluation, with little control over confounding variables and a lack of objective outcome measures.
The purpose of this article is to present information on the design and testing of 2 telehealth interventions for cardiac patients: HeartCare and E-CHANGE. The HeartCare project was a randomized trial of a home support program for patients after coronary artery bypass grafting (CABG) surgery. E-CHANGE is an Internet-based home support program designed to increase lifestyle exercise after a cardiac event. Lessons learned from these 2 projects regarding design considerations, system use, effectiveness, and research challenges are discussed.
In a recently completed study, HeartCare, a customized computer home support program for CABG surgery patients, was developed and tested.6,15 In this 3-group randomized experiment, recovery outcomes (symptom experiences, physical function, depressed mood, family functioning, and cardiac risk reduction behaviors) of patients receiving HeartCare were compared with the outcomes of patients receiving a lower technology home recovery program (an audiotaped) and patients receiving usual care. HeartCare patients had 6 months of tailored, sequenced CABG surgery recovery information and public and private electronic communication services via Web-TV.
The HeartCare system was designed to use automated algorithms to electronically tailor home information for patients based on factors taken into account by nurses when providing individualized care, such as information preferences, gender, reading level, comorbidities, and stage of recovery. Patients in the audiotape group received a validated, audiotaped recovery coaching program that included 16 minutes of information on what to expect during the first month of CABG recovery and management of recovery symptoms.16 All 3 study groups received usual care, which consisted of in-hospital discharge counseling, take-home information pamphlets about recovery, and instructions to call the surgeon's office should problems arise.
Patients accessed the HeartCare system an average of once a week (average session length was 15 minutes) over the 6-month period, with greatest use in the first month of recovery. After adjusting for baseline levels of comorbidity and cardiac functional status, the 3 study groups' recovery trajectories on the outcome measures were compared over weeks 1, 4, 12, and 26. Results, reported in greater detail elsewhere,15 showed that HeartCare patients experienced significantly fewer symptoms, less physical dysfunction, and less depressed mood than did patients in the audiotape group. No significant differences were found in family function or cardiac risk-reduction behaviors. The research team concluded that the HeartCare intervention did not have sufficient strength to achieve the desired lifestyle health behavior changes regarding diet and exercise. Thus, an electronic system that focused more intensively on behavior change was determined to be necessary, and the design of the E-CHANGE intervention described below was begun.
Recently, a pilot study was conducted to design and test E-CHANGE, an Internet-based electronic intervention consisting of a sequence of nurse-led activities designed to increase cardiac patients' exercise after a cardiac event. The E-CHANGE pilot intervention was based on a small-group, face-to-face behavior change program, CHANGE (Change Habits by Applying New Goals and Experiences),17 that used a cognitive-behavior change framework and contemporary health behavior techniques, including self-efficacy enhancement, problem-solving techniques to overcome barriers, relapse prevention techniques, and behavior feedback mechanisms. E-CHANGE consisted of 7 behavior change modules that participants accessed by Internet connection (Web-TV) in their homes to participate in structured assistance with exercise behavior change, an exercise tracking and graphing function, and communication with a nurse "coach." An outline of the content of the 7 behavior change modules is provided in Figure 1. The exercise diary and graphing function allowed participants to see their exercise progress and determine if they needed assistance to prevent exercise relapse. The e-mail function allowed the participant to communicate with the nurse coach; the nurse gave feedback about exercise and the use of the lifestyle change strategies and answered any questions regarding the behavior change modules. In addition, electronic information about healthy cardiac living and reducing cardiovascular risk factors was provided. The pilot E-CHANGE intervention was designed to be completed by the participant over a 3-month period, beginning in the last month of a formal cardiac rehabilitation program and ending 2 months after completion of the cardiac rehabilitation program. E-CHANGE was built to assist people in the transition from the structured, formal exercise of a cardiac rehabilitation program to free-living lifestyle exercise maintenance.
A pilot test of the E-CHANGE program was conducted with a convenience sample of 25 subjects: 7 participants in a cardiac rehabilitation program comprised the E-CHANGE group, who were matched with a comparison group of 18 cardiac rehabilitation program participants. Matching was based on sex, age, race, and comorbidity. All subjects (18 men and 7 women; 4 African Americans; mean age = 66 years) met the inclusion and exclusion criteria of having had a cardiac event (myocardial infarction, CABG surgery, and/or angioplasty), participating in a cardiac rehabilitation program, older than 20 years, speaks and reads English, and free of clinical features that constitute the criteria for high risk for safe participation in cardiac exercise programs.18-20 Most (86%) of the subjects had previous experience with computers, 24% had no Internet access or experience accessing the World Wide Web, and only 10% stated they used the Internet for health information. Exercise was measured in both groups for 6 months using portable heart rate wristwatch monitors and diaries.21-24
Tables 1 and 2 provide a summary of the findings of the E-CHANGE pilot study. Subjects in the E-CHANGE group averaged over 6 hours more exercise in the first 2 months (exercise adoption) as compared with those in the usual care group. Similar group differences in exercise frequency (number of exercise sessions) were found. Exercise intensity (time exercised in target heart rate zone) was also higher in the E-CHANGE group. In addition, as can be seen in Table 1, the metabolic equivalents in energy expenditure due to moderate- or higher-intensity exercise by those in the E-CHANGE group were 3 times that of the usual care group. Positive group differences of similar magnitude were also found in exercise maintenance (3-6 months after the cardiac rehabilitation program; Table 2). The last row of both tables indicates the percentage of participants continuing to exercise in the study groups at the end of the adoption and maintenance periods and shows that the percentage of individuals still exercising at 6 months was greater in the E-CHANGE group. Given the small sample size of this pilot study relative to the dispersion of exercise measures (large standard deviations), significance tests were not conducted. We conclude, however, that the E-CHANGE intervention is feasible and holds promise to be an effective way to increase exercise in cardiac patients.
Lessons Learned About Designing and Testing Telehealth Interventions for Cardiac Patients
Our experience with these projects has taught us much about designing, using, and testing telehealth systems for cardiac patients. In particular, we have learned about issues related to (1) balancing standardization and tailoring of electronic interventions, (2) adaptations specific to the purpose and context of use of the system, (3) nurse caseload for telehealth systems, (4) client need to learn how to use computer systems, (5) preservation of nursing values in electronic systems, and (6) need for theoretically driven content and structure of the telehealth system. Lastly, we have learned a considerable amount about conducting research on the effectiveness of electronic nursing care systems.
Standardization Versus Tailoring
In both projects, we learned that computer-delivered interventions need not be limited to standardized information and intervention approaches. There are a number of ways to filter and tailor information for patients. Information presented in the HeartCare system was tailored to each person based on timeframe after recovery, health status, comorbidities, cardiac risk factors, gender, and information preferences. To do so required that we (1) establish a standard recovery trajectory, (2) index all Web resources according to topic, (3) establish a tailoring algorithm, and (4) present pages to patients in a temporal sequence. Using the tailoring data collected by a nurse in a hospital discharge assessment, patient factors were matched to relevant Web pages. Each time a patient entered the HeartCare system from their home, the matching algorithm developed a personal set of Web pages containing tailored information in a series of menus that changed over 4 recovery periods. The menus were theoretically driven, time sequenced, and tailored to each patient. Tailoring was made apparent to patients through menu heading labels as "Important Recovery Information," "Special Information for You," and "Especially for Women." A standard recovery trajectory that included 4 distinct phases of recovery over the first 6 months of recovery was determined for patients: 1 to 2 weeks, 3 to 6 weeks, 7 to 12 weeks, and 13 to 26 weeks postdischarge.6 These phases were chosen based on a review of the literature on CABG surgery patients' time-relevant information needs and recovery goals.
Although providing information at these times was chosen because it is consistent with changes in recovery needs, it also was recognized that not all patients follow this recovery trajectory. If necessary, the natural progression of recovery information based on a fairly predicable trajectory was adjusted based on the occurrence of untoward events, such as complications that arose or situational changes in patients' lives. There was a wide variance in physical functioning postoperatively among the HeartCare participants, with some requiring delays in the timing of information that was provided, whereas other participants' recovery information was advanced or retrieved from the next phase based on clinical relevance or if the patient desired particular information not yet readily accessible.
In E-CHANGE, a tailoring algorithm that provided tailored information based on sex, race, beginning level of exercise, and past experiences with exercise was developed. For, example, in a section designed to increase exercise self-efficacy, short stories were added, in which women who were African Americans and with little past exercise experience received a story of exercise success from a woman who matched their profile (female, African American, little past experience with exercise). Information was timed based on the patient's progression through the 7 behavior change modules. Patient completion of a module triggered access to the next module. Again, manual adjustment by the nurse could be done if needed. In E-CHANGE, the opportunity to graph exercise over time and review the results of the graphed information in several formats and over several time periods (weekly, monthly, etc) allowed participants to receive feedback on their behavior and reflect on the success of the new strategies that they were applying to increase their exercise. Thus, we learned that computer-delivered interventions can capitalize on the standardization that computers allow while also permitting the use of elaborate algorithms to tailor information.
Purpose and Context of Use
Another important lesson learned from our experience with telehealth interventions for cardiac patients is that the purpose and context of use of telehealth systems are important considerations in their design. Improving outcomes in cardiac patients is characterized by such diverse goals as symptom management, regaining optimal functional status, integration of a new sense of self, return to social roles, and cardiac risk factor modification. In our projects, the 2 interventions had different purposes. The HeartCare project was built to provide support and information for self-care during a recovery period after an acute cardiac event, whereas the E-CHANGE intervention was designed to assist cardiac patients in making long-term changes in behavior, in this case, lifestyle exercise. We learned that different features were needed for a system designed to support recovery as compared with one built to promote long-term health behavior change. For example, in the HeartCare project, during the early recovery period after a cardiac event, participants entered the system almost daily (some people entered multiple times a day) as they sought assistance for symptom management, whereas in the exercise lifestyle E-CHANGE project, the nurse coach had to prompt individuals to enter the system at least weekly during the first few weeks to complete the behavior change modules. We found that patients' perception of the "urgency" of their need for information or support influenced their behavior regarding use of the system. We also learned that the features and content of HeartCare that assist patients in understanding their recovery and engaging in self-care for symptom management were vastly different from the features that provide the interactive content needed in the E-CHANGE system, in which patients completed short vignettes, self-evaluation activities, and exercise graphing.
Electronic Care Nurse Caseload
Determining the caseload for nurse management of an electronic care system is an important issue to be studied as more computer-assisted care approaches are developed. The intensity of nurse time to manage a caseload of patients on an electronic care system (how frequent the nurse needs to log in and how long it takes the nurse to interact on the computer for a set of patients) is an important issue. We have found that nurse time online and the resultant caseload that can be handled are dependent on the purpose of the electronic system. A system designed to assist someone in engaging in long-term behavior change needs less frequent nurse moderation than does a nurse monitoring system; however, we found that E-CHANGE required considerably more total time on the part of the nurse than did the HeartCare system. This was primarily because nurse review and feedback on the behavior change module activities completed by subjects in E-CHANGE required considerable time. Because sustained contact with a healthcare professional has been shown to enhance exercise behavior change,25 the nurse in the E-CHANGE system engaged in considerable online interactions with the patient. One way to reduce the time resources required for this type of care is to standardize some of the nurse response messages, such as nurse messages acknowledging that patients have electronically recorded their exercise as instructed.
Client Need to Learn How to Use Electronic Systems
We found that teaching the navigation and use of an electronic care system was an essential part of our intervention. Patient access to and ability to use the technology cannot be assumed. We gradually introduced the functions available on the systems, moving from the simple to the more complex functions. In both the HeartCare and E-CHANGE systems, we did this over a period of 2 to 3 days. For example, in E-CHANGE, we introduced the patients first to the more common functions of Email-to-the-Nurse and the behavior change modules and then engaged them in how to use the exercise diary and graphing functions. We included sample and practice exercises. In the HeartCare project, patients were introduced to the system in the hospital on the third to fourth postoperative day and also received a 10-minute quick refresher training session on the first day at home. As the patient first entered the electronic system, we "seeded" the system with messages from the nurse to which the patient needed to reply. This assisted the nurse in knowing if the patient was able to use the different components of the system and troubleshoot problems early.
Preservation of Nursing Values in Electronic Systems
Nurses have a set of professional values that must be preserved as electronic nursing care systems are designed, implemented, and tested. Nurses will be more likely to use computers as assistive to care if the nursing values of individualizing care, maintaining caring interpersonal relationships, and fostering autonomy are preserved in the design of electronic care systems. Individualizing care to the unique needs of patients is a basic precept of nursing care. As we demonstrated in the HeartCare and E-CHANGE projects, movement away from the "one size fits all" approach to providing information, support, and services through electronic systems can be accomplished by the use of tailored algorithms and design features specific to the purpose and context of the system's use.
Another nursing value to be preserved in the design of telehealth interventions is the ability to form and maintain caring interpersonal relationships with patients. A number of features can be included in the design of electronic care systems to support relationship building between the nurse and the patient. Trust building is accomplished by genuine caring and encouragement to patients to share their thoughts and feelings. To support relationship building in the E-CHANGE program, a picture and short biography of the nurse (in which the nurse introduced herself as a coach) were included on the introductory Web pages. We carefully crafted questions in the system introductory screens that opened a discussion between the nurse and the patient about the preferred names (first or last) to be used by both in their system interactions. The introductory screens also included statements of disclosure by the nurse to the patient about her background and experience in providing care to cardiac patients who are engaging in health behavior change as well as an invitation to patients to share their backgrounds regarding exercise experiences with the nurse. Patients were encouraged to tell their "stories" about their cardiac event, recovery, and current interest in improving lifestyle exercise. Although many of the introductory screens were scripted and standardized, they supported a systematic and effective approach to building a helping relationship with the patient.
Fostering patient autonomy is another value central to nursing. Electronic systems of care can foster patient autonomy in several ways, such as including decision-making components,7 teaching problem-solving skills,17 offering office visit preparation materials, and providing information that is appropriate to their needs in a timely way. Assisting patients in learning to use Internet healthcare resources is a health literacy issue today that must be addressed to assist patients become partners in making decisions regarding their health.
Theoretically Driven Content and Structure
Theory-based interventions should provide the most utility for testing the effectiveness of telehealth interventions. We have learned that the theories driving the content of telehealth interventions usually differ from the theories driving the structure of the interventions. The content of the HeartCare system was based on the self-regulation theory of Johnson,26 which focuses on patient self-management through cognitive restructuring, and Litwak's theory27 addressing the complementary nature of formal and informal caregiving systems. Several theories on health behavior change were used in the E-CHANGE intervention, including expectancy-value motivation,28,29 problem solving,30 relapse prevention,31 and self-efficacy enhancement.32 In both projects, in addition to the theories driving the content, another set of theories were used in the design and evaluation of the systems, including theories from the fields of ergonomics,33 systems engineering,34 informatics,35-37 economics,38 and linguistics.39 Importantly, we learned that an interdisciplinary team is necessary to optimally design and evaluate telehealth interventions.
Systematic evaluation of the effectiveness and efficiency of electronic interventions is needed. Several challenges have arisen in our experience using experimental designs to test the effectiveness of electronic interventions. For example, given the rapid growth of knowledge and change in computer technology, we have found that it is difficult to "freeze" the intervention during the study period. A randomized trial examining patient outcomes over time may take a year or more, yet during this period, it is tempting to update the intervention to take advantage of new capabilities in technology that may enhance the intervention. For example, in the HeartCare project, the ability to add a "search" component to the intervention became technologically available during the study period. Our study team carefully considered the advantages of such a feature for our subjects and decided to add the feature, although it was an alteration in the intervention during the trial period.
Another research challenge was the development of the intervention nurse study protocols for this relatively new type of nursing. Decisions regarding the frequency and type of nurse moderator contacts, whether electronic contacts should be nurse initiated or patient initiated, the balance of standardized messages versus individualized messages, and when to break protocol and pick up the telephone to handle an emergency situation were issues that needed to be addressed by the study team. Reducing intervention drift by the nurse moderators over the study period also was a challenge. To manage intervention drift, we used written materials containing step-by-step directions for the nurse management regarding patient situations that might arise, intervention check lists, and monitoring of the nurse interactions by a third party (with subject informed consent). Intervention dose also was difficult to measure. The study teams struggled with definitions of the dose of an electronic nursing intervention. We measured intervention dose using the number of log-ins, time online, number of intervention modules completed, number of self-assessments completed, and the number of times data were graphed.
In summary, electronic nursing care systems represent a new environment for therapeutic nurse-patient relationships and the delivery of care. The experiences and suggestions provided herein about the design, use, and test of electronic systems may be of help to other researchers designing telehealth interventions and assist our progress toward realizing the future promise of these interventions for cardiac patients.
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