The successful use of implantable ventricular assist devices (VADs) in the United States during the early 1990s transformed the treatment of advanced heart failure (AHF). Since then, the design and use of VADs evolved from a bridge-to-heart transplant (BTT), bridge-to-myocardial recovery (BTR) to an alternative to transplant referred to as destination therapy (DT)1,2 Multiple studies have consistently shown that the safety and efficacy of VADs are life-sustaining while enhancing quality of life (QOL) when compared with conventional AHF medical management.1,3 However, despite major advancements in technology, most notably in smaller and more durable devices, the daily care required for VADs remains complex for patients and their caregivers.4,5 Typically, VAD care consists of not only a technical, but a nontechnical daily regimen, to 1) maintain the functionality of the VAD components, 2) reduce AHF symptom burden, 3) prevent complications, and 4) ultimately improve QOL.4,6
Caregivers, often a patient’s family member, provide or assist patients in completing the daily VAD care regimen, manage and respond to VAD-related emergencies, and serve as a liaison between the patient and the VAD care team (e.g., VAD nurses/coordinators).4–6 It is worth noting that during the postimplantation hospitalization, the patient’s ability to “self-manage” the complex, daily VAD care regimen is, at times, hampered by functional and physical limitations, as well as hemodynamic instability. Furthermore, the patient’s lack of self-confidence (low self-efficacy) to perform VAD self-management results in high dependency on caregivers.5
Thus, the availability of a dedicated caregiver remains an important criterion for a patient to be considered initially for a VAD implant. It is also customary that all VAD centers in the United States expect patients and/or caregivers to manage the VAD after hospital discharge.7 These customary practices have been in place since the first use of VADs, nearly 3 decades ago.7,8 Yet, there exists a paucity of research about the extent to which the patients and caregivers are prepared for VAD self-management before hospital discharge. The purpose of this study was to explore the process of preparing patients and caregivers for VAD self-management before hospital discharge and to describe their perceived experiences of the discharge process.
Design and Sample
We conducted a descriptive study using a portion of the data that were collected from an instrumentation research (i.e., parent study) that was approved by an institutional review board and has been published elsewhere.8,9 For the purposes of clarity, some of the procedures employed in the parent study are described here. Study participants were recruited from four online support groups that were not publicly accessible. Member of these support groups were mainly VAD patients and caregivers. At the time of the study, there were over 900 members (VAD patients and caregivers) in these groups. A one-page recruitment flyer containing study purpose and contact information of the principal investigator (PI) was circulated on-line with assistance from support group leaders. Study inclusion and exclusion criteria were as follows:
- Patients were included in the study if they were 1) 18 years or older educated at 5th grade or higher, 2) recipients of a continuous flow left-ventricular assist device (LVAD) as a bridge to transplant or myocardial recovery, or destination therapy, 3) discharged from the hospital for at least 1 month, and 4) being treated by a VAD center in the United States. Patients were excluded from the study if they did not speak, write, and/or comprehend English language, or if they had any physical or mental condition that could impair their ability to understand instructions and complete a questionnaire.
- Caregivers were included in the study if they were 1) 18 years or older educated at 5th grade or higher, 2) caring for patients with continuous flow LVADs at home for a minimum of days a week, 3) have enacted the caregiving role for at least 1 month at the time of recruitment, and 4) caregiver for a VAD patient treated in the United States. Caregivers were excluded if they were unable to provide a written informed consent.
Interested participants for the parent study were instructed to contact the PI via telephone to confirm their participation in the study. A total of 257 potential study participants (129 patients and 128 caregivers) were screened by the PI. Of these, 250 (125 patients and 125 caregivers) were deemed eligible to participate. Reasons for patient’s exclusion were recent heart transplantation (n = 1) and refusal to participate without further explanation (n = 3). Two caregivers caring for patients outside the United States and 1 caregiver caring for newly transplanted patient were excluded from the study.
A self-administered demographic questionnaire and a VAD Hospital Discharge Survey were used to collect data. The eight-item survey, attached in the parent study, was developed by the study team to capture salient information regarding the extent of patient and caregiver preparations for VAD self-management and their experiences of the hospital discharge process. A copy of the survey is found in the Appendix (see Appendix, Supplemental Digital Content, https://links.lww.com/ASAIO/A262). Several response formats with comment sections were used to elicit data. Two independent lay persons (1 male and 1 female) were asked by the PI to review and judge the face validity10 of the survey. The two judges appraised the content (questions) of the survey according to its relevance to the purpose of the study. Revisions of the survey were completed after receiving feedback from the judges. The judges then rated the revised survey and when upon achieving 100% inter-rater agreement on the clarity and readability of all survey questions, the survey was finalized.
Next, research packets containing study instruction, an informed consent form, data collection tools, and a stamped envelope were sent to 250 participants. One month was given to the participants in returning completed packets to the study team. To encourage participation in the study, patients and caregivers who did not return the packets after 1 month were contacted by the study team via telephone or e-email. A total of two telephone or e-mail reminders (2-week intervals) were completed for each participant. At the end of 2 months, a total of 218 packets with completed data (87.2% return rate) were received by the study team.
Data provided by nondyadic (i.e., not paired) sample of 102 patients and 116 caregivers were managed and analyzed with IBM SPSS 22.0 software.11 Summary statistics based on mean, standard deviations (±), and frequency distributions were calculated to characterize the sample and describe the processes involved in preparing VAD patients and caregivers for self-management before hospital discharge, along with their perceived experiences of the discharge process. Student’s t test and chi-square statistics were used, depending on the variable characteristics, to determine the differences between patients’ and caregivers’ reported data. Content analytic procedures12 were used to summarize the written comments in the survey.
Characteristics of the Study Participants
The demographic characteristics of the 218 participants (102 patients and 116 caregivers) are summarized in Table 1. The participants’ mean age was 50.1, standard deviation (SD) ± 13.3, years; patients’ mean age was slightly higher (51.4 ± 13.8 years) than caregivers (48.9 ± 12.7 years), but not significantly different (p > 0.05). A majority of the participants were White (80%), married (77%), had some college education (42%), and were living in the Midwestern (31%) region of the United States. Patients were predominantly male (66%), whereas caregivers were predominantly female (80%) (p < 0.001). Furthermore, 60% of the patients were either on disability or unemployed, whereas 66% of the caregivers held a full-time or part-time job (p < 0.001).
All patients had continuous flow LVAD designs (85% axial and 15% magnetic-levitation). Nearly 70% of the patients had the LVAD as BTT (70%), and the remaining 30% had the LVAD as DT (20%) or BTR (10%). LVAD implant durations ranged from 2 and 74 months, mean 19.7 ± 15.0 months. Regarding support systems for VAD care, 95% of the patients defined an assigned caregiver. Although 84% of the caregivers had some level of support from other family members, friends, or home care registered nurses, they spent an average of 4.98 ± 7.58 hours per day performing VAD care tasks and procedures, as well as providing or assisting patients with activities of daily living.
Hospital Discharge Preparations
The process of preparing patients and caregivers for hospital discharge included the following components: 1) completion of a VAD self-management education and training, 2) validation of VAD self-management competencies, and 3) provision of resource materials for the daily VAD self-management. All caregivers (100%) and most (97%) of the patients reported that “hands-on” instruction was the method employed by the VAD care team in conducting the VAD care education and training. More than half of the patients (54%) and caregivers (57%) viewed videos as a supplement for learning about the VAD system and the associated care (Table 2). Their competencies of VAD self-management were typically evaluated with skill demonstration (94%) (Table 3). Moreover, 60% of the participants were required to pass a quiz regarding knowledge of the operations of the VAD system and the associated care (Table 3).
On average, the estimated time spent by the participants for VAD self-management education, training, and competency evaluation was 13.1 ± 14.4 hours. Although patients spent a slightly longer time (13.6 ± 14.4 hours) than caregivers (12.7 ± 14.4 hours) in these activities, the difference was not significant (p > 0.05). Before hospital discharge, the VAD care teams provided the majority of the participants with educational materials for VAD care, such as videos (52%), manuals (89%), and binders (90%) containing hospital and first responders’ information (Table 2).
Hospital Discharge Experience
The majority of the patients (75%) and caregivers (76%) were satisfied with the process employed by their VAD care teams in providing the essential knowledge and skills for VAD self-management. When asked about their preparedness for discharge, only 75% of patients, as compared with 94% of caregivers, felt adequately prepared for hospital discharge (p < 0.001) following their completion of VAD care education, training, and competency validation. Nevertheless, the data about their perceived experiences with the hospital discharge process were subsumed by recurring phrases used by participants in the comment section of the survey such as “very satisfied with care” and “well prepared” for home discharge.
We report the first data-based description of an important aspect of the discharge planning process for patients with VADs: Patient/caregiver’s readiness for VAD self-management in home settings. Our data, generated from a large sample of VAD patients and caregivers across the United States, provide the starting point to bridge the gap of knowledge regarding the extent to which patients and caregivers are prepared for VAD self-management. Based on our findings, it appeared that many VAD centers in the United States employed three distinct phases of preparing patients and caregivers for VAD self-management before hospital discharge. The first phase, completion of a VAD care education and training, is implemented in many forms. In this study, “hands on” and “videos” were the most utilized teaching/learning methods, whereas the lecture was the least. Studies have supported the effectiveness of “learning by doing” and “learning by example” for adult learners in various educational contexts and settings, including hospitals.13
The second phase is referred to as the competency validation stage, which consisted of an evaluation of the learning outcomes of the patient/caregiver. Our study showed that the most common methods to evaluate the VAD care competencies were skill demonstration and quiz (paper and pencil test). Both of these evaluation methods are appropriate for this learning context,13 but the importance of a quiz as a supplement for assessing the patient/caregiver competencies should be explored with future research. Although the origin of having patients/caregivers complete a VAD care knowledge quiz before discharge is unknown, such an evaluation method may not be useful in validating VAD care competency. This method only assesses the knowledge domain of learning, not the psychomotor domain.13,14 Correct performance of skill, a psychomotor domain of learning, is required for VAD care (e.g., switching VAD controllers) and is crucial for maintaining and managing the normal operations of the VAD system.13,14 Additionally, completing a quiz/examination may be an added burden to the already stressed learners waiting for hospital discharge; research gaps exist regarding this issue. Lastly, quizzes may disadvantage those who have poor literacy or difficulty speaking/understanding English language.
The final phase is the provision of resources for VAD care in home settings before, or the day of, discharge. The existing VAD educational materials within the field show a diverse mix of resources available to patients and caregivers. We speculate that these resource manuals and videos are designed to assist patients and caregivers in maintaining VAD care competencies. However, the basis of this routine practice and the relevance, readability, comprehensibility, and overall quality of the content in these materials are unknown. Anecdotal evidence suggests that these materials are developed by device manufacturers15,16 subjected for critiques from experts or research. Nevertheless, a comprehensive and efficient education/training is crucial before discharge to ensure smooth transitions from hospital to home with positive outcomes.
Overall, the patient/caregiver preparations for VAD self-management before hospital discharge are both extensive and intensive processes. Study participants were satisfied with the preparations for hospital discharge, despite the fact that it took them an average of 13 hours to complete the required phases of VAD care education and training. Although this was not generated from a dyadic sample, the VAD care team may increase their efforts on educating/training caregivers’ prehospital discharge, subsequently focusing on patient education once they are functionally and emotionally ready for learning, such as during clinic visits. It is not uncommon for patients to demonstrate a decrease in functional capacity and cognitive function within 6 months post-VAD implant, which is thought to affect the patient’s competence and confidence with VAD self-care.17,18
The weaknesses inherent to survey research19 such as self-selection bias, use of self-administered questionnaires, and convenient nondyadic sampling are the main limitations of this study. The relatively restricted (i.e., small number of questions) and minimal validity of the survey may not capture the depth and breadth of data needed for the study’s purpose. Additionally, we have no information on the programs represented within the study along with specifics of discharge education/training protocols, as the participants were recruited online. We found no standard training/assessment curriculum across VAD centers; therefore, patients and caregivers at different centers may not have had equivalent education and competency assessments. Thus, the study findings must be interpreted cautiously, as purely descriptive, and cannot be generalized.
Future research should address the limitations above, with close attention to the equal representation of patient-caregiver dyads from diverse large samples of adults and older adults from multiple VAD centers nationwide. Factors that may affect VAD care competency acquisitions and outcomes (e.g., age, education, cognitive function, health literacy, readiness to learn, psychological distress, VAD indications, caregiver burden, etc.) are also worthwhile to explore.6,14,17 Longitudinal study designs may be imperative to critically evaluate the extent to which patient and caregiver factors, such as VAD-related complications (e.g., infection, stroke), patient’s independence and functional capacity, as and the availability of caregivers, impact VAD self-care competency outcomes over time. Such outcomes include, but are not limited to hospital readmission, morbidity, health, and quality of life. Moreover, the curriculum and content validity of the VAD care education/training materials or protocols across centers require scrutiny. These future studies are crucial to determine if there are variability in practice and create sound evidence underpinning hospital discharge process guidelines for VAD programs in the United States. Equally crucial is to understand how the VAD care education/training impacts the acquisition and maintenance of patients’ VAD care self-efficacy17,20 after hospitalization. Emerging data showed that VAD care self-efficacy is associated with adherence and are both predictors of QOL outcomes.17,20
Future studies should also examine the effect of eliminating lectures and examinations, before hospital discharge, on patients/learning outcomes. The need for and frequency of assessments and reassessments of patient and caregiver VAD care competencies after hospital discharge warrants investigations. Finally, a systematic evaluation of appropriate staffing pattern required for delivering effective and efficient VAD education/training programs are of utmost important to for a comprehensive evidence-based hospital discharge process for VAD patients and caregivers. Overall, despite the study limitations, our study findings have merit for stimulating the scientific advancements of VAD self-management acquired during the hospital discharge process that can be applied to total artificial hearts and perhaps other artificial organs such as lung and kidneys.
Based on our data, generated from relatively homogenous sample, we found evidence for a three-phase process of preparing patients and caregivers for VAD self-management. Before hospital discharge, patients’/caregivers’ VAD care knowledge and skills are ensured through education/training, competency validation, and provision of educational materials. VAD patient and caregiver preparations for hospital discharge involved extensive and intensive processes. The high degree of participants’ satisfaction with the hospital discharge process employed by their VAD centers in the United States is notable. We found a discrepancy between patients’ high satisfaction with VAD education and low independence for LVAD management. A large percentage of caregivers for VAD patients provide many hours of daily care, highlighting the need to improve patient self-management skills. Additional research is needed to advance VAD self-management science and to create evidence-based practice guidelines, tailored to assist patients in optimizing their health, VAD longevity, and QOL.
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