Palliative care for patients with heart failure and family caregivers in rural Appalachia: a randomized controlled trial.

BACKGROUND: Heart failure (HF) is a debilitating disease with worsening symptoms and family caregiving burden. HF affects more than 8 million Americans. West Virginia has the highest HF death rate in the U.S. and limited healthcare services. This study tested whether the family HF palliative and end-of-life care intervention (FamPALcare) improved patient and caregiver outcomes at 3- and 6-month study endpoints. METHODS: This study used a randomized controlled trial design. Patients with HF and their caregivers were randomly assigned together to the intervention (n = 21) or control (n = 18) group. The intervention included five telephone coaching sessions on the HF home, palliative, and end-of-life care. The outcome data collected at baseline and at 3 and 6 months were from the patients' (a) HF-related health status and depression/anxiety scale scores; and from caregivers' (b) caregiving burden and depression/anxiety scale scores; and (c) anonymous ratings on the 11-item FamPALcare helpfulness scale, completed by the intervention participants. RESULTS: The mean age of the patients was 65.66 (SD = 13.72) years, and 67% were White males. The mean age of the caregivers was 62.05 (SD = 13.14) years, and 77% were White females. Compared to the controls, patients in the intervention group had significantly greater scores for HF-related health status (p < .05) and lower depression/anxiety scores at 6 months, the study endpoint. The family caregivers in the intervention group had significantly lower scores on caregiving burden (p < .05) and depression/anxiety (p < .01) at 3 months. The mean helpfulness rating was M = 4.46 out of 5 (SD = 0.49). CONCLUSIONS: The FamPALcare intervention was found to be effective at improving patient HF-related health status and reducing caregiver burden and improving both patient and caregiver depression and anxiety scores. The FamPALcare HF intervention was found feasible and consistently delivered (fidelity). The FamPALcare intervention's cost-effectiveness and helpfulness ratings information will be used to plan for subsequent clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT04153890, Registered on 4 November 2019, https://clinicaltrials.gov/ct2/show/NCT04153890 .

Using telehealth to assess depression and suicide ideation and provide mental health interventions to groups of chronically ill adolescents and young adults.

Telehealth distance health care is a significant resource for young, chronically ill patient populations given their numerous medical complexities and their concomitant depression and/or suicide ideation experiences. This manuscript shares the telehealth methods used to prepare for a larger study of interventions for increasing adolescents' and young adults' chronic care resiliency and skills for preventing depression. The young patients in this study were prescribed lifelong home parenteral nutrition infusions, treatment for those with short gut bowel diseases. The training methods for our mental health nurse and psychologist to conduct depression and suicide ideation assessments from a distance are presented. The study implementation methods of group facilitated interventions and discussion are reviewed. The group discussions were conducted via audiovisual telehealth devices over encrypted firewall-protected connections with patients in their own homes and professionals in an office. The results of assessments of the 40 participants, 25% (n = 10) with depressive symptoms or suicide ideation, are described. Following participants' assessments, their subsequent depression measures were all in the normal range, without any suicide ideation, across the year of the study. Patient evaluation ratings were high in the areas of being able to connect with other young patients in similar situations, using the audiovisual equipment, and learning new useful information from the interventions. The methods developed for the study ensured that the safety and well-being of participants were supported through telehealth.

Verifying intervention fidelity procedures for a palliative home care intervention with pilot study results.

Fidelity (consistency of intervention implementation) is essential to rigorous research. Intervention fidelity maintains study internal validity, intervention reproducibility, and transparency in the research conduct. The purpose of this manuscript is to describe intervention fidelity strategies/procedures developed for a pilot study testing a new palliative care nursing intervention (FamPALcare) for families managing advanced lung disease. The procedures described herein are based on the fidelity best practices recommendations from the NIH Consortium. An evidence-based checklist guided observational ratings of the fidelity procedures used and the intervention content implemented in each intervention session. Descriptive data on how participants understood (received), enacted, or used the intervention information were summarized. The fidelity checklist observational scores found ≥93% of the planned intervention content was implemented, and the fidelity strategies were adhered to consistently during each intervention session. The small variation (7%) in implementation was expected and related to participants' varying experiences, input, and/or questions. The helpfulness scale items include participants' ability to use home care resources, to anticipate and manage end-of-life symptoms, and to use Advance Directive forms. The high ratings (M = 4.4) on the 1-5 (very helpful) Likert Helpfulness Scale verified participants utilized the information from the intervention. Furthermore, there was an improvement in patients' breathlessness scores and completion of Advance Directive forms at 3 months after baseline. It is essential to plan intervention fidelity strategies to use throughout a study and to report fidelity results.

Palliative care for rare advanced lung diseases in underserved Appalachia: Study protocol for a randomized controlled trial.

AIM: To pilot test a home end-of-life and palliative care intervention for family caregivers and patients with rare advanced lung diseases and to estimate effect-size for the power analysis in a future clinical trial. DESIGN: This study uses a parallel randomized control trial. Families are randomly assigned to the intervention group or the control group in a 1:1 fashion. METHODS: The study population includes patients with rare advanced lung diseases and their family caregivers who are involved in patients' home care. The control group receives standard care through their hospital or outpatient clinics. The intervention group receives standard care plus 2-weekly home end-of-life and palliative care coaching by experienced community nurses. Primary outcome is breathlessness measured by shortness of breath scale. Secondary outcomes are: (a) caregivers' anxiety and depression measures; (b) the presence of patient's signed advance directives in the medical record or not; and (c) Helpfulness of intervention measured by self-report Helpfulness scale. The study was funded in October 2018 and received ethical Institutional Review Board approval in February 2019. DISCUSSION: West Virginia has one of the highest incidence rates of lung disease deaths in the nation. However, there is inadequate home end-of-life and palliative care for this underserved population. This is an initial interventional study of nurse-led coaching home-based palliative care for rare advanced lung diseases in rural Appalachia. Developing research collaboration with clinicians is essential for enrolment. Enrolment was successful due to regular meetings with pulmonologists who screened patients per the study inclusion criteria in their specialty clinic and made direct referrals to the research assistants. Results of this study will be used in the future trial. IMPACT: The findings will contribute to the evidence-based home nursing care, planning for family/patient preferences and supportive end-of-life palliative care for managing advanced lung diseases at home. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03813667; registered January 23, 2019. https://clinicaltrials.gov/ct2/show/NCT03813667.

Maintaining Intervention Fidelity When Using Technology Delivery Across Studies.

The current standard in healthcare research is to maintain scientific fidelity of any intervention being tested. Fidelity is defined as the consistent delivery of interventions that ensures that all participants are provided the same information, guidance, and/or materials. Notably, the methods for ensuring fidelity of intervention delivery must also be consistent. This article describes our Intervention and Technology Delivery Fidelity Checklists used to ensure consistency. These checklists were completed by trained nurse observers who rated the intervention implementation and the technology delivery. Across our clinical trials and pilot studies, the fidelity scores were tabulated and compared. Intervention information and materials were delivered by a variety of devices including telehealth monitors, videophones, and/or iPads. Each of the devices allows audiovisual connections between health professionals from their offices and patients and participants in their homes. Our checklists guide the monitoring of fidelity of technology delivery. Overall checklist ratings across our studies demonstrate consistent intervention, implementation, and technology delivery approaches. Uniquely, the fidelity checklist verifies the interventionist's correct use of the technology devices to ensure consistent audiovisual delivery. Checklist methods to ensure intervention fidelity and technology delivery are essential research procedures, which can be adapted for use by researchers across multiple disciplines.

Study protocol of coaching end-of-life palliative care for advanced heart failure patients and their family caregivers in rural appalachia: a randomized controlled trial.

BACKGROUND: Heart failure (HF) afflicts 6.5 million Americans with devastating consequences to patients and their family caregivers. Families are rarely prepared for worsening HF and are not informed about end-of-life and palliative care (EOLPC) conservative comfort options especially during the end stage. West Virginia (WV) has the highest rate of HF deaths in the U.S. where 14% of the population over 65 years have HF. Thus, there is a need to investigate a new family EOLPC intervention (FamPALcare), where nurses coach family-managed advanced HF care at home. METHODS: This study uses a randomized controlled trial (RCT) design stratified by gender to determine any differences in the FamPALcare HF patients and their family caregiver outcomes versus standard care group outcomes (N = 72). Aim 1 is to test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF. Aim 2 is to assess implementation of the FamPALcare intervention and research procedures for subsequent clinical trials. Intervention group will receive routine standard care, plus 5-weekly FamPALcare intervention delivered by community-based nurses. The intervention sessions involve coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions based on patients' preferences. Data are collected at baseline, 3, and 6 months. Recruitment is from sites affiliated with a large regional hospital in WV and community centers across the state. DISCUSSION: The outcomes of this clinical trial will result in new knowledge on coaching techniques for EOLPC and approaches to palliative and end-of-life rural home care. The HF population in WV will benefit from a reduction in suffering from the most common advanced HF symptoms, selecting their preferred EOLPC care options, determining their advance directives, and increasing skills and resources for advanced HF home care. The study will provide a long-term collaboration with rural community leaders, and collection of data on the implementation and research procedures for a subsequent large multi-site clinical trial of the FamPALcare intervention. Multidisciplinary students have opportunity to engage in the research process. TRIAL REGISTRATION: ClinicalTrials.gov NCT04153890, Registered on 4 November 2019.

Identification of Depressive Signs in Patients and Their Family Members During iPad-based Audiovisual Sessions.

Home parenteral nutrition requires a daily life-sustaining intravenous infusion over 12 hours. The daily intravenous infusion home care procedures are stringent, time-consuming tasks for patients and family caregivers who often experience depression. The purposes of this study were (1) to assess home parenteral nutrition patients and caregivers for depression and (2) to assess whether depressive signs can be seen during audiovisual discussion sessions using an Apple iPad Mini. In a clinical trial (N = 126), a subsample of 21 participants (16.7%) had depressive symptoms. Of those with depression, 13 participants were home parenteral nutrition patients and eight were family caregivers; ages ranged from 20 to 79 years (with 48.9 [standard deviation, 17.37] years); 76.2% were female. Individual assessments by the mental health nurse found factors related to depressive symptoms across all 21 participants. A different nurse observed participants for signs of depression when viewing the videotapes of the discussion sessions on audiovisual technology. Conclusions are that depression questionnaires, individual assessment, and observation using audiovisual technology can identify depressive symptoms. Considering the growing provision of healthcare at a distance, via technology, recommendations are to observe and assess for known signs and symptoms of depression during all audiovisual interactions.

Symptom perceptions and self-care behaviors in patients who self-manage heart failure.

BACKGROUND: Patients with heart failure (HF) are at heightened risk for acute exacerbation requiring hospitalization. Although timely reporting of symptoms can expedite outpatient treatment and avoid the need for hospitalization, few patients recognize and respond to symptoms until acutely ill. OBJECTIVE: The purpose of this study was to explore patients' perceptions of symptoms and self-care behaviors for symptom relief, leading up to a HF hospitalization. METHODS: To examine prehospitalization symptom scenarios, semistructured interviews were conducted with 60 patients hospitalized for acute decompensated HF. RESULTS: Thirty-seven patients (61.7%) said that they had a sense that "something just wasn't quite right" before their symptoms began but were unable to specify further. Signs and symptoms most often recognized by the patients were related to dyspnea (85%), fatigue (53.3%), and edema (41.7%). Few patients interpreted their symptoms as being related to worsening HF and most often attributed symptoms to changes in diet (18.3%) and medications (13.3%). Twenty-six patients (43.3%) used self-care strategies to relieve symptoms before hospital admission. More than 40% of the patients had symptoms at least 2 weeks before hospitalization. CONCLUSIONS: Despite the wide dissemination of HF evidence-based guidelines, important components of symptom self-management remain suboptimal. Because most of HF self-management occurs in the postdischarge environment, research is needed that identifies how patients interpret symptoms of HF in the specific contexts in which patients self-manage their HF. These findings suggest the need for interventions that will help patients expeditiously recognize, accurately interpret, and use appropriate and safe self-care strategies for symptoms.

Nurse-Led Multidisciplinary Heart Failure Group Clinic Appointments: Methods, Materials, and Outcomes Used in the Clinical Trial.

BACKGROUND: The Self-management and Care of Heart Failure through Group Clinics Trial evaluated the effects of multidisciplinary group clinic appointments on self-care skills and rehospitalizations in high-risk heart failure (HF) patients. OBJECTIVE: The purpose of this article is to (1) describe key Self-management and Care of Heart Failure through Group Clinics Trial group clinic interactive learning strategies, (2) describe resources and materials used in the group clinic appointment, and (3) present results supporting this patient-centered group intervention. METHODS: This clinical trial included 198 HF patients (randomized to either group clinical appointments or to standard care). Data were collected from 72 group clinic appointments via patients' (1) group clinic session evaluations, (2) HF self-care behaviors skills, (3) HF-related discouragement and quality of life scores, and (4) HF-related reshopitalizations during the 12-month follow-up. Also, the costs of delivery of the group clinical appointments were tabulated. RESULTS: Overall, patients rated group appointments as 4.8 of 5 on the "helpfulness" in managing HF score. The statistical model showed a 33% decrease in the rate of rehospitalizations (incidence rate ratio, 0.67) associated with the intervention over the 12-month follow-up period when compared with control patients (χ(2)1=3.9, P=.04). The total cost for implementing 5 group appointments was $243.58 per patient. CONCLUSION: The intervention was associated with improvements in HF self-care knowledge and home care behavior skills and managing their for HF care. In turn, better self-care was associated with reductions in HF-related hospitalizations.

Creating patient and family education web sites: assuring accessibility and usability standards.

This article gives details about the methods and processes used to ensure that usability and accessibility were achieved during development of the Home Parenteral Nutrition Family Caregivers Web site, an evidence-based health education Web site for the family members and caregivers of chronically ill patients. This article addresses comprehensive definitions of usability and accessibility and illustrates Web site development according to Section 508 standards and the national Health and Human Services' Research-Based Web Design and Usability Guidelines requirements.

Part I: heart failure home management: patients, multidisciplinary health care professionals and family caregivers' perspectives.

Using qualitative research study methods, this study identified the key factors that patients, health care professionals, and family caregivers perceived as most helpful in effectively managing heart failure (HF) at home. These key factors were the following: (a) family caregiver involvement, (b) continuous learning about HF, (c) acceptance of and coping with HF diagnosis, (d) learning from other patients with HF, (e) guidance for daily problem solving, (f) lifestyle changes, and (g) financial resources.

Part 2: enhancing heart failure home management: integrated evidence for a new family caregiver educational plan.

This article describes how the qualitative data integrated from patients, health care professionals, and family caregivers have been developed into a new heart failure (HF) educational plan for family caregivers to manage the complexities of HF self-management at home. In addition, the educational plan describes potential strategies and teaching materials based on these integrated data.

Creating patient and family education web sites: design and content of the home parenteral nutrition family caregivers web site.

When managing chronic illnesses, caregivers repeatedly seek online information about providing complex, long-term care but often neglect to find information about how to care for themselves. Poor health among caregivers is not only detrimental to their own well-being but may also result in harm to those for whom they care. For this reason, caregivers need access to information and activities about caring for themselves in addition to the information about managing home care they are already likely to seek. The HPN Family Caregivers Web site was developed to guide caregivers through the process of caring for themselves by establishing a caregiving routine, self-monitoring their mental and physical health, and practicing good sleep hygiene, while also managing the complexities of home care. While Web site information, activities, and algorithms for managing chronic illnesses need to be specific to each population, the content guiding caregivers to care for their own health is universal.

Impact of Sleep Apnea, Daytime Sleepiness, Comorbidities, and Depression on Patients' Heart Failure Health Status.

There is a gap in current research on common factors that impact patients with advanced heart failure (HF). The purpose of this secondary data analysis was to explore associations of those factors with three empirically verified measures of HF-related clinical, physical, and mental health status. Baseline data of 198 advanced systolic HF (EF < 40%) patients were analyzed. Patients were 61.6% male, with a mean age of 62.3 (SD = 13.2) years. The multivariable general linear modeling results indicated that patients who had poorer scores on HF-related clinical status were those who had sleep apnea (ß = -6.6, p < .05), daytime sleepiness (ß = -9.4, p < .01), four or more comorbidities (ß = -11.8, p < .001), and depression (ß = -18.7, p < .001). Depression was associated with all three measures of HF-related health status. These findings alert nurses to assess for sleep apnea and to use known screening measures for daytime sleepiness, depression, and comorbidities.

Themes of Stressors, Emotional Fatigue, and Communication Challenges Found in Mobile Care Discussion Sessions With Patients Requiring Lifelong Home Parenteral Nutrition Infusions.

BACKGROUND: The purpose of this article is to examine themes and topics that emerged from 35 discussion sessions with teens and young adults requiring long-term home parenteral nutrition (HPN) intravenous infusions. The goal was to gain a more detailed understanding of participants' challenges and successes of living with HPN. METHODS: These patients were invited to attend 3 discussion group sessions facilitated by health professionals. A secure iPad Mini was selected as the mobile tablet device for hosting these encrypted audio-visual group discussions. Content analysis, a standard research data-sorting technique, was used to summarize the anonymous data. Words, phrases, and topics in patients' discussions were coded and grouped together with similar concepts and subsequently categorized into themes. RESULTS: Themes in these discussions were related to patients' daily, complex management of HPN. These "themes" included having multiple repetitive illness-related stressors and how those stressors were managed; managing emotions; communication challenges with professionals, family, friends, and using social media; and lastly, the least frequent but no less important theme discussed was how HPN effects their daily lives. CONCLUSION: Teens and young adults living with lifelong HPN face a variety of unique psychological, physical, and emotional stressors and may benefit from numerous methods for managing these challenges.

Complex home care: Part 2- family annual income, insurance premium, and out-of-pocket expenses.

Annual costs paid by families for intravenous infusion of home parenteral nutrition (HPN) health insurance premiums, deductibles, co-payments for health services, and the wide range of out-of-pocket home health care expenses are significant. The costs of managing complex chronic care at home cannot be completely understood until all out-of-pocket costs have been defined, described, and tabulated. Non-reimbursed and out-of-pocket costs paid by families over years for complex chronic care negatively impact the financial stability of families. National health care reform must take into account the long-term financial burdens of families caring for those with complex home care. Any changes that may increase the out-of-pocket costs or health insurance costs to these families can also have a negative long-term impact on society when greater numbers of patients declare bankruptcy or qualify for medical disability.

Complex home care: part III--economic impact on family caregiver quality of life and patients' clinical outcomes.

Family caregivers perform a significant role in the care of patients with chronic illnesses and prescribed life-long complex home care treatments. Both quantitative and qualitative data from this study suggest the mental health burdens and financial costs of home parenteral nutrition (HPN) caregiving are extensive. In this study, the variability in HPN out-of-pocket expenses and the uncertainty of incurring such extensive costs created additional financial worries within already stressed families. Based on these data, interventions to improve caregivers' sleepiness, depression, and physical health could be hypothesized to improve both patients' and caregivers' quality of life and reduce the frequency of patients' catheter-related infections. These specific nursing interventions also could improve caregiver health and subsequently reduce the costs of caregivers' health care.

Complex home care: Part I--Utilization and costs to families for health care services each year.

As many as 120 persons per million people in the United States are dependent on the lifelong, complex, technology-based care of home parenteral nutrition (HPN) infusions. However, data for costs paid by families for HPN-related health care services and for non-reimbursed expenditures are rarely tabulated and most often underestimated. The goals of this study were to describe health care services used by families to manage HPN, report the frequency of each service used annually, and estimate the average annual non-reimbursed costs to families for these health services. The numerous and varied types of services reported and the time required to coordinate and access HPN services illustrates the challenges faced by patients and their family caregivers. The lack of a coordinated and efficient system for delivering complex chronic care results in poorer outcomes for HPN patients and their families on-reimbursed costs and the extensive amount of time required to coordinate multi-professional services negatively impacts the clinical outcomes and quality of life of complex chronic home care.