ENABLE: CHF-PC (Comprehensive Heartcare For Patients and Caregivers)
ENABLE: CHF-PC (Comprehensive Heartcare For Patients and Caregivers)
Background: Early palliative care (EPC) is recommended but rarely integrated with advanced
 heart failure (HF) care. This pilot study engaged patients and family caregivers to study the
 feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture,
 Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers).

 An EPC feasibility study (4/1/14-8/31/15) was conducted for patients with New York Heart
 Association (NYHA) Functional Class III/IV HF and their caregivers in academic medical
 centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person
 palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls.
 Patient- and caregiver-reported outcomes were collected for quality of life (QOL), symptom,
 health, anxiety, and depression outcomes at baseline, 12- and 24-weeks. Linear mixed-models
 were used to assess baseline to week 24 longitudinal changes. The intervention was tailored
 to rural, older adults (age≥65) with advanced HF in reducing HF morbidity and improving
 patient and caregiver QOL and quality of care.
High quality trials have demonstrated positive patient and family caregiver outcomes from
 early palliative care (EPC) in cancer However, given the difficulties in prognostication, the
 prevalence of sudden cardiac death, and an erratic illness trajectory, it is not clear when
 or how to integrate palliative care in HF. Furthermore, the high morbidity and mortality of
 HF in persons with low income, poor education, minority race, and residence in rural,
 medically-underserviced areas further complicates appropriate timing of integration.

 To address these challenges, patients and family members were actively engaged to aid in the
 development of ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive
 Heartcare for Patients and Caregivers), a telephonic EPC intervention for rural-dwelling,
 underserved HF patients and their family caregivers. In a proof-of-concept, formative
 evaluation study, materials and protocols were translated from our successful EPC ENABLE
 oncology model to a HF population. This study demonstrated acceptability, feasibility, and a
 signal of potential efficacy in an educationally, socioeconomically, and racially homogeneous
 sample of 11 patient-caregiver dyads. Thus, the current ENABLE CHF-PC feasibility trial was
 conducted in a northeastern and a southeastern US academic center to capture the perspectives
 of a more demographically and culturally-diverse sample. The purpose of this study was to: 1)
 determine the feasibility of recruiting and retaining patient-caregiver dyads for 24 weeks in
 a rural, racially-diverse sample and 2) explore longitudinal patient and caregiver outcomes
 including QOL, global health, anxiety, and depression to inform intervention and protocol
 modifications for a larger clinical efficacy trial.

 Study Design: In this feasibility study, conducted April 1, 2014 to December 31, 2015,
 individuals with American College of Cardiology (ACC) /American Heart Association (AHA) Class
 C/D and/or NYHA Stage III/IV HF and their family caregivers received the ENABLE CHF-PC
 intervention and were followed for 24 weeks. The study protocol was approved by the
 institutional review boards of Dartmouth College (Lebanon, New Hampshire) and the University
 of Alabama at Birmingham (Birmingham, Alabama).

 Setting and Sample: Study participants were recruited from cardiology clinics at
 Dartmouth-Hitchcock Medical Center (DHMC) and the University of Alabama at Birmingham (UAB).
 Study coordinators at both sites reviewed outpatient cardiology clinic schedules to identify
 eligible patients. Following physician approval, a study coordinator approached patients and
 their caregivers during a clinic appointment to explain the study and obtain consent.

 Data Collection and Measures: Study coordinators completed measures with patients and
 caregivers by phone at baseline, 12- and 24-weeks. Baseline demographics included age,
 gender, race/ethnicity, religion, marital and work status, educational level, and medical
 insurance. Clinical characteristics abstracted from electronic health records included NYHA
 class, ejection fraction, presence of an implanted heart device, medications, and laboratory
 data. These data were entered into the Seattle Heart Failure Model (SHFM) a web-based
 calculator to compute 1-, 2- and 5-year survival estimates
 https://depts.washington.edu/shfm/). Nurse coaches also informed patients and caregivers that
 the purpose of this pilot trial was to determine acceptability in a new population - patients
 with heart failure from 2 distinctly different regions/cultures. Nurses recorded sessions,
 and tracked patient and caregiver feedback on intervention components that were found to be
 helpful or in need of improvement.

 Statistical Analysis: The feasibility primary aim was determined by monitoring study status
 (enrolled, deceased, lost to follow-up) and calculating intervention and measurement
 completion (e.g. actual # completed/possible # per protocol). Patient and caregiver
 demographic characteristics were tabulated and compared between sites with bivariate tests of
 association and effect sizes (Cohen's d or d-equivalent or nominal variables). Associations
 were assessed between baseline characteristics and participant attrition using simple
 logistic regressions. Estimated odds ratios were used to determine associations between
 patient characteristics and attrition.

 Longitudinal, fitted, linear mixed methods, adjusted for covariates associated with attrition
 were used to estimate participant-reported outcomes' changes from baseline to follow-up
 (12-week and 24-week means combined). Change estimates were transformed to effect sizes
 (Cohen's d) using baseline estimates of pooled standard deviations. Change was estimated
 overall and by site. All analyses were conducted using SAS v9.4.

 Due to the exploratory nature of the study, the analysis relied on effect size estimation
 using Cohen's guidelines for magnitude of effect size d (i.e. small: 0.2, moderate: 0.5, and
 large: 0.8) rather than hypothesis testing to interpret results; however p-values are also
 provided for completeness.
Patient Inclusion Criteria:

 1. English-speaking and able to complete baseline interview

 2. Age ≥65 (Age criteria was reduced to ≥50 y/o given regional experience with HF
 population)

 3. NYHA Stage III/IV heart failure; American College of Cardiology (ACC) Class C/D

 4. Have a land-based phone or reliable cellular phone service

 5. Have an agreeable partner willing to participate in the study* (recommended) *In our
 previous studies we have not required patients to have a care partner for eligibility.
 In this study it is essential that we have an adequate number of caregivers to test
 the caregiver intervention. Therefore patients without a care partner will still be
 considered but the final study sample size may need to be adjusted to ensure an
 adequate caregiver sample.

 Patient Exclusion Criteria:

 1. Non-correctable hearing loss

 2. Dementia or significant confusion (as measured by a Callahan score of ≤3

 3. Diagnostic and Statistical Manual (DSM) -IV Axis I diagnosis (e.g. schizophrenia,
 bipolar disorder) or active substance use disorder

 Caregiver Inclusion Criteria:

 1. "Caregiver" is identified by the patient as "a person who knows you well and is
 involved in your medical care". May be a spouse or adult family member or friend
 living in the same household or considered by the patient to be the primary caregiver
 and be willing to participate."

 2. English-speaking and able to complete baseline interview 3. Have a land-based phone or
 reliable cellular phone service.

 Caregiver Exclusion Criteria:

 1. Non-correctable hearing loss.