Clinical trial NCT03177447: ENABLE: CHF-PC (Comprehensive Heartcare For Patients and Caregivers)
Official title: ENABLE: CHF-PC (Educate, Nurture, Advise, Before Life Ends: Comprehensive Heartcare for Patients and Caregivers)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Congestive
Keywords: Cardiac Failure
Congestive Heart Failure
Heart Decompensation
Heart Failure, Congestive
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Palliative Care Research Center
First posted: 2017-06-06
Enrollment: 62
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of recruitment for a large-scale RCT.
timeFrame: From Date of Enrollment to 24 Weeks
measure: Feasibility of retention for a large-scale RCT.
timeFrame: From Date of Enrollment to 24 Weeks
measure: Feasibility of intervention completion for a large-scale RCT.
timeFrame: From Date of Enrollment to 24 Weeks
measure: Feasibility of measurement completion for a large-scale RCT.
timeFrame: From Date of Enrollment to 24 Weeks
Secondary outcomes:
measure: Patient Quality of Life
timeFrame: Baseline, week 12, and week 24.
measure: Patient Quality of Care
timeFrame: Baseline, week 12, and week 24.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center, Dartmouth College, Dartmouth-Hitchcock Heart & Vascular Center
state: New Hampshire
Study officials:
affiliation: University of Alabama at Birmingham
name: Marie A. Bakitas, DNSc, NP-C
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakitas M, Dionne-Odom JN, Pamboukian SV, Tallaj J, Kvale E, Swetz KM, Frost J, Wells R, Azuero A, Keebler K, Akyar I, Ejem D, Steinhauser K, Smith T, Durant R, Kono AT. Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial. BMC Palliat Care. 2017 Aug 31;16(1):45. doi: 10.1186/s12904-017-0226-8.