East Coast Divide: Results of ENABLE CHF-PC Early Palliative Care for Heart Failure
Rachel Wells, MSN, RN1; Deborah Ejem, PhD1; J. Nicholas Dionne-Odom, PhD, RN1; Elizabeth Kvale, MD; MSPH2; Marie Bakitas, , DNSc1,2
BACKGROUND
1School
RESULTS
 Advanced heart failure (HF) patients and family
caregivers’ (CGs) access to palliative care (PC)
support and resources is insufficient, particularly in
underserved and rural areas.
 We conducted a formative evaluation / intervention
development study to create an early PC
intervention for patients with advanced HF:
ENABLE CHF-PC (Educate, Nurture, Advise,
Before Life Ends: Comprehensive Heartcare for
Patients and Caregivers).1
 Intervention was based on successful early PC
model for patients with cancer. 2-5
OBJECTIVES
 To determine feasibility of recruiting and retaining
25 patient-caregiver dyads from 2 sites for 24
weeks for the ENABLE CHF-PC intervention, and
 To assess appropriateness of study procedures
and materials for different communities.
METHODS
Lessons Learned
Feasibility
A. Recruitment:
61 Pts (DH n=32 & UAB n=29) 48
CGs (DH n=29 & UAB n=19)
consented and completed baseline
data collection (Table) Sample:
Site differences were:
Patient- Age (UAB 6 yrs younger)
Race (DH mostly white)
Marital status (UAB >unmarried)
Religion (UAB >Protestant)
CGs – Race (DH mostly white)
Religion (UAB >Protestant)
Study Flow Diagram
B. Retention
UAB < measure completion
UAB> withdrawals (10 vs 1)
Outcomes
 Established Dartmouth site & committed on-site
team able to easily reach recruitment & retention
goals.
 Moderate effect size improvements in patients’ quality of
life, symptoms, physical health, and mental health
Patient-reported Outcome Measures - Change from Baseline (Adjusted)
All patients
Dartmouth
UAB
Mean (SE)
p*
Effect size †
Mean (SE)
p*
Effect size †
Mean (SE)
p*
Effect size †
Physical limitation
13.30 (4.4)
0.003
0.50
9.90 (6.1)
0.11
0.37
17.90 (6.2)
0.01
0.67
Symptoms
10.80 (4.3)
0.01
0.44
5.30 (5.5)
0.34
0.21
17.00 (6.6)
0.01
0.69
Social limitation
8.40 (5.1)
0.10
0.28
6.20 (6.7)
0.36
0.21
11.10 (7.8)
0.16
0.37
Quality of life
10.70 (4.0)
0.009
0.4
10.40 (5.4)
0.06
0.39
11.30 (6.2)
0.07
0.42
KCCQ functional status
11.60 (4.0)
0.005
0.49
6.90 (5.3)
0.20
0.29
17.50 (5.8)
0.004
0.74
KCCQ clinical summary
MSAS-HF Symptom Burden
Index
10.30 (3.9)
0.009
0.44
7.80 (5.2)
0.14
0.33
13.70 (5.7)
0.02
0.58
-25.80 (7.1)
0.0004
-0.54
-24.20 (8.0)
0.003
-0.50
-25.7 (12.8)
0.05
-0.54
Anxiety
-1.00 (0.5)
0.08
-0.29
-0.70 (0.6)
0.28
-0.20
-1.20 (0.9)
0.20
-0.34
Depression
-1.10 (0.6)
0.07
-0.28
-0.90 (0.7)
0.17
-0.23
-1.20 (1.1)
0.28
-0.31
2.70 (1.5)
0.08
0.32
1.50 (2.0)
0.47
0.18
3.80 (2.0)
0.07
0.46
3.00 (1.4)
0.04
0.36
1.90 (1.8)
0.30
0.23
4.40 (2.2)
0.05
0.53
Patient activation
0.20 (0.2)
0.26
0.17
0.20 (0.2)
0.35
0.17
0 (0.3)
0.95
0
Decision support
0.30 (0.2)
0.10
0.30
0.20 (0.2)
0.45
0.2
0.30 (0.3)
0.23
0.30
Goal setting
0.30 (0.2)
0.09
0.29
0.30 (0.2)
0.25
0.29
0.20 (0.2)
0.48
0.20
Problem solving
0.30 (0.2)
0.14
0.27
0.20 (0.2)
0.29
0.18
0.20 (0.3)
0.59
0.18
0 (0.2)
0.92
0
-0.10 (0.2)
0.61
-0.09
0.10 (0.3)
0.80
0.09
KCCQ
HADS
PROMIS
Global Physical Health T
score
Global Mental Health T score
 UAB site “learning curve” challenges included:
 new cardiology/clinic culture & investigators
 new palliative/supportive care
culture/procedures & space issues
 dyads’ limited understanding of early PC
 dyads’ issues in keeping scheduled data and
intervention calls
 dyads’ health literacy barriers
 younger patient population
CONCLUSIONS
PACIC
Study Modifications
Care Coordination
 Recruitment & Data Collection- Centralized in
experienced community-based recruitment service &
added BVAMC & clinics for underserved & minority
patients.
 Design
 Single arm pilot study Birmingham, AL & Lebanon, NH
 Sample (n=50 dyads)
 Pt. Inclusion criteria:
NYHA III/IV, English
speaking, age >50.
Exclusions: noncorrectable hearing loss,
dementia, significant
confusion (Callahan
score <3), DSM-IV axis I
diagnosis (e.g.
schizophrenia, bipolar)
or active substance
disorder.
 CGs - “someone who
knows you well & is
involved in your care”.
of Nursing, 2Department of Medicine, Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at Birmingham
PACIC Summary Score
0.20 (0.1)
0.14
0.23
0.10 (0.2)
0.42
0.11
0.10 (0.2)
0.50
0.11
SE = standard error; KCCQ = Kansas City Cardiomyopathy Questionnaire; MSAS-HF = Memorial Symptom Assessment Scale-Heart Failure; HADS = Hospital Anxiety and
Depression Scale; PROMIS = Patient Reported Outcomes Measurement Information System; PACIC = Patient Assessment of Chronic Illness Care. All change from
baseline estimates were adjusted for measures associated with attrition (e.g. religious preference, baseline PACIC-Patient Activation subscale and
SHFM 1-year survival probability).
*
p-values from t-test or Fisher's exact tests, as appropriate.
Effect size: Cohen's d or d-equivalent; small: d~0.2, medium d~0.5, large d~0.8.
 Intervention development/feasibility trials are critical to
create effective interventions & study procedures.
 Noted between-site differences during pilot-testing in initial
recruitment, demographics, attrition, and outcomes allowing
for strategy refinement
 R01-funded ENABLE CHF-PC RCT instruments & materials
tailored for minority, underserved population.
 Moderate effect size improvements in caregivers’ quality
of life, mental health, and burden
REFERENCES
Caregiver-reported Outcomes - Change from Baseline to 24 weeks (Adjusted for BCOS)
All caregivers
Dartmouth
UAB
Mean (SE)
p
Effect
size†
3.70 (2.0)
0.07
0.40
2.30 (2.2)
0.30
0.25
6.70 (3.8)
0.09
0.73
Anxiety
-0.20 (0.5)
0.69
-0.07
0.10 (0.7)
0.86
0.03
-0.70 (0.9)
0.42
-0.23
Depression
-1.30 (0.7)
0.08
-0.32
-1.10 (0.9)
0.26
-0.27
-1.90 (1.1)
0.11
-0.47
Global Physical Health
1.70 (1.4)
0.21
0.22
1.60 (1.8)
0.38
0.2
1.60 (2.2)
0.45
0.20
Global Mental Health
1.80 (1.3)
0.18
0.24
1.00 (1.8)
0.57
0.13
3.20 (1.8)
0.08
0.43
Objective burden
-1.10 (0.5)
0.02
-0.33
-0.50 (0.6)
0.39
-0.15
-2.10 (0.8)
0.01
-0.63
Demand burden
-0.60 (0.4)
-0.28
-0.04 (0.3)
-1.20 (0.8)
0.16
-0.56
-1.30 (0.4)
-0.58
-1.40 (0.5)
0.22
0.00
3
-0.19
Stress burden
-0.62
-1.40 (0.7)
0.07
-0.62
Total Score
-3.10 (1.0)
0.09
0.00
1
0.00
2
-0.53
-2.40 (1.0)
0.03
-0.41
-4.60 (2.0)
0.03
-0.78
Self-affirmation
0.40 (0.8)
0.58
0.11
0.30 (0.9)
0.70
0.08
0.60 (1.4)
0.68
0.16
Outlook on life
0.40 (0.4)
0.41
0.16
0.50 (0.6)
0.41
0.20
0.40 (0.7)
0.61
0.16
BCOS score
*
Mean (SE)
p
*
Effect
size†
Mean (SE)
p
*
Effect
size†
HADS
PROMIS
 Branded & modified patient/CG guidebooks for low
literacy & cultural diversity.
MBCB
PAC
UAB Team: Nick Dionne-Odom, PhD, Imat Akyar, PhD, Amanda Erba, RN, Konda Keebler, RN,
Rachel Wells, RN, Tasha Smith, PhD
DH Team: Alan Kono, MD
Vicky Beggs, MS, RN
Jen Frost, MS, RN
Kate MacKay, RN
PAC Total
0.90 (1.2)
0.43
0.15
0.90 (1.4)
0.52
0.15
1.10 (2.0)
0.57
0.19
SE = standard error; BCOS = Bakas Caregiving Outcomes Scale; HADS = Hospital Anxiety and Depression Scale; PROMIS = Patient Reported
Outcomes Measurement Information System; MBCB = Montgomery Borgatta Caregiver Burden Scale; PAC = Positive Aspects of Caregiving.
*
p-values from t-test or Fisher's exact tests, as appropriate.
†
Effect size: Cohen's d or d-equivalent; small: d~0.2, medium d~0.5, large d~0.8..
All change estimates were adjusted for the baseline measures most strongly associated with caregiver attrition: caregiver education, baseline
BCOS score and baseline MBCB - objective burden subscale.
1Dionne-Odom,
JN et al. J Pall Med, 2014;17: 995-1004.
M, et al. JCO. 2015;331438-45.
3Dionne-Odom J, et al. JCO. 2015;33:1446-52.
4Bakitas M, et al. JAMA. 2009;302:741-9.
5Bakitas M, et al. Pall Support Care. 2009;7:75-86.
2Bakitas
ACKNOWLEDGEMENT
We thank Julie Schach, James Mapson, Cynthia D Johnson, Cynthia Y Johnson,
Lori Higgins for assisting with recruitment and data collection and all patients and
caregivers for contributing their time and feedback.
FUNDING
This study is supported by a Pilot/Exploratory grant from the
National Palliative Care Research Center.
Rachel Wells is a Robert Wood Johnson
Foundation Future of Nursing Scholar.