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

Table 3 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 ^†
KCCQ
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	10.30 (3.9)	0.009	0.44	7.80 (5.2)	0.14	0.33	13.70 (5.7)	0.02	0.58
MSAS-HF Symptom Burden Index	−25.80 (7.1)	0.0004	−0.54	−24.20 (8.0)	0.003	−0.50	−25.7 (12.8)	0.05	−0.54
HADS
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
PROMIS
Global Physical Health T score	2.70 (1.5)	0.08	0.32	1.50 (2.0)	0.47	0.18	3.80 (2.0)	0.07	0.46
Global Mental Health T score	3.00 (1.4)	0.04	0.36	1.90 (1.8)	0.30	0.23	4.40 (2.2)	0.05	0.53
PACIC
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
Care Coordination	0 (0.2)	0.92	0	−0.10 (0.2)	0.61	−0.09	0.10 (0.3)	0.80	0.09
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

Abbreviations: 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

ISSN: 1472-684X