Table 1.

Selected clinical trials and intervention studies of team-based palliative care in heart failure

Study	Study Type	Setting/Subject	Provider Training	Intervention Domains	Intervention Components	Intervention Development	Team Members (Team Liaison in bold)	Outcomes/ Results	Limitations
Aiken 20068	Prospective, Single Center, Randomized Controlled Trial (Blinded Enrollers & Interviewers)	Home-based COPD or NYHA IIIb/IV HF, prognosis ≤ 2 yrs n = 190 (129 HF) 100 case (67 HF) 90 control (62 HF)	Providers had chronic disease & EOLC experience 2 week workshop Monthly lectures by content experts Communication training with validated modules	Disease Awareness Symptom Management Self-care Knowledge of resources EOLC/ACP Physical/Mental Functioning Medical Service Utilization	PhoenixCare Model 1–6 clinic/home/phone visits/month Scheduled meetings Referrals prn Protocol customized to disease/morbidity Parallel with usual, curative treatment	– –	RN Case Manager Medical Director SW Chaplain PCP Family Community Agencies	Among cases: Better self-care, resource use, legal documents, vitality, physical function, self- rated health Lower symptom distress No difference in ED visits	Single center Did not achieve planned enrollment High early death rate Non-HF enrollees
Bekelman 20149	Prospective, Single Center, Mixed-Methods Feasibility Pilot	Outpatient HF (82% NYHA II/III) n = 17	2 day workshop algorithm for symptom management manualized counseling protocol	Symptom Management Illness Adjustment Depression	CASA(Collaborative Care to Alleviate Symptoms & Adjust to Illness) 6–8 RN-led phone/clinic visits for symptom control 5 SW/Psych-led phone visits for adjustment/mood Weekly meetings, recs relayed to PCP	Use of “collaborative care model,” validated in CAD patients	PCP RN SW Psychologist Cardiologist PCS	1 withdrawal <5% missed data 85% of recs implemented All depression treated Patients gave (+) feedback, requested more program flexibility	Single center Small cohort No control Protocol changed throughout study Limited domains
Brannstrom 201410 (Sweden)	Prospective, Single Center, Randomized Controlled Trial	Home-based NYHA III/IV HF n = 72 36 case 36 control	– –	Disease Education ACP Symptom Management Communication Goals of Care	PREFER(Palliative advanced home caRE and heart FailurE caRe) Parallel with usual curative treatment Total home care unit, comprehensive services Mon–Fri Phone/home visits for diuretics, prn Resume care with PCP at 6 months with individual care plan Bi-monthly meetings	Based on “The 6 S’s” PC model (Self-image, Self- determination, Social interaction, Symptom control, Synthesis, Surrender) Relied on data from Swedish palliative registry Care structure per ESC guidelines	PCS HF Cardiologist Cardiologist HF RN PC RN PT/OT	Among cases: Improved QoL, total symptom, & self-efficacy domains of KCCQ Only nausea improved (of 9 symptoms) NYHA class improved more often 15 (vs. 53) hospitalizations Nearly 5x more RN visits	Single center Small cohort Non-blinded Patients knew providers before enrollment Non-US study
Dionne- Odom11 2014	Prospective, Single Center Feasibility Pilot	Community- based/Rural HF (86% NYHA III/IV) n = 11 dyads (patient/caregiver)	24 or more hours of training Periodic audits All providers from previous ENABLE studies	Problem-solving Symptom Management Self-care Communication Care Coordination Community Resource Use Decision-making/ACP Life Review Creating a Legacy	ENABLE(Educate, Nurture, Advise, Before Life Ends):PC-CHF In-person team PC assessment AP PC RN coach-led phone visits 6 with patients 3 with caregivers Charting Your Course guidebook Monthly follow-up calls for reinforcement	Based on cancer ENABLE studies, translated to HF External clinician expert advisory (Cardiology, IM)	AP PC RN Coach Caregiver PCP Internist Cardiologist	Deemed feasible Doctor concerns re: prognostics, poor patient understanding, & parallel PC Patients desired earlier talks small to medium effect sizes of efficacy scores	Single center Small cohort No control Participants received small remuneration
Enguidanos 200512	Prospective, Controlled Trial	Home-based HF, COPD, Cancer prognosis ≤ 1 yr n = 298 (82 HF) 159 case (31 HF) 139 control (51 HF)	providers had expertise treating symptoms and in biopsychosocial intervention	Decision-making/ACP Communication Continuity of Care Psychosocial Support Spiritual Support Symptom Control Comfort Care Healthcare Team Support	KPPC(Kaiser Permanente Palliative Care) Home visits by RN, MD, SW, et al, prn Parallel with usual, curative treatment	Domains derived from consensus statement by ICU EOLC experts	Family RN MD SW	Among cases: No improved HF severity More home deaths (less difference in HF) Less days on service 52% decrease in cost of HF care	Non-randomized May only be generalizable to managed care organizations Non-HF enrollees
Evangelista 201213	Prospective, Single Center, Cohort Study	Outpatient NYHA II/II HF, hospitalized n = 36	– –	ACP	Outpatient PCS consultation 1 week after discharge Phone interviews at baseline, 3 months	– –	PCS or PC NP	AD completers had better perceived health Greatly improved AD knowledge AD completion only increased 28% to 42%	Single center Small Cohort No control Limited domains
Evangelista 201414	Prospective, Single Center, Cohort Study	Outpatient NYHA II/III HF, hospitalized n = 42 29 ≥ 2 PC visits 13 < 2 PC visits	– –	Symptom Management Illness Understanding Goals of Care Decision-making Care Coordination	PC program brochure & explanation letter at discharge Outpatient PCS consult 1 week after discharge Phone interviews at baseline, 3 months Ongoing PC contact encouraged	– –	PCS or PC NP	Significantly better control, activation, & symptom burden with > 1 PC visit	Single center Small Cohort No control
Schellinger 201115	Prospective, Multi-site/ Single System Implementation Study	Outpatient HF, referred for ACP n = 1894 602 completed ACP 1292 did not	Certified, 26-hour training in skills for communication Un-quantified ‘staff time’ to educate system employees	ACP	“Respecting Choices:” Disease- Specific ACP Call center to track referrals, schedule interviews In-depth ACP talk with patient & proxy documentation of goals, values, and preferences in medical record	Based on “Respecting Choices” program, validated in multiple RCTs	Certified Facilitator Caregiver/Proxy RN SW Referral Coordinator	Completers were older & referred more from clinics or home care Completers had higher rates of good ACP documentation & choosing hospice No difference in 60-dy admission	Non-randomized Limited domains May only be generalizable to systems using “Respecting Choices”
Schwarz 201216	Retrospective, Single Center Descriptive Study	Inpatient NYHA IV HF, referred for transplant & early PC n = 20	– –	Symptom Management Goals of Therapy ACP Hospice Referral EOLC	Chart review Interviews re: impact of PC on patients, caregivers, providers Non-standardized tool (1 PCS & 1 HF cardiologist scored impact of PC)	– –	PCS HF Cardiologist NP SW Psychiatrist Hospital Chaplain	Reduced pain More holistic care (spiritual, psychosocial) Increased patient clarity, continuity 30% with ADs completed Medium-to-large impact scores	Single center Small cohort Retrospective No control Non- standardized assessment tool
Wong 201317(China)	Retrospective, Single Center Descriptive Study	Home-based NYHA III/IV HF n = 44	– –	Resource Utilization	Scheduled, hospital- based HF visits Home visits, prn	Data from single center registry of all HF patients recruited to PC	MD RN Counselor	68% died at 2 yr Mean time to death 5.5 months Reduced HF/all- cause admission	Single center Small cohort Retrospective No control Non-US study Limited domains

COPD - chronic obstructive pulmonary disease; HF - heart failure; NYHA - New York Heart Association; PC - palliative care; ACP - advance care planning; EOLC - end of life communication; RN - registered nurse; Psych - psychologist; MD - medical doctor; NP - nurse practitioner; SW - social work; PCP - primary care physician; AP - advanced practice; PCS - palliative care specialist; CAD - coronary artery disease; ESC - European Society of Cardiology; IM - internal medicine; RCT - randomized controlled trial; ED - emergency department; PT - physical therapy; OT - occupational therapy; KCCQ - Kansas City Cardiomyopathy Questionnaire; AD - advance directive; prn – as needed; QoL – quality of life; yr – year

Data from Refs 8–17.