African American Recruitment in Early Heart Failure Palliative Care Trials: Outcomes and Comparison With the ENABLE CHF-PC Randomized Trial.

BACKGROUND: Palliative care trial recruitment of African Americans (AAs) is a formidable research challenge. OBJECTIVES: Examine AA clinical trial recruitment and enrollment in a palliative care randomized controlled trial (RCT) for heart failure (HF) patients and compare patient baseline characteristics to other HF palliative care RCTs. METHODS: This is a descriptive analysis the ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends: Comprehensive Heartcare for Patients and Caregivers) RCT using bivariate statistics to compare racial and patient characteristics and differences through recruitment stages. We then compared the baseline sample characteristics among three palliative HF trials. RESULTS: Of 785 patients screened, 566 eligible patients with NYHA classification III-IV were approached; 461 were enrolled and 415 randomized (AA = 226). African Americans were more likely to consent than Caucasians (55%; P FDR = .001), were younger (62.7 + 8; P FDR = .03), had a lower ejection fraction (39.1 + 15.4; PFDR = .03), were more likely to be single (P FDR = .001), and lack an advanced directive (16.4%; P FDR < .001). AAs reported higher goal setting (3.3 + 1.3; P FDR = .007), care coordination (2.8 + 1.3; P FDR = .001) and used more "denial" coping strategies (0.8 + 1; P FDR = .001). Compared to two recent HF RCTs, the ENABLE CHF-PC sample had a higher proportion of AAs and higher baseline KCCQ clinical summary scores. CONCLUSION: ENABLE CHF-PC has the highest reported recruitment rate and proportion of AAs in a palliative clinical trial to date. Community-based recruitment partnerships, recruiter training, ongoing communication with recruiters and clinician co-investigators, and recruiter racial concordance likely contributed to successful recruitment of AAs. These important insights provide guidance for design of future HF palliative RCTs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02505425.

Examining Adherence and Dose Effect of an Early Palliative Care Intervention for Advanced Heart Failure Patients.

CONTEXT: Research priority guidelines highlight the need for examining the "dose" components of palliative care (PC) interventions, such as intervention adherence and completion rates, that contribute to optimal outcomes. OBJECTIVES: Examine the "dose" effect of PC intervention completion vs. noncompletion on quality of life (QoL) and healthcare use in patients with advanced heart failure (HF) over 32 weeks. METHODS: Secondary analysis of the ENABLE CHF-PC intervention trial for patients with New York Heart Association (NYHA) Class III/IV HF. "Completers" defined as completing a single, in-person outpatient palliative care consultation (OPCC) plus 6 weekly, PC nurse coach-led telehealth sessions. "Non-completers" were defined as either not attending the OPCC or completing <6 telehealth sessions. Outcome variables were QoL and healthcare resource use (hospital days; emergency department visits). Mixed models were used to model dose effects for "completers" vs "noncompleters" over 32 weeks. RESULTS: Of 208 intervention group participants, 81 (38.9%) were classified as "completers" with a mean age of 64.6 years; 72.8% were urban-dwelling; 92.5% had NYHA Class III HF. 'Completers' vs. "non-completers"" groups were well-balanced at baseline; however "noncompleters" did report higher anxiety (6.0 vs 7.0, P < 0.05, d = 0.28). Moderate, clinically significant, improved QoL differences were found at 16 weeks in "completers" vs. "non-completers" (between-group difference: -9.71 (3.18), d = 0.47, P = 0.002) but not healthcare use. CONCLUSION: Higher intervention completion rates of an early PC intervention was associated with QoL improvements in patients with advanced HF. Future work should focus on identifying the most efficacious "dose" of intervention components and increasing adherence to them. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02505425.

Effect of an Early Palliative Care Telehealth Intervention vs Usual Care on Patients With Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial.

Importance: National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations. Objective: To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure. Design, Setting, and Participants: A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals. Interventions: The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks. Main Outcomes and Measures: Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered "fairly good" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits). Results: Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety, d = -0.02 [95% CI, -0.20 to 0.16]; HADS-depression, d = -0.09 [95% CI, -0.24 to 0.06]). Conclusions and Relevance: This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement. Trial Registration: ClinicalTrials.gov Identifier: NCT02505425.

Effects of a Telehealth Early Palliative Care Intervention for Family Caregivers of Persons With Advanced Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial.

Importance: Family caregivers of persons with advanced heart failure perform numerous daily tasks to assist their relatives and are at high risk for distress and poor quality of life. Objective: To determine the effect of a nurse-led palliative care telehealth intervention (Educate, Nurture, Advise, Before Life Ends Comprehensive Heart Failure for Patients and Caregivers [ENABLE CHF-PC]) on quality of life and mood of family caregivers of persons with New York Heart Association Class III/IV heart failure over 16 weeks. Design, Setting, and Participants: This single-blind randomized clinical trial enrolled caregivers aged 18 years and older who self-identified as an unpaid close friend or family member who knew the patient well and who was involved with their day-to-day medical care. Participants were recruited from outpatient heart failure clinics at a large academic tertiary care medical center and a Veterans Affairs medical center from August 2016 to October 2018. Intervention: Four weekly psychosocial and problem-solving support telephonic sessions lasting between 20 and 60 minutes facilitated by a trained nurse coach plus monthly follow-up for 48 weeks. The usual care group received no additional intervention. Main Outcomes and Measures: The primary outcomes were quality of life (measured using the Bakas Caregiver Outcomes Scale), mood (anxiety and/or depressive symptoms measured using the Hospital Anxiety and Depression Scale), and burden (measured using the Montgomery-Borgatta Caregiver Burden scales) over 16 weeks. Secondary outcomes were global health (measured using the PROMIS Global Health instrument) and positive aspects of caregiving. Results: A total of 158 family caregivers were randomized, 82 to the intervention and 76 to usual care. The mean (SD) age was 57.9 (11.6) years, 135 (85.4%) were female, 82 (51.9%) were African American, and 103 (65.2%) were the patient's spouse or partner. At week 16, the mean (SE) Bakas Caregiver Outcomes Scale score was 66.9 (2.1) in the intervention group and 63.9 (1.7) in the usual care group; over 16 weeks, the mean (SE) Bakas Caregiver Outcomes Scale score improved 0.7 (1.7) points in the intervention group and 1.1 (1.6) points in the usual care group (difference, -0.4; 95% CI, -5.1 to 4.3; Cohen d = -0.03). At week 16, no relevant between-group differences were observed between the intervention and usual care groups for the Hospital Anxiety and Depression Scale anxiety measure (mean [SE] improvement from baseline, 0.3 [0.3] vs 0.4 [0.3]; difference, -0.1 [0.5]; d = -0.02) or depression measure (mean [SE] improvement from baseline, -0.2 [0.4] vs -0.3 [0.3]; difference, 0.1 [0.5]; d = 0.03). No between-group differences were observed in the Montgomery-Borgatta Caregiver Burden scales (d range, -0.18 to 0.0). Differences in secondary outcomes were also not significant (d range, -0.22 to 0.0). Conclusions and Relevance: This 2-site randomized clinical trial of a telehealth intervention for family caregivers of patients with advanced heart failure, more than half of whom were African American and most of whom were not distressed at baseline, did not demonstrate clinically better quality of life, mood, or burden compared with usual care over 16 weeks. Future interventions should target distressed caregivers and assess caregiver effects on patient outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02505425.

Protocol driven palliative care consultation: Outcomes of the ENABLE CHF-PC pilot study.

BACKGROUND: Little has been reported about protocol-driven outpatient palliative care consultation (OPCC) for advanced heart failure (HF). OBJECTIVES: To describe evaluation practices and treatment recommendations made during protocol-driven OPCCs for advanced HF. METHODS: We performed content analysis of OPCCs completed as part of ENABLE CHF-PC, an early palliative care HF intervention, conducted at sites in the Northeast and Southeast. T-tests, Fisher's exact, and Chi-square tests were used to evaluate sociodemographic, outcome measures, and site content differences. RESULTS: Of 61 ENABLE CHF-PC participants, 39 (64%) had an OPCC (Northeast, n=27; Southeast, n=12). Social and medical history assessed most were close relationships (n=35, 90%), family support (n=33, 85%), advance directive status (n=33, 85%), functional status (n=30, 77%); and symptoms were mood (n= 35, 90%), breathlessness (n=28, 72%), and chest pain (n=24, 62%). Treatment recommendations focused on care coordination (n=13, 33%) and specialty referrals (n=12, 31%). Between-site OPCC differences included assessment of family support (Northeast vs. Southeast: 100% vs. 50%), code status (96% vs. 58%), goals of care discussions (89% vs. 41.7%), and prognosis understanding (85% vs. 33%). CONCLUSION: OPCCs for HF focused on evaluating medical and social history, along with goals of care and code status discussions. Symptom evaluation commonly included mood disorders, pain, dyspnea, and fatigue. Notable regional differences were found in topics evaluated and OPCC completion rates.

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.

BACKGROUND: Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. We 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). METHODS: We conducted an EPC feasibility study (4/1/14-8/31/15) for patients with NYHA 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 outpatient palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. We collected patient- and caregiver-reported outcomes of quality of life (QOL), symptom, health, anxiety, and depression at baseline, 12- and 24-weeks. We used linear mixed-models to assess baseline to week 24 longitudinal changes. RESULTS: We enrolled 61 patients and 48 caregivers; between-site demographic differences included age, race, religion, marital, and work status. Most patients (69%) and caregivers (79%) completed all intervention sessions; however, we noted large between-site differences in measurement completion (38% southeast vs. 72% northeast). Patients experienced moderate effect size improvements in QOL, symptoms, physical, and mental health; caregivers experienced moderate effect size improvements in QOL, depression, mental health, and burden. Small-to-moderate effect size improvements were noted in patients' hospital and ICU days and emergency visits. CONCLUSIONS: Between-site demographic, attrition, and participant-reported outcomes highlight the importance of intervention pilot-testing in culturally diverse populations. Observations from this pilot feasibility trial allowed us to refine the methodology of an in-progress, full-scale randomized clinical efficacy trial. TRIAL REGISTRATION: Clinicaltrials.gov NCT03177447 (retrospectively registered, June 2017).