Meaning-centered pain coping skills training for patients with metastatic cancer: Results of a randomized controlled pilot trial.

OBJECTIVE: For patients with advanced cancer, pain is a common and debilitating symptom that can negatively impact physical, emotional, and spiritual well-being. This trial examined the feasibility and initial effects of Meaning-Centered Pain Coping Skills Training (MCPC), a cognitive-behavioral pain management intervention with an emphasis on enhancing meaning (i.e., a personal sense of purpose, worth, and significance) and peace. METHODS: We enrolled 60 adults with stage IV solid tumor cancers and moderate-severe pain between February 2021 and February 2022. Participants were randomized 1:1 to MCPC + usual care or usual care alone. Meaning-Centered Pain Coping Skills Training consisted of four weekly 60-min individual sessions via videoconference or telephone, delivered by a trained therapist using a manualized protocol. Participants completed validated measures of pain severity, pain interference, pain self-efficacy, spiritual well-being (i.e., meaning, peace, and faith), and psychological distress at baseline and 5-week and 10-week follow-ups. RESULTS: All feasibility metrics exceeded prespecified benchmarks. Fifty-eight percent of screened patients were eligible, and 69% of eligible patients consented. Of those assigned to MCPC, 93% completed all sessions and 100% of those who completed follow-ups reported using coping skills weekly. Retention was strong at 5-week (85%) and 10-week (78%) follow-ups. Meaning-Centered Pain Coping Skills Training participants reported better scores than control participants across outcome measures, including moderate-to-large sized differences at 10-week follow-up in pain severity (Cohen's d = -0.75 [95% confidence interval: -1.36, -0.14]), pain interference (d = -0.82 [-1.45, -0.20]), and pain self-efficacy (d = 0.74 [0.13, 1.35]). CONCLUSIONS: MCPC is a highly feasible, engaging, and promising approach for improving pain management in advanced cancer. Future efficacy testing is warranted. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04431830, registered 16 June 2020.

Polypharmacy in Palliative Care for Advanced Heart Failure: The PAL-HF Experience.

BACKGROUND: Palliative care (PC) in advanced heart failure (HF) aims to improve symptoms and quality of life (QOL), in part through medication management. The impact of PC on polypharmacy (>5 medications) remains unknown. METHODS AND RESULTS: We explored patterns of polypharmacy in the Palliative Care in HF (PAL-HF) randomized controlled trial of standard care vs interdisciplinary PC in advanced HF (N = 150). We describe differences in medication counts between arms at 2, 6, 12, and 24 weeks for HF (12 classes) and PC (6 classes) medications. General linear mixed models were used to evaluate associations between treatment arm and polypharmacy over time. The median age of the patients was 72 years (interquartile range 62-80 years), 47% were female, and 41% were Black. Overall, 48% had ischemic etiology, and 55% had an ejection fraction of 40% or less. Polypharmacy was present at baseline in 100% of patients. HF and PC medication counts increased in both arms, with no significant differences in counts by drug class at any time point between arms. CONCLUSIONS: In a trial of patients with advanced HF considered eligible for PC, polypharmacy was universal at baseline and increased during follow-up with no effect of the palliative intervention on medication counts relative to standard care.

Who Benefits Most? A Multisite Study of Coaching and Resident Well-being.

BACKGROUND: Coaching has been shown to improve resident well-being; however, not all benefit equally. OBJECTIVE: Assess predictors of changes in resident physician well-being and burnout in a multisite implementation of a Professional Development Coaching Program. DESIGN: Pre- and post-implementation surveys administered to participant cohorts at implementation sites in their intern year. Effect size was calculated comparing pre- and post-intervention paired data. PARTICIPANTS: In total, 272 residents in their intern year at five internal medicine residency programs (Boston Medical Center, University Hospitals Cleveland Medical Center, Duke University, Emory University, Massachusetts General Hospital). Analyses included 129 residents with paired data. INTERVENTIONS: Interns were paired with a faculty coach trained in positive psychology and coaching skills and asked to meet quarterly with coaches. MAIN MEASURES: Primary outcomes included Maslach Burnout Inventory depersonalization (DP) and emotional exhaustion (EE) subscales, and the PERMA well-being scale. Key predictors included site, demographics, intolerance of uncertainty, hardiness-resilience, gratitude, and coping. Program moderators included were reflection, goal setting, and feedback. KEY RESULTS: Well-being (PERMA) changed from baseline to follow-up in all participants; females showed a decline and males an increase (-1.41 vs. .83, p = 0.04). Self-reflection was associated with positive change in PERMA (mean positive change 1.93, p = 0.009). Burnout (EE) declined in non-Hispanic white residents vs. Black/Asian/Hispanic/other residents (-1.86, p = 0.021). Burnout improved with increased goal setting. CONCLUSION: Coaching programs should consider tailored approaches to support residents whose well-being is impacted by gender and/or race, and who have higher intolerance of uncertainty and lower resilience at baseline. Coaching skills of goal setting and reflection may positively affect interns and teach coping skills.

Implementation of an Intensive Telehealth Intervention for Rural Patients with Clinic-Refractory Diabetes.

BACKGROUND: Rural patients with type 2 diabetes (T2D) may experience poor glycemic control due to limited access to T2D specialty care and self-management support. Telehealth can facilitate delivery of comprehensive T2D care to rural patients, but implementation in clinical practice is challenging. OBJECTIVE: To examine the implementation of Advanced Comprehensive Diabetes Care (ACDC), an evidence-based, comprehensive telehealth intervention for clinic-refractory, uncontrolled T2D. ACDC leverages existing Veterans Health Administration (VHA) Home Telehealth (HT) infrastructure, making delivery practical in rural areas. DESIGN: Mixed-methods implementation study. PARTICIPANTS: 230 patients with clinic-refractory, uncontrolled T2D. INTERVENTION: ACDC bundles telemonitoring, self-management support, and specialist-guided medication management, and is delivered over 6 months using existing VHA HT clinical staffing/equipment. Patients may continue in a maintenance protocol after the initial 6-month intervention period. MAIN MEASURES: Implementation was evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The primary effectiveness outcome was hemoglobin A1c (HbA1c). KEY RESULTS: From 2017 to 2020, ACDC was delivered to 230 patients across seven geographically diverse VHA sites; on average, patients were 59 years of age, 95% male, 80% white, and 14% Hispanic/Latinx. Patients completed an average of 10.1 of 12 scheduled encounters during the 6-month intervention period. Model-estimated mean baseline HbA1c was 9.56% and improved to 8.14% at 6 months (- 1.43%, 95% CI: - 1.64, - 1.21; P < .001). Benefits persisted at 12 (- 1.26%, 95% CI: - 1.48, - 1.05; P < .001) and 18 months (- 1.08%, 95% CI - 1.35, - 0.81; P < .001). Patients reported increased engagement in self-management and awareness of glycemic control, while clinicians and HT nurses reported a moderate workload increase. As of this submission, some sites have maintained delivery of ACDC for up to 4 years. CONCLUSIONS: When strategically designed to leverage existing infrastructure, comprehensive telehealth interventions can be implemented successfully, even in rural areas. ACDC produced sustained improvements in glycemic control in a previously refractory population.

Spirituality in Serious Illness and Health.

Importance: Despite growing evidence, the role of spirituality in serious illness and health has not been systematically assessed. Objective: To review evidence concerning spirituality in serious illness and health and to identify implications for patient care and health outcomes. Evidence Review: Searches of PubMed, PsycINFO, and Web of Science identified articles with evidence addressing spirituality in serious illness or health, published January 2000 to April 2022. Independent reviewers screened, summarized, and graded articles that met eligibility criteria. Eligible serious illness studies included 100 or more participants; were prospective cohort studies, cross-sectional descriptive studies, meta-analyses, or randomized clinical trials; and included validated spirituality measures. Eligible health outcome studies prospectively examined associations with spirituality as cohort studies, case-control studies, or meta-analyses with samples of at least 1000 or were randomized trials with samples of at least 100 and used validated spirituality measures. Applying Cochrane criteria, studies were graded as having low, moderate, serious, or critical risk of bias, and studies with serious and critical risk of bias were excluded. Multidisciplinary Delphi panels consisting of clinicians, public health personnel, researchers, health systems leaders, and medical ethicists qualitatively synthesized and assessed the evidence and offered implications for health care. Evidence-synthesis statements and implications were derived from panelists' qualitative input; panelists rated the former on a 9-point scale (from "inconclusive" to "strongest evidence") and ranked the latter by order of priority. Findings: Of 8946 articles identified, 371 articles met inclusion criteria for serious illness; of these, 76.9% had low to moderate risk of bias. The Delphi panel review yielded 8 evidence statements supported by evidence categorized as strong and proposed 3 top-ranked implications of this evidence for serious illness: (1) incorporate spiritual care into care for patients with serious illness; (2) incorporate spiritual care education into training of interdisciplinary teams caring for persons with serious illness; and (3) include specialty practitioners of spiritual care in care of patients with serious illness. Of 6485 health outcomes articles, 215 met inclusion criteria; of these, 66.0% had low to moderate risk of bias. The Delphi panel review yielded 8 evidence statements supported by evidence categorized as strong and proposed 3 top-ranked implications of this evidence for health outcomes: (1) incorporate patient-centered and evidence-based approaches regarding associations of spiritual community with improved patient and population health outcomes; (2) increase awareness among health professionals of evidence for protective health associations of spiritual community; and (3) recognize spirituality as a social factor associated with health in research, community assessments, and program implementation. Conclusions and Relevance: This systematic review, analysis, and process, based on highest-quality evidence available and expert consensus, provided suggested implications for addressing spirituality in serious illness and health outcomes as part of person-centered, value-sensitive care.

How Does Spiritual Well-Being Change Over Time Among US Patients with Heart Failure and What Predicts Change?

Few studies have examined how spiritual well-being changes over time in patients with heart failure. We conducted a secondary analysis of data from the Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) trial (N = 314). Spiritual well-being was measured using the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp) at baseline and 12-month follow-up. Of the 165 patients with spiritual well-being data at follow-up, 65 (39%) experienced probable clinically meaningful changes (> 0.5 SD) in spiritual well-being (35 improved, 30 declined). Increased pain (p = 0.04), decreased dyspnea (p < 0.01), and increased life completion (p = 0.02) were associated with improvement in overall spiritual well-being. Exploratory analyses found different predictors for FACIT-Sp subscales.

The Cost-Effectiveness of Palliative Care: Insights from the PAL-HF Trial.

BACKGROUND: In a randomized control trial, Palliative Care in Heart Failure (PAL-HF) improved heart failure-related quality of life, though cost-effectiveness remains unknown. The aim of this study was to evaluate the cost-effectiveness of the PAL-HF trial, which provided outpatient palliative care to patients with advanced heart failure. METHODS AND RESULTS: Outcomes for usual care and PAL-HF strategies were compared using a Markov cohort model over 36 months from a payer perspective. The model parameters were informed by PAL-HF trial data and supplemented with meta-analyses and Medicare administrative data. Outcomes included hospitalization, place of death, Medicare expenditures, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. Simulated mortality rates were the same for PAL-HF and usual care cohorts, at 89.7% at 36 months. In the base case analysis, the PAL-HF intervention resulted in an incremental gain of 0.03 QALYs and an incremental cost of $964 per patient for an incremental cost-effectiveness ratio of $29,041 per QALY. In 1-way sensitivity analyses, an intervention cost of up to $140 per month is cost effective at $50,000 per QALY. Of 1000 simulations, the PC intervention had a 66.1% probability of being cost effective at a $50,000 willingness-to-pay threshold assuming no decrease in hospitalization. In a scenario analysis, PAL-HF decreased payer spending through reductions in noncardiovascular hospitalizations. CONCLUSIONS: These results from this single-center trial are encouraging that palliative care for advanced heart failure is an economically attractive intervention. Confirmation of these findings in larger multicenter trials will be an important part of developing the evidence to support more widespread implementation of the PAL-HF palliative care intervention.

Applied Rapid Qualitative Analysis to Develop a Contextually Appropriate Intervention and Increase the Likelihood of Uptake.

BACKGROUND: Rapid approaches to collecting and analyzing qualitative interview data can accelerate discovery timelines and intervention development while maintaining scientific rigor. We describe the application of these methods to a program designed to improve care coordination between the Veterans Health Administration (VHA) and community providers. METHODS: Care coordination between VHA and community providers can be challenging in rural areas. The Telehealth-based Coordination of Non-VHA Care (TECNO Care) intervention was designed to improve care coordination among VHA and community providers. To ensure contextually appropriate implementation of TECNO Care, we conducted preimplementation interviews with veterans, VHA administrators, and VHA and community providers involved in community care. Using both a rapid approach and qualitative analysis, an interviewer and 1-2 note-taker(s) conducted interviews. RESULTS: Over 5 months, 18 stakeholders were interviewed and we analyzed these data to identify how best to deliver TECNO Care. Responses relevant to improving care coordination include health system characteristics; target population; metrics and outcomes; challenges with the current system; and core components. Veterans who frequently visit VHA or community providers and are referred for additional services are at risk for poor outcomes and may benefit from additional care coordination. Using these data, we designed TECNO Care to include information on VHA services and processes, assist in the timely completion of referrals, and facilitate record sharing. CONCLUSION: Rapid qualitative analysis can inform near real-time intervention development and ensure relevant content creation while setting the stage for stakeholder buy-in. Rigorous and timely analyses support the delivery of contextually appropriate, efficient, high-value patient care.

A novel decision aid for acute myeloid leukemia: a feasibility and preliminary efficacy trial.

PURPOSE: Acute myeloid leukemia (AML) is a hematologic malignancy characterized by a poor prognosis but also a paradoxical possibility of cure. This renders decision-making complex and imminent. Unfortunately, many patients with AML misestimate their prognosis and treatment risk. While decision aids can improve illness understanding and reduce decisional conflict, there are no validated decision aids for AML. We developed and tested a novel AML decision aid (NCT03442452). METHODS: Patients (n = 20) were recruited at Duke University from May 2018 to February 2019. Participants completed assessments of AML knowledge and decisional conflict, before and after using the electronic decision aid. The primary endpoint was feasibility (endpoint met if > 80% of study participants completed all study components). Secondary analyses of efficacy were conducted using paired t tests for dependent pre-/post-samples. RESULTS: The primary endpoint of feasibility was met (100% of participants completed all study components). Secondary analyses showed improved knowledge and reduced decisional conflict after using the decision aid. Knowledge scores improved from a mean of 11.8 (out of 18) correct items at baseline to 15.1 correct items after using the decision aid (mean difference 3.35; p < 0.0001). Decisional conflict scores reduced significantly from baseline to post-test as well (mean difference - 6.5; p = 0.02). CONCLUSION: These findings suggest that our AML decision aid is a useful tool to improve the patient experience and promote shared decision-making in AML. A randomized efficacy trial is planned.

Current measures of distress may not account for what's most important in existential care interventions: Results of the outlook trial.

OBJECTIVE: Compare the efficacy of two interventions addressing emotional and existential well-being in early life-limiting illness. METHOD: Primary trial analysis (n = 135) included patients with advanced cancer, congestive heart failure, or end-stage renal disease; Arm 1 received the Outlook intervention, addressing issues of life completion and preparation, and Arm 2 received relaxation meditation (RM). Primary outcomes at five weeks (primary endpoint) and seven weeks (secondary): completion and preparation (QUAL-E); secondary outcomes: anxiety (POMS) quality of life (FACT-G) and spiritual well-being (FACIT-Sp) subscales of faith, meaning, and peace. RESULTS: Average age was 62; 56% were post-high school-educated, 54% were married, 52% white, 44% female, and 70% had a cancer diagnosis. At baseline, participants demonstrated low levels of anxiety (<5 on POMS subscale) and depression (<10 on CESD) relative to population norms. Results of the primary analysis revealed no significant differences in mean Preparation by treatment arm at five weeks (14.4 Outlook vs. 14.8 RM; between-group difference -0.4 [95% CI, -1.6, 0.8], p = 0.49) or seven weeks (15.2 vs.15.4; between-group difference -0.2 [95% CI, -1.5, 1.0], p = 0.73). There were also no significant differences in mean Life Completion by treatment arm between five weeks (26.6 Outlook vs. 26.3 RM; between-group difference 0.2 [95% CI, -1.2, 1.7], p = 0.76) or seven weeks (26.5 vs. 27.5; between-group difference -1.0 [95% CI, -2.7, 0.7], p = 0.23). Compared to RM, Outlook participants did not have significant differences over time in the secondary outcomes of overall quality of life, anxiety, depression, FACT-G subscales, and FACIT-Sp subscales. DISCUSSION: In early-stage life-limiting illness, Outlook did not demonstrate a significant difference in primary or secondary outcomes relative to RM. Results underscore the importance of pre-screening for distress. Qualitatively, Outlook participants were able to express suppressed emotions, place illness context, reflect on adaptations, and strengthen identity. Screening for distress and identifying specified measures of distress, beyond anxiety and depression, is essential in our ability to adequately assess the multi-dimensional mechanisms that decrease existential suffering.

Enhancing meaning in the face of advanced cancer and pain: Qualitative evaluation of a meaning-centered psychosocial pain management intervention.

OBJECTIVES: The objectives of this study were to obtain patient evaluations of the content, structure, and delivery modality of Meaning-Centered Pain Coping Skills Training (MCPC), a novel psychosocial intervention for patients with advanced cancer and pain. MCPC aims to help patients connect with valued sources of meaning in their lives (e.g., family relationships), while providing training in evidence-based cognitive and behavioral skills (e.g., guided imagery) to reduce pain. METHODS: Semi-structured interviews were conducted with 12 patients with stage IV solid tumor cancers and persistent pain. Transcripts were analyzed using methods from applied thematic analysis. RESULTS: When evaluating MCPC's educational information and skills training descriptions, participants described ways in which this content resonated with their experience. Many coped with their pain and poor prognosis by relying on frameworks that provided them with a sense of meaning, often involving their personally held religious or spiritual beliefs. They also expressed a need for learning ways to cope with pain in addition to taking medication. A few participants offered helpful suggestions for refining MCPC's content, such as addressing common co-occurring symptoms of sleep disturbance and fatigue. Concerning MCPC's structure and delivery modality, most participants preferred that sessions include their family caregiver and described remote delivery (i.e., telephone or videoconference) as being more feasible than attending in-person sessions. SIGNIFICANCE OF RESULTS: Participants were interested in an intervention that concurrently focuses on learning pain coping skills and enhancing a sense of meaning. Using remote delivery modalities may reduce access barriers (e.g., travel) that would otherwise prevent many patients from utilizing psychosocial services.

Identifying core curricular components for behavioral health training in internal medicine residency: Qualitative interviews with residents, faculty, and behavioral health clinicians.

OBJECTIVE: Behavioral health services frequently delivered by primary care providers include care for mental health and substance abuse disorders and assistance with behavioral risk factor reduction. Internal medicine residencies in the United States lack formal expectations regarding training in behavioral health for residents. This qualitative study aimed to determine learners' and teachers' perceptions about appropriate behavioral health curricular components for internal medicine residents. METHOD: Focus groups and interviews were conducted with the following individuals from the Duke Outpatient Clinic: residents with continuity practice (n = 27), advanced practice providers (n = 2), internal medicine attending physicians (n = 4), internal medicine/psychiatry attending physicians (n = 2), and behavioral health clinicians (n = 4). A focus group leader asked regarding residents' successes and challenges in managing behavioral health issues and about specific learning components considered necessary to understand and manage these behavioral health conditions. Transcripts were coded using an editing analysis style to identify central themes and concordance/discordance between groups. RESULTS: Regarding mental health management (Theme 1), residents emphasized a need for better care coordination with specialty mental health, while attendings and behavioral health clinicians gave priority to residents' skills in primary management of mental health. Residents, attendings, and behavioral health clinicians all emphasized advanced interviewing skills (Theme 2) with subthemes: eliciting the patient's perspective, managing time in encounters, improving patients' understanding, and patient counseling. CONCLUSIONS: Internal medicine residents, attendings, and behavioral health clinicians may differ significantly in their perceptions of primary care's role in mental health care. Future internal medicine behavioral health curricula should specifically address these attitudinal differences. Curricula should also emphasize interview skills training as an essential component of behavioral health learning.

Triadic treatment decision-making in advanced cancer: a pilot study of the roles and perceptions of patients, caregivers, and oncologists.

PURPOSE: The research on cancer treatment decision-making focuses on dyads; the full "triad" of patients, oncologists, and caregivers remains largely unstudied. We investigated how all members of this triad perceive and experience decisions related to treatment for advanced cancer. METHODS: At an academic cancer center, we enrolled adult patients with advanced gastrointestinal or hematological malignancies, their caregivers, and their oncologists. Triad members completed a semi-structured qualitative interview and a survey measuring decisional conflict and perceived influence of the other triad members on treatment decisions. RESULTS: Seventeen patients, 14 caregivers, and 10 oncologists completed the study. Patients and caregivers reported little decisional regret and voiced high satisfaction with their decisions, but levels of decisional conflict were high. We found sizeable disagreement among triad members' perceptions and preferences. For example, patients and oncologists disagreed about the caregiver's influence on the decision 56% of the time. In addition, many patients and caregivers preferred to defer to their oncologist about treatment decisions, felt like no true decision existed, and disagreed with their oncologist about how many treatment options had been presented. CONCLUSIONS: Patients, caregivers, and oncologists have discordant perceptions of the cancer treatment decision-making process, and bring different preferences about how they want to make decisions. These data suggest that oncologists should assess patients' and caregivers' decisional preferences, explicitly signal that a decision needs to be made whenever approaching an important crossroads in treatment and ensure that patients and caregivers understand the full range of presented options.

Patient experiences of acute myeloid leukemia: A qualitative study about diagnosis, illness understanding, and treatment decision-making.

BACKGROUND: Patients with acute myeloid leukemia (AML) face a unique, difficult situation characterized by sudden changes in health, complex information, and pressure to make quick treatment decisions amid sizeable tradeoffs. Yet, little is known about patients' experiences with AML. We used qualitative methods to learn about their experiences with diagnosis and treatment decision-making to identify areas for improvement. METHODS: We recruited hospitalized patients with AML to participate in semi-structured qualitative interviews about their experiences being diagnosed with AML, receiving information, and making a treatment decision. Interviews were conducted during their hospitalization for induction chemotherapy. We analyzed data by using a constant comparison approach. RESULTS: Thirty-two patients completed an interview. Four main themes emerged: (a) shock and suddenness, (b) difficulty processing information, (c) poor communication, and (d) uncertainty. Patients frequently described their diagnosis as shocking. They also felt that the amount of information was too great and too difficult to process, which negatively impacted their understanding. Patients frequently described a lack of emotional support from clinicians and described uncertainty about their prognosis, the number and nature of available treatments, and what to expect from treatment. CONCLUSIONS: Acute myeloid leukemia poses a sudden, emotionally challenging, information-laden situation, where little time is available to make important decisions. This results in difficulty processing information and is sometimes complicated by a lack of emotive communication from clinicians. Results indicate a need for targeted interventions to improve AML patients' understanding of illness and treatment options and to address their traumatic experiences around diagnosis.

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).

Effects of enhanced caregiver training program on cancer caregiver's self-efficacy, preparedness, and psychological well-being.

PURPOSE: We examined the effects of an enhanced informal caregiver training (Enhanced-CT) protocol in cancer symptom and caregiver stress management to caregivers of hospitalized cancer patients. METHODS: We recruited adult patients in oncology units and their informal caregivers. We utilized a two-armed, randomized controlled trial design with data collected at baseline, post-training, and at 2 and 4 weeks after hospital discharge. Primary outcomes were self-efficacy for managing patients' cancer symptoms and caregiver stress and preparedness for caregiving. Secondary outcomes were caregiver depression, anxiety, and burden. The education comparison (EDUC) group received information about community resources. We used general linear models to test for differences in the Enhanced-CT relative to the EDUC group. RESULTS: We consented and randomized 138 dyads: Enhanced-CT = 68 and EDUC = 70. The Enhanced-CT group had a greater increase in caregiver self-efficacy for cancer symptom management and stress management and preparation for caregiving at the post-training assessment compared to the EDUC group but not at 2- and 4-week post-discharge assessments. There were no intervention group differences in depression, anxiety, and burden. CONCLUSION: An Enhanced-CT protocol resulted in short-term improvements in self-efficacy for managing patients' cancer symptoms and caregiver stress and preparedness for caregiving but not in caregivers' psychological well-being. The lack of sustained effects may be related to the single-dose nature of our intervention and the changing needs of informal caregivers after hospital discharge.

The feasibility and acceptability of a chaplain-led intervention for caregivers of seriously ill patients: A Caregiver Outlook pilot study.

OBJECTIVE: When caring for a loved one with a life-limiting illness, a caregiver's own physical, emotional, and spiritual suffering can be profound. While many interventions focus on physical and emotional well-being, few caregiver interventions address existential and spiritual needs and the meaning that caregivers ascribe to their role. To evaluate the feasibility and acceptability of the process and content of Caregiver Outlook, we employed a manualized chaplain-led intervention to improve well-being by exploring role-related meaning among caregivers of patients with a life-limiting illness. METHOD: We conducted a single-arm pre-post pilot evaluation among caregivers of patients with advanced cancer or amyotrophic lateral sclerosis (ALS). Caregivers completed three chaplain-led intervention sessions focusing on (1) a relationship review, (2) forgiveness, and (3) legacy. Outcomes administered at baseline and at 1 and 2 weeks after the intervention included quality of life, anxiety, depression, spiritual well-being, religious coping, caregiver burden, and grief. RESULTS: The sample (N = 31) included a range of socioeconomic status groups, and the average age was approximately 60 years. A third of them worked full-time. Some 74% of our participants cared for a spouse or partner, and the other quarter of the sample cared for a parent (13%), child (10%), or other close family member (3%). At baseline, participants did not demonstrate clinical threshold levels of anxiety, depression, or other indicators of distress. Outcomes were stable over time. The qualitative results showed the ways in which Caregiver Outlook was assistive: stepping back from day-to-day tasks, the opportunity to process emotions, reflecting on support received, provoking thoughts and emotions between sessions, discussing role changes, stimulating communication with others, and the anonymity of a phone conversation. Both religious and nonreligious participants were pleased with administration of the chaplain intervention. SIGNIFICANCE OF RESULTS: The acceptability and feasibility of Caregiver Outlook were demonstrated among caregivers of patients with an advanced illness. Our pilot findings suggest minor modifications to study participant screening, interventionist guidance, and the study measures.

Transcending differences to study the transcendent: an exploratory study of researchers' and chaplains' reflections on interdisciplinary spiritual care research collaboration.

BACKGROUND: Despite recognition of the centrality of professional board-certified chaplains (BCC) in palliative care, the discipline has little research to guide its practices. To help address this limitation, HealthCare Chaplaincy Network funded six proposals in which BCCs worked collaboratively with established researchers. Recognizing the importance of interdisciplinary collaboration in the development of a new field, this paper reports on an exploratory study of project members' reflections over time on the benefits and challenges of conducting inter-disciplinary spiritual care research. METHODS: Data collection occurred in two stages. Stage 1 entailed two independent, self-reflective focus groups, organized by professional discipline, mid-way through the site projects. Stage 2 entailed end-of-project site reports and a conference questionnaire. RESULTS: Eighteen professionals participated in the group discussions. Stage 1: researchers perceived chaplains as eager workers passionately committed to their patients and to research, and identified challenges faced by chaplains in learning to conduct research. Chaplains perceived researchers as passionate about their work, were concerned research might uncover negative findings for their profession, and sensed they used a dissimilar paradigm from their research colleagues regarding the 'ways of relating' to knowledge and understanding. Stage 2: researchers and chaplains noted important changes they ascribed to the interdisciplinary collaboration that were classified into six domains of cultural and philosophical understanding: respect; learning; discovery; creativity; fruitful partnerships; and learning needs. CONCLUSIONS: Chaplains and researchers initially expressed divergent perspectives on the research collaborations. During the projects' lifespans, these differences were acknowledged and addressed. Mutual appreciation for each discipline's strengths and contributions to inter-professional dialogue emerged.

What constitutes quality of family experience at the end of life? Perspectives from family members of patients who died in the hospital.

OBJECTIVE: Most palliative care efforts focus on assessing and improving the quality of life and quality of care for patients. Palliative care views the family as the unit of care; therefore, excellent comprehensive palliative care should also address the needs of the family and the caregiver(s). While the recent literature has offered detailed descriptions of caregiving needs in the home setting, it is crucial to describe the needs of family members who provide care for patients with advanced illness in an inpatient setting, where family members serve as the key intermediaries and decision makers. Therefore, we sought to define the relevant aspects of quality of experience for families of hospitalized patients. METHOD: We convened a series of focus groups to identify the domains important for the quality of experience of dying patients' family members. Participants included bereaved family members of patients who had died at a Veterans Administration (VA) or private academic medical center. We conducted four in-depth follow-up interviews to probe for additional details and validate our interpretation of the focus group findings. RESULTS: Participants (n = 14) ranged in age from 46 to 83, with a mean of 62. All were female; 64% were Caucasian, 21% African American, and 14% did not report their ethnicity. Content analysis yielded 64 attributes of quality of family experience constituting eight domains: completion, symptom impact, decision making, preparation, relationship with healthcare providers, affirmation of the whole person, post-death care, and supportive services. SIGNIFICANCE OF RESULTS: Our data have implications for clinical guidance in assisting family members in the inpatient palliative setting, which often includes patient incapacity for communication and decision making. They suggest the importance of developing corresponding methods to assist families with the tasks involved with life completion, being prepared for a crisis and imminent death, and post-death care. Provider communications and relationships are central to the processes of meeting the clinical needs of family members. Our findings should inform the development of measures to assess family experience.

The palliative care in heart failure trial: rationale and design.

BACKGROUND: The progressive nature of heart failure (HF) coupled with high mortality and poor quality of life mandates greater attention to palliative care as a routine component of advanced HF management. Limited evidence exists from randomized, controlled trials supporting the use of interdisciplinary palliative care in HF. METHODS: PAL-HF is a prospective, controlled, unblinded, single-center study of an interdisciplinary palliative care intervention in 200 patients with advanced HF estimated to have a high likelihood of mortality or rehospitalization in the ensuing 6 months. The 6-month PAL-HF intervention focuses on physical and psychosocial symptom relief, attention to spiritual concerns, and advanced care planning. The primary end point is health-related quality of life measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale score at 6 months. Secondary end points include changes in anxiety/depression, spiritual well-being, caregiver satisfaction, cost and resource utilization, and a composite of death, HF hospitalization, and quality of life. CONCLUSIONS: PAL-HF is a randomized, controlled clinical trial that will help evaluate the efficacy and cost effectiveness of palliative care in advanced HF using a patient-centered outcome as well as clinical and economic end points.