A Pilot of a Telehealth-Hospice Transition Intervention for Children and Young Adults with Cancer.

BACKGROUND AND AIMS: Telehealth can improve care for patients with progressive cancer enrolling in hospice. Coordinated telehealth visits (patient/family-hospital-hospice) may improve communication, satisfaction with and interdisciplinary hospice collaboration. This pilot examines the impact of three coordinated telehealth visits on these outcomes. METHODS: This is a prospective pilot study of 0-29-year-old patients with cancer initiating hospice care between 2021-2023. Adult patients, caregivers, oncology and palliative care clinicians, hospice nurses and administrators were surveyed about feasibility and acceptability with telehealth (Technology Acceptance Model 2) after first and third telehealth visits. Hospice satisfaction (Consumer Assessment of Healthcare Providers and Systems) was completed by caregivers after visit 3 and during bereavement. Healthcare professionals completed the Assessment of Interprofessional Team Collaboration Scale II (AITCS-II). Survey responses were summarized and differences in scores were analyzed. RESULTS: Of 40 eligible patients, 24 enrolled, 19 completed visit 1, and 13 completed visit 3. Fourteen caregivers and two adult patients completed visit 1 surveys; nine caregivers and two adult patients completed visit 3 surveys. Participants highly rated telehealth acceptability after visit 1 (Median: 4.5, IQR: 4.0-4.7) and 3 (Median: 4.4, IQR: 4.0-4.7). Hospice services were rated as highly satisfactory at visit 3 (Median: 4.0, IQR: 3.7-4.0) and during bereavement (Median: 3.7, IQR: 3.5-4.0). Healthcare professionals (n = 85 surveys) reported excellent interprofessional collaboration (Hospital clinicians median: 99/115 and hospice teams 111/115). CONCLUSIONS: Participants found coordinated telehealth visits to be feasible, acceptable, and satisfactory. Telehealth may be utilized as an acceptable alternative to clinic visits and fosters hospital-hospice collaboration.

Symptoms and quality of life in adults with cystic fibrosis: A cross-sectional analysis of the InSPIRe:CF trial.

BACKGROUND: People living with cystic fibrosis (CF) experience a high symptom burden. Due to the changing landscape of CF in the era of modulator therapy, we sought to examine the epidemiology of symptoms and their association with quality of life, to help CF clinicians improve symptom screening in clinic. METHODS: Using baseline data from a trial of specialist palliative care in adults with CF, we examined symptom prevalence, distress, and association with quality of life (measured with the Functional Assessment of Chronic Illness Therapy Total Score). RESULTS: Among 262 participants, median age was 33, and 78% were on modulator therapy. The most common symptoms were lack of energy (n = 194, 74%) and cough (190, 73%), whereas the most distressing were difficulty sleeping (range 0-4, mean 2.19, SD 1.15) and pain (mean 2.04, SD 1.1). The symptoms that impaired quality of life the most were extrapulmonary: lack of energy (average quality of life score -29.8, 95% CI -36.8 to -22.8), feeling sad (-29.8, 95% CI -35.6 to -23.9) and worrying (-28.7, 95% CI -34.9 to -22.5). CONCLUSIONS: The symptoms that were associated with the lowest quality of life were extrapulmonary. CF clinicians may consider screening for common symptoms that affect quality of life the most (lack of energy, worrying, difficulty sleeping, feeling irritable, pain, and shortness of breath). These symptoms may identify people living with CF who are most at risk for a decreased quality of life and may benefit from additional support.

Criteria for Enrollment of Patients With COPD in Palliative Care Trials: A Systematic Review.

CONTEXT: Use of palliative care interventions in chronic obstructive pulmonary disease (COPD) has increased in recent years and inclusion criteria used to identify patients with COPD appropriate for palliative care vary widely. We evaluated the inclusion criteria to identify ways to improve enrollment opportunities for patients with COPD. OBJECTIVES: To determine inclusion criteria used to select patients with COPD for palliative care trials. METHODS: A systematic review was conducted to determine criteria used to select patients with COPD for palliative care randomized controlled trials. A narrative synthesis was conducted for all trials. RESULTS: Inclusion criteria were highly heterogeneous. Most studies (n = 11, 79%) used a combination of criteria to identify patients with COPD. Commonly used criteria included hospitalization for an acute exacerbation of COPD (n = 8, 57%), home supplemental oxygen use (n = 8, 57%), and spirometry values confirming COPD (n = 6, 43%). Three studies (21.4%) used Modified Medical Research Council score and two studies (21%) used physician prognosis or a performance scale. CONCLUSION: The most common criteria, a hospitalization for acute exacerbation of COPD or supplemental oxygen use at home, both have the benefit of selecting patients who have a higher symptom burden or higher healthcare utilization who might therefore benefit more from palliative care. By describing the landscape and variability of previously used inclusion criteria, this article serves as a resource for clinicians and researchers. Developing a consistent set of inclusion criteria in the future would help generate generalizable results that can be translated into clinical practice to improve the lives of patients with COPD. PROSPERO REGISTRATION NUMBER: CRD42022306752.

The Scope of Practice of an Embedded Pediatric Palliative Oncology Clinic.

CONTEXT: Pediatric palliative care (PPC) improves end-of-life (EOL) outcomes for children with cancer. Though PPC visits are the 'intervention' in studies focused on EOL care, the content of PPC visits within pediatric oncology is poorly understood. OBJECTIVES: This study aimed to understand the scope of PPC practice during visits for children with cancer and their families. METHODS: This was a retrospective cohort study of patients 0-27 years with cancer seen in PPC clinic within an academic pediatric oncology center between 2017 and 2022. During each PPC visit, documenting providers chose the domains discussed or managed (goals of care, symptom management, and care coordination with respective subdomains). Data was abstracted from the electronic health record, PPC clinic database, and Cancer Registry. The differences in frequency and addressed domains were analyzed by demographics, visit type, diagnosis group, and proximity to EOL. RESULTS: Across 351 patients, 1919 outpatient PPC visits occurred. Median domains were higher in visits <90 days vs. 91+ days from EOL (12.0 vs. 10.0; p < 0.0001); pain and hospice collaboration were particularly discussed closer to EOL. Psychological symptoms like anxiety (30.7% vs. 21.1%; p < 0.001) were addressed more in follow-ups than initial visits. Compared to brain tumor or leukemia/lymphoma visits, solid tumor visits addressed more symptom management subdomains, especially pain (79.9%; p < 0.0001). CONCLUSION: The scope of PPC practice is broad and varied. Each visit encompasses many subdomains, the most common being care coordination with oncology teams and helping patients/families cope with the disease. More domains were addressed in solid tumor visits and near EOL.

Social Deprivation and End-of-Life Care Use Among Adults With Cancer.

PURPOSE: Socioeconomic differences are partially responsible for racial inequities in cancer outcomes, yet the association of area-level socioeconomic disadvantage and race with end-of-life (EOL) cancer care quality is poorly understood. METHODS: This retrospective study used electronic medical records from an academic health system to identify 33,635 adults with cancer who died between 2013 and 2019. Using multivariable logistic regression, we examined associations between decedent characteristics and EOL care, including emergency department (ED) visits, intensive care unit (ICU) stays, palliative care consultation (PCC), hospice order, and in-hospital deaths. Social deprivation index was used to measure socioeconomic disadvantages. RESULTS: Racially minoritized decedents had higher odds of ICU stay than the least deprived White decedents (eg, other race Q3: aOR, 2.06 [99% CI, 1.26 to 0.3.39]). White and Black decedents from more deprived areas had lower odds of ED visit (White Q3: aOR, 0.382 [99% CI, 0.263 to 0.556]; Black Q3: aOR, 0.566 [99% CI, 0.373 to 0.858]) than least deprived White decedents. Compared with White decedents living in least deprived areas, racially minoritized decedents had higher odds of receiving PCC and hospice order, whereas White decedents in most deprived areas had lower odds of PCC (aOR, 0.727 [99% CI, 0.592 to 0.893]) and hospice order (aOR, 0.845 [99% CI, 0.724 to 0.986]). Greater deprivation was associated with greater odds of hospital death relative to least deprived White decedents, but only among minoritized decedents (eg, Black Q4: aOR, 2.16 [99% CI, 1.82 to 2.56]). CONCLUSION: Area-level socioeconomic disadvantage is not uniformly associated with poorer EOL cancer care, with differences among decedents of different racial groups.

Feeding after congenital heart surgery: a mixed-methods study of the caregiver experience.

OBJECTIVES: Feeding difficulties after congenital heart surgery are a common concern for caregivers of children with CHD. Insight into the intricacies of their experience is lacking. With a better understanding, healthcare providers can continue to optimize the approach and support mechanisms for these families. This study will explore the psychosocial impacts on caregivers, define barriers to care, and identify areas to improve their care. STUDY DESIGN: This mixed-methods study combined semi-structured interviews with surveys. Purposive sampling targeted caregivers of a child who underwent heart surgery and was discharged with alternative enteral feeding access. A hybrid inductive-deductive methodology was used to analyse interview transcripts. Survey scores were compared to interview content for concordance. RESULTS: Fifteen interviews were conducted with socio-demographically diverse caregivers. Feeding difficulties were often identified as their greatest challenge, with the laborious feeding schedule, sleep deprivation, and tube management being common contributors. Most caregivers described feeling overwhelmed and worried. Time-intensive feeding schedules and lack of appropriate childcare options precluded caregivers' ability to work. Barriers to care included imperfect feeding education, proximity of specialist clinics, and issues with medical supply companies. Caregiver proposals for improved care addressed easing the transition home, improving emotional support mechanisms, and intensifying feeding therapy for expedited tube removal. CONCLUSION: This study describes the psychosocial toll on the caregiver, typical barriers to care, and ideas for improved provision of care. These themes and ideas can be used to advance the family-centered approach to feeding difficulties after heart surgery.

The Validity of Patient-Reported Outcome Measures of Quality of Life in Palliative Care: A Systematic Review.

Importance: A recent systematic review and meta-analysis found that palliative care was not associated with improvement in quality of life (QOL) in terminal noncancer illness. Among potential reasons for a null effect, it is unclear if patient-reported outcome measures (PROMs) measuring QOL were derived or validated among populations with advanced life-limiting illness (ALLI). Objective: To systematically review the derivation and validation of QOL PROMs from a recent meta-analysis of randomized controlled trials (RCT) of palliative care interventions in people with terminal noncancer illness. Evidence Review: EMBASE, MEDLINE, and PsycINFO were searched from inception to January 8, 2023 for primary validation studies of QOL PROMs in populations with ALLI, defined as adults with a progressive terminal condition and an estimated median survival of less than or equal to one year. The primary outcome was the proportion of PROMs that were derived or validated in ≥1 ALLI population. Findings: Twenty-one unique studies of derivation (n = 13) and validation (n = 11, 3 studies evaluated both) provided data on 9657 participants (mean age 63 years, 50% female) across 15 unique QOL PROMs and subscales. Among studies of validation, 9 were in people with cancer (n = 2289, n = 5 PROMs), 1 in neurodegenerative disease (n = 23, n = 1 PROM), and 1 with mixed diseases (n = 248, n = 1 PROM). Across 15 QOL PROMs and subscales, 47% (n = 7) were derived or validated in an ALLI population. The majority of these seven PROMs were exclusively derived or validated among people with cancer (57%, n = 4). QOL PROMs such as Quality of Life at End of Life, EuroQoL-5 Dimension 5-level, and 36-item Short Form Survey demonstrated validity in more than one terminal noncancer illness. Conclusions: Most QOL PROMs that measured the effect of palliative care on QOL in RCTs were neither derived nor validated in an ALLI population. These findings raise questions about the inferences that palliative care does not improve QOL among people with terminal noncancer illness.

Pulmonary Function and Quality of Life in Adults with Cystic Fibrosis.

PURPOSE: People living with cystic fibrosis (CF) experience impaired quality of life, but the extent to which pulmonary function is associated with quality of life in CF remains unclear METHODS: Using baseline data from a trial of specialist palliative care in adults with CF, we examined the association between pulmonary obstruction and quality of life (measured with the Functional Assessment of Chronic Illness Therapy Total Score). RESULTS: Among 262 participants, median age was 33, and 78% were on modulator therapy. The median quality of life score was higher in those with mild obstruction (135, IQR 110-156) compared to moderate (125, IQR 109-146) and severe obstruction (120, IQR 106-136). In an unadjusted model, we observed a non-significant trend toward lower quality of life with increased obstruction-compared to participants with mild obstruction, those with moderate obstruction had quality of life score 7.46 points lower (95% CI -15.03 to 0.10) and those with severe obstruction had a score 9.98 points lower (95% CI -21.76 to 1.80). However, this association was no longer statistically significant in the adjusted model, which may reflect confounding due to sex, age, BMI, and modulator therapy. Comorbidities (depression and anxiety) and social determinants of health (financial insecurity and education) were also associated with quality of life. CONCLUSION: Advancing our understanding of patient-centered markers of quality of life, rather than focusing on pulmonary function alone, may help identify novel interventions to improve quality of life in this patient population.

Decision support training for advanced cancer family caregivers: Study protocol for the CASCADE factorial trial.

BACKGROUND: Patients with advanced cancer face numerous decisions when diagnosed and often receive decision support from family caregivers. The CASCADE (CAre Supporters Coached to be Adept DEcision partners) factorial trial intervention aims to train caregivers in skills to provide effective decision support to patients and identify most effective intervention components. METHODS: This is a 2-site, single-blind, 24 factorial trial to test components of the CASCADE decision support training intervention for family caregivers of patients with newly-diagnosed advanced cancer delivered by specially-trained, telehealth, palliative care lay coaches over 24 weeks. Family caregivers (target N = 352) are randomly assigned to one of 16 combinations of four components with two levels each: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision support communication training (1 session vs. none); 3) Ottawa Decision Guide training (1 session vs. none) and 4) monthly follow-up (1 call vs. calls for 24 weeks). The primary outcome is patient-reported decisional conflict at 24 weeks. Secondary outcomes include patient distress, healthcare utilization, caregiver distress, and quality of life. Mediators and moderators (e.g., sociodemographics, decision self-efficacy, social support) will be explored between intervention components and outcomes. Results will be used to build two versions of CASCADE: one with only effective components (d ≥ 0.30) and another optimized for scalability and cost. DISCUSSION: This protocol describes the first factorial trial, informed by the multiphase optimization strategy, of a palliative care decision-support intervention for advanced cancer family caregivers and will address the field's need to identify effective components that support serious illness decision-making. TRIAL REGISTRATION: NCT04803604.

Interventions to improve outcomes for caregivers of patients with advanced cancer: a meta-analysis.

BACKGROUND: Family caregivers of patients with advanced cancer often have poor quality of life (QOL) and mental health. We examined the effectiveness of interventions offering support for caregivers of patients with advanced cancer on caregiver QOL and mental health outcomes. METHODS: We searched Ovid MEDLINE, EMBASE, Cochrane CENTRAL, and Cumulative Index to Nursing and Allied Health Literature databases from inception through June 2021. Eligible studies reported on randomized controlled trials for adult caregivers of adult patients with advanced cancer. Meta-analysis was conducted for primary outcomes of QOL, physical well-being, mental well-being, anxiety, and depression, from baseline to follow-up of 1-3 months; secondary endpoints were these outcomes at 4-6 months and additional caregiver burden, self-efficacy, family functioning, and bereavement outcomes. Random effects models were used to generate summary standardized mean differences (SMD). RESULTS: Of 12 193 references identified, 56 articles reporting on 49 trials involving 8554 caregivers were eligible for analysis; 16 (33%) targeted caregivers, 19 (39%) patient-caregiver dyads, and 14 (29%) patients and their families. At 1- to 3-month follow-up, interventions had a statistically significant effect on overall QOL (SMD = 0.24, 95% confidence interval [CI] = 0.10 to 0.39); I2 = 52.0%), mental well-being (SMD = 0.14, 95% CI = 0.02 to 0.25; I2 = 0.0%), anxiety (SMD = 0.27, 95% CI = 0.06 to 0.49; I2 = 74.0%), and depression (SMD = 0.34, 95% CI = 0.16 to 0.52; I2 = 64.4) compared with standard care. In narrative synthesis, interventions demonstrated improvements in caregiver self-efficacy and grief. CONCLUSIONS: Interventions targeting caregivers, dyads, or patients and families led to improvements in caregiver QOL and mental health. These data support the routine provision of interventions to improve well-being in caregivers of patients with advanced cancer.

Clinician perspectives on barriers and solutions to symptom management in cystic fibrosis.

People living with cystic fibrosis (PLwCF) experience high symptom burden. 146 clinicians completed online surveys regarding barriers and solutions to symptom management between September and October 2020. The surveys contained both closed-ended and free-text entries. The symptom management specialists that CF clinicians most wished to consult included mental health (88, 65%), palliative care (59, 41%), and pain specialists (48, 33%). Barriers to symptom management included concerns about controlled substances prescribed for symptom control causing addiction and precluding transplantation, a lack of trust and collaboration among clinical specialties, a lack of symptom management specialists with CF expertise, and a worry about the affordability of specialist-level symptom management care. Potential solutions included non-pharmacological approaches, expanding access to affordable specialist symptom management care, the creation of clinical care guidelines for symptom management in CF, and having CF clinicians and symptom management specialists work alongside each other in CF clinic to build interdisciplinary trust and education.

Public Health and Palliative Care.

Meeting the needs of people at the end of life (EOL) is a public health (PH) concern, yet a PH approach has not been widely applied to EOL care. The design of hospice in the United States, with its focus on cost containment, has resulted in disparities in EOL care use and quality. Individuals with non-cancer diagnoses, minoritized individuals, individuals of lower socioeconomic status, and those who do not yet qualify for hospice are particularly disadvantaged by the existing hospice policy. New models of palliative care (both hospice and non-hospice) are needed to equitably address the burden of suffering from a serious illness.

Building a Cardiac Palliative Care Program: A Qualitative Study of the Experiences of Ten Program Leaders From Across the United States.

CONTEXT: Palliative care is guideline-recommended for patients with advanced heart failure (HF). However, studies on how cardiac palliative care is provided in the United States are lacking. OBJECTIVES: To study how cardiac palliative care programs provide services, and to identify challenges and facilitators they encountered in program development. METHODS: In this qualitative descriptive study, we used purposive and snowball sampling approaches to identify cardiac palliative care program leaders across the United States, administered a survey and conducted semi-structured interviews. Interview transcripts were coded and evaluated using thematic analysis. RESULTS: While cardiac palliative care programs vary in their organizational setup, they all provide comprehensive interdisciplinary palliative care services, ideally across the care continuum. They predominantly serve HF patients who are evaluated for advanced therapies or have complex needs. The challenges which cardiac palliative care programs face include reaching those cardiac patients who need palliative care the most and collaborating with cardiologists who do not see value added from palliative care for their patients. Facilitators of cardiac palliative care program development include building personal relationships with cardiology providers, proactively assessing local institution needs, and tailoring palliative care services to meet patient and provider needs. CONCLUSION: Cardiac palliative care programs vary in their organizational setup but provide similar services and face similar challenges. The challenges and facilitators we identified can inform the development of future cardiac palliative care programs.

Trends in Obesity Prevalence among US Older Adults in the Last Two Years of Life, 1998-2018.

CONTEXT: The prevalence of obesity has grown in the US over the decades. The temporal trends of body mass index categories in the last two years of life are poorly understood. OBJECTIVES: To describe the trends in body mass categories in the last two years of life over the past two decades controlling for other demographic changes. METHODS: We performed a cross-sectional study of prospectively collected survey data from the nationally representative Health and Retirement Study (HRS) among decedents who died between 1998 and 2018. We categorized BMI into five categories and calculated the proportion of decedents with each BMI category during each four epochs (1998-2003, 2004-2008, 2009-2013, 2014-2018). We examined trends in regression models with survey wave groupings modeled as an orthogonal polynomial and adjusted for factors commonly associated with BMI: sex, age, race, ethnicity, education, and tobacco use. RESULTS: The analytic cohort included 14,797 decedents. From 1998-2003 to 2014-2018 time periods, those categorized as having mild-to-moderate obesity in the last two years of life increased from 12.4% to 14.8% (linear trend P < 0.001), a 19% increase. Severe obesity increased from 1.9% to 4.3%, a 126% increase (linear trend P < 0.001). Underweight decreased from 9.9% to 5.9%, a 40% decrease (linear trend P < 0.001), adjusted for demographic factors. Adjusted quadratic temporal trends for BMI category were nonsignificant, except for in mild-to-moderate obesity. CONCLUSION: Severe obesity has increased greatly while underweight has decreased. As obesity increases in the final years of life, it is critical to assess how the existing and future palliative services and end of life care system address body size and weight.

Embedded Specialist Palliative Care in Cystic Fibrosis: Results of a Randomized Feasibility Clinical Trial.

Background: Cystic fibrosis (CF) is a progressive genetic disease characterized by multisystem symptom burden. Specialist palliative care (PC), as a model of care, has been shown to be effective in improving quality of life and reducing symptom burden in other conditions, but has not been tested in CF. Objectives: To develop and test the feasibility and acceptability of a specialist PC intervention embedded within an outpatient CF clinic. Design: Single-site, equal-allocation randomized pilot study comparing usual care with addition of four protocolized quarterly visits with a PC nurse practitioner. Participants: Adults with CF age ≥18 years with any of the following: FEV1% predicted ≤50, ≥2 CF-related hospitalizations in the past 12 months, supplemental oxygen use, or noninvasive mechanical ventilation use, and moderate-or-greater severity of any symptoms on the Edmonton Symptom Assessment Scale. Measurements: Randomization rate, intervention visit completion, data completements, participant ratings of intervention acceptability and benefit, and intervention delivery fidelity. Results: We randomized 50 adults with CF of 65 approached (77% randomization rate) to intervention (n = 25) or usual care (n = 25), mean age 38, baseline mean FEV1% predicted 41.8 (usual care), and 41.2 (intervention). No participants withdrew, five were lost to follow-up, and two died (88% retention). In the intervention group, 23 of 25 completed all study visits; 94% stated the intervention was not burdensome, and 97.6% would recommend the intervention to others with CF. More than 90% of study visits addressed topics prescribed by intervention manual. Conclusions: Adding specialist PC to standard clinic visits for adults with CF is feasible and acceptable.

Prevalence of unmet pain and symptom management needs in adults with cystic fibrosis.

BACKGROUND: Although people living with CF (PLwCF) commonly report pain and other symptoms, little is known regarding their experiences of living with and accessing treatment for burdensome symptoms. METHODS: PLwCF completed online questionnaires assessing symptom prevalence and distress and were also asked about experiences accessing pain and symptom treatment, using both closed-ended and free-text entries. RESULTS: Pain was the most prevalent symptom experienced among the 55 participants (76%) and the symptom that most commonly caused distress (64%). PLwCF not on CFTR modulator therapy were likelier to endorse pain as distressing (p = 0.007). Respondents expressed that their pain was commonly underrecognized and undermanaged, they desired a multi-modal approach to treatment, and noted concerns about disease progression affecting their symptom management options. CONCLUSIONS: Our study suggests that PLwCF often have unmet symptom management needs that may impair quality of life.

Barriers of Acceptance to Hospice Care: a Randomized Vignette-Based Experiment.

BACKGROUND: The per diem financial structure of hospice care may lead agencies to consider patient-level factors when weighing admissions. OBJECTIVE: To investigate if treatment cost, disease complexity, and diagnosis are associated with hospice willingness to accept patients. DESIGN: In this 2019 online survey study, individuals involved in hospice admissions decisions were randomized to view one of six hypothetical patient vignettes: "high-cost, high-complexity," "low-cost, high-complexity," and "low-cost, low-complexity" within two diseases: heart failure and cystic fibrosis. Vignettes included demographics, prognoses, goals, and medications with costs. Respondents indicated their perceived likelihood of acceptance to their hospice; if likelihood was <100%, respondents were asked the barriers to acceptance. We used bivariate tests to examine associations between demographic, clinical, and organizational factors and likelihood of acceptance. PARTICIPANTS: Individuals involved in hospice admissions decisions MAIN MEASURES: Likelihood of acceptance to hospice care KEY RESULTS: N=495 (76% female, 53% age 45-64). Likelihoods of acceptance in cystic fibrosis were 79.8% (high-cost, high-complexity), 92.4% (low-cost, high-complexity), and 91.5% (low-cost, low-complexity), and in heart failure were 65.9% (high-cost, high-complexity), 87.3% (low-cost, high-complexity), and 96.6% (low-cost, low-complexity). For both heart failure and cystic fibrosis, respondents were less likely to accept the high-cost, high-complexity patient than the low-cost, high-complexity patient (65.9% vs. 87.3%, 79.8% vs. 92.4%, both p<0.001). For heart failure, respondents were less likely to accept the low-cost, high-complexity patient than the low-cost, low-complexity patient (87.3% vs. 96.6%, p=0.004). Treatment cost was the most common barrier for 5 of 6 vignettes. CONCLUSIONS: This study suggests that patients receiving expensive and/or complex treatments for palliation may have difficulty accessing hospice.

Integrating specialist palliative care to improve care and reduce suffering: cystic fibrosis (InSPIRe:CF) - study protocol for a multicentre randomised clinical trial.

INTRODUCTION: Cystic fibrosis (CF) is a life-limiting genetic disorder estimated to affect more than 160 000 individuals and their families worldwide. People living with CF commonly experience significant physical and emotional symptom burdens, disruptions to social roles and complex treatment decision making. While palliative care (PC) interventions have been shown to relieve many such burdens in other serious illnesses, no rigorous evidence exists for palliative care in CF. Thus, this study aims to compare the effect of specialist palliative care plus usual CF care vs usual CF care alone on patient quality of life. METHODS AND ANALYSIS: This is a five-site, two-arm, partially masked, randomised superiority clinical trial. 264 adults with CF will be randomly assigned to usual CF care or usual CF care plus a longitudinal palliative care intervention delivered by a palliative care specialist. The trial's primary outcome is patient quality of life (measured with the Functional Assessment of Chronic Illness Therapy-Palliative care instrument). Secondary outcomes include symptom burden, satisfaction with care and healthcare utilisation. Outcomes will be measured at 12 months (primary endpoint) and 15 months (secondary endpoint). In addition, we will conduct qualitative interviews with patient participants, caregivers, and palliative care and CF care team members to explore perceptions of the intervention's impact and barriers and facilitators to dissemination. ETHICS AND DISSEMINATION: Human subjects research ethics approval was obtained from all participating sites, and all study participants gave informed consent. We will publish the results of this trial in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN53323164.