Implementing Patient-Centered Outcomes Research Institute Stakeholder Engagement Principles in Models of Palliative Care Delivery and Advance Care Planning Research.

BACKGROUND: Given the many challenges of conducting research that addresses the palliative and end-of-life care needs of patients with serious illnesses, stakeholder engagement starting from the moment of study conceptualization and design is critical to ensure successful participant recruitment, data collection, intervention delivery, data analysis, and dissemination. METHODS: Guided by a conceptual model published by the Patient-Centered Outcomes Research Institute (PCORI) entitled, "Measuring What Matters for Advancing the Science and Practice of Engagement"14 and with the support of a PCORI Engagement Officer, representatives from 9 PCORI-funded study teams formed a working group to survey team members and review, outline, and describe key lessons learned and best practices for promoting stakeholder engagement in palliative care research. RESULTS: Almost all study teams engaged with patients/caregivers, clinicians, researchers, and health care system experts as stakeholder partners. About half the teams also included payers and training institutions as part of their stakeholder advisors as well as a range of content experts. Study teams relied on a variety of support structures and resources, and they employed 10 distinct methods for maintaining engagement. All engagement methods were generally considered to be effective by teams who used the method, though there was some variability in team-rated engagement quality of each method. Nine barriers to stakeholder engagement were identified across the 9 studies as well as 9 strategies (or facilitators) to overcome these barriers. We share examples of how stakeholder engagement impacted studies in all phases, including the preparatory phase, study initiation phase, execution phase, and data analysis/dissemination phase. CONCLUSIONS: Teams utilized a variety of resources and support structures as well as capitalized on multiple engagement methods for fostering stakeholder engagement, resulting in a high level of collaboration and integration.

Priority areas for outcomes improvement among older adults undergoing inpatient general surgery inclusive of geriatric-pertinent complications.

BACKGROUND: Comprehensive studies on priority areas for improving geriatric surgery outcomes, inclusive of geriatric-pertinent data, are limited. METHODS: The ACS NSQIP geriatric database (2014-2018) was used to abstract older adults (≥65 years) undergoing inpatient general surgery procedures. Thirty-day complication, functional decline, and mortality rates were analyzed, with a focus on two geriatric-pertinent complications: delirium and new/worsening pressure ulcers. RESULTS: There were 9062 patients; 41.9% were ≥75 years. Mean age was 73.9 years. The majority of patients were female (54.0%), White (77.7%), and had independent functional status before surgery (94.0%). Overall 30-day complication, functional decline, and mortality rates were 33.6%, 34.5%, and 3.5%, respectively; failure to the rescue rate was 9.7%. Including geriatric-pertinent complications increased the overall complication rate by 20.4%. Delirium emerged as the leading complication (11.9%), followed by bleeding (11.1%), and wound-related complications (10.1%); these three accounted for 53.7% of complications. Delirium and pressure ulcers were associated with a >50% rate of postoperative functional decline (52.0% and 71.4%, respectively); pressure ulcers were also notable for a 25.5% failure to the rescue rate. Both were also among complications most likely to occur following the 3 most common procedures (colorectal surgery, pancreatic resections, and exploratory laparotomy), which overall accounted for approximately 79.6% of complications, 73.4% of patients experiencing functional decline, and 82.3% of mortality. CONCLUSIONS: Delirium is the leading complication among older adults undergoing inpatient surgery. Overall, a small number of complications and procedure groups account for most surgical morbidity and mortality among older adults and thus constitute priority areas for outcomes improvement.

Occurrence and Predictors of Postoperative Preauricular and Masticatory Muscle Pain Symptoms After Surgical Removal of Third Molars: A Single-Blind Randomized Controlled Trial Comparing Dental Assistants Supporting the Mandible and the Restful Jaw Device.

BACKGROUND: During third molar removal, the mandible is supported by a dental assistant (DA) to counter downward forces during surgery, and with sedation, to maintain airway patency. The Restful Jaw device (PEP Design; Saint Paul) provides this support instead of the DA. PURPOSE: This study compared the occurrence of postoperative preauricular and masticatory muscle pain symptoms (PMMPS) between the device and DAs providing mandibular support, using two outcome measures. Secondary aims identify predictors of outcome and providers' opinions of the device. STUDY DESIGN, SETTING, SAMPLE: In this multisite, single-blind, two-arm parallel randomized trial, participants without preoperative PMMPS had surgical removal of third molars, with sedation and bite blocks were randomly assigned to manual support or the device. EXPOSURE VARIABLE: The exposed group was randomly assigned to the device and the nonexposed group to manual support. MAIN OUTCOME VARIABLE(S): The primary outcome was patient-reported PMMPS. Two secondary outcomes were pain assessed with the temporomandibular disorder Pain Screener and providers' views on the device. Outcomes were assessed at 1-, 3-, and 6-month postsurgery. COVARIATES: The covariates are baseline demographics (eg, sex), clinical characteristics (eg, eruption status), and third molar surgeries. ANALYSES: For occurrence of pain, generalized estimating equations assessed differences between groups. Logistic regression analysis assessed predictors of pain at 1 month, per the Screener. The level for statistical significance was 5%. RESULTS: Enrollment was 86 and 83 participants in the device and DA groups, respectively. The average age was 20.8 years; the majority were female (65%) and Caucasian (66%). The retention rate was ≥95.9%. The groups did not differ significantly for occurrence of pain using the primary and secondary outcome measures at any follow-up (P ≥ .46). Fully impacted molars were associated with occurrence of pain (odds ratio = 3.44; 95% confidence interval 1.49-7.92; P = .004). CONCLUSION AND RELEVANCE: Occurrence of pain using the primary and secondary outcome measures did not differ significantly between groups at any follow-up and was associated with removal of fully impacted third molars. Four out of five surgeons reported wanting to use the device on a regular basis when performing this procedure in sedated patients.

Trajectories of Palliative Care Needs in the ICU and Long-Term Psychological Distress Symptoms.

OBJECTIVES: While palliative care needs are assumed to improve during ICU care, few empiric data exist on need trajectories or their impact on long-term outcomes. We aimed to describe trajectories of palliative care needs during ICU care and to determine if changes in needs over 1 week was associated with similar changes in psychological distress symptoms at 3 months. DESIGN: Prospective cohort study. SETTING: Six adult medical and surgical ICUs. PARTICIPANTS: Patients receiving mechanical ventilation for greater than or equal to 2 days and their family members. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the 13-item Needs at the End-of-Life Screening Tool (NEST; total score range 0-130) completed by family members at baseline, 3, and 7 days. The Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and Post-Traumatic Stress Scale (PTSS) were completed at baseline and 3 months. General linear models were used to estimate differences in distress symptoms by change in need (NEST improvement ≥ 10 points or not). One-hundred fifty-nine family members participated (median age, 54.0 yr [interquartile range (IQR), 44.0-63.0 yr], 125 [78.6%] female, 54 [34.0%] African American). At 7 days, 53 (33%) a serious level of overall need and 35 (22%) ranked greater than or equal to 1 individual need at the highest severity level. NEST scores improved greater than or equal to 10 points in only 47 (30%). Median NEST scores were 22 (IQR, 12-40) at baseline and 19 (IQR, 9-37) at 7 days (change, -2.0; IQR, -11.0 to 5.0; p = 0.12). There were no differences in PHQ-9, GAD-7, or PTSS change scores by change in NEST score (all p > 0.15). CONCLUSIONS: Serious palliative care needs were common and persistent among families during ICU care. Improvement in needs was not associated with less psychological distress at 3 months. Serious needs may be commonly underrecognized in current practice.

Acceptability of a Serious Illness Conversation Guide to Black Americans: Results from a focus group and oncology pilot study.

OBJECTIVES: Serious illness conversations (SICs) can improve the experience and well-being of patients with advanced cancer. A structured Serious Illness Conversation Guide (SICG) has been shown to improve oncology patient outcomes but was developed and tested in a predominantly White population. To help address disparities in advanced cancer care, we aimed to assess the acceptability of the SICG among African Americans with advanced cancer and their clinicians. METHODS: A two-phase study conducted in Charleston, SC, included focus groups to gather perspectives on the SICG in Black Americans and a single-arm pilot study of a revised SICG with surveys and qualitative exit interviews to evaluate patient and clinician perspectives. We used descriptive analysis of survey results and thematic analysis of qualitative data. RESULTS: Community-based and patient focus group participants (N = 20) reported that a simulated conversation using an adapted SICG built connection, promoted control, and fostered consideration of religious faith and family. Black patients with advanced cancer (N = 23) reported that SICG-guided conversations were acceptable, helpful, and promoted conversations with loved ones. Oncologists found conversations feasible to implement and skill-building, and also identified opportunities for training and implementation that could support meeting the needs of their patients with low health literacy. An adapted SICG includes language to assess the strength and affirm the clinician-patient relationship. SIGNIFICANCE OF RESULTS: An adapted structured communication tool to facilitate SIC, the SICG, appears acceptable to Black Americans with advanced cancer and seems feasible for use by oncology clinicians working with this population. Further testing in other marginalized populations may address disparities in advanced cancer care.

The Fierce Urgency of Now: Addressing Racial and Ethnic Disparities in Serious Illness Care.

Racial and ethnic disparities in serious illness care are profound and require an urgent response. We present actionable recommendations for health care organizations, providers, and policymakers to address disparities and advance equity.

From Barriers to Assets: Rethinking factors impacting advance care planning for African Americans.

OBJECTIVE: We aimed to explore multiple perspectives regarding barriers to and facilitators of advance care planning (ACP) among African Americans to identify similarities or differences that might have clinical implications. METHOD: Qualitative study with health disparities experts (n = 5), community members (n = 9), and seriously ill African American patients and caregivers (n = 11). Using template analysis, interviews were coded to identify intrapersonal, interpersonal, and systems-level themes in accordance with a social ecological framework.ResultParticipants identified seven primary factors that influence ACP for African Americans: religion and spirituality; trust and mistrust; family relationships and experiences; patient-clinician relationships; prognostic communication, care preferences, and preparation and control. These influences echo those described in the existing literature; however, our data highlight consistent differences by group in the degree to which these factors positively or negatively affect ACP. Expert participants reinforced common themes from the literature, for example, that African Americans were not interested in prognostic information because of mistrust and religion. Seriously ill patients were more likely to express trust in their clinicians and to desire prognostic communication; they and community members expressed a desire to prepare for and control the end of life. Religious belief did not appear to negate these desires.Significance of resultsThe literature on ACP in African Americans may not accurately reflect the experience of seriously ill African Americans. What are commonly understood as barriers to ACP may in fact not be. We propose reframing stereotypical barriers to ACP, such as religion and spirituality, or family, as cultural assets that should be engaged to enhance ACP. Although further research can inform best practices for engaging African American patients in ACP, findings suggest that respectful, rapport-building communication may facilitate ACP. Clinicians are encouraged to engage in early ACP using respectful and rapport building communication practices, including open-ended questions.

Design and Evaluation of an Interdisciplinary Health Disparities Research Curriculum.

BACKGROUND: Disparities in health and healthcare are widely documented for underrepresented racial and ethnic populations across a spectrum of diseases and care settings. An evidence base for addressing racial and ethnic disparities in health and healthcare requires investigators trained to conduct health disparities research. OBJECTIVE: To increase knowledge, stimulate interest, teach skills to evaluate and conduct, and foster collaborations in health disparities research. DESIGN: We designed, implemented and evaluated a Health Disparities Research Curriculum (HDRC). Participants were early-stage investigators. INTERVENTION: HDRC included twelve monthly sessions during 2015-2016. Instructors were mostly HDR investigators. Sessions combined didactic presentations, discussions, small group activities, and participant presentations. MEASURES: Pre- and post-surveys to assess participants' perceptions of knowledge and skills. RESULTS: Of 21 enrollees, 13 were from under-represented groups and 14 were women. Four reported some prior training in HDR, and 12 reported currently conducting HDR. Among the 12 participants who completed both the pre and post HDRC survey, initially the most commonly cited barriers to pursuing HDR were lack of knowledge (N = 6) and funding (N = 7). In the post-survey, the number citing lack of knowledge decreased (N = 2) and the number listing lack of funding increased (N = 9). There were increases in the number of participants reporting increased knowledge of HDR methods (pre-post: 4 vs. 8) and competence to design (3 vs. 7) and implement (2 vs. 9) HDR research. CONCLUSIONS: The Duke HDRC augments efforts to reduce health disparities by providing training in HDR for young investigators. Our data indicate that the course was feasible, well-received, and increased perceived knowledge and competence. HDRC and similar courses may increase the quantity, quality and scope of HDR and thus move us closer to health equity.

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.

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.

Discriminatory and valuing communication behaviors in cardiology encounters.

OBJECTIVE: Many have found racial differences in clinician-patient communication using validated codebooks that represent effective communication. No codebooks used for examining racial differences, however, have included patient input. In this paper, we describe creating codebook with Black patient advocates to determine if we could reliably code discriminatory/valuing communication and assess racial differences in these behaviors. METHODS: We created a codebook for discriminatory/valuing communication behaviors with the input of Black patient advocates. We used the codebook to analyze data from 101 audio recorded encounters between White cardiologists and Black and White patients. We examined the differences in the prevalence of behaviors in cardiology encounters. RESULTS: In comparison to White patients, cardiologists made fewer tailoring statements to their Black patients (68% vs. 49%, p = 0.07). Coders found 4 instances of stereotyping behaviors and only Black patients (p = 0.12). We found no significant associations between any of the other outcomes and patient race. Black patients had a lower incidence of tailoring statements (p = 0.13), lower incidence of interrupting statements (p = 0.16), and higher rushed global score (p = 0.14). CONCLUSION AND PRACTICE IMPLICATIONS: We found that coders can reliably identify discriminatory/valuing behaviors in cardiology encounters. Future work should apply these codes to other datasets to assess their validity and generalizability.

Perspectives on Transfusions for Hospice Patients With Blood Cancers: A Survey of Hospice Providers.

CONTEXT: Patients with blood cancers have low rates of hospice use. While lack of transfusion access in hospice is posited to substantially contribute to these low rates, little is known about the perspectives of hospice providers regarding transfusion access in hospice. OBJECTIVES: To characterize hospice providers' perspectives regarding care for patients with blood cancers and transfusions in the hospice setting. METHODS: In 2022, we conducted a cross-sectional survey of a sample of hospices in the United States regarding their experience caring for patients with blood cancers, perceived barriers to hospice use, and interventions to increase enrollment. RESULTS: We received 113 completed surveys (response rate = 23.5%). Of the cohort, 2.7% reported that their agency always offers transfusions, 40.7% reported sometimes offering transfusions, and 54.9% reported never offering transfusions. In multivariable analyses, factors associated with offering transfusions included nonprofit ownership (OR 5.93, 95% CI, 2.2-15.2) and daily census >50 patients (OR 3.06, 95% CI, 1.19-7.87). Most respondents (76.6%) identified lack of transfusion access in hospice as a barrier to hospice enrollment for blood cancer patients. The top intervention considered as "very helpful" for increasing enrollment was additional reimbursement for transfusions (72.1%). CONCLUSION: In this national sample of hospices, access to palliative transfusions was severely limited and was considered a significant barrier to hospice use for blood cancer patients. Moreover, hospices felt increased reimbursement for transfusions would be an important intervention. These data suggest that hospice providers are supportive of increasing transfusion access and highlight the critical need for innovative hospice payment models to improve end-of-life care for patients with blood cancers.

Race differences in patient trust and distrust from audio-recorded cardiology encounters.

OBJECTIVE: Many have reported racial disparities in self-reported trust in clinicians but have not directly assessed expressions of trust and distrust in physician-patient encounters. We created a codebook to examine racial differences in patient trust and distrust through audio-recorded cardiologist-patient interactions. METHODS: We analyzed data from a randomized controlled trial of audio-recorded outpatient cardiology encounters (50 White and 51 Black patients). We created a codebook for trust and distrust that was applied to recordings between White cardiologists and White and Black patients. We assessed differences in trust, distrust, and guardedness while adjusting for patient age, sex, and first appointment with the cardiologist. RESULTS: Compared to White patients, Black patients had significantly lower expressions of trust ([IRR] [95 % CI]: 0.59 [0.41, 0.84]) and a significantly lower mean guarded/open score ([ß] [95 % CI] -0.38 [-0.71, -0.04]). There was no statistically significant association between race and odds of at least one distrustful expression (OR [95 % CI] 1.36 [0.37, 4.94]). CONCLUSION AND PRACTICE IMPLICATIONS: We found that coders can reliably identify patient expressions of trust and distrust rather than relying on problematic self-reported measures. Results suggest that White clinicians can improve their communication with Black patients to increase expressions of trust.

BOLD: Blood-gas and Oximetry Linked Dataset.

Pulse oximeters measure peripheral arterial oxygen saturation (SpO2) noninvasively, while the gold standard (SaO2) involves arterial blood gas measurement. There are known racial and ethnic disparities in their performance. BOLD is a dataset that aims to underscore the importance of addressing biases in pulse oximetry accuracy, which disproportionately affect darker-skinned patients. The dataset was created by harmonizing three Electronic Health Record databases (MIMIC-III, MIMIC-IV, eICU-CRD) comprising Intensive Care Unit stays of US patients. Paired SpO2 and SaO2 measurements were time-aligned and combined with various other sociodemographic and parameters to provide a detailed representation of each patient. BOLD includes 49,099 paired measurements, within a 5-minute window and with oxygen saturation levels between 70-100%. Minority racial and ethnic groups account for ~25% of the data - a proportion seldom achieved in previous studies. The codebase is publicly available. Given the prevalent use of pulse oximeters in the hospital and at home, we hope that BOLD will be leveraged to develop debiasing algorithms that can result in more equitable healthcare solutions.

Racial Differences in Shared Decision-Making About Critical Illness.

Importance: Shared decision-making is the preferred method for evaluating complex tradeoffs in the care of patients with critical illness. However, it remains unknown whether critical care clinicians engage diverse patients and caregivers equitably in shared decision-making. Objective: To compare critical care clinicians' approaches to shared decision-making in recorded conversations with Black and White caregivers of patients with critical illness. Design, Setting, and Participants: This thematic analysis consisted of unstructured clinician-caregiver meetings audio-recorded during a randomized clinical trial of a decision aid about prolonged mechanical ventilation at 13 intensive care units in the US. Participants in meetings included critical care clinicians and Black or White caregivers of patients who underwent mechanical ventilation. The codebook included components of shared decision-making and known mechanisms of racial disparities in clinical communication. Analysts were blinded to caregiver race during coding. Patterns within and across racial groups were evaluated to identify themes. Data analysis was conducted between August 2021 and April 2023. Main Outcomes and Measures: The main outcomes were themes describing clinician behaviors varying by self-reported race of the caregivers. Results: The overall sample comprised 20 Black and 19 White caregivers for a total of 39 audio-recorded meetings with clinicians. The duration of meetings was similar for both Black and White caregivers (mean [SD], 23.9 [13.7] minutes vs 22.1 [11.2] minutes, respectively). Both Black and White caregivers were generally middle-aged (mean [SD] age, 47.6 [9.9] years vs 51.9 [8.8] years, respectively), female (15 [75.0%] vs 14 [73.7%], respectively), and possessed a high level of self-assessed health literacy, which was scored from 3 to 15 with lower scores indicating increasing health literacy (mean [SD], 5.8 [2.3] vs 5.3 [2.0], respectively). Clinicians conducting meetings with Black and White caregivers were generally young (mean [SD] age, 38.8 [6.6] years vs 37.9 [8.2] years, respectively), male (13 [72.2%] vs 12 [70.6%], respectively), and White (14 [77.8%] vs 17 [100%], respectively). Four variations in clinicians' shared decision-making behaviors by caregiver race were identified: (1) providing limited emotional support for Black caregivers, (2) failing to acknowledge trust and gratitude expressed by Black caregivers, (3) sharing limited medical information with Black caregivers, and (4) challenging Black caregivers' preferences for restorative care. These themes encompass both relational and informational aspects of shared decision-making. Conclusions and Relevance: The results of this thematic analysis showed that critical care clinicians missed opportunities to acknowledge emotions and value the knowledge of Black caregivers compared with White caregivers. These findings may inform future clinician-level interventions aimed at promoting equitable shared decision-making.

Validating a tool to measure spiritual beliefs, needs and resources in serious illness: The I-SPIRIT.

BACKGROUND: Seriously ill patients rely on spiritual and existential beliefs to support coping and approach crucial treatment and healthcare decisions. Yet, we lack gold standard, validated approaches to gathering information on those spiritual beliefs. Therefore, we developed I-SPIRIT, a spiritual needs and beliefs inventory for those with serious illness (IIR-10-050). METHODS: In prior work to develop measure content, we interviewed a total of 74 participants: 20 patients (veterans with Stage IV cancer, CHF, COPD, ESRD), 19 caregivers, 14 chaplains, 10 social workers, 12 nurses, and 5 physicians. Using directed content analyses, we identified over 50 attributes of spiritual experience comprising five domains: overall importance of spirituality; affiliations and practices; impact on decisions; spiritual needs; and spiritual resources. We then translated these attributes into individual items with Likert response scales. In the quantitative validation of I-SPIRIT, we administered the instrument and a battery of comparison measures to 249 seriously ill veterans. The comparison measures captured general spiritual well-being, religious coping, and emotional functioning. Convergent and discriminant validity was examined with the FACIT-sp (faith, meaning, and purpose), BMMRS (religious/spirituality), POMS and PHQ-8 (emotional function), and FACT-G (quality of life). We administered the I-SPIRIT a week later, for test-retest reliability. RESULTS: Psychometric analyses yielded a final I-SPIRIT Tool including 30 items. Results demonstrated reliability and validity and yielded a tool with three main components: Spiritual Beliefs (seven items); Spiritual Needs (nine items); and Spiritual Resources (14 items). The Spiritual Beliefs items include key practices and affiliations, and impact of beliefs on healthcare. Higher levels of Spiritual Needs were associated with higher anxiety and depression. CONCLUSION: The I-Spirit measures relevance of spirituality, spiritual needs and spiritual resources and demonstrates validity, reliability, and acceptability for patients with serious illness.

Design and pilot test of an implicit bias mitigation curriculum for clinicians.

Introduction: Clinician implicit racial bias (IB) may lead to lower quality care and adverse health outcomes for Black patients. Educational efforts to train clinicians to mitigate IB vary widely and have insufficient evidence of impact. We developed and pilot-tested an evidence-based clinician IB curriculum, "REACHing Equity." Methods: To assess acceptability and feasibility, we conducted an uncontrolled one-arm pilot trial with post-intervention assessments. REACHing Equity is designed for clinicians to: (1) acquire knowledge about IB and its impact on healthcare, (2) increase awareness of one's own capacity for IB, and (3) develop skills to mitigate IB in the clinical encounter. We delivered REACHing Equity virtually in three facilitated, interactive sessions over 7-9 weeks. Participants were health care providers who completed baseline and end-of-study evaluation surveys. Results: Of approximately 1,592 clinicians invited, 37 participated, of whom 29 self-identified as women and 24 as non-Hispanic White. Attendance averaged 90% per session; 78% attended all 3 sessions. Response rate for evaluation surveys was 67%. Most respondents agreed or strongly agreed that the curriculum objectives were met, and that REACHing Equity equipped them to mitigate the impact of implicit bias in clinical care. Participants consistently reported higher self-efficacy for mitigating IB after compared to before completing the curriculum. Conclusions: Despite apparent barriers to clinician participation, we demonstrated feasibility and acceptability of the REACHing Equity intervention. Further research is needed to develop objective measures of uptake and clinician skill, test the impact of REACHing Equity on clinically relevant outcomes, and refine the curriculum for uptake and dissemination.ClinicalTrials.gov ID: NCT03415308.

Mobile Application-Based Communication Facilitation Platform for Family Members of Critically Ill Patients: A Randomized Clinical Trial.

Importance: Unmet and racially disparate palliative care needs are common in intensive care unit (ICU) settings. Objective: To test the effect of a primary palliative care intervention vs usual care control both overall and by family member race. Design, Setting, and Participants: This cluster randomized clinical trial was conducted at 6 adult medical and surgical ICUs in 2 academic and community hospitals in North Carolina between April 2019 and May 2022 with physician-level randomization and sequential clusters of 2 Black patient-family member dyads and 2 White patient-family member dyads enrolled under each physician. Eligible participants included consecutive patients receiving mechanical ventilation, their family members, and their attending ICU physicians. Data analysis was conducted from June 2022 to May 2023. Intervention: A mobile application (ICUconnect) that displayed family-reported needs over time and provided ICU attending physicians with automated timeline-driven communication advice on how to address individual needs. Main Outcomes and Measures: The primary outcome was change in the family-reported Needs at the End-of-Life Screening Tool (NEST; range 0-130, with higher scores reflecting greater need) score between study days 1 and 3. Secondary outcomes included family-reported quality of communication and symptoms of depression, anxiety, and posttraumatic stress disorder at 3 months. Results: A total of 111 (51% of those approached) family members (mean [SD] age, 51 [15] years; 96 women [86%]; 15 men [14%]; 47 Black family members [42%]; 64 White family members [58%]) and 111 patients (mean [SD] age, 55 [16] years; 66 male patients [59%]; 45 Black patients [41%]; 65 White patients [59%]; 1 American Indian or Alaska Native patient [1%]) were enrolled under 37 physicians randomized to intervention (19 physicians and 55 patient-family member dyads) or control (18 physicians and 56 patient-family member dyads). Compared with control, there was greater improvement in NEST scores among intervention recipients between baseline and both day 3 (estimated mean difference, -6.6 points; 95% CI, -11.9 to -1.3 points; P = .01) and day 7 (estimated mean difference, -5.4 points; 95% CI, -10.7 to 0.0 points; P = .05). There were no treatment group differences at 3 months in psychological distress symptoms. White family members experienced a greater reduction in NEST scores compared with Black family members at day 3 (estimated mean difference, -12.5 points; 95% CI, -18.9 to -6.1 points; P < .001 vs estimated mean difference, -0.3 points; 95% CI, -9.3 to 8.8 points; P = .96) and day 7 (estimated mean difference, -9.5 points; 95% CI, -16.1 to -3.0 points; P = .005 vs estimated mean difference, -1.4 points; 95% CI, -10.7 to 7.8; P = .76). Conclusions and Relevance: In this study of ICU patients and family members, a primary palliative care intervention using a mobile application reduced unmet palliative care needs compared with usual care without an effect on psychological distress symptoms at 3 months; there was a greater intervention effect among White family members compared with Black family members. These findings suggest that a mobile application-based intervention is a promising primary palliative care intervention for ICU clinicians that directly addresses the limited supply of palliative care specialists. Trial Registration: ClinicalTrials.gov Identifier: NCT03506438.