Racial Disparities in Evidence-Based Management of Metabolic Dysfunction-Associated Steatotic Liver Disease in Patients With Type 2 Diabetes.

OBJECTIVE: To assess frequency of evidence-based management (EBM) of metabolic dysfunction-associated steatotic liver disease (MASLD) in patients with type 2 diabetes (T2D), and to examine for racial/ethnic disparities in the receipt of EBM. METHODS: We conducted a cross-sectional analysis of patients with T2D and presumptive MASLD in an academic health care system between 2019 and 2021. Presumptive MASLD was defined as at least 1 alanine aminotransferase value ≥30 U/L with exclusions for alcohol overuse, viral hepatitis, liver transplantation, chemotherapy use, and liver disease other than MASLD. We calculated the proportion of patients receiving EBM, defined as a composite of liver ultrasound, transient elastography, or hepatology evaluation. We also examined the association between race/ethnicity and EBM via a logistic regression model. RESULTS: Our sample included 6532 patients; mean age was 58.0 (SD 13.1), 41.7% were female and 3.9%, 26.6%, 58.7%, and 5.8% were of Latino/a/x ethnicity, non-Latino (NL) Black race, NL White race, and NL Asian race, respectively. Rates of EBM were low overall (11.5%), with lower odds of EBM in NL Black versus NL White patients (adjusted odds ratio 0.75; 95% confidence interval 0.59, 0.96). Odds of hepatology evaluation and placement of MASLD diagnosis codes were also lower in NL Black versus NL White patients. CONCLUSION: Racial disparities exist in the receipt of EBM among patients with T2D and presumptive MASLD. These findings highlight the need for research to identify drivers of disparities, and to support development of clinical interventions that equitably facilitate EBM of MASLD in patients with T2D.

Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial.

Importance: Although psychological distress is common among survivors of critical illness, there are few tailored therapies. Objective: To determine the optimal method for delivering a mindfulness intervention via a mobile app for critical illness survivors. Design, Setting, and Participants: This randomized clinical trial used a 2 × 2 × 2 factorial design and was conducted at 3 sites among survivors of critical illness with elevated postdischarge symptoms of depression. The study was conducted between August 2019 and July 2023. Interventions: Participants were randomized to 1 of 8 different groups as determined by 3 two-level intervention component combinations: intervention introduction method (mobile app vs therapist call), mindfulness meditation dose (once daily vs twice daily), and management of increasing symptoms (mobile app vs therapist call). Main Outcomes and Measures: The primary outcome was the 9-item Patient Health Questionnaire (PHQ-9) depression scale score (range, 0-27) at 1 month. Secondary outcomes included anxiety (7-item Generalized Anxiety Disorder) and posttraumatic stress disorder (Posttraumatic Stress Scale) symptoms at 1 and 3 months, adherence, and feasibility. General linear models were used to compare main effects and interactions of the components among intervention groups. A formal decisional framework was used to determine an optimized intervention version. Results: A total of 247 participants (mean [SD] age, 50.2 [15.4] years; 104 [42.1%] women) were randomized. Twice-daily meditation compared with once-daily meditation was associated with a 1.2 (95% CI, 0.04-2.4)-unit lower mean estimated PHQ-9 score at 1 month and a 1.5 (95% CI, 0.1-2.8)-unit lower estimated mean score at 3 months. The other 2 intervention components had no main effects on the PHQ-9. Across-group adherence was high (217 participants [87.9%] using the intervention at trial conclusion) and retention was strong (191 [77.3%] and 182 [73.7%] at 1 and 3 months, respectively). Conclusions and Relevance: A mindfulness intervention for survivors of critical illness that included an app-based introduction, twice-daily guided meditation, and app-based management of increasing depression symptoms was optimal considering effects on psychological distress symptoms, adherence, and feasibility. Trial Registration: ClinicalTrials.gov Identifier: NCT04038567.

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.

Factors Associated With Hospital Admission in the Last Month: A Retrospective Single Center Analysis.

CONTEXT: Driven by concerns about care quality, patient experience, and national metrics, health systems are increasingly focusing on identifying risk factors for patients who are hospitalized in the last month of life. OBJECTIVE: To evaluate patient factors associated with hospital admission in the last month (30 days). METHODS: We analyzed a retrospective cohort of 8488 patients with a primary care visit in a tertiary health system in the last year of life using a linked electronic health record and decedent dataset. We examined healthcare utilization (primary care, emergency, hospital, intensive care unit encounters) and end-of-life related outcomes (palliative care consultation, do-not-resuscitate orders, advance care planning documentation, hospice at hospital discharge, death in health system). Multivariable logistic regressions identified patient factors associated with admission in the last month. RESULTS: About 2202 (25.9%) patients had a hospital admission in the last month. Among the 1282 (15.1%) who died in a health system facility, most (1103/1282, 86.0%) were admitted to the hospital in the last month. Among patients with a hospital admission and discharged in the last month, 60.9% (686/1126) were discharged on hospice. Compared to those without these diseases, metastatic cancer, liver disease, or heart failure had the highest odds of admission in the last month (adjusted OR 2.36 95%CI 2.05-2.72; 2.28, 95%CI 1.98-2.62; and 2.17 95%CI 1.93-2.45 respectively). CONCLUSIONS: As patients with heart or liver disease or metastatic cancer had the highest odds of admission in the last month, collaborative interventions between primary, palliative, and specialty care may improve quality of care at the end of life.

Trajectories of Physical Resilience Among Older Veterans With Stage 4 CKD.

RATIONALE & OBJECTIVE: Although functional impairment is common among older adults with chronic kidney disease (CKD), functional reserve before an acute health event and physical resilience after the event have not been characterized in this population. The purpose of this study was to identify distinct patterns of physical function before and after an acute health event among older veterans with stage 4 CKD. STUDY DESIGN: Prospective cohort study. SETTING & PARTICIPANTS: National sample of veterans≥70 years of age with an estimated glomerular filtration rate (eGFR) of<30mL/min/1.73m2 who had an acute care encounter (emergency department visit or hospitalization) during the follow-up period (n = 272). PREDICTORS: Demographic characteristics, eGFR, basic and instrumental activities of daily living (ADL/IADL) difficulty, symptom burden, cognition, depressive symptoms, social support. OUTCOME: Function measured using the life-space mobility assessment obtained by telephone survey before and after an acute care encounter. ANALYTICAL APPROACH: General growth mixture models to identify classes of functional trajectories. Calculation of percentages for demographic characteristics and means for eGFR, ADL/IADL difficulty, symptom burden, cognition, depressive symptoms, and social support by trajectory class. RESULTS: Four trajectory classes were identified and characterized by different levels of life-space mobility before (reserve) and change in life-space mobility after (resilience) an acute care encounter: (1) low reserve, low resilience (n=91), (2) high reserve, high resilience (n=23), (3) moderate reserve, moderate resilience (n=89), and (4) high reserve, low resilience (n=69). Mean levels of ADL/IADL difficulty, symptom burden, cognition, and depressive symptoms, but not demographic characteristics, eGFR, or social support, differed by trajectory class. LIMITATIONS: Veteran cohort was primarily male. CONCLUSIONS: Among older adults with stage 4 CKD, physical function trajectories before and after an acute health event vary. Integrating reserve and resilience into care for this population may be useful for anticipating changes in function and developing tailored treatment plans.

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.

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.

Prescribing of evidence-based diabetes pharmacotherapy in patients with metabolic dysfunction-associated steatohepatitis.

INTRODUCTION: Metabolic dysfunction-associated steatohepatitis (MASH) is highly prevalent in type 2 diabetes (T2D). Pioglitazone and glucagon-like peptide-1 receptor agonists (GLP-1RA) are medications used in T2D that can resolve MASH and should be considered in all patients with T2D and MASH. We assessed prescription rates of evidence-based T2D pharmacotherapy (EBP) in MASH, and ascertained racial/ethnic disparities in prescribing. RESEARCH DESIGN AND METHODS: We conducted a cross-sectional study on patients in Duke University Health System with diagnosis codes for T2D and MASH between January 2019 and January 2021. Only patients with ≥1 primary care or endocrinology encounter were included. The primary outcome was EBP, defined as ≥1 prescription for pioglitazone and/or a GLP-1RA during the study period. A multivariable logistic regression model was used to examine the primary outcome. RESULTS: A total of 847 patients with T2D and MASH were identified; mean age was 59.7 (SD 12) years, 61.9% (n=524) were female, and 11.9% (n=101) and 4.6% (n=39) were of Black race and Latino/a/x ethnicity, respectively. EBP was prescribed in 34.8% (n=295). No significant differences were noted in the rates of EBP use across racial/ethnic groups (Latino/a/x vs White patients: adjusted OR (aOR) 1.82, 95% CI 0.78 to 4.28; Black vs White patients: aOR 0.76, 95% CI 0.44 to 1.33, p=0.20). CONCLUSIONS: EBP prescriptions, especially pioglitazone, are low in patients with T2D and MASH, regardless of race/ethnicity. These data underscore the need for interventions to close the gap between current and evidence-based care.

Meaning-centered pain coping skills training for patients with metastatic cancer: Protocol for a randomized controlled efficacy trial.

BACKGROUND: Many patients with advanced cancer describe pain as a debilitating symptom that greatly interferes with daily activities and enjoyment of life. Psychosocial interventions can improve cancer-related pain but rarely address spiritual concerns (e.g., loss of meaning, peace), which can influence the pain experience for those facing life-threatening illness. To address these needs, we systematically developed and pilot tested a novel psychosocial intervention called Meaning-Centered Pain Coping Skills Training (MCPC). In this randomized controlled trial, we aim to determine MCPC's efficacy for reducing pain interference (primary outcome) and improving secondary outcomes. We will also estimate MCPC's cost-effectiveness. METHOD/DESIGN: Patients (target N = 210) with advanced solid tumor malignancies (Stage IV) and clinically-elevated pain interference will be enrolled and block randomized with equal allocation to MCPC + enhanced usual care or enhanced usual care alone. MCPC's four, videoconferenced, 45-60 min weekly sessions will be individually delivered by trained study therapists. Primary (pain interference) and secondary (pain severity, anxiety and depressive symptoms, pain self-efficacy, social support, spiritual well-being) patient-reported outcomes will be assessed at baseline, and 8-weeks (primary endpoint) and 12-weeks after baseline. CONCLUSION: Our MCPC intervention is the first to systematically address the biopsychosocial-spiritual aspects of pain in patients with advanced cancer. If MCPC demonstrates efficacy, next steps will involve hybrid efficacy-effectiveness and implementation work to broaden access to this brief, manualized, remotely-delivered intervention, with the goal of reducing suffering in patients with life-threatening illness.

Comparison of weight captured via electronic health record and cellular scales to the gold-standard clinical method.

Introduction: Obtaining body weights remotely could improve feasibility of pragmatic trials. This investigation examined whether weights collected via cellular scale or electronic health record (EHR) correspond to gold standard in-person study weights. Methods: The agreement of paired weight measurements from cellular scales were compared to study scales from a weight loss intervention and EHR-collected weights were compared to study scales from a weight loss maintenance intervention. Differential weight change estimates between intervention and control groups using both pragmatic methods were compared to study collected weight. In the Log2Lose feasibility weight loss trial, in-person weights were collected bi-weekly and compared to weights collected via cellular scales throughout the study period. In the MAINTAIN weight loss maintenance trial, in-person weights were collected at baseline, 14, 26, 42 and 56 weeks. All available weights from the EHR during the study period were obtained. Results: On average, in Log2Lose cellular scale weights were 0.6 kg (95% CI: -2.9, 2.2) lower than in-person weights; in MAINTAIN, EHR weights were 2.8 kg (SE: -0.5, 6.0) higher than in-person weights. Estimated weight change using pragmatic methods and study scales in both studies were in the same direction and of similar magnitude. Conclusion: Both methods can be used as cost-effective and real-world surrogates within a tolerable variability for the gold-standard. Trial registration: NCT02691260; NCT01357551.

Qualitative Analysis of Barriers and Facilitators to Glaucoma Medication Adherence in a Randomized Controlled Trial Intervention.

OBJECTIVE: In the Medication Adherence In Glaucoma To Improve Care trial, 200 veterans with medically-treated glaucoma were randomized to an intervention designed to improve glaucoma medication adherence or to usual care. In the 6 months after intervention, the mean proportion of doses taken on schedule was higher for participants in the intervention group compared with controls (0.85 vs. 0.62, P < 0.001). The purpose of this study was to use a mixed-methods approach to compare barriers and facilitators with adherence among participants through qualitative analysis of structured interviews. DESIGN: This is an analysis of interviews conducted from patients participating in a clinical trial. PARTICIPANTS: Participants from the intervention arm were separated into quartiles based on medication adherence according to the electronic monitor to sample from high and low responders to the intervention. We interviewed 23 participants; 11 participants with low adherence and 12 with high adherence. METHODS: Interviews were conducted over telephone and transcribed. Staff members used grounded theory to conduct content analysis and code the transcribed interviews. The iterative process produced categories of common barriers and facilitators for medication adherence. MAIN OUTCOME MEASURES: The frequency of responses addressing common barriers and facilitators were compared between participants with high and low adherence. RESULTS: In the lowest- and highest-adherence groups, a difficult schedule was the most cited barrier for regular drop usage (63.6% and 58.3%, respectively). In the lowest and highest-adherence groups, the most cited facilitator for adherence was use of the smart bottle (100% and 91.7%, respectively). In the lowest-adherence group, 72.7% of participants cited that improved ability to administer drops was a benefit from the intervention. In the highest-adherence group, 75% of participants cited increased disease knowledge and formation of habits as facilitators from the intervention. Of the 22 of 23 participants who mentioned the smart bottle, 100% cited that they had increased adherence and would continue using the smart bottle. CONCLUSIONS: Using dosing reminders and personalized patient education may be important avenues for addressing difficulties with adhering to an eye drop schedule to improve glaucoma self-management. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Mobile Mindfulness for Psychological Distress and Burnout among Frontline COVID-19 Nurses: A Pilot Randomized Trial.

Rationale: The coronavirus disease (COVID-19) pandemic exacerbated psychological distress and burnout in frontline healthcare workers. Interventions addressing psychological distress and burnout among these workers are lacking. Objectives: To determine the feasibility and explore the impact of mobile mindfulness to treat psychological distress and burnout among nurses in frontline COVID-19 units. Methods: We conducted a pilot randomized trial of 102 nurses working in COVID-19 units at a single hospital between May 2021 and January 2022. Participants were randomized to mobile mindfulness (intervention) or waiting list (control). The primary outcome was feasibility, assessed by comparing rates of randomization, retention, and intervention completion to predefined targets. Secondary outcomes were changes in psychological distress (Patient Health Questionnaire-9, General Anxiety Disorder-7, Perceived Stress Scale-4) and burnout symptoms (Maslach Burnout Inventory) after 1 month. Results: We randomized 102 of 113 consented individuals (90%, target 80%), and 88 completed follow-up (86%, target 80%). Among 69 intervention participants, 19 completed ⩾1 mindfulness session per week (28%, target 60%), and 13 completed ⩾75% of mindfulness sessions (19%, target 50%). Intervention participants had greater decreases in Patient Health Questionnaire-9 scores than control subjects (difference in differences, -2.21; 95% confidence interval, -3.99, -0.42; P = 0.016), but the Maslach Burnout Inventory depersonalization scores decreased more in the control arm than in the intervention arm (difference in differences, 1.60; 95% confidence interval, 0.18, 3.02; P = 0.027). There were no other changes in emotional distress or burnout symptoms. Conclusions: This trial of mobile mindfulness in frontline nurses met feasibility targets for randomization and retention, but participants had modest intervention use. Intervention participants had a reduction in depression symptoms, but not in burnout. Clinical trial registered with www.clinicaltrials.gov (NCT04816708).

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.

Effect of a Coaching Intervention to Improve Cardiologist Communication: A Randomized Clinical Trial.

Importance: Communication between cardiologists and patients can significantly affect patient comprehension, adherence, and satisfaction. To our knowledge, a coaching intervention to improve cardiologist communication has not been tested. Objective: To evaluate the effect of a communication coaching intervention to teach evidence-based communication skills to cardiologists. Design, Setting, and Participants: This 2-arm randomized clinical trial was performed at outpatient cardiology clinics at an academic medical center and affiliated community clinics, and from February 2019 through March 2020 recruited 40 cardiologists and audio recorded 161 patients in the preintervention phase and 240 in the postintervention phase. Data analysis was performed from March 2022 to January 2023. Interventions: Half of the cardiologists were randomized to receive a coaching intervention that involved three 1:1 sessions, 2 of which included feedback on their audio-recorded encounters. Communication coaches taught 5 skills derived from motivational interviewing: (1) sitting down and making eye contact with all in the room, (2) open-ended questions, (3) reflective statements, (4) empathic statements, and (5) "What questions do you have?" Main Outcomes and Measures: Coders unaware of study arm coded these behaviors in the preintervention and postintervention audio-recorded encounters (objective communication). Patients completed a survey after the visit to report perceptions of communication quality (subjective communication). Results: Analysis included 40 cardiologists (mean [SD] age, 47 [9] years; 7 female and 33 male) and 240 patients in the postintervention phase (mean [SD] age, 58 [15] years; 122 female, 118 male). When controlling for preintervention behaviors, cardiologists in the intervention vs control arm were more likely to make empathic statements (intervention: 52 of 117 [44%] vs control: 31 of 113 [27%]; P = .05); to ask, "What questions do you have?" (26 of 117 [22%] vs 6 of 113 [5%]; P = .002); and to respond with empathy when patients expressed negative emotions (mean ratio of empathic responses to empathic opportunities, 0.50 vs 0.20; P = .004). These effects did not vary based on patient or cardiologist race or sex. We found no arm differences for open-ended questions or reflective statements and were unable to assess differences in patient ratings due to ceiling effects. Conclusions and Relevance: In this randomized clinical trial, a communication coaching intervention improved 2 key communication behaviors: expressing empathy and eliciting questions. Empathic communication is a harder-level skill that may improve the patient experience and information comprehension. Future work should explore how best to assess the effect of communication coaching on patient perceptions of care and clinical outcomes and determine its effectiveness in larger, more diverse samples of cardiologists. Trial Registration: ClinicalTrials.gov Identifier: NCT03464110.

Characterization of POLE c.1373A > T p.(Tyr458Phe), causing high cancer risk.

The cancer syndrome polymerase proofreading-associated polyposis results from germline mutations in the POLE and POLD1 genes. Mutations in the exonuclease domain of these genes are associated with hyper- and ultra-mutated tumors with a predominance of base substitutions resulting from faulty proofreading during DNA replication. When a new variant is identified by gene testing of POLE and POLD1, it is important to verify whether the variant is associated with PPAP or not, to guide genetic counseling of mutation carriers. In 2015, we reported the likely pathogenic (class 4) germline POLE c.1373A > T p.(Tyr458Phe) variant and we have now characterized this variant to verify that it is a class 5 pathogenic variant. For this purpose, we investigated (1) mutator phenotype in tumors from two carriers, (2) mutation frequency in cell-based mutagenesis assays, and (3) structural consequences based on protein modeling. Whole-exome sequencing of two tumors identified an ultra-mutator phenotype with a predominance of base substitutions, the majority of which are C > T. A SupF mutagenesis assay revealed increased mutation frequency in cells overexpressing the variant of interest as well as in isogenic cells encoding the variant. Moreover, exonuclease repair yeast-based assay supported defect in proofreading activity. Lastly, we present a homology model of human POLE to demonstrate structural consequences leading to pathogenic impact of the p.(Tyr458Phe) mutation. The three lines of evidence, taken together with updated co-segregation and previously published data, allow the germline variant POLE c.1373A > T p.(Tyr458Phe) to be reclassified as a class 5 variant. That means the variant is associated with PPAP.

Feasibility of Mobile App-based Coping Skills Training for Cardiorespiratory Failure Survivors: The Blueprint Pilot Randomized Controlled Trial.

Rationale: Psychological distress symptoms are common among patients recently hospitalized with cardiorespiratory failure, yet there are few effective postdischarge therapies that are relevant to their experiences. Objectives: To determine the feasibility and clinical impact of two different versions of a month-long self-guided mobile app-based coping skills program called Blueprint in comparison to usual care (UC) control. Methods: Patients hospitalized with a serious cardiopulmonary diagnoses were recruited from adult intensive care units and stepdown units at a large academic medical center. Participants with elevated psychological distress symptoms just after discharge were randomized in a 1:1:1 ratio to Blueprint with a therapist (BP/therapist), Blueprint without a therapist (BP/no therapist), or UC control. All study procedures were conducted remotely. Blueprint is a self-guided, symptom-responsive, mobile app-based adaptive coping skills program with 4 themed weeks with different daily audio, video, and text content. Participants completed surveys via the app platform at baseline and 1 and 3 months later. The primary outcome was feasibility. Additional outcomes included the HADS (Hospital Anxiety and Depression Scale) total score, the PTSS (Post-Traumatic Stress Scale), and a 100-point quality of life visual analog scale. Results: Of 63 patients who consented, 45 (71%) with elevated distress were randomized to BP/therapist (n = 16 [36%]), BP/no therapist (n = 14 [31%]), and UC (n = 15 [33%]). Observed rates were similar to target feasibility benchmarks, including consented patients who were randomized (71.4%), retention (75.6%), and intervention adherence (97% with weekly use). Estimated mean differences (95% confidence intervals) at 1 month compared with baseline included: HADS total (BP/therapist, -3.8 [-6.7 to -0.6]; BP/no therapist, -4.2 [-7.6 to -0.0]; UC, -3.4 [-6.6 to 0.2]); PTSS (BP/therapist, -6.7 [-11.3 to -2.1]; BP/no therapist, -9.1 [-14.4 to -3.9]; UC, -4.2 [-10.8 to 2.3]); and quality of life (BP/therapist, -4.5 [-14.3 to 4.6]; BP/no therapist, 14.0 [-0.9 to 29.0]; UC, 8.7 [-3.5 to 20.9]). Conclusions: Among survivors of cardiorespiratory failure, a mobile app-based postdischarge coping skills training intervention demonstrated evidence of feasibility and clinical impact compared with UC control. A larger trial is warranted to test the efficacy of this approach. Clinical trial registered with ClinicalTrials.gov (NCT04329702).

How Medication Adherence Affects Disease Management in Veterans with Glaucoma: Lessons Learned from a Clinical Trial.

INTRODUCTION: We conducted a secondary, real-world clinical assessment of a randomized controlled trial to determine how a glaucoma medication adherence intervention impacted the clinical outcomes of participants at 12 months post-randomization. Participants included veterans at a VA eye clinic with medically treated glaucoma who reported poor adherence and their companions, if applicable. METHODS: The treatment group received a glaucoma education session with drop administration instruction and virtual reminders from a "smart bottle" (AdhereTech) for their eye drops. The control group received a general eye health class and the smart bottle with the reminder function turned off. Medical chart extraction determined if participants in each group experienced visual field progression, additional glaucoma medications, or a recommendation for surgery or laser due to inadequate intraocular pressure control over the 12 months following randomization. The main outcome measure was disease progression, defined as visual field progression or escalation of glaucoma therapy, in the 12 months following randomization. RESULTS: Thirty-six versus 32% of the intervention (n = 100) versus control (n = 100) groups, respectively, experienced disease intensification. There was no difference between the intervention and control groups in terms of intensification (intervention vs. control group odds ratio: 1.20; 95% confidence interval: [0.67, 2.15]), including when age, race, and disease severity were accounted for in the logistic regression model. Those whose study dates included time during the COVID-19 pandemic were evenly distributed between groups. CONCLUSIONS: A multifaceted intervention that improved medication adherence for glaucoma for 6 months did not affect the clinical outcomes measured at 12 months post-randomization. Twelve months may not be long enough to see the clinical effect of this intervention or more than 6 months of intervention are needed.

A Visual Tool to Help Develop a Statistical Analysis Plan for Randomized Trials in Palliative Care.

Collaboration with a statistician about the design of a statistical analysis plan can be enhanced by illustrating how statisticians conceptualize their task. This conceptualization can be represented by a directed acyclic graph (DAG), which illustrates the statistician's approach and also provides an actionable tool to assist in the development of the plan.

Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial.

BACKGROUND: Cognitive Behavioral Therapy for Insomnia (CBTi) is recommended as first-line treatment for insomnia, yet patient access to CBTi is limited. Self-help CBTi could increase patient access. Self-help CBTI with provider sup]port is more effective and is preferred by patients. Self-help CBTi has not been evaluated in veterans; a population with greater medical and mental health morbidity and more severe sleep difficulties than non-veterans. Moreover, those with mental health conditions have been largely excluded from prior CBTi self-help trials. Stablishing the efficacy of provider-supported Self-help CBTi is an important first step for expanding veteran access to CBTi. METHODS: In a 2-armed randomized controlled trial, a provider-supported self-help CBTi (Tele-Self CBTi) is compared to Health Education for improving insomnia severity (primary outcome) among treatment-seeking veterans with insomnia disorder. Tele-Self CBTi is comprised of two treatment components: self-help CBTi via a professionally designed manual developed using an iterative process of expert review and patient input; and 6 telephone-based support sessions lasting >20 min. Outcomes are assessed at baseline, 8 weeks, and 6 months after baseline. The primary outcome, insomnia severity, is measured using the Insomnia Severity Index. Secondary outcomes include self-reported and actigraphy-assessed sleep, fatigue, depression symptoms, and sleep-related quality of life. CONCLUSION: Innovative approaches are essential to improving overall health among veterans; a population with highly prevalent insomnia disorder. If effective, Tele-Self CBTi may bridge the gap between unavailable resources and high demand for CBTi and serve as the entry level intervention in a stepped model of care. GOV IDENTIFIER: NCT03727438.