Nurse-Supported Self-Directed Cognitive Behavioral Therapy for Insomnia: A Randomized Clinical Trial.

Importance: Cognitive behavioral therapy for insomnia (CBTi) is the standard of care for treating insomnia disorder, but access is limited. Alternative approaches are needed to expand access to the standard of care. Objective: To examine the effectiveness of a nurse-supported, self-directed behavioral insomnia intervention for decreasing insomnia severity and improving sleep outcomes among veterans, a population with considerable mental health comorbidity. Design, Setting, and Participants: This randomized clinical trial included 178 patients with insomnia disorder who were recruited from a Veterans Affairs hospital (Durham VA Healthcare System) from September 2019 to April 2022 and randomized following baseline assessment; follow-ups were conducted at 8 weeks (primary end point) and 6 months. Data analysis was primarily conducted during the summer of 2023 and concluded in May 2024. Intervention: Six weekly phone calls from a nurse interventionist plus assigned treatment manual readings covering CBTi treatment components. The health education manual focused on health topics but not sleep. Main Outcomes and Measures: The primary outcome was the Insomnia Severity Index (score range, 0-28; remission <8; differential improvement of 3 points targeted) score assessed at 8 weeks postrandomization. Secondary outcomes were sleep outcomes, depression, fatigue, treatment response, and remission. Results: Of 178 study participants, the mean (SD) age was 55.1 (13.2) years, and 128 (71.9%) identified as men. At 8 weeks, Insomnia Severity Index scores decreased by an estimated mean (SE) of 5.7 (0.51) points in the intervention group and 2.0 (0.47) points in the control group, a differential mean improvement of 3.7 points (95% CI, -5.0 to -2.4; P < .001). Differences were sustained at 6 months (mean, -2.8; 95% CI, -4.4 to -1.3; P < .001). The intervention also resulted in greater improvements at 8 weeks postrandomization in diary sleep onset latency, wake after sleep onset, and sleep efficiency and actigraphy sleep efficiency; these differences were sustained at 6 months. At 8 weeks, depression and fatigue were significantly reduced, and the odds of treatment response and remission were greater in the intervention group compared with controls. Conclusions and Relevance: This randomized clinical trial found that despite greater prevalence of mental health conditions and sleep difficulties among veterans, a nurse-supported self-directed CBTi was more effective than health education control for reducing insomnia severity and improving sleep outcomes. Although less effective than therapist-delivered CBTi, findings were comparable with other trials using modified CBTi protocols. Trial Registration: ClinicalTrials.gov Identifier: NCT03727438.

Conducting Comparative Effectiveness, Multisite Palliative Care and Advance Care Planning Trials: Lessons Learned and Future Directions From PCORI-Funded Studies.

The Patient-Centered Outcomes Research Institute (PCORI) funded multiple large-scale comparative effectiveness clinical trials evaluating palliative care (PC) and advance care planning (ACP) healthcare delivery models. This article provides an overview of the most common barriers our investigative teams encountered while implementing these trials and the strategies we utilized to overcome these challenges, with particular attention to identifying research partners for multisite trials; addressing contracting and regulatory issues; creating a team governance structure; training and engaging study staff across sites; recruiting, consenting, and enrolling study participants; collecting PC and ACP data and study outcomes; and managing multisite collaborations. The goal of this article is to provide guidance on how to best plan for and conduct rigorous trials evaluating PC and ACP healthcare delivery interventions moving forward.

A guide to successful management of collaborative partnerships in quantitative research: An illustration of the science of team science.

Data-intensive research continues to expand with the goal of improving healthcare delivery, clinical decision-making, and patient outcomes. Quantitative scientists, such as biostatisticians, epidemiologists, and informaticists, are tasked with turning data into health knowledge. In academic health centres, quantitative scientists are critical to the missions of biomedical discovery and improvement of health. Many academic health centres have developed centralized Quantitative Science Units which foster dual goals of professional development of quantitative scientists and producing high quality, reproducible domain research. Such units then develop teams of quantitative scientists who can collaborate with researchers. However, existing literature does not provide guidance on how such teams are formed or how to manage and sustain them. Leaders of Quantitative Science Units across six institutions formed a working group to examine common practices and tools that can serve as best practices for Quantitative Science Units that wish to achieve these dual goals through building long-term partnerships with researchers. The results of this working group are presented to provide tools and guidance for Quantitative Science Units challenged with developing, managing, and evaluating Quantitative Science Teams. This guidance aims to help Quantitative Science Units effectively participate in and enhance the research that is conducted throughout the academic health centre-shaping their resources to fit evolving research needs.

Mobile App-Based Mindfulness Intervention for Addressing Psychological Distress Among Survivors of Hospitalization for COVID-19 Infection.

BACKGROUND: Psychological distress symptoms are present and persistent among many patients who survive a critical illness like COVID-19. RESEARCH QUESTION: Could a self-directed mobile app-delivered mindfulness intervention be feasibly and rapidly implemented within a clinical trials network to reduce distress symptoms? STUDY DESIGN AND METHODS: A randomized clinical trial was conducted between January 2021 and May 2022 at 29 US sites and included survivors of hospitalization due to COVID-19-related illness with elevated symptoms of depression at discharge. Participants were randomized to intervention or usual care control. The intervention consisted of four themed weeks of daily audio, video, and text content. All study procedures were virtual. The primary outcome was depression symptoms assessed with the Patient Health Questionnaire 9 at 3 months. Secondary outcomes included anxiety (Generalized Anxiety Disorder 7-item scale), quality of life (EQ-5D), and adherence. We used general linear models to estimate treatment arm differences in outcomes over time. RESULTS: Among 56 randomized participants (mean age ± SD, 51.0 ± 13.2 years; 38 female [67.9%]; 14 Black participants [25%]), 45 (intervention: n = 23 [79%]; control: n = 22 [81%]) were retained at 6 months. There was no difference in mean improvement between intervention and control participants at 3 months in Patient Health Questionnaire 9 (-0.5 vs 0.1), Generalized Anxiety Disorder 7-item scale (-0.3 vs 0.1), or EQ-5D (-0.03 vs 0.02) scores, respectively; 6-month results were similar. Only 15 participants (51.7%) initiated the intervention, whereas the mean number ± SD of the 56 prescribed intervention activities completed was 12.0 ± 15.2. Regulatory approvals delayed trial initiation by nearly a year. INTERPRETATION: Among survivors of COVID-19 hospitalization with elevated psychological distress symptoms, a self-directed mobile app-based mindfulness intervention had poor adherence. Future psychological distress interventions mobilized at broad scale should focus efforts on patient engagement and regulatory simplification to enhance success. TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT04581200; URL: www.clinicaltrials.gov.

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.

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.

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.

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.

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.