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.

The high price of equity in pulse oximetry: A cost evaluation and need for interim solutions.

Disparities in pulse oximetry accuracy, disproportionately affecting patients of color, have been associated with serious clinical outcomes. Although many have called for pulse oximetry hardware replacement, the cost associated with this replacement is not known. The objective of this study was to estimate the cost of replacing all current pulse oximetry hardware throughout a hospital system via a single-center survey in 2023 at an academic medical center (Duke University) with three hospitals. The main outcome was the cost of total hardware replacement as identified by current day prices for hardware. New and used prices for 3,542/4,136 (85.6%) across three hospitals for pulse oximetry devices were found. The average cost to replace current pulse oximetry hardware is $6,834.61 per bed. Replacement and integration costs are estimated at $14.2-17.4 million for the entire medical system. Extrapolating these costs to 5,564 hospitals in the United States results in an estimated cost of $8.72 billion. "Simply replacing" current pulse oximetry hardware to address disparities may not be simple, cheap, or timely. Solutions for addressing pulse oximetry accuracy disparities leveraging current technology may be necessary, and might also be better. Trial Registration: Pro00113724, exempt.

A survey of skin tone assessment in prospective research.

Increasing evidence supports reduced accuracy of noninvasive assessment tools, such as pulse oximetry, temperature probes, and AI skin diagnosis benchmarks, in patients with darker skin tones. The FDA is exploring potential strategies for device regulation to improve performance across diverse skin tones by including skin tone criteria. However, there is no consensus about how prospective studies should perform skin tone assessment in order to take this bias into account. There are several tools available to conduct skin tone assessments including administered visual scales (e.g., Fitzpatrick Skin Type, Pantone, Monk Skin Tone) and color measurement tools (e.g., reflectance colorimeters, reflectance spectrophotometers, cameras), although none are consistently used or validated across multiple medical domains. Accurate and consistent skin tone measurement depends on many factors including standardized environments, lighting, body parts assessed, patient conditions, and choice of skin tone assessment tool(s). As race and ethnicity are inadequate proxies for skin tone, these considerations can be helpful in standardizing the effect of skin tone on studies such as AI dermatology diagnoses, pulse oximetry, and temporal thermometers. Skin tone bias in medical devices is likely due to systemic factors that lead to inadequate validation across diverse skin tones. There is an opportunity for researchers to use skin tone assessment methods with standardized considerations in prospective studies of noninvasive tools that may be affected by skin tone. We propose considerations that researchers must take in order to improve device robustness to skin tone bias.

Utility of Skin Tone on Pulse Oximetry in Critically Ill Patients: A Prospective Cohort Study.

OBJECTIVE: Pulse oximetry, a ubiquitous vital sign in modern medicine, has inequitable accuracy that disproportionately affects minority Black and Hispanic patients, with associated increases in mortality, organ dysfunction, and oxygen therapy. Previous retrospective studies used self-reported race or ethnicity as a surrogate for skin tone which is believed to be the root cause of the disparity. Our objective was to determine the utility of skin tone in explaining pulse oximetry discrepancies. DESIGN: Prospective cohort study. SETTING: Patients were eligible if they had pulse oximetry recorded up to 5 minutes before arterial blood gas (ABG) measurements. Skin tone was measured using administered visual scales, reflectance colorimetry, and reflectance spectrophotometry. PARTICIPANTS: Admitted hospital patients at Duke University Hospital. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Sao2-Spo2 bias, variation of bias, and accuracy root mean square, comparing pulse oximetry, and ABG measurements. Linear mixed-effects models were fitted to estimate Sao2-Spo2 bias while accounting for clinical confounders.One hundred twenty-eight patients (57 Black, 56 White) with 521 ABG-pulse oximetry pairs were recruited. Skin tone data were prospectively collected using six measurement methods, generating eight measurements. The collected skin tone measurements were shown to yield differences among each other and overlap with self-reported racial groups, suggesting that skin tone could potentially provide information beyond self-reported race. Among the eight skin tone measurements in this study, and compared with self-reported race, the Monk Scale had the best relationship with differences in pulse oximetry bias (point estimate: -2.40%; 95% CI, -4.32% to -0.48%; p = 0.01) when comparing patients with lighter and dark skin tones. CONCLUSIONS: We found clinical performance differences in pulse oximetry, especially in darker skin tones. Additional studies are needed to determine the relative contributions of skin tone measures and other potential factors on pulse oximetry discrepancies.

Utility of skin tone on pulse oximetry in critically ill patients: a prospective cohort study.

Importance: Pulse oximetry, a ubiquitous vital sign in modern medicine, has inequitable accuracy that disproportionately affects Black and Hispanic patients, with associated increases in mortality, organ dysfunction, and oxygen therapy. Although the root cause of these clinical performance discrepancies is believed to be skin tone, previous retrospective studies used self-reported race or ethnicity as a surrogate for skin tone. Objective: To determine the utility of objectively measured skin tone in explaining pulse oximetry discrepancies. Design Setting and Participants: Admitted hospital patients at Duke University Hospital were eligible for this prospective cohort study if they had pulse oximetry recorded up to 5 minutes prior to arterial blood gas (ABG) measurements. Skin tone was measured across sixteen body locations using administered visual scales (Fitzpatrick Skin Type, Monk Skin Tone, and Von Luschan), reflectance colorimetry (Delfin SkinColorCatch [L*, individual typology angle {ITA}, Melanin Index {MI}]), and reflectance spectrophotometry (Konica Minolta CM-700D [L*], Variable Spectro 1 [L*]). Main Outcomes and Measures: Mean directional bias, variability of bias, and accuracy root mean square (ARMS), comparing pulse oximetry and ABG measurements. Linear mixed-effects models were fitted to estimate mean directional bias while accounting for clinical confounders. Results: 128 patients (57 Black, 56 White) with 521 ABG-pulse oximetry pairs were recruited, none with hidden hypoxemia. Skin tone data was prospectively collected using 6 measurement methods, generating 8 measurements. The collected skin tone measurements were shown to yield differences among each other and overlap with self-reported racial groups, suggesting that skin tone could potentially provide information beyond self-reported race. Among the eight skin tone measurements in this study, and compared to self-reported race, the Monk Scale had the best relationship with differences in pulse oximetry bias (point estimate: -2.40%; 95% CI: -4.32%, -0.48%; p=0.01) when comparing patients with lighter and dark skin tones. Conclusions and relevance: We found clinical performance differences in pulse oximetry, especially in darker skin tones. Additional studies are needed to determine the relative contributions of skin tone measures and other potential factors on pulse oximetry discrepancies.

An App Platform-Facilitated Collaborative Palliative Care Intervention for Outpatients With Interstitial Lung Disease: A Pilot Randomized Trial.

Rationale: Outpatients with interstitial lung disease often experience serious symptoms, yet infrequently receive palliative care. Objective: To determine the feasibility and clinical impact of a mobile application (PCplanner) in an outpatient setting. Methods: We conducted a pilot randomized controlled trial among adults with interstitial lung disease in a single-center academic clinic. Clinical outcomes included change in Needs at the End-of-Life Screening Tool (NEST) scale between baseline and 3 months as well as frequency of advance care planning discussions and referrals to palliative care services. Results: Observed feasibility outcomes were similar to targeted benchmarks including randomization rates (82.1% vs 80%) and retention (84.8% vs 80%). Mean NEST scores between the intervention and control group were 38.9 (SD, 18.9) vs 41.5 (SD, 20.5) at baseline, 34.6 (SD, 18.9) vs 33.6 (SD, 19.4) at 1 month after clinic visit, 40.5 (SD, 21.6) vs 35.3 (SD, 25.0) at 3 months after clinic visit. Changes in NEST scores between baseline and 3 months showed no difference in the primary outcome (P = 0.481, 95% CI [-8.45, 17.62]). Conclusion: Among patients with interstitial lung disease, a mobile app designed to focus patients and clinicians on palliative care principles demonstrated evidence of feasibility. Although changes in self-reported needs were similar between intervention and control groups, more patients in the intervention group updated their advance directives and code status compared to the control group. Clinical Trial Registration: Palliative Care Planner (PCplanner) NCT05095363. https://www.clinicaltrials.gov/study/NCT05095363.

ENCoDE - a skin tone and clinical dataset from a prospective trial on acute care patients.

Background: Although hypothesized to be the root cause of the pulse oximetry disparities, skin tone and its use for improving medical therapies have yet to be extensively studied. Studies previously used self-reported race as a proxy variable for skin tone. However, this approach cannot account for skin tone variability within race groups and also risks the potential to be confounded by other non-biological factors when modeling data. Therefore, to better evaluate health disparities associated with pulse oximetry, this study aimed to create a unique baseline dataset that included skin tone and electronic health record (EHR) data. Methods: Patients admitted to Duke University Hospital were eligible if they had at least one pulse oximetry value recorded within 5 minutes before an arterial blood gas (ABG) value. We collected skin tone data at 16 different body locations using multiple devices, including administered visual scales, colorimetric, spectrophotometric, and photography via mobile phone cameras. All patients' data were linked in Duke's Protected Analytics Computational Environment (PACE), converted into a common data model, and then de-identified before publication in PhysioNet. Results: Skin tone data were collected from 128 patients. We assessed 167 features per skin location on each patient. We also collected over 2000 images from mobile phones measured in the same controlled environment. Skin tone data are linked with patients' EHR data, such as laboratory data, vital sign recordings, and demographic information. Conclusions: Measuring different aspects of skin tone for each of the sixteen body locations and linking them with patients' EHR data could assist in the development of a more equitable AI model to combat disparities in healthcare associated with skin tone. A common data model format enables easy data federation with similar data from other sources, facilitating multicenter research on skin tone in healthcare. Description: A prospectively collected EHR-linked skin tone measurements database in a common data model with emphasis on pulse oximetry disparities.

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.

The High Price of Equity in Pulse Oximetry: A cost evaluation and need for interim solutions.

Importance: Disparities in pulse oximetry accuracy, disproportionately affecting patients of color, have been associated with serious clinical outcomes. Although many have called for pulse oximetry hardware replacement, the cost associated with this replacement is not known. Objective: To estimate the cost of replacing all pulse oximetry hardware throughout a hospital system. Design: Single-center survey, 2023. Setting: Single center. Participants: One academic medical center with three hospitals. Main Outcomes and Measures: Cost of fleet replacement as identified by current day prices for hardware. Results: New and used prices for 5,079/5,678 (89.5%) across three hospitals for pulse oximetry devices were found. The average equipment cost to replace pulse oximetry hardware is $15,704.12 per bed. Replacement and integration costs are estimated at $28.5-31.8 million for the entire medical system. Extrapolating these costs to 5,564 hospitals in the United States results in an estimated cost of $14.1 billion. Conclusions and Relevance: "Simply replacing" pulse oximetry hardware to address disparities may be neither simple, cheap, or timely. Solutions for addressing pulse oximetry accuracy disparities leveraging current technology may be necessary. Trial Registration: Pro00113724, exempt.

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).

Palliative care phenotypes among critically ill patients and family members: intensive care unit prospective cohort study.

OBJECTIVE: Because the heterogeneity of patients in intensive care units (ICUs) and family members represents a challenge to palliative care delivery, we aimed to determine if distinct phenotypes of palliative care needs exist. METHODS: Prospective cohort study conducted among family members of adult patients undergoing mechanical ventilation in six medical and surgical ICUs. The primary outcome was palliative care need measured by the Needs at the End-of-Life Screening Tool (NEST, range from 0 (no need) to 130 (highest need)) completed 3 days after ICU admission. We also assessed quality of communication, clinician-family relationship and patient centredness of care. Latent class analysis of the NEST's 13 items was used to identify groups with similar patterns of serious palliative care needs. RESULTS: Among 257 family members, latent class analysis yielded a four-class model including complex communication needs (n=26, 10%; median NEST score 68.0), family spiritual and cultural needs (n=21, 8%; 40.0) and patient and family stress needs (n=43, 31%; 31.0), as well as a fourth group with fewer serious needs (n=167, 65%; 14.0). Interclass differences existed in quality of communication (median range 4.0-10.0, p<0.001), favourable clinician-family relationship (range 34.6%-98.2%, p<0.001) and both the patient centredness of care Eliciting Concerns (median range 4.0-5.0, p<0.001) and Decision-Making (median range 2.3-4.5, p<0.001) scales. CONCLUSIONS: Four novel phenotypes of palliative care need were identified among ICU family members with distinct differences in the severity of needs and perceived quality of the clinician-family interaction. Knowledge of need class may help to inform the development of more person-centred models of ICU-based palliative care.