Limited English Proficiency and Sepsis Mortality by Race and Ethnicity.

Importance: Patients with limited English proficiency (LEP) face multiple barriers and are at risk for worse health outcomes compared with patients with English proficiency (EP). In sepsis, a major cause of mortality in the US, the association of LEP with health outcomes is not widely explored. Objective: To assess the association between LEP and inpatient mortality among patients with sepsis and test the hypothesis that LEP would be associated with higher mortality rates. Design, Setting, and Participants: This retrospective cohort study of hospitalized patients with sepsis included those who met the Centers for Disease Control and Prevention's sepsis criteria, received antibiotics within 24 hours, and were admitted through the emergency department. Data were collected from the electronic medical records of a large New England tertiary care center from January 1, 2016, to December 31, 2019. Data were analyzed from January 8, 2021, to March 2, 2023. Exposures: Limited English proficiency, gathered via self-reported language preference in electronic medical records. Main Outcomes and Measures: The primary outcome was inpatient mortality. The analysis used multivariable generalized estimating equation models with propensity score adjustment and analysis of covariance to analyze the association between LEP and inpatient mortality due to sepsis. Results: A total of 2709 patients met the inclusion criteria, with a mean (SD) age of 65.0 (16.2) years; 1523 (56.2%) were men and 327 (12.1%) had LEP. Nine patients (0.3%) were American Indian or Alaska Native, 101 (3.7%) were Asian, 314 (11.6%) were Black, 226 (8.3%) were Hispanic, 38 (1.4%) were Native Hawaiian or Other Pacific Islander or of other race or ethnicity, 1968 (72.6%) were White, and 6 (0.2%) were multiracial. Unadjusted mortality included 466 of 2382 patients with EP (19.6%) and 69 of 327 with LEP (21.1%). No significant difference was found in mortality odds for the LEP compared with EP groups (odds ratio [OR], 1.12 [95% CI, 0.88-1.42]). When stratified by race and ethnicity, odds of inpatient mortality for patients with LEP were significantly higher among the non-Hispanic White subgroup (OR, 1.76 [95% CI, 1.41-2.21]). This significant difference was also present in adjusted analyses (adjusted OR, 1.56 [95% CI, 1.02-2.39]). No significant differences were found in inpatient mortality between LEP and EP in the racial and ethnic minority subgroup (OR, 0.99 [95% CI, 0.63-1.58]; adjusted OR, 0.91 [95% CI, 0.56-1.48]). Conclusions and Relevance: In a large diverse academic medical center, LEP had no significant association overall with sepsis mortality. In a subgroup analysis, LEP was associated with increased mortality among individuals identifying as non-Hispanic White. This finding highlights a potential language-based inequity in sepsis care. Further studies are needed to understand drivers of this inequity, how it may manifest in other diverse health systems, and to inform equitable care models for patients with LEP.

Feasibility of Weekly Electronic Health Record-Embedded Patient-Reported Outcomes for Patients Starting Oral Cancer-Directed Therapy.

PURPOSE: To examine the feasibility of integrating a symptom management platform into the electronic health record (EHR) using electronic patient-reported outcomes (ePROs) during oral cancer-directed therapy (OCDT) and explore the impact of prompting oncology nurse navigators (ONNs) to respond to severe symptomatic adverse events (SAEs). MATERIALS AND METHODS: Adults prescribed OCDT at Dana-Farber Cancer Institute were consecutively invited to participate. Participants received weekly messages to complete ePROs. The first half enrolled in a passive (P) group where ePROs responses could be viewed anytime, but outreach was not expected. The second half enrolled in an active (A) group where severe SAEs prompted emails to ONNs for outreach within 1 business day. Feasibility was the proportion of participants completing ≥2 ePROs during the first 30 days. Participants were followed for up to 90 days. RESULTS: From June 25, 2019, to August 18, 2021, 100 participants enrolled, and 96 remained enrolled for at least 30 days. Overall, average age was 59 years, 80% female, and 9% used the platform in Spanish. Twenty-two A (45%) and 27 P (57%) participants met the feasibility threshold (P = .26). ePROs returned at 30 days were similar (P = .50): 0 ePROs 17 A, 13 P; 1 ePRO 10 A, 7 P; 2 ePROs 3 A, 5 P; 3 ePROs 1 A, 4 P; 4 ePROs 7 A, 8 P; and 5 ePROs 11 A, 10 P. Documented telephone encounters at 30 days were similar (109 A, 101 P; P = .86). CONCLUSION: EHR-embedded ePROs administered weekly for people on OCDT was feasible, although many went incomplete. ePRO completion was not clearly affected by nursing calls for severe SAEs. Future efforts will investigate improving engagement and addressing symptoms proactively.

A Multiyear Survey Evaluating Clinician Electronic Health Record Satisfaction.

OBJECTIVES: We assessed how clinician satisfaction with a vendor electronic health record (EHR) changed over time in the 4 years following the transition from a homegrown EHR system to identify areas for improvement. METHODS: We conducted a multiyear survey of clinicians across a large health care system after transitioning to a vendor EHR. Eligible clinicians from the first institution to transition received a survey invitation by email in fall 2016 and then eligible clinicians systemwide received surveys in spring 2018 and spring 2019. The survey included items assessing ease/difficulty of completing tasks and items assessing perceptions of the EHR's value, usability, and impact. One item assessing overall satisfaction and one open-ended question were included. Frequencies and means were calculated, and comparison of means was performed between 2018 and 2019 on all clinicians. A multivariable generalized linear model was performed to predict the outcome of overall satisfaction. RESULTS: Response rates for the surveys ranged from 14 to 19%. The mean response from 3 years of surveys for one institution, Brigham and Women's Hospital, increased for overall satisfaction between 2016 (2.85), 2018 (3.01), and 2019 (3.21, p < 0.001). We found no significant differences in mean response for overall satisfaction between all responders of the 2018 survey (3.14) and those of the 2019 survey (3.19). Systemwide, tasks rated the most difficult included "Monitoring patient medication adherence," "Identifying when a referral has not been completed," and "Making a list of patients based on clinical information (e.g., problem, medication)." Clinicians disagreed the most with "The EHR helps me focus on patient care rather than the computer" and "The EHR allows me to complete tasks efficiently." CONCLUSION: Survey results indicate room for improvement in clinician satisfaction with the EHR. Usability of EHRs should continue to be an area of focus to ease clinician burden and improve clinician experience.

Examining Real-World Adherence to Nusinersen for the Treatment of Spinal Muscular Atrophy Using Two Large US Data Sources.

INTRODUCTION: Spinal muscular atrophy (SMA) is a rare neuromuscular disease characterized by progressive muscular atrophy and weakness. Nusinersen was the first treatment approved for SMA. Per the US label, the nusinersen administration schedule consists of three loading doses at 14-day intervals, a fourth loading dose 30 days later, and maintenance doses every 4 months thereafter. Using two large US databases, we evaluated real-world adherence to nusinersen with its unique dosing schedule among generalizable populations of patients with SMA. METHODS: Patients with SMA treated with nusinersen, likely to have complete information on date of treatment initiation, were identified in the Optum® de-identified electronic health records (EHR) database (7/2017-9/2019), and in the Merative™ MarketScan® Research Databases from commercial (1/2017-6/2020) and Medicaid claims (1/2017-12/2019). Baseline demographics, number of nusinersen administrations on time, and distribution of inter-dose intervals were summarized. RESULTS: Totals of 67 and 291 patients were identified in the EHR and claims databases, respectively. Most nusinersen doses were received on time (93.9% EHR, 80.5% claims). Adherence was higher during the maintenance phase (90.6%) than the loading phase (71.1%) in the claims analysis, in contrast with the EHR analysis (95.5% and 92.6%, respectively), suggesting that not all loading doses of nusinersen may be accurately captured in claims. Inter-dose intervals captured in both databases aligned with the expected dosing schedule. CONCLUSION: Most nusinersen doses were received on time, consistent with the recommended schedule. Our findings also highlight the importance of careful methodological approaches when using real-world administrative databases for evaluation of nusinersen treatment patterns.

Adherence to medicines in the real world is important for patients with chronic disease to see long-term benefits of treatment. This study shows the importance and challenges of measuring adherence using real-world administrative data sources. This is especially important for drugs given through lumbar puncture with unique dosing schedules, such as nusinersen for the treatment of spinal muscular atrophy. In this study, most patients with spinal muscular atrophy received their nusinersen doses on time.

The Association of the First Surge of the COVID-19 Pandemic with the High- and Low-Value Outpatient Care Delivered to Adults in the USA.

BACKGROUND: The first surge of the COVID-19 pandemic entirely altered healthcare delivery. Whether this also altered the receipt of high- and low-value care is unknown. OBJECTIVE: To test the association between the April through June 2020 surge of COVID-19 and various high- and low-value care measures to determine how the delivery of care changed. DESIGN: Difference in differences analysis, examining the difference in quality measures between the April through June 2020 surge quarter and the January through March 2020 quarter with the same 2 quarters' difference the year prior. PARTICIPANTS: Adults in the MarketScan® Commercial Database and Medicare Supplemental Database. MAIN MEASURES: Fifteen low-value and 16 high-value quality measures aggregated into 8 clinical quality composites (4 of these low-value). KEY RESULTS: We analyzed 9,352,569 adults. Mean age was 44 years (SD, 15.03), 52% were female, and 75% were employed. Receipt of nearly every type of low-value care decreased during the surge. For example, low-value cancer screening decreased 0.86% (95% CI, -1.03 to -0.69). Use of opioid medications for back and neck pain (DiD +0.94 [95% CI, +0.82 to +1.07]) and use of opioid medications for headache (DiD +0.38 [95% CI, 0.07 to 0.69]) were the only two measures to increase. Nearly all high-value care measures also decreased. For example, high-value diabetes care decreased 9.75% (95% CI, -10.79 to -8.71). CONCLUSIONS: The first COVID-19 surge was associated with receipt of less low-value care and substantially less high-value care for most measures, with the notable exception of increases in low-value opioid use.

A Quality Improvement Intervention Leveraging a Safety Net Model for Surveillance Colonoscopy Completion.

Systems to address follow-up testing of clinically positive surveillance colonoscopy results are lacking. The impact of an ambulatory safety net (ASN) intervention on rates of colonoscopy completion was assessed. The ASN team identified patients using an electronic registry, conducted patient outreach, coordinated care, and tracked colonoscopy completion. In all, 701 patients were captured in the ASN program: 58.1% (407/701) had possible barriers to follow-up colonoscopy completion, with rates of 80.1% (236/294) if no barrier, and 40.9% (287/701) overall. Colonoscopy completion likelihood increased with prior polypectomy (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.1-2.3), and decreased with White race (OR, 0.5; 95% CI, 0.3-0.9), increased inpatient visits (OR, 0.6; 95% CI, 0.4-0.9), more outreach attempts (OR, 0.6; 95% CI, 0.5-0.7), and fair/poor/inadequate preparation (OR, 0.4; 95% CI, 0.2-0.7) in logistic regression models. An ASN model for quality improvement promotes colonoscopy completion rates and identifies patient barriers.

Contributors to Gender Differences in Burnout and Professional Fulfillment: A Survey of Physician Faculty.

BACKGROUND: This study was conducted to describe gender differences in physician burnout and professional fulfillment and to explore their potential contributors. METHODS: This was a single-center, cross-sectional survey study of physician faculty at Brigham and Women's Hospital, an academic medical center in Boston. The population included all physician faculty who practiced clinical medicine in 2017 (n = 2,388). The study was conducted using the Stanford Physician Wellness Survey. Burnout and professional fulfillment were the main outcome measures assessed. Other variables assessed included ratings of culture of wellness, personal resilience, and efficiency of practice factors associated with physician experience. RESULTS: The study population consisted of 1,066 faculty, of whom 46.4% were female and 59.8% were younger than 50. Female physicians reported significantly higher rates of burnout (42.4% vs. 34.4%, p = 0.01) and lower rates of professional fulfillment (35.1% vs. 50.4%, p < 0.01) than male physicians. Female physicians reported lower ratings for self-compassion and multiple culture of wellness factors. After adjusting for demographic factors and academic rank, the study team identified multiple culture of wellness factors (perceived appreciation, schedule control, work environment diversity and inclusion) and self-compassion as attenuating the significant relationship between gender and burnout. Only perceived appreciation attenuated the significant relationship between gender and professional fulfillment. CONCLUSION: This study demonstrated higher rates of burnout and lower rates of professional fulfillment among female vs. male physician faculty. Culture of wellness factors and self-compassion may contribute to gender differences in burnout and professional fulfillment and potentially represent modifiable targets for efforts seeking to eliminate gender disparities in physicians' workplace experiences.

The Burden of Opioid-Related Adverse Drug Events on Hospitalized Previously Opioid-Free Surgical Patients.

OBJECTIVE: Opioid analgesics are a mainstay for acute pain management, but postoperative opioid administration has risks. We examined the prevalence, risk factors, and consequences of opioid-related adverse drug events (ORADEs) in a previously opioid-free surgical population. METHODS: A retrospective, observational, cohort study using administrative, billing, clinical, and medication administration data from two hospitals. Data were collected for all adult patients who were opioid-free at admission, underwent surgery between October 1, 2015, and September 30, 2016, and received postoperative opioids. Potential ORADEs were determined based on inpatient billing codes or postoperative administration of naloxone. We determined independent predictors of ORADE development using multivariable logistic regression. We measured adjusted inpatient mortality, hospital costs, length of hospital stay, discharge destination, and readmission within 30 days for patients with and without ORADEs. RESULTS: Among 13,389 hospitalizations where opioid-free patients had a single qualifying surgery, 12,218 (91%) received postoperative opioids and comprised the study cohort. Of these, we identified 1111 (9.1%) with a potential ORADE. Independent predictors of ORADEs included older age, several markers of disease severity, longer surgeries, and concurrent benzodiazepine use. Opioid-related adverse drug events were strongly associated with the route and duration of opioids administered postoperatively: 18% increased odds per day on intravenous opioids. In analyses adjusted for several covariates, presence of an ORADE was associated with 32% higher costs of hospitalization, 45% longer postoperative length of stay, 36% lower odds of discharge home, and 2.2 times the odds of death. CONCLUSIONS: We demonstrate a high rate and severe consequences of potential ORADEs in previously opioid-free patients receiving postoperative opioids. Knowledge of risk factors and predictors of ORADEs can help develop targeted interventions to minimize the development of these potentially dangerous and costly events.

Does adherence to evidence-based practices during childbirth prevent perinatal mortality? A post-hoc analysis of 3,274 births in Uttar Pradesh, India.

BACKGROUND: Evidence-based practices that reduce childbirth-related morbidity and mortality are core processes to quality of care. In the BetterBirth trial, a matched-pair, cluster-randomised controlled trial of a coaching-based implementation of the WHO Safe Childbirth Checklist (SCC) in Uttar Pradesh, India, we observed a significant increase in adherence to practices, but no reduction in perinatal mortality. METHODS: Within the BetterBirth trial, we observed birth attendants in a subset of study sites providing care to labouring women to assess the adherence to individual and groups of practices. We observed care from admission to the facility until 1 hour post partum. We followed observed women/newborns for 7-day perinatal health outcomes. Using this observational data, we conducted a post-hoc, exploratory analysis to understand the relationship of birth attendants' practice adherence to perinatal mortality. FINDINGS: Across 30 primary health facilities, we observed 3274 deliveries and obtained 7-day health outcomes. Adherence to individual practices, containing supply preparation and direct provider care, varied widely (0·51 to 99·78%). We recorded 166 perinatal deaths (50·71 per 1000 births), including 56 (17·1 per 1000) stillbirths. Each additional practice performed was significantly associated with reduced odds of perinatal (OR: 0·82, 95% CI: 0·72, 0·93) and early neonatal mortality (OR: 0·78, 95% CI: 0·71, 0·85). Each additional practice as part of direct provider care was associated strongly with reduced odds of perinatal (OR: 0·73, 95% CI: 0·62, 0·86) and early neonatal mortality (OR: 0·67, 95% CI: 0·56, 0·80). No individual practice or single supply preparation was associated with perinatal mortality. INTERPRETATION: Adherence to practices on the WHO SCC is associated with reduced mortality, indicating that adherence is a valid indicator of higher quality of care. However, the causal relationships between practices and outcomes are complex. FUNDING: Bill & Melinda Gates Foundation. TRIAL REGISTRATION DETAILS: ClinicalTrials.gov: NCT02148952; Universal Trial Number: U1111-1131-5647.

Measuring Goal-Concordant Care: Results and Reflections From Secondary Analysis of a Trial to Improve Serious Illness Communication.

CONTEXT: Many consider goal-concordant care (GCC) to be the most important of advance care planning and palliative care. Researchers face significant challenges in attempting to measure this outcome. We conducted a randomized controlled trial to assess the effects of a system-level intervention to improve serious illness communication on GCC and other outcomes. OBJECTIVES: To describe our measurement approach to GCC, present findings from a post-hoc analysis of trial data, and discuss lessons learned about measuring GCC. METHODS: Using trial data collected to measure GCC, we analyzed ratings and rankings from a nonvalidated survey of patient priorities in the setting of advanced cancer, the Life Priorities Scale, and compared outcomes with correlative measures. RESULTS: Participants commonly rated several predetermined and literature-derived priorities as important but did so in ways that were commonly incongruent with rankings. Ratings were frequently stable over time; rankings less so. Rankings are more likely to help assess the degree to which care is goal concordant but may be best augmented by corollary measures that signal achievement of a given priority. CONCLUSION: Measuring GCC remains a fundamental challenge to palliative care researchers. Ratings attest to the fact that many things matter to patients; however, rankings can better determine what matters most. Insights gained from our experience may guide future research aiming to use this outcome to assess the effect of intervention to improve serious illness care.

Patient and clinician experience of a serious illness conversation guide in oncology: A descriptive analysis.

BACKGROUND/OBJECTIVE: Oncology guidelines recommend earlier communication with patients about prognosis and goals-of-care in serious illness. However, current evidence leaves gaps in our understanding of the experience of these conversations. This analysis evaluates the patient and clinician experience of a conversation using a Serious Illness Conversation Guide (SICG). DESIGN/SETTING: Secondary analysis from a cluster-randomized clinical trial in a northeastern cancer center. PARTICIPANTS: Physicians, advanced practice clinicians, and patients with advanced cancer who received the intervention. INTERVENTION: SICG, clinician training, systems-changes. MAIN OUTCOMES AND MEASURES: The patient questionnaire assessed perceptions of the conversation and impact on anxiety, hopefulness, peacefulness, sense of control over medical decisions, closeness with their clinician, and behaviors. The clinician questionnaire assessed feasibility, acceptability, and impact on satisfaction in their role. RESULTS: We enrolled 54 clinicians and 163 patients; 41 clinicians and 118 patients had a SICG discussion. Most patients described the conversation as worthwhile (79%) and reported no change or improvement in their sense of peacefulness, hopefulness, and anxiety (on average 79%); 56% reported feeling closer with their clinician. Qualitative patient data described positive behavior changes, including enhanced planning for future care and increased focus on personal priorities. Nearly 90% of clinicians agreed that the SICG facilitated timely, effective conversations, and 70% reported increased satisfaction in their role. CONCLUSION: Conversations using a SICG were feasible, acceptable, and were associated with positive experiences for both patients and clinicians in oncology in ways that align with national recommendations for serious illness communication. This trial is registered at ClinicalTrials.gov: NCT01786811 https://clinicaltrials.gov/ct2/show/NCT01786811.

Effect of a Mammography Screening Decision Aid for Women 75 Years and Older: A Cluster Randomized Clinical Trial.

Importance: Guidelines recommend that women 75 years and older be informed of the benefits and harms of mammography before screening. Objective: To test the effects of receipt of a paper-based mammography screening decision aid (DA) for women 75 years and older on their screening decisions. Design, Setting, and Participants: A cluster randomized clinical trial with clinician as the unit of randomization. All analyses were completed on an intent-to-treat basis. The setting was 11 primary care practices in Massachusetts or North Carolina. Of 1247 eligible women reached, 546 aged 75 to 89 years without breast cancer or dementia who had a mammogram within 24 months but not within 6 months and saw 1 of 137 clinicians (herein referred to as PCPs) from November 3, 2014, to January 26, 2017, participated. A research assistant (RA) administered a previsit questionnaire on each participant's health, breast cancer risk factors, sociodemographic characteristics, and screening intentions. After the visit, the RA administered a postvisit questionnaire on screening intentions and knowledge. Interventions: Receipt of the DA (DA arm) or a home safety (HS) pamphlet (control arm) before a PCP visit. Main Outcomes and Measures: Participants were followed up for 18 months for receipt of mammography screening (primary outcome). To examine the effects of the DA, marginal logistic regression models were fit using generalized estimating equations to allow for clustering by PCP. Adjusted probabilities and risk differences were estimated to account for clustering by PCP. Results: Of 546 women in the study, 283 (51.8%) received the DA. Patients in each arm were well matched; their mean (SD) age was 79.8 (3.7) years, 428 (78.4%) were non-Hispanic white, 321 (of 543 [59.1%]) had completed college, and 192 (35.2%) had less than a 10-year life expectancy. After 18 months, 9.1% (95% CI, 1.2%-16.9%) fewer women in the DA arm than in the control arm had undergone mammography screening (51.3% vs 60.4%; adjusted risk ratio, 0.84; 95% CI, 0.75-0.95; P = .006). Women in the DA arm were more likely than those in the control arm to rate their screening intentions lower from previsit to postvisit (69 of 283 [adjusted %, 24.5%] vs 47 of 263 [adjusted %, 15.3%]), to be more knowledgeable about the benefits and harms of screening (86 [adjusted %, 25.5%] vs 32 [adjusted %, 11.7%]), and to have a documented discussion about mammography with their PCP (146 [adjusted %, 47.4%] vs 111 [adjusted %, 38.9%]). Almost all women in the DA arm (94.9%) would recommend the DA. Conclusions and Relevance: Providing women 75 years and older with a mammography screening DA before a PCP visit helps them make more informed screening decisions and leads to fewer women choosing to be screened, suggesting that the DA may help reduce overscreening. Trial Registration: ClinicalTrials.gov Identifier: NCT02198690.

Nurses' and auxiliary nurse midwives' adherence to essential birth practices with peer coaching in Uttar Pradesh, India: a secondary analysis of the BetterBirth trial.

BACKGROUND: The BetterBirth trial tested the effect of a peer coaching program around the WHO Safe Childbirth Checklist for birth attendants in primary-level facilities in Uttar Pradesh, India on a composite measure of perinatal and maternal mortality and maternal morbidity. This study aimed to examine the adherence to essential birth practices between two different cadres of birth attendants-nurses and auxiliary nurse midwives (ANMs)-during and after a peer coaching intervention for the WHO Safe Childbirth Checklist. METHODS: This is a secondary analysis of birth attendant characteristics, coaching visits, and behavior uptake during the BetterBirth trial through birth attendant surveys, coach observations, and independent observations. Descriptive statistics were calculated overall, and by staffing cadre (staff nurses and ANMs) for demographic characteristics. Logistic regression using the Pearson overdispersion correction (to account for clustering by site) was used to assess differences between staff nurses and ANMs in the intervention group during regular coaching (2-month time point) and 4 months after the coaching program ended (12-month time point). RESULTS: Of the 570 birth attendants who responded to the survey in intervention and control arms, 474 were staff nurses (83.2%) and 96 were ANMs (16.8%). In the intervention arm, more staff nurses (240/260, 92.3%) received coaching at all pause points compared to ANMs (40/53, 75.5%). At baseline, adherence to practices was similar between ANMs and staff nurses (~ 30%). Overall percent adherence to essential birth practices among ANMs and nurses was highest at 2 months after intervention initiation, when frequent coaching visits occurred (68.1% and 64.1%, respectively, p = 0.76). Practice adherence tapered to 49.2% among ANMs and 56.1% among staff nurses at 12 months, which was 4 months after coaching had ended (p = 0.68). CONCLUSIONS: Overall, ANMs and nurses responded similarly to the coaching intervention with the greatest increase in percent adherence to essential birth practices after 2 months of coaching and subsequent decrease in adherence 4 months after coaching ended. While coaching is an effective strategy to support some aspects of birth attendant competency, the structure, content, and frequency of coaching may need to be customized according to the birth attendant training and competency. TRIAL REGISTRATION: ClinicalTrials.gov: NCT2148952; Universal Trial Number: U1111-1131-5647.

Evaluating an Intervention to Improve Communication Between Oncology Clinicians and Patients With Life-Limiting Cancer: A Cluster Randomized Clinical Trial of the Serious Illness Care Program.

IMPORTANCE: Earlier clinician-patient conversations about patients' values, goals, and preferences in serious illness (ie, serious illness conversations) are associated with better outcomes but occur inconsistently in cancer care. OBJECTIVE: To evaluate the efficacy of a communication quality-improvement intervention in improving the occurrence, timing, quality, and accessibility of documented serious illness conversations between oncology clinicians and patients with advanced cancer. DESIGN, SETTING, PARTICIPANTS: This cluster randomized clinical trial in outpatient oncology was conducted at the Dana-Farber Cancer Institute and included physicians, advanced-practice clinicians, and patients with cancer who were at high risk of death. MAIN OUTCOMES AND MEASURES: The primary outcomes (goal-concordant care and peacefulness at the end of life) are published elsewhere. Secondary outcomes are reported herein, including (1) documentation of at least 1 serious illness conversation before death, (2) timing of the initial conversation before death, (3) quality of conversations, and (4) their accessibility in the electronic medical record (EMR). RESULTS: We enrolled 91 clinicians (48 intervention, 43 control) and 278 patients (134 intervention, 144 control). Of enrolled patients, 58% died during the study (n=161); mean age was 62.3 years (95% CI, 58.9-65.6 years); 55% were women (n=88). These patients were cared for by 76 of the 91 enrolled clinicians (37 intervention, 39 control); years in practice, 11.5 (95% CI, 9.2-13.8); 57% female (n=43). Medical record review after patients' death demonstrated that a significantly higher proportion of intervention patients had a documented discussion compared with controls (96% vs 79%, P = .005) and intervention conversations occurred a median of 2.4 months earlier (median, 143 days vs 71 days, P < .001). Conversation documentation for intervention patients was significantly more comprehensive and patient centered, with a greater focus on values or goals (89% vs 44%, P < .001), prognosis or illness understanding (91% vs 48%, P < .001), and life-sustaining treatment preferences (63% vs 32%, P = .004). Documentation about end-of-life care planning did not differ between arms (80% intervention vs 68% control, P = .08). Significantly more intervention patients had documentation that was accessible in the EMR (61% vs 11%, P < .001). CONCLUSIONS AND RELEVANCE: This communication quality-improvement intervention resulted in more, earlier, better, and more accessible serious illness conversations documented in the EMR. To our knowledge, this is the first such study to demonstrate improvement in all 4 of these outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01786811.

Effect of the Serious Illness Care Program in Outpatient Oncology: A Cluster Randomized Clinical Trial.

Importance: High-quality conversations between clinicians and seriously ill patients about values and goals are associated with improved outcomes but occur infrequently. Objective: To examine feasibility, acceptability, and effect of a communication quality-improvement intervention (Serious Illness Care Program) on patient outcomes. Design, Setting, and Participants: A cluster randomized clinical trial of the Serious Illness Care Program in an outpatient oncology setting was conducted. Patients with advanced cancer (n = 278) and oncology clinicians (n = 91) participated between September 1, 2012, and June 30, 2016. Data analysis was performed from September 1, 2016, to December 27, 2018. All analyses were conducted based on intention to treat. Interventions: Tools, training, and system changes. Main Outcomes and Measures: The coprimary outcomes included goal-concordant care (Life Priorities) and peacefulness (Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire) at the end of life. Secondary outcomes included therapeutic alliance (Human Connection Scale), anxiety (Generalized Anxiety Disorder 7 scale), depression (Patient Health Questionnaire 9), and survival. Uptake and effectiveness of clinician training, clinician use of the conversation tool, and conversation duration were evaluated. Results: Data from 91 clinicians in 41 clusters (72.9% participation; intervention, n = 48; control, n = 43; 52 [57.1%] women) and 278 patients (45.8% participation; intervention, n = 134; control, n = 144; 148 [53.2%] women) were analyzed. Forty-seven clinicians (97.9%) rated the training as effective (mean [SD] score, 4.3 [0.7] of 5.0 possible); of 39 who received a reminder, 34 (87.2%) completed at least 1 conversation (median duration, 19 minutes; range, 5-70). Peacefulness, therapeutic alliance, anxiety, and depression did not differ at baseline. The coprimary outcomes were evaluated in 64 patients; no significant differences were found between the intervention and control groups. However, the trial demonstrated significant reductions in the proportion of patients with moderate to severe anxiety (10.2% vs 5.0%; P = .05) and depression symptoms (20.8% vs 10.6%; P = .04) in the intervention group at 14 weeks after baseline. Anxiety reduction was sustained at 24 weeks (10.4% vs 4.2%; P = .02), but depression reduction was not sustained (17.8% vs 12.5%; P = .31). Survival and therapeutic alliance did not differ between groups. Conclusions and Relevance: The results of this cluster randomized clinical trial were null with respect to the coprimary outcomes of goal-concordant care and peacefulness at the end of life. Methodologic challenges for the primary outcomes, including measure selection and sample size, limit the conclusions that can be drawn from the study. However, the significant reductions in anxiety and depression in the intervention group are clinically meaningful and require further study. Trial Registration: ClinicalTrials.gov identifier: NCT01786811.

Availability of Safe Childbirth Supplies in 284 Facilities in Uttar Pradesh, India.

Objectives Vital to implementation of the World Health Organization (WHO) Safe Childbirth Checklist (SCC), designed to improve delivery of 28 essential birth practices (EBPs), is the availability of safe birth supplies: 22 EBPs on the SCC require one or more supplies. Mapping availability of these supplies can determine the scope of shortages and need for supply chain strengthening. Methods A cross-sectional survey on the availability of functional and/or unexpired supplies was assessed in 284 public-sector facilities in 38 districts in Uttar Pradesh, India. The twenty-three supplies were categorized into three non-mutually exclusive groups: maternal (8), newborn (9), and infection control (6). Proportions and mean number of supplies available were calculated; means were compared across facility types using t-tests and across districts using a one-way ANOVA. Log-linear regression was used to evaluate facility characteristics associated with supply availability. Results Across 284 sites, an average of 16.9 (73.5%) of 23 basic childbirth supplies were available: 63.4% of maternal supplies, 79.1% of newborn supplies, and 78.7% of infection control supplies. No facility had all 23 supplies available and only 8.5% had all four medicines assessed. Significant variability was observed by facility type and district. In the linear model, facility type and distance from district hospital were significant predictors of higher supply availability. Conclusions for Practice In Uttar Pradesh, more remote sites, and primary and community health centers, were at higher risk of supply shortages. Supply chain management must be improved for facility-based delivery and quality of care initiatives to reduce maternal and neonatal harm.

Factors associated with the use of cognitive aids in operating room crises: a cross-sectional study of US hospitals and ambulatory surgical centers.

BACKGROUND: Operating room (OR) crises are high-acuity events requiring rapid, coordinated management. Medical judgment and decision-making can be compromised in stressful situations, and clinicians may not experience a crisis for many years. A cognitive aid (e.g., checklist) for the most common types of crises in the OR may improve management during unexpected and rare events. While implementation strategies for innovations such as cognitive aids for routine use are becoming better understood, cognitive aids that are rarely used are not yet well understood. We examined organizational context and implementation process factors influencing the use of cognitive aids for OR crises. METHODS: We conducted a cross-sectional study using a Web-based survey of individuals who had downloaded OR cognitive aids from the websites of Ariadne Labs or Stanford University between January 2013 and January 2016. In this paper, we report on the experience of 368 respondents from US hospitals and ambulatory surgical centers. We analyzed the relationship of more successful implementation (measured as reported regular cognitive aid use during applicable clinical events) with organizational context and with participation in a multi-step implementation process. We used multivariable logistic regression to identify significant predictors of reported, regular OR cognitive aid use during OR crises. RESULTS: In the multivariable logistic regression, small facility size was associated with a fourfold increase in the odds of a facility reporting more successful implementation (p = 0.0092). Completing more implementation steps was also significantly associated with more successful implementation; each implementation step completed was associated with just over 50% higher odds of more successful implementation (p ≤ 0.0001). More successful implementation was associated with leadership support (p < 0.0001) and dedicated time to train staff (p = 0.0189). Less successful implementation was associated with resistance among clinical providers to using cognitive aids (p < 0.0001), absence of an implementation champion (p = 0.0126), and unsatisfactory content or design of the cognitive aid (p = 0.0112). CONCLUSIONS: Successful implementation of cognitive aids in ORs was associated with a supportive organizational context and following a multi-step implementation process. Building strong organizational support and following a well-planned multi-step implementation process will likely increase the use of OR cognitive aids during intraoperative crises, which may improve patient outcomes.

Mortality Trends After a Voluntary Checklist-based Surgical Safety Collaborative.

OBJECTIVE: To determine whether completion of a voluntary, checklist-based surgical quality improvement program is associated with reduced 30-day postoperative mortality. BACKGROUND: Despite evidence of efficacy of team-based surgical safety checklists in improving perioperative outcomes in research trials, effective methods of population-based implementation have been lacking. The Safe Surgery 2015 South Carolina program was designed to foster state-wide engagement of hospitals in a voluntary, collaborative implementation of a checklist program. METHODS: We compared postoperative mortality rates after inpatient surgery in South Carolina utilizing state-wide all-payer discharge claims from 2008 to 2013, linked with state vital statistics, stratifying hospitals on the basis of completion of the checklist program. Changes in risk-adjusted 30-day mortality were compared between hospitals, using propensity score-adjusted difference-in-differences analysis. RESULTS: Fourteen hospitals completed the program by December 2013. Before program launch, there was no difference in mortality trends between the completion cohort and all others (P = 0.33), but postoperative mortality diverged thereafter (P = 0.021). Risk-adjusted 30-day mortality among completers was 3.38% in 2010 and 2.84% in 2013 (P < 0.00001), whereas mortality among other hospitals (n = 44) was 3.50% in 2010 and 3.71% in 2013 (P = 0.3281), reflecting a 22% difference between the groups on difference-in-differences analysis (P = 0.0021). CONCLUSIONS: Despite similar pre-existing rates and trends of postoperative mortality, hospitals in South Carolina completing a voluntary checklist-based surgical quality improvement program had a reduction in deaths after inpatient surgery over the first 3 years of the collaborative compared with other hospitals in the state. This may indicate that effective large-scale implementation of a team-based surgical safety checklist is feasible.

Perception of Safety of Surgical Practice Among Operating Room Personnel From Survey Data Is Associated With All-cause 30-day Postoperative Death Rate in South Carolina.

OBJECTIVE: To evaluate whether the perception of safety of surgical practice among operating room (OR) personnel is associated with hospital-level 30-day postoperative death. BACKGROUND: The relationship between improvements in the safety of surgical practice and benefits to postoperative outcomes has not been demonstrated empirically. METHODS: As part of the Safe Surgery 2015: South Carolina initiative, a baseline survey measuring the perception of safety of surgical practice among OR personnel was completed. We evaluated the relationship between hospital-level mean item survey scores and rates of all-cause 30-day postoperative death using binomial regression. Models were controlled for multiple patient, hospital, and procedure covariates using supervised principal components regression. RESULTS: The overall survey response rate was 38.1% (1793/4707) among 31 hospitals. For every 1 point increase in the hospital-level mean score for respect [adjusted relative risk (aRR) 0.78, 95% CI 0.65-0.93, P = 0.0059], clinical leadership (aRR 0.86, 95% CI 0.74-0.9932, P = 0.0401), and assertiveness (aRR 0.71, 95% CI 0.54-0.93, P = 0.01) among all survey respondents, there were associated decreases in the hospital-level 30-day postoperative death rate after inpatient surgery ranging from 14% to 29%. Higher hospital-level mean scores for the statement, "I would feel safe being treated here as a patient," were associated with significantly lower hospital-level 30-day postoperative death rates (aRR 0.83, 95% CI 0.70-0.97, P = 0.02). Although most findings seen among all OR personnel were seen among nurses, they were often absent among surgeons. CONCLUSIONS: Perception of OR safety of surgical practice was associated with hospital-level 30-day postoperative death rates.