Attitudes of Clinicians and Patient Safety Culture Before and After the ARRIVE Trial.

OBJECTIVE: To assess the attitudes of intrapartum clinicians about elective induction of labor before and after A Randomized Trial of Induction Versus Expectant Management (ARRIVE) and to assess the effect of different attitudes on patient safety culture. DESIGN: Repeated cross-sectional design. SETTING: Online surveys. PARTICIPANTS: Clinicians (883 nurses and 201 physicians in the before-ARRIVE group and 1,741 nurses and 574 physicians in the after-ARRIVE group) who provided intrapartum care at 35 hospitals in California in 2017 and 57 hospitals in Michigan in 2020 and participated in statewide quality improvement efforts to reduce use of cesarean. METHODS: We used annual nulliparous, term, singleton, vertex cesarean rates to stratify hospitals into performance quartiles. We used cumulative proportional odds logistic regression to examine induction attitudes before and after ARRIVE by role and hospital performance quartile as well as induction attitudes and patient safety culture among clinicians. We used content analysis to examine qualitative data. RESULTS: After ARRIVE, physicians' attitudes shifted in favor of induction at hospitals within the top three performance categories (top quartile: M = 3.48 vs. 2.81, p < .0001), whereas nurses' attitudes did not change (p = .388). After ARRIVE, attitudes among clinicians were more aligned at hospitals with stronger patient safety cultures. Qualitative themes included The Timing of Induction is Important, Who Should Have Inductions, Need for Clear Protocols and More Staff, and Ideas to Improve the Induction of Labor Process. CONCLUSION: Physician attitudes about induction were significantly different before versus after ARRIVE, whereas nurse attitudes were not. Differences in attitudes may erode the quality of team-based care; intentional interdisciplinary engagement is essential when implementing ARRIVE findings.

Continuous Remote Patient Monitoring in Patients With Heart Failure (Cascade Study): Protocol for a Mixed Methods Feasibility Study.

BACKGROUND: Heart failure (HF) is a prevalent chronic disease and is associated with increases in mortality and morbidity. HF is a leading cause of hospitalizations and readmissions in the United States. A potentially promising area for preventing HF readmissions is continuous remote patient monitoring (CRPM). OBJECTIVE: The primary aim of this study is to determine the feasibility and preliminary efficacy of a CRPM solution in patients with HF at NorthShore University HealthSystem. METHODS: This study is a feasibility study and uses a wearable biosensor to continuously remotely monitor patients with HF for 30 days after discharge. Eligible patients admitted with an HF exacerbation at NorthShore University HealthSystem are being recruited, and the wearable biosensor is placed before discharge. The biosensor collects physiological ambulatory data, which are analyzed for signs of patient deterioration. Participants are also completing a daily survey through a dedicated study smartphone. If prespecified criteria from the physiological data and survey results are met, a notification is triggered, and a predetermined electronic health record-based pathway of telephonic management is completed. In phase 1, which has already been completed, 5 patients were enrolled and monitored for 30 days after discharge. The results of phase 1 were analyzed, and modifications to the program were made to optimize it. After analysis of the phase 1 results, 15 patients are being enrolled for phase 2, which is a calibration and testing period to enable further adjustments to be made. After phase 2, we will enroll 45 patients for phase 3. The combined results of phases 1, 2, and 3 will be analyzed to determine the feasibility of a CRPM program in patients with HF. Semistructured interviews are being conducted with key stakeholders, including patients, and these results will be analyzed using the affective adaptation of the technology acceptance model. RESULTS: During phase 1, of the 5 patients, 2 (40%) were readmitted during the study period. The study completion rate for phase 1 was 80% (4/5), and the study attrition rate was 20% (1/5). There were 57 protocol deviations out of 150 patient days in phase 1 of the study. The results of phase 1 were analyzed, and the study protocol was adjusted to optimize it for phases 2 and 3. Phase 2 and phase 3 results will be available by the end of 2022. CONCLUSIONS: A CRPM program may offer a low-risk solution to improve care of patients with HF after hospital discharge and may help to decrease readmission of patients with HF to the hospital. This protocol may also lay the groundwork for the use of CRPM solutions in other groups of patients considered to be at high risk. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36741.

Facilitators of and Barriers to Successful Implementation of the One Key Question® Pregnancy Intention Screening Tool.

Background: One Key Question® (OKQ) is a tool that embeds a patient-centered screening into routine visits with the goal of making pregnancy intention screening universal, but widespread implementation has not yet been adopted. We aimed to explore the barriers and facilitators of OKQ implementation to better understand how to best implement the tool across different settings. Methods: We invited staff and clinicians from one obstetrics and gynecology clinic and one family medicine clinic, which previously implemented OKQ, to complete surveys and qualitative interviews about their experiences with the tool. The interview guide and thematic analysis of the interview transcripts were informed by the Consolidated Framework for Implementation Research (CFIR). Main Findings: Major facilitators of OKQ implementation are the simplicity of the tool, engagement of clinic leadership, and compatibility between the perceived goals of the tool and those of practice staff and clinicians. Although participants indicated that OKQ had a minimal impact on clinic workflow during its implementation, preimplementation time concerns were a major barrier to implementation in both clinics. Barriers seen in the family medicine practice included OKQ distracting from the visit agenda, and concerns about the OKQ gold standard protocol of screening each patient at every visit. Participants even suggested asking OKQ only during annual check-up appointments. Conclusions: The perceived alignment between the tool's goals and those of clinic stakeholders was an important facilitator of OKQ implementation success. However, characteristics of the clinic setting, such as competing medical priorities and time constraints, influenced initial attitudes toward the feasibility of the intervention. Clinical Trial Registration Number: NCT03947788.

Psychometric validation of a patient-reported experience measure of obstetric racism© (The PREM-OB Scale™ suite).

BACKGROUND: Perinatal quality improvement lacks valid tools to measure adverse hospital experiences disproportionately impacting Black mothers and birthing people. Measuring and mitigating harm requires using a framework that centers the lived experiences of Black birthing people in evaluating inequitable care, namely, obstetric racism. We sought to develop a valid patient-reported experience measure (PREM) of Obstetric Racism© in hospital-based intrapartum care designed for, by, and with Black women as patient, community, and content experts. METHODS: PROMIS© instrument development standards adapted with cultural rigor methodology. Phase 1 included item pool generation, modified Delphi method, and cognitive interviews. Phase 2 evaluated the item pool using factor analysis and item response theory. RESULTS: Items were identified or written to cover 7 previously identified theoretical domains. 806 Black mothers and birthing people completed the pilot test. Factor analysis concluded a 3 factor structure with good fit indices (CFI = 0.931-0.977, RMSEA = 0.087-0.10, R2  > .3, residual correlation < 0.15). All items in each factor fit the IRT model and were able to be calibrated. Factor 1, "Humanity," had 31 items measuring experiences of safety and accountability, autonomy, communication, and empathy. A 12-item short form was created to ease respondent burden. Factor 2, "Racism," had 12 items measuring experiences of neglect and mistreatment. Factor 3, "Kinship," had 7 items measuring hospital denial and disruption of relationships between Black mothers and their child or support system. CONCLUSIONS: The PREM-OB Scale™ suite is a valid tool to characterize and quantify obstetric racism for use in perinatal improvement initiatives.

Continuous Remote Patient Monitoring: Evaluation of the Heart Failure Cascade Soft Launch.

OBJECTIVE: We report on our experience of deploying a continuous remote patient monitoring (CRPM) study soft launch with structured cascading and escalation pathways on heart failure (HF) patients post-discharge. The lessons learned from the soft launch are used to modify and fine-tune the workflow process and study protocol. METHODS: This soft launch was conducted at NorthShore University HealthSystem's Evanston Hospital from December 2020 to March 2021. Patients were provided with non-invasive wearable biosensors that continuously collect ambulatory physiological data, and a study phone that collects patient-reported outcomes. The physiological data are analyzed by machine learning algorithms, potentially identifying physiological perturbation in HF patients. Alerts from this algorithm may be cascaded with other patient status data to inform home health nurses' (HHNs') management via a structured protocol. HHNs review the monitoring platform daily. If the patient's status meets specific criteria, HHNs perform assessments and escalate patient cases to the HF team for further guidance on early intervention. RESULTS: We enrolled five patients into the soft launch. Four participants adhered to study activities. Two out of five patients were readmitted, one due to HF, one due to infection. Observed miscommunication and protocol gaps were noted for protocol amendment. The study team adopted an organizational development method from change management theory to reconfigure the study protocol. CONCLUSION: We sought to automate the monitoring aspects of post-discharge care by aligning a new technology that generates streaming data from a wearable device with a complex, multi-provider workflow into a novel protocol using iterative design, implementation, and evaluation methods to monitor post-discharge HF patients. CRPM with structured escalation and telemonitoring protocol shows potential to maintain patients in their home environment and reduce HF-related readmissions. Our results suggest that further education to engage and empower frontline workers using advanced technology is essential to scale up the approach.

Culture That Facilitates Change: A Mixed Methods Study of Hospitals Engaged in Reducing Cesarean Deliveries.

PURPOSE: Large-scale efforts to reduce cesarean deliveries have shown varied levels of impact; yet understanding factors that contribute to hospitals' success are lacking. We aimed to characterize unit culture differences at hospitals that successfully reduced their cesarean rates compared with those that did not. METHODS: A mixed methods study of California hospitals participating in a statewide initiative to reduce cesarean delivery. Participants included nurses, obstetricians, family physicians, midwives, and anesthesiologists practicing at participating hospitals. Hospitals' net change in nulliparous, term, singleton, and vertex cesarean delivery rates classified them as successful if they achieved either a minimum 5 percentage point reduction or rate of fewer than 24%. The Labor Culture Survey was used to quantify differences in unit culture. Key informant interviews were used to explore quantitative findings and characterize additional cultural barriers and facilitators. RESULTS: Out of 55 hospitals, 37 (n = 840 clinicians) meeting inclusion criteria participated in the Labor Culture Survey. Physicians' individual attitudes differed by hospital success on 5 scales: best practices (P = .003), fear (P = .001), cesarean safety (P = .014), physician oversight (P <.001), and microculture (P = .044) scales. Patient ability to make informed decisions showed poor agreement across all hospitals, but was higher at successful hospitals (38% vs 29%, P = .01). Important qualitative themes included: ease of access to shared resources on best practices, fear of bad outcomes, personal resistance to change, collaborative practice and effective communication, leadership engagement, and cultural flexibility. CONCLUSIONS: Successful hospitals' culture and context was measurably different from nonresponders. Leveraging these contextual factors may facilitate success.

Effects of clinic-level implementation of One Key Question® on reproductive health counseling and patient satisfaction.

OBJECTIVE: We evaluated the effect of clinic level implementation of the One Key Question (OKQ) intervention, including physician and staff training and workflow adjustments, on reproductive counseling and patient satisfaction in primary care and ob/gyn. STUDY DESIGN: We implemented the OKQ intervention in one primary care and one ob/gyn practice, while observing another primary care and ob/gyn practice that each provided usual care (control practices). We surveyed separate patient cohorts at two time points: 26 before and 33 after the primary care practice implemented OKQ, 38 before and 36 after the ob/gyn practice implemented OKQ, 26 and 37 at the primary care control practice, and 31 and 37 at the ob/gyn control practice. We used chi square tests to assess OKQ's effects on counseling rates and patient satisfaction, comparing intervention to control practices across time points. RESULTS: In primary care, from before to after implementation, the intervention practice did not significantly increase reproductive counseling (69-76%, p = 0.58), but increased patient satisfaction (81-97%, p = 0.04) while the control practice demonstrated a decrease in patient satisfaction over the same time periods. In the ob/gyn clinics, no significant change in reproductive counseling or patient satisfaction was seen in the intervention practice, while the control practice demonstrated a decrease in patient satisfaction. CONCLUSIONS: Implementing OKQ appears to increase patient satisfaction. Larger studies are needed to assess whether this clinic-level intervention may increase reproductive counseling. IMPLICATIONS: Further studies of the impact of clinic-level implementation of OKQ are needed.

One Key Question® and the Desire to Avoid Pregnancy Scale: A comparison of two approaches to asking about pregnancy preferences.

OBJECTIVE: To facilitate assessment of patients' pregnancy preferences, we compared responses to One Key Question® with the validated Desire to Avoid Pregnancy (DAP) scale and assessed their relationships to patient-reported reproductive health behaviors. METHODS: In this after-visit survey in primary care and obstetrics-gynecology practices, women ages 18-49 (n = 177) answered "Would you like to become pregnant in the next year?" and the 14-item DAP scale. We performed one-way ANOVA to compare DAP scores (0-4 scale, 4 = highest preference to avoid pregnancy) across One Key Question® responses ("Yes," "Unsure," "Ok either way," "No but sometime in the future," "No never"). We used logistic regression to test association of One Key Question® and DAP with contraceptive and folic acid use. RESULTS: Most patients did not want to become pregnant in the next year, based on One Key Question® (7% "Yes," 4% "Unsure," 11% "Ok either way," 53% "In the future," 25% "Never"). The mean DAP score overall was 2.52 (SD = 1.03, Range: 0-4, Cronbach's α = 0.96). Scores differed by One Key Question® response ("Yes" mean DAP = 0.84, "Unsure" 1.64, "Ok" 1.42, "In the future" 2.94, "Never" 2.78, p < 0.001) yet varied markedly within each One Key Question® response group. Contraceptive use was lower among those who answered "Yes" (46%; OR = 0.14, 95% CI 0.04-0.48) vs. "No, future" (86%). Similarly, odds of contraceptive use increased with DAP score (OR = 1.69, 9% CI 1.18-2.42; predicted 51% for DAP = 0, 90% for DAP = 4). CONCLUSION: One Key Question® responses correlate with DAP scores, and contraceptive use correlates with not desiring pregnancy by both approaches. IMPLICATIONS STATEMENT: One Key Question® and the Desire to Avoid Pregnancy scale can both identify women wishing to avoid pregnancy to help clinicians address patients' contraceptive needs. Given the range of preferences associated with One Key Question® responses, clinicians who use it should proceed with further discussion to fully understand patients' feelings.

Cesarean overuse and the culture of care.

OBJECTIVE: To assess hospital unit culture and clinician attitudes associated with varying rates of primary cesarean delivery. DATA SOURCES/STUDY SETTING: Intrapartum nurses, midwives, and physicians recruited from 79 hospitals in California participating in efforts to reduce cesarean overuse. STUDY DESIGN: Labor unit culture and clinician attitudes measured using a survey were linked to the California Maternal Data Center for birth outcomes and hospital covariates. METHODS: Association with primary cesarean delivery rates was assessed using multivariate Poisson regression adjusted for hospital covariates. PRINCIPAL FINDINGS: 1718 respondents from 70 hospitals responded to the Labor Culture Survey. The "Unit Microculture" subscale was strongly associated with primary cesarean rate; the higher a unit scored on 8-items describing a culture supportive of vaginal birth (eg, nurses are encouraged to spend time in rooms with patients, and doulas are welcomed), the cesarean rate decreased by 41 percent (95% CI = -47 to -35 percent, P < 0.001). Discordant attitudes between nurses and physicians were associated with increased cesarean rates. CONCLUSIONS: Hospital unit culture, clinician attitudes, and consistency between professions are strongly associated with primary cesarean rates. Improvement efforts to reduce cesarean overuse must address culture of care as a key part of the change process.

Measuring labor and delivery unit culture and clinicians' attitudes toward birth: Revision and validation of the Labor Culture Survey.

BACKGROUND: Cesarean delivery rates in the United States vary widely between hospitals, which cannot be fully explained by hospital or patient factors. Cultural factors are hypothesized to play a role in cesarean overuse, yet tools to measure labor culture are lacking. The aim of this study was to revise and validate a survey tool to measure hospital culture specific to cesarean overuse. METHODS: A panel of clinicians and researchers compiled an item bank from validated surveys, added newly created items, and performed four rounds of iterative revision and consolidation. Obstetricians, family physicians, midwives, anesthesiologists, and labor nurses were recruited from 79 hospitals in California. Exploratory factor analysis was used to reduce the number of survey items and identify latent constructs to form the basis of subscales. Confirmatory factor analysis examined reliability in 31 additional hospitals. Poisson regression assessed associations between hospitals' mean score on each individual item and cesarean rates. RESULTS: A total of 1718 individuals from 70 hospitals were included in the exploratory factor analysis. The final Labor Culture Survey (LCS) consisted of 29 items and six subscales: "Best Practices to Reduce Cesarean Overuse," "Fear of Vaginal Birth," "Unit Microculture," "Physician Oversight," "Maternal Agency," and "Cesarean Safety." CONCLUSIONS: The revised LCS is a valid and reliable tool to measure constructs shown to be associated with cesarean rates. These findings support prior research that has shown that hospital culture is measurable, and that clinician attitudes are predictive of clinician behaviors. Unique to our survey is the construct of labor and delivery unit microculture.

Do provider birth attitudes influence cesarean delivery rate: a cross-sectional study.

BACKGROUND: When used judiciously, cesarean sections can save lives; but in the United States, prior research indicates that cesarean birth rates have risen beyond the threshold to help women and infants and become a contributor to increased maternal mortality and rising healthcare costs. Healthy People 2020 has set the goal for nulliparous, term, singleton, vertex (NTSV) cesarean birth rate at no more than 23.9% of births. Currently, cesarean rates vary from 6% to 69% in US hospitals, unexplained by clinical or demographic factors. This wide variation in cesarean use is also seen among individual providers of intrapartum care. Previous research of birth attitudes found providers of intrapartum care hold widely differing views, which may be a key underlying factor influencing practice variation; however, further study is needed to determine if differences in attitudes are associated with differences in clinical outcomes. The purpose of this study was to estimate the association between individual provider attitudes towards birth and their low-risk primary cesarean rate. METHODS: Four hundred providers were drawn from a stratified random sample of all California providers of intrapartum care in 2013 and surveyed for their attitudes towards various aspects of labor and birth. Providers' NTSV cesarean birth rates were obtained for 2013 and 2014. Covariates included gender, years of experience, practice location, and primary hospital's NTSV cesarean rate. We used adjusted multivariate Poisson regression to compare cesarean rates and linear regression to compare attitude scores of providers meeting versus not meeting the Healthy People 2020 (HP2020) goal. RESULTS: Two hundred nine total participants (obstetricians, family physicians, and midwives) completed surveys, of which 109 perform cesareans. Providers' NTSV cesarean rate was significantly associated with their composite attitudes score [IRR for each one-point increase 1.21 (95% CI 1.002-1.45)]. Physicians meeting the HP2020 goal held attitudes which were significantly more favorable towards vaginal birth: mean 2.70 (95% CI 2.58-2.83) versus 2.91 (95% CI 2.82-3.00), p < 0.01. CONCLUSIONS: Provider attitudinal differences are associated with NTSV cesarean rates. Those meeting the HP2020 goal hold attitudes more favorable towards vaginal birth. These findings may present a modifiable target for quality improvement initiatives to decrease low risk primary cesareans.

Incidence and Predictors of Repeat Bone Mineral Densitometry: A Longitudinal Cohort Study.

BACKGROUND: Existing guidelines for repeat screening and treatment monitoring intervals regarding the use of dual-energy x-ray absorptiometry (DXA) scans are conflicting or lacking. The Choosing Wisely campaign recommends against repeating DXA scans within 2 years of initial screening. It is unclear how frequently physicians order repeat scans and what clinical factors contribute to their use. OBJECTIVE: To estimate cumulative incidence and predictors of repeat DXA for screening or treatment monitoring in a regional health system. DESIGN: Retrospective longitudinal cohort study PARTICIPANTS: A total of 5992 women aged 40-84 years who received initial DXA screening from 2006 to 2011 within a regional health system in Sacramento, CA. MAIN MEASURES: Two- and five-year cumulative incidence and hazard rations (HR) of repeat DXA by initial screening result (classified into three groups: low or high risk of progression to osteoporosis, or osteoporosis) and whether women were prescribed osteoporosis drugs after initial DXA. KEY RESULTS: Among women not treated after initial DXA, 2-year cumulative incidence for low-risk, high-risk, and osteoporotic women was 8.0%, 13.8%, and 19.6%, respectively, increasing to 42.9%, 60.4%, and 57.4% by 5 years after initial screening. For treated women, median time to repeat DXA was over 3 years for all groups. Relative to women with low-risk initial DXA, high-risk initial DXA significantly predicted repeat screening for untreated women [adjusted HR 1.67 (95% CI 1.40-2.00)] but not within the treated group [HR 1.09 (95% CI 0.91-1.30)]. CONCLUSIONS: Repeat DXA screening was common in women both at low and high risk of progression to osteoporosis, with a substantial proportion of women receiving repeat scans within 2 years of initial screening. Conversely, only 60% of those at high-risk of progression to osteoporosis were re-screened within 5 years. Interventions are needed to help clinicians make higher-value decisions regarding repeat use of DXA scans.