Implementing a Family-Centered Rounds Intervention Using Novel Mentor-Trios.

BACKGROUND AND OBJECTIVES: Patient and Family Centered I-PASS (PFC I-PASS) emphasizes family and nurse engagement, health literacy, and structured communication on family-centered rounds organized around the I-PASS framework (Illness severity-Patient summary-Action items-Situational awareness-Synthesis by receiver). We assessed adherence, safety, and experience after implementing PFC I-PASS using a novel "Mentor-Trio" implementation approach with multidisciplinary parent-nurse-physician teams coaching sites. METHODS: Hybrid Type II effectiveness-implementation study from 2/29/19-3/13/22 with ≥3 months of baseline and 12 months of postimplementation data collection/site across 21 US community and tertiary pediatric teaching hospitals. We conducted rounds observations and surveyed nurses, physicians, and Arabic/Chinese/English/Spanish-speaking patients/parents. RESULTS: We conducted 4557 rounds observations and received 2285 patient/family, 1240 resident, 819 nurse, and 378 attending surveys. Adherence to all I-PASS components, bedside rounding, written rounds summaries, family and nurse engagement, and plain language improved post-implementation (13.0%-60.8% absolute increase by item), all P < .05. Except for written summary, improvements sustained 12 months post-implementation. Resident-reported harms/1000-resident-days were unchanged overall but decreased in larger hospitals (116.9 to 86.3 to 72.3 pre versus early- versus late-implementation, P = .006), hospitals with greater nurse engagement on rounds (110.6 to 73.3 to 65.3, P < .001), and greater adherence to I-PASS structure (95.3 to 73.6 to 72.3, P < .05). Twelve of 12 measures of staff safety climate improved (eg, "excellent"/"very good" safety grade improved from 80.4% to 86.3% to 88.0%), all P < .05. Patient/family experience and teaching were unchanged. CONCLUSIONS: Hospitals successfully used Mentor-Trios to implement PFC I-PASS. Family/nurse engagement, safety climate, and harms improved in larger hospitals and hospitals with better nurse engagement and intervention adherence. Patient/family experience and teaching were not affected.

Cystic Fibrosis-Related Diabetes Workshop: Research Priorities Spanning Disease Pathophysiology, Diagnosis, and Outcomes.

Cystic fibrosis (CF) is a recessive disorder arising from mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein. CFTR is expressed in numerous tissues, with high expression in the airways, small and large intestine, pancreatic and hepatobiliary ducts, and male reproductive tract. CFTR loss in these tissues disrupts regulation of salt, bicarbonate, and water balance across their epithelia, resulting in a systemic disorder with progressive organ dysfunction and damage. Pancreatic exocrine damage ultimately manifests as pancreatic exocrine insufficiency that begins as early as infancy. Pancreatic remodeling accompanies this early damage, during which abnormal glucose tolerance can be observed in toddlers. With increasing age, however, insulin secretion defects progress such that CF-related diabetes (CFRD) occurs in 20% of teens and up to half of adults with CF. The relevance of CFRD is highlighted by its association with increased morbidity, mortality, and patient burden. While clinical research on CFRD has greatly assisted in the care of individuals with CFRD, key knowledge gaps on CFRD pathogenesis remain. Furthermore, the wide use of CFTR modulators to restore CFTR activity is changing the CFRD clinical landscape and the field's understanding of CFRD pathogenesis. For these reasons, the National Institute of Diabetes and Digestive and Kidney Diseases and the Cystic Fibrosis Foundation sponsored a CFRD Scientific Workshop, 23-25 June 2021, to define knowledge gaps and needed research areas. This article describes the findings from this workshop and plots a path for CFRD research that is needed over the next decade.

Cystic Fibrosis-Related Diabetes Workshop: Research Priorities Spanning Disease Pathophysiology, Diagnosis, and Outcomes.

Cystic fibrosis (CF) is a recessive disorder arising from mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein. CFTR is expressed in numerous tissues, with high expression in the airways, small and large intestine, pancreatic and hepatobiliary ducts, and male reproductive tract. CFTR loss in these tissues disrupts regulation of salt, bicarbonate, and water balance across their epithelia, resulting in a systemic disorder with progressive organ dysfunction and damage. Pancreatic exocrine damage ultimately manifests as pancreatic exocrine insufficiency that begins as early as infancy. Pancreatic remodeling accompanies this early damage, during which abnormal glucose tolerance can be observed in toddlers. With increasing age, however, insulin secretion defects progress such that CF-related diabetes (CFRD) occurs in 20% of teens and up to half of adults with CF. The relevance of CFRD is highlighted by its association with increased morbidity, mortality, and patient burden. While clinical research on CFRD has greatly assisted in the care of individuals with CFRD, key knowledge gaps on CFRD pathogenesis remain. Furthermore, the wide use of CFTR modulators to restore CFTR activity is changing the CFRD clinical landscape and the field's understanding of CFRD pathogenesis. For these reasons, the National Institute of Diabetes and Digestive and Kidney Diseases and the Cystic Fibrosis Foundation sponsored a CFRD Scientific Workshop, 23-25 June 2021, to define knowledge gaps and needed research areas. This article describes the findings from this workshop and plots a path for CFRD research that is needed over the next decade.

Family, nurse, and physician beliefs on family-centered rounds: A 21-site study.

BACKGROUND: Variation exists in family-centered rounds (FCR). OBJECTIVE: We sought to understand patient/family and clinician FCR beliefs/attitudes and practices to support implementation efforts. DESIGNS, SETTINGS AND PARTICIPANTS: Patients/families and clinicians at 21 geographically diverse US community/academic pediatric teaching hospitals participated in a prospective cohort dissemination and implementation study. INTERVENTION: We inquired about rounding beliefs/attitudes, practices, and demographics using a 26-question survey coproduced with family/nurse/attending-physician collaborators, informed by prior research and the Consolidated Framework for Implementation Research. MAIN OUTCOME AND MEASURES: Out of 2578 individuals, 1647 (64%) responded to the survey; of these, 1313 respondents participated in FCR and were included in analyses (616 patients/families, 243 nurses, 285 resident physicians, and 169 attending physicians). Beliefs/attitudes regarding the importance of FCR elements varied by role, with resident physicians rating the importance of several FCR elements lower than others. For example, on adjusted multivariable analysis, attending physicians (odds ratio [OR] 3.0, 95% confidence interval [95% CI] 1.2-7.8) and nurses (OR 3.1, 95% CI 1.3-7.4) were much more likely than resident physicians to report family participation on rounds as very/extremely important. Clinician support for key FCR elements was higher than self-reported practice (e.g., 88% believed family participation was important on rounds; 68% reported it often/always occurred). In practice, key elements of FCR were reported to often/always occur only 23%-70% of the time. RESULT: Support for nurse and family participation in FCR is high among clinicians but varies by role. Physicians, particularly resident physicians, endorse several FCR elements as less important than nurses and patients/families. The gap between attitudes and practice and between clinician types suggests that attitudinal, structural, and cultural barriers impede FCR.

Intervention, individual, and contextual determinants to high adherence to structured family-centered rounds: a national multi-site mixed methods study.

BACKGROUND: Effective communication in transitions between healthcare team members is associated with improved patient safety and experience through a clinically meaningful reduction in serious safety events. Family-centered rounds (FCR) can serve a critical role in interprofessional and patient-family communication. Despite widespread support, FCRs are not utilized consistently in many institutions. Structured FCR approaches may prove beneficial in increasing FCR use but should address organizational challenges. The purpose of this study was to identify intervention, individual, and contextual determinants of high adherence to common elements of structured FCR in pediatric inpatient units during the implementation phase of a large multi-site study implementing a structured FCR approach. METHODS: We performed an explanatory sequential mixed methods study from September 2019 to October 2020 to evaluate the variation in structured FCR adherence across 21 pediatric inpatient units. We analyzed 24 key informant interviews of supervising physician faculty, physician learners, nurses, site administrators, and project leaders at 3 sites using a qualitative content analysis paradigm to investigate site variation in FCR use. We classified implementation determinants based on the Consolidated Framework for Implementation Research. RESULTS: Provisional measurements of adherence demonstrated considerable variation in structured FCR use across sites at a median time of 5 months into the implementation. Consistent findings across all three sites included generally positive clinician beliefs regarding the use of FCR and structured rounding approaches, benefits to learner self-efficacy, and potential efficiency gains derived through greater rounds standardization, as well as persistent challenges with nurse engagement and interaction on rounds and coordination and use of resources for families with limited English proficiency. CONCLUSIONS: Studies during implementation to identify determinants to high adherence can provide generalizable knowledge regarding implementation determinants that may be difficult to predict prior to implementation, guide adaptation during the implementation, and inform sustainment strategies.

Association of Patient and Family Reports of Hospital Safety Climate With Language Proficiency in the US.

Importance: Patients with language barriers have a higher risk of experiencing hospital safety events. This study hypothesized that language barriers would be associated with poorer perceptions of hospital safety climate relating to communication openness. Objective: To examine disparities in reported hospital safety climate by language proficiency in a cohort of hospitalized children and their families. Design, Setting, and Participants: This cohort study conducted from April 29, 2019, through March 1, 2020, included pediatric patients and parents or caregivers of hospitalized children at general and subspecialty units at 21 US hospitals. Randomly selected Arabic-, Chinese-, English-, and Spanish-speaking hospitalized patients and families were approached before hospital discharge and were included in the analysis if they provided both language proficiency and health literacy data. Participants self-rated language proficiency via surveys. Limited English proficiency was defined as an answer of anything other than "very well" to the question "how well do you speak English?" Main Outcomes and Measures: Primary outcomes were top-box (top most; eg, strongly agree) 5-point Likert scale ratings for 3 Children's Hospital Safety Climate Questionnaire communication openness items: (1) freely speaking up if you see something that may negatively affect care (top-box response: strongly agree), (2) questioning decisions or actions of health care providers (top-box response: strongly agree), and (3) being afraid to ask questions when something does not seem right (top-box response: strongly disagree [reverse-coded item]). Covariates included health literacy and sociodemographic characteristics. Logistic regression was used with generalized estimating equations to control for clustering by site to model associations between openness items and language proficiency, adjusting for health literacy and sociodemographic characteristics. Results: Of 813 patients, parents, and caregivers who were approached to participate in the study, 608 completed surveys (74.8% response rate). A total of 87.7% (533 of 608) of participants (434 [82.0%] female individuals) completed language proficiency and health literacy items and were included in the analyses; of these, 14.1% (75) had limited English proficiency. Participants with limited English proficiency had lower odds of freely speaking up if they see something that may negatively affect care (adjusted odds ratio [aOR], 0.26; 95% CI, 0.15-0.43), questioning decisions or actions of health care providers (aOR, 0.19; 95% CI, 0.09-0.41), and being unafraid to ask questions when something does not seem right (aOR, 0.44; 95% CI, 0.27-0.71). Individuals with limited health literacy (aOR, 0.66; 95% CI, 0.48-0.91) and a lower level of educational attainment (aOR, 0.59; 95% CI, 0.36-0.95) were also less likely to question decisions or actions. Conclusions and Relevance: This cohort study found that limited English proficiency was associated with lower odds of speaking up, questioning decisions or actions of providers, and being unafraid to ask questions when something does not seem right. This disparity may contribute to higher hospital safety risk for patients with limited English proficiency. Dedicated efforts to improve communication with patients and families with limited English proficiency are necessary to improve hospital safety and reduce disparities.

Patient safety after implementation of a coproduced family centered communication programme: multicenter before and after intervention study

OBJECTIVE: To determine whether medical errors, family experience, and communication processes improved after implementation of an intervention to standardize the structure of healthcare provider-family communication on family centered rounds. DESIGN: Prospective, multicenter before and after intervention study. SETTING: Pediatric inpatient units in seven North American hospitals, 17 December 2014 to 3 January 2017. PARTICIPANTS: All patients admitted to study units (3106 admissions, 13171 patient days); 2148 parents or caregivers, 435 nurses, 203 medical students, and 586 residents. INTERVENTION: Families, nurses, and physicians coproduced an intervention to standardize healthcare provider-family communication on ward rounds ("family centered rounds"), which included structured, high reliability communication on bedside rounds emphasizing health literacy, family engagement, and bidirectional communication; structured, written real-time summaries of rounds; a formal training programme for healthcare providers; and strategies to support teamwork, implementation, and process improvement. MAIN OUTCOME MEASURES: Medical errors (primary outcome), including harmful errors (preventable adverse events) and non-harmful errors, modeled using Poisson regression and generalized estimating equations clustered by site; family experience; and communication processes (eg, family engagement on rounds). Errors were measured via an established systematic surveillance methodology including family safety reporting. RESULTS: The overall rate of medical errors (per 1000 patient days) was unchanged (41.2 (95% confidence interval 31.2 to 54.5) pre-intervention v 35.8 (26.9 to 47.7) post-intervention, P=0.21), but harmful errors (preventable adverse events) decreased by 37.9% (20.7 (15.3 to 28.1) v 12.9 (8.9 to 18.6), P=0.01) post-intervention. Non-preventable adverse events also decreased (12.6 (8.9 to 17.9) v 5.2 (3.1 to 8.8), P=0.003). Top box (eg, "excellent") ratings for six of 25 components of family reported experience improved; none worsened. Family centered rounds occurred more frequently (72.2% (53.5% to 85.4%) v 82.8% (64.9% to 92.6%), P=0.02). Family engagement 55.6% (32.9% to 76.2%) v 66.7% (43.0% to 84.1%), P=0.04) and nurse engagement (20.4% (7.0% to 46.6%) v 35.5% (17.0% to 59.6%), P=0.03) on rounds improved. Families expressing concerns at the start of rounds (18.2% (5.6% to 45.3%) v 37.7% (17.6% to 63.3%), P=0.03) and reading back plans (4.7% (0.7% to 25.2%) v 26.5% (12.7% to 7.3%), P=0.02) increased. Trainee teaching and the duration of rounds did not change significantly. CONCLUSIONS: Although overall errors were unchanged, harmful medical errors decreased and family experience and communication processes improved after implementation of a structured communication intervention for family centered rounds coproduced by families, nurses, and physicians. Family centered care processes may improve safety and quality of care without negatively impacting teaching or duration of rounds. TRIAL REGISTRATION: ClinicalTrials.gov NCT02320175.

Families as Partners in Hospital Error and Adverse Event Surveillance.

Importance: Medical errors and adverse events (AEs) are common among hospitalized children. While clinician reports are the foundation of operational hospital safety surveillance and a key component of multifaceted research surveillance, patient and family reports are not routinely gathered. We hypothesized that a novel family-reporting mechanism would improve incident detection. Objective: To compare error and AE rates (1) gathered systematically with vs without family reporting, (2) reported by families vs clinicians, and (3) reported by families vs hospital incident reports. Design, Setting, and Participants: We conducted a prospective cohort study including the parents/caregivers of 989 hospitalized patients 17 years and younger (total 3902 patient-days) and their clinicians from December 2014 to July 2015 in 4 US pediatric centers. Clinician abstractors identified potential errors and AEs by reviewing medical records, hospital incident reports, and clinician reports as well as weekly and discharge Family Safety Interviews (FSIs). Two physicians reviewed and independently categorized all incidents, rating severity and preventability (agreement, 68%-90%; κ, 0.50-0.68). Discordant categorizations were reconciled. Rates were generated using Poisson regression estimated via generalized estimating equations to account for repeated measures on the same patient. Main Outcomes and Measures: Error and AE rates. Results: Overall, 746 parents/caregivers consented for the study. Of these, 717 completed FSIs. Their median (interquartile range) age was 32.5 (26-40) years; 380 (53.0%) were nonwhite, 566 (78.9%) were female, 603 (84.1%) were English speaking, and 380 (53.0%) had attended college. Of 717 parents/caregivers completing FSIs, 185 (25.8%) reported a total of 255 incidents, which were classified as 132 safety concerns (51.8%), 102 nonsafety-related quality concerns (40.0%), and 21 other concerns (8.2%). These included 22 preventable AEs (8.6%), 17 nonharmful medical errors (6.7%), and 11 nonpreventable AEs (4.3%) on the study unit. In total, 179 errors and 113 AEs were identified from all sources. Family reports included 8 otherwise unidentified AEs, including 7 preventable AEs. Error rates with family reporting (45.9 per 1000 patient-days) were 1.2-fold (95% CI, 1.1-1.2) higher than rates without family reporting (39.7 per 1000 patient-days). Adverse event rates with family reporting (28.7 per 1000 patient-days) were 1.1-fold (95% CI, 1.0-1.2; P = .006) higher than rates without (26.1 per 1000 patient-days). Families and clinicians reported similar rates of errors (10.0 vs 12.8 per 1000 patient-days; relative rate, 0.8; 95% CI, .5-1.2) and AEs (8.5 vs 6.2 per 1000 patient-days; relative rate, 1.4; 95% CI, 0.8-2.2). Family-reported error rates were 5.0-fold (95% CI, 1.9-13.0) higher and AE rates 2.9-fold (95% CI, 1.2-6.7) higher than hospital incident report rates. Conclusions and Relevance: Families provide unique information about hospital safety and should be included in hospital safety surveillance in order to facilitate better design and assessment of interventions to improve safety.