A guide to critical appraisal of quality improvement reports.

Quality improvement (QI) has become an integral part of healthcare. Despite efforts to improve the reporting of QI through frameworks such as the SQUIRE 2.0 guidelines, there is no standard or well-accepted guide to evaluate published QI for rigor, validity, generalizability, and applicability. User's Guides for evaluation of published clinical research have been employed routinely for over 25 years; however, similar tools for critical appraisal of QI are limited and uncommonly used. In this article we propose an approach to guide the critical review of QI reports focused on evaluating the methodology, improvement results, and applicability and feasibility for implementation in other settings. The resulting Quality Improvement Critical Knowledge (QUICK) Tool can be used by those reviewing manuscripts submitted for publication, as well as healthcare providers seeking to understand how to apply published QI to their local context.

Prospective Study of the Multisite Spread of a Medication Safety Intervention: Factors Common to Hospitals With Improved Outcomes.

Context and implementation approaches can impede the spread of patient safety interventions. The objective of this article is to characterize factors associated with improved outcomes among 9 hospitals implementing a medication safety intervention. Nephrotoxic Injury Negated by Just-in-Time Action (NINJA) is a pharmacist-driven intervention that led to a sustained reduction in nephrotoxic medication-associated acute kidney injury (NTMx-AKI) at 1 hospital. Using qualitative comparative analysis, the team prospectively assessed the association between context and implementation factors and NTMx-AKI reduction during NINJA spread to 9 hospitals. Five hospitals reduced NTMx-AKI. These 5 had either (1) a pharmacist champion and >2 pharmacists working on NINJA (Scon 1.0, Scov 0.8) or (2) a nephrologist-implementing NINJA with minimal competing organizational priorities (Scon 1.0, Scov 0.2). Interviews identified ways NINJA team leaders obtained pharmacist support or successfully implemented without that support. In conclusion, these findings have implications for future spread of NINJA and suggest an approach to study spread of safety interventions more broadly.

Family Management Skills Reported by Parents of Preterm Infants in the NICU Using the Self- and Family Management Framework (SFMF).

BACKGROUND: Across the globe, family-integrated care (FICare) has become an evidence-based standard in which parents deliver the majority of infant care in the neonatal intensive care unit (NICU). Because of extensive barriers to parent presence, adaptations to FICare may be required for successful implementation. Family management theory may provide structure to the Parent Education of FICare and help nurses guide parents' skill development as equal care members. PURPOSE: To identify family management skills employed by NICU parents using the Self- and Family Management Framework (SFMF). METHODS: We conducted secondary analyses of qualitative interview data from NICU parents (n = 17) who shared their experiences of using family management skills to care for their infant. We categorized skills according to 3 main self- and family management processes: Focusing on Infant Illness Needs; Activating Resources; and Living With Infant Illness. RESULTS: Parents reported several family management skills currently identified in the SFMF, as well as new skills such as conflict management, power brokerage, and addressing resources related to social determinants of health. Parent activation of resources was critical to sustaining parent focus on the infant's illness needs. IMPLICATIONS FOR PRACTICE AND RESEARCH: By teaching skills that parents reported as helping them manage infant care, neonatal nurses may better facilitate parent integration into the care team. Future researchers can incorporate the skills identified in this study into the design of family management interventions that facilitate FICare implementation in the United States.

Shift-to-shift handoffs in the NICU: lessons learned from a large scale audit.

OBJECTIVE: Describe the frequency of best practice behaviors during NICU provider and nursing shift-to-shift handoffs and identify strengths and opportunities for improvement. STUDY DESIGN: Observational study of handoff characteristics among 40 centers participating in a learning collaborative over a 10-month period. Data were gathered using a handoff audit tool that outlined best practices. Comparisons of behaviors between nurse-to-nurse and provider-to-provider handoffs were made where appropriate. RESULTS: Overall, 946 audits of shift-to-shift handoffs were analyzed. While many behaviors were demonstrated reliably, differences between nurse-to-nurse vs provider-to-provider handoffs were noted. Families were present for 5.9% of handoffs and, among those who were present, 48.2% participated by contributing information, asking questions, and sharing goals. CONCLUSIONS: Observation and measurement of handoff behaviors can be used to identify opportunities to improve handoff communication, family participation, and human factors that support handoff. Auditing handoffs is feasible and necessary to improve these critical transitions in infants' care.

Challenging Cases in Statistical Process Control for Quality Improvement in Neonatal Intensive Care.

Effective quality improvement (QI) depends on rigorous analysis of time-series data through methods such as statistical process control (SPC). As use of SPC has become more prevalent in health care, QI practitioners must also be aware of situations that warrant special attention and potential modifications to common SPC charts, which include skewed continuous data, autocorrelation, small persistent changes in performance, confounders, and workload or productivity measures. This article reviews these situations and provides examples of SPC approaches for each.

Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease: A Series of N-of-1 Diet Trials.

INTRODUCTION: Evidence about specific carbohydrate diet (SCD) for inflammatory bowel disease (IBD) is limited. We conducted 54 single-subject, double-crossover N-of-1 trials comparing SCD with a modified SCD (MSCD) and comparing each with the participant's baseline, usual diet (UD). METHODS: Across 19 sites, we recruited patients aged 7-18 years with IBD and active inflammation. Following a 2-week baseline (UD), patients were randomized to 1 of 2 sequences of 4 alternating 8-week SCD and MSCD periods. Outcomes included fecal calprotectin and patient-reported symptoms. We report posterior probabilities from Bayesian models comparing diets. RESULTS: Twenty-one (39%) participants completed the trial, 9 (17%) completed a single crossover, and 24 (44%) withdrew. Withdrawal or early completion occurred commonly (lack of response [n = 11], adverse events [n = 11], and not desiring to continue [n = 6]). SCD and MSCD performed similarly for most individuals. On average, there was <1% probability of a clinically meaningful difference in IBD symptoms between SCD and MSCD. The average treatment difference was -0.3 (95% credible interval -1.2, 0.75). There was no significant difference in the ratio of fecal calprotectin geometric means comparing SCD and MSCD (0.77, 95% credible interval 0.51, 1.10). Some individuals had improvement in symptoms and fecal calprotectin compared with their UD, whereas others did not. DISCUSSION: SCD and MSCD did not consistently improve symptoms or inflammation, although some individuals may have benefited. However, there are inherent difficulties in examining dietary changes that complicate study design and ultimately conclusions regarding effectiveness.

Application of a Risk Management Framework to Parent Sleep During Skin-to-Skin Care in the NICU.

As NICU staff work to increase the frequency, duration, and comfort of skin-to-skin care (SSC) sessions, barriers to implementation are frequently encountered. Safety concerns are often raised when parents fall asleep during SSC intentionally or unintentionally. We present a risk management framework that we use in clinical practice to address risk related to parent sleep during SSC. Our approach is based on the steps of the Risk Management Life Cycle, which include the following: establish context, identify risk, analyze risk, respond to risk, and monitor and adapt response to risk. Clinicians may use this framework in clinical practice to manage risks related to prolonged SSC, specifically when parents relax and fall asleep during SSC.

Contextual Factors Affecting Implementation of Pediatric Quality Improvement Programs.

OBJECTIVE: Context is a critical determinant of the effectiveness of quality improvement programs. We assessed the role of contextual factors in influencing the efforts of 5 diverse quality improvement projects as part of the Pediatric Quality Measure Program (PQMP) directed by the Agency for Health Care Research and Quality. METHODS: We conducted a mixed methods study of 5 PQMP grantees involving semistructured interviews followed by structured worksheets to identify influential contextual factors. Semistructured interviews and worksheets were completed between August and October 2020. Participants were comprised of PQMP grantee teams (2-4 team members per team for a total of 15 participants). Coding and analysis was based on the Tailored Implementation for Chronic Diseases (TICD) framework. RESULTS: Despite heterogeneity in the process and outcome targets of the PQMP initiatives, professional interactions, incentives and resources, and capacity for organizational change were the domains most commonly identified as influential across the grantees. While social, political, and legal factors was not commonly referenced as an important domain, payer or funder policies (a factor within this domain) was highlighted as one of the most influential factors. Overall, the incentives and resources domain was identified as the most influential. CONCLUSIONS: We found that using a determinant framework, such as the TICD, is valuable in facilitating comparisons across heterogeneous projects, allowing us to identify key contextual factors influencing the implementation of pediatric quality measures across a diverse range of clinical topics and settings. Future quality improvement work should account for this and include resources to support infrastructure development in addition to program implementation.

Context in Implementation Science.

Changing health care delivery systems and processes of care to improve health care quality is complex. What is done (intervention) is equally important as how it is done (implementation) and where it is done (context). Furthermore, it has been consistently observed that among groups participating in multisite quality improvement (QI) efforts and implementation studies, significant heterogeneity in the improvements is seen. Our objective is to provide a step-by-step guide to assist both researchers and groups practicing QI on the frontlines in addressing context in planning, implementing, and disseminating their QI and implementation interventions. We discuss in depth a sample of the >60 available dissemination and implementation frameworks that consider context. We then provide an approach to addressing context in QI and implementation initiatives and discuss an application of this approach, using a published study as an example. Finally, we discuss next steps for the field of context and implementation science. Data from networks of health systems working together on QI are needed on both network-wide rates of process and outcome measures. Also needed are segmented/stratified data that inform our understanding of the influence of context on successful implementation in subgroups. Finally, multisite prospective studies are needed to develop an in-depth understanding of how specific context and implementation factors affect the successful spread of proven interventions.

A clinical-academic partnership to develop a family management intervention for parents of preterm infants.

AIMS: To examine the critical role that an academic clinical partnership played in the development and refinement of a family management intervention in the Neonatal Intensive Care Unit (NICU). BACKGROUND: Clinical-academic partnerships enable earlier infusion of implementation science principles into development of evidence-based interventions, yet partners often report difficulty leveraging resources, personnel and expertise to create beneficial outcomes for all. DESIGN: Longitudinal qualitative descriptive design. METHODS: To develop and refine the intervention, designated time was taken during meetings of the NICU's Parent Partnership Council (PPC), a committee comprised of nursing, physician and allied health leadership and former NICU parents. Partnership was also achieved by having bedside clinical nurses, in addition to medical and nursing students, participate as research team members. Qualitative data were collected via email, research team and Council meetings, and informal individual chats with key stakeholders (N = 25) and NICU mothers (N = 22). Qualitative data were analysed deductively using thematic analysis based on MacPhee's partnership logic model and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) model. The consolidated criteria for reporting qualitative research checklist guided our work. RESULTS: During Council meetings, the clinical-academic nurse, Director of Family-Integrated Care and Council members identified the need for a family management intervention, and worked together to develop and refine PREEMIE PROGRESS. Mothers found the intervention had numerous strengths and perceived a benefit knowing they helped future parents. CONCLUSIONS: This work was only possible by leveraging both the university's technology/research resources and the clinical expertise of the NICU staff and PPC. Co-authored presentations, publications and grant funding continued this NICU's legacy in family-centred care and helped shape the clinical-academic nurse's career. RELEVANCE TO CLINICAL PRACTICE: Clinical-academic partnerships can promote excellence in nursing practice, research and education through swifter knowledge translation and earlier infusion of implementation science principles into the development of evidence-based nursing interventions.

A Useful and Sustainable Role for N-of-1 Trials in the Healthcare Ecosystem.

Clinicians and patients often try a treatment for an initial period to inform longer-term therapeutic decisions. A more rigorous approach involves N-of-1 trials. In these single-patient crossover trials, typically conducted in patients with chronic conditions, individual patients are given candidate treatments in a double-blinded, random sequence of alternating periods to determine the most effective treatment for that patient. However, to date, these trials are rarely done outside of research settings and have not been integrated into general care where they could offer substantial benefit. Designating this classical, N-of-1 trial design as type 1, there also are new and evolving uses of N-of-1 trials that we designate as type 2. In these, rather than focusing on optimizing treatment for chronic diseases when multiple approved choices are available, as is typical of type 1, a type 2 N-of-1 trial tests treatments designed specifically for a patient with a rare disease, to facilitate personalized medicine. While the aims differ, both types face the challenge of collecting individual-patient evidence using standard, trusted, widely accepted methods. To fulfill their potential for producing both clinical and research benefits, and to be available for wide use, N-of-1 trials will have to fit into the current healthcare ecosystem. This will require generalizable and accepted processes, platforms, methods, and standards. This also will require sustainable value-based arrangements among key stakeholders. In this article, we review opportunities, stakeholders, issues, and possible approaches that could support general use of N-of-1 trials and deliver benefit to patients and the healthcare enterprise. To assess and expand the benefits of N-of-1 trials, we propose multistakeholder meetings, workshops, and the generation of methods, standards, and platforms that would support wider availability and the value of N-of-1 trials.

Quality Improvement Initiative to Improve Healthcare Providers' Attitudes towards Mothers with Opioid Use Disorder.

INTRODUCTION: Individuals with opioid use disorder often report feelings of shame and describe feeling judged negatively. These feelings are especially true for pregnant women with opioid use disorder. The Ohio Perinatal Quality Collaborative conducted a multimodal quality improvement initiative for infants born with Neonatal Abstinence Syndrome (NAS). An important component of the project was focused on improving staff attitudes toward mothers of infants with NAS. METHODS: The Ohio Perinatal Quality Collaborative implemented an education program for healthcare providers at 39 participating hospital units regarding opioid use as a chronic disease and principles of nonjudgmental, trauma-informed care. Healthcare providers partnered with the mother of infants with NAS in the care of the infant and connected with local community resources. This work was a subcomponent of an overall multimodal quality improvement project. Healthcare provider attitudes were measured with the "Attitude Measurement: Brief Scales" questionnaire anonymously, at 3 different time points throughout the project. Attitude change was measured by pretraining and posttraining scores. ANOVA methods were used to compare individual items and a summary score across the 3 surveys. RESULTS: Summary scores improved significantly from 18.99 at baseline (January-March 2014) to 19.94 (P < 0.0001) in February 2015 and were maintained at 20.05 in July 2016. CONCLUSIONS: A nonjudgmental attitude toward mothers of infants with NAS is an important component of compassionate care. Improving healthcare provider attitudes can benefit a mother of an infant with NAS and help preserve the mother-infant dyad.

Association between Elevated Urine Neutrophil Gelatinase-Associated Lipocalin and Postoperative Acute Kidney Injury in Neonates.

OBJECTIVE: To examine the incidence of postoperative neonatal acute kidney injury (AKI) following general surgical procedures and to test the hypothesis that postoperative urine neutrophil gelatinase-associated lipocalin (uNGAL) concentrations predict AKI. The secondary objective was to evaluate for an association between AKI and hospital mortality. STUDY DESIGN: Prospective observational study of infants undergoing abdominal and thoracic surgical procedures in the neonatal intensive care unit from October 2018 to March 2020. The primary outcome was incidence of neonatal AKI (defined by the neonatal modified Kidney Diseases Improving Global Outcomes criteria) following each procedure to postoperative day 5. Severe AKI was defined as stage 2 or 3 AKI. Urine samples were obtained pre- and postoperatively at 6 time points to evaluate for levels of uNGAL. Secondary outcomes were in-hospital mortality and length of stay. RESULTS: Subjects (n = 141) underwent a total of 192 general surgical procedures during the study period. Neonatal AKI and severe AKI occurred following 36 (18%) and 15 (8%) procedures (n = 33 subjects). Percent change of uNGAL from 24 hours preoperatively to 24 hours postoperatively was greater in subjects with neonatal AKI (190.2% [IQR 0.0, 1666.7%] vs 0.7% [IQR -31.2%,140.2%], P = .0374). The strongest association of uNGAL and AKI occurred at 24 hours postoperatively (area under the receiver operator curves of 0.81, 95% CI 0.72, 0.89). Increased mortality risk was observed in subjects with any postoperative AKI (aOR 11.1 95% CI 2.0, 62.8, P = .0063) and severe AKI (aOR 13.8; 95% CI 3.0, 63.1, P = .0007). CONCLUSION: Elevation in uNGAL 24 hours postoperative was associated with AKI. Neonates with postoperative AKI had increased mortality.

Protein Enrichment of Donor Breast Milk and Impact on Growth in Very Low Birth Weight Infants.

Protein content is often inadequate in donor breast milk (DBM), resulting in poor growth. The use of protein-enriched target-pooled DBM (DBM+) has not been examined. We compared three cohorts of very low birth weight (VLBW) infants, born ≤ 1500 g: DBM cohort receiving > 1-week target-pooled DBM (20 kcal/oz), MBM cohort receiving ≤ 1-week DBM, and DBM+ cohort receiving > 1-week DBM+. Infants followed a standardized feeding regimen with additional fortification per clinical discretion. Growth velocities and z-scores were calculated for the first 4 weeks (n = 69 for DBM, 71 for MBM, 70 for DBM+) and at 36 weeks post-menstrual age (n = 58, 64, 59, respectively). In total, 60.8% MBM infants received fortification >24 kcal/oz in the first 30 days vs. 78.3% DBM and 77.1% DBM+. Adjusting for SGA, length velocity was greater with DBM+ than DBM in week 1. Average weight velocity and z-score change were improved with MBM compared to DBM and DBM+, but length z-score decreased similarly across all groups. Incidences of NEC and feeding intolerance were unchanged between eras. Thus, baseline protein enrichment appears safe in stable VLBW infants. Weight gain is greatest with MBM. Linear growth comparable to MBM is achievable with DBM+, though the overall length trajectory remains suboptimal.

Technology-Enabled Health Care Collaboration in Pediatric Chronic Illness: Pre-Post Interventional Study for Feasibility, Acceptability, and Clinical Impact of an Electronic Health Record-Linked Platform for Patient-Clinician Partnership.

BACKGROUND: Mobile health (mHealth) technology has the potential to support the Chronic Care Model's vision of closed feedback loops and patient-clinician partnerships. OBJECTIVE: This study aims to evaluate the feasibility, acceptability, and short-term impact of an electronic health record-linked mHealth platform (Orchestra) supporting patient and clinician collaboration through real-time, bidirectional data sharing. METHODS: We conducted a 6-month prospective, pre-post, proof-of-concept study of Orchestra among patients and parents in the Cincinnati Children's Hospital inflammatory bowel disease (IBD) and cystic fibrosis (CF) clinics. Participants and clinicians used Orchestra during and between visits to complete and view patient-reported outcome (PRO) measures and previsit plans. Surveys completed at baseline and at 3- and 6-month follow-up visits plus data from the platform were used to assess outcomes including PRO completion rates, weekly platform use, disease self-efficacy, and impact on care. Analyses included descriptive statistics; pre-post comparisons; Pearson correlations; and, if applicable, effect sizes. RESULTS: We enrolled 92 participants (CF: n=52 and IBD: n=40), and 73% (67/92) completed the study. Average PRO completion was 61%, and average weekly platform use was 80%. Participants reported improvement in self-efficacy from baseline to 6 months (7.90 to 8.44; P=.006). At 6 months, most participants reported that the platform was useful (36/40, 90%) and had a positive impact on their care, including improved visit quality (33/40, 83%), visit collaboration (35/40, 88%), and visit preparation (31/40, 78%). PRO completion was positively associated with multiple indicators of care impact at 3 and 6 months. CONCLUSIONS: Use of an mHealth tool to support closed feedback loops through real-time data sharing and patient-clinician collaboration is feasible and shows indications of acceptability and promise as a strategy for improving pediatric chronic illness management.

Orchestrated Testing of Formula Type to Reduce Length of Stay in Neonatal Abstinence Syndrome.

BACKGROUND: Despite the standardization of care, formula feeding varied across sites of the Ohio Perinatal Quality Collaborative (OPQC). We used orchestrated testing (OT) to learn from this variation and improve nonpharmacologic care of infants with neonatal abstinence syndrome (NAS) requiring pharmacologic treatment in Ohio. METHODS: To test the impact of formula on length of stay (LOS), treatment failure, and weight loss among infants hospitalized with NAS, we compared caloric content (high versus standard) and lactose content (low versus standard) using a 22 factorial design. During October 2015 to June 2016, OPQC sites joined 1 of 4 OT groups. We used response plots to examine the effect of each factor and control charts to track formula use and LOS. We used the OT results to revise the nonpharmacologic bundle and implemented it during 2017. RESULTS: Forty-seven sites caring for 546 NAS infants self-selected into the 4 OT groups. Response plots revealed the benefit of high-calorie formula (HCF) on weight loss, treatment failure, and LOS. The nonpharmacologic treatment bundle was updated to recommend HCF when breastfeeding was not possible. During implementation, HCF use increased, and LOS decreased from 17.1 to 16.4 days across the OPQC. CONCLUSIONS: OT revealed that HCF was associated with shorter LOS in OPQC sites. Implementation of a revised nonpharmacologic care bundle was followed by additional LOS improvement in Ohio. Despite some challenges in the implementation of OT, our findings support its usefulness for learning in improvement networks.