"Like not having an arm": a qualitative study of the impact of visitor restrictions on cancer care during the COVID-19 pandemic.

PURPOSE: Visitor restriction policies to prevent the spread of COVID-19 among patients and clinicians were widespread during the pandemic, resulting in the exclusion of caregivers at key points of cancer care and treatment decision-making. The aim of this study was to explore how visitor restrictions impacted cancer treatment decision-making and care from patient and physician perspectives. METHODS: Sixty-seven interviews, including 48 cancer patients and 19 cancer and palliative care physicians from four academic cancer centers in the USA between August 2020 and July 2021. RESULTS: Visitor restrictions that prevented caregivers from participating in clinic appointments and perioperative hospital care created challenges in cancer care that spanned three domains: practical, social, and informational. We identified eight themes that characterized challenges within the three domains across all three groups, and that these challenges had negative emotional and psychological consequences for both groups. Physicians perceived that patients' negative experiences due to lack of support through the physical presence of caregivers may have worsened patient outcomes. CONCLUSIONS: Our data demonstrate the tripartite structure of the therapeutic relationship in cancer care with caregivers providing critical support in the decision-making and care process to both patients and physicians. Caregiver absences led to practical, psychosocial, and informational burdens on both groups, and likely increased the risk of burnout among physicians. Our findings suggest that the quality of cancer care can be enhanced by engaging caregivers and promoting their physical presence during clinical encounters.

Analysis of FRAME data (A-FRAME): An analytic approach to assess the impact of adaptations on health services interventions and evaluations.

Introduction: Tracking adaptations during implementation can help assess and interpret outcomes. The framework for reporting adaptations and modifications-expanded (FRAME) provides a structured approach to characterize adaptations. We applied the FRAME across multiple health services projects, and developed an analytic approach to assess the impact of adaptations. Methods: Mixed methods analysis of research diaries from seven quality improvement (QI) and research projects during the early stages of the COVID-19 pandemic. Using the FRAME as a codebook, discrete adaptations were described and categorized. We then conducted a three-step analysis plan: (1) calculated the frequency of adaptations by FRAME categories across projects; (2) qualitatively assessed the impact of adaptations on project goals; and (3) qualitatively assessed relationships between adaptations within projects to thematically consolidate adaptations to generate more explanatory value on how adaptations influenced intervention progress and outcomes. Results: Between March and July 2020, 42 adaptations were identified across seven health services projects. The majority of adaptations related to training or evaluation (52.4%) with the goal of maintaining the feasibility (66.7%) of executing projects during the pandemic. Five FRAME constructs offered the most explanatory benefit to assess the impact of adaptations on program and evaluation goals, providing the basis for creating an analytic approach dubbed the "A-FRAME," analysis of FRAME data. Using the A-FRAME, the 42 adaptations were consolidated into 17 succinct adaptations. Two QI projects discontinued altogether. Intervention adaptations related to staffing, training, or delivery, while evaluation adaptations included design, recruitment, and data collection adjustments. Conclusions: By sifting qualitative data about adaptations into the A-FRAME, implementers and researchers can succinctly describe how adaptations affect interventions and their evaluations. The simple and concise presentation of information using the A-FRAME matrix can help implementers and evaluators account for the influence of adaptations on program outcomes.

Role matters in understanding 'quality' in palliative care: a qualitative analysis of patient, caregiver and practitioner perspectives.

OBJECTIVES: To compare the discussions from two panels on the concept of palliative care quality for patients with advanced cancer, exploring the priorities reflected in each group's perspectives. DESIGN: We convened two RAND-UCLA appropriateness panel discussions on palliative care quality in advanced cancer. Discussions were audio-recorded and transcribed verbatim. Panel transcripts were analysed thematically using a matrix approach to examine perceptions and experiences of quality. SETTING: Discussions were framed within the context of advanced cancer care and palliative care. PARTICIPANTS: The patient-caregiver panel had 9 patients with current or a history of cancer and caregivers, and the practitioner panel had 10 expert practitioners representing fields of oncology, primary care, social work, palliative care, nursing, pain management and ethics. RESULTS: Our analysis identified three thematic categories for understanding quality common across both groups and nine subthemes within those categories. At the highest level, quality was conceived as: (1) the patient and caregiver experience of care, (2) technical competence and (3) the structure of health system. Among the subthemes, four were present in only one of the two group's discussions: 'purpose and action' was specific to the patient-caregiver panel, whereas 'adhering to best medical practice', 'mitigating unintended consequences and side effects', and 'health system resources and costs' were specific to the practitioner panel. CONCLUSIONS: While both panels aligned on the three key domains of quality, the particular dimensions through which they perceived quality varied in relation to their experience and role as a professional provider of care versus recipient of healthcare services. These differences suggest the importance of adopting a collaborative approach to quality measurement and improvement so that the values of all interested parties are represented in improvement efforts.

What Patients Facing Cancer and Caregivers Want From Communication in Times of Crisis: A Qualitative Study in the Early Months of the COVID-19 Pandemic.

BACKGROUND: Interpersonal communication is a cornerstone of patient-centered care. We aimed to identify what patients with cancer and caregivers may want from communication during a public health crisis. METHODS: We interviewed 15 patients (8 Veteran, 7 non-Veteran) and caregivers from regionally, racially, and ethnically diverse backgrounds across the US about serious illness care and quality of care during the COVID-19 pandemic Using an iterative, inductive and deductive process, 2 coders analyzed content associated with the code "Communication," which appeared 71 times, and identified 5 themes. RESULTS: Participants identified as White (10), Latino/a (3), Asian (1), and Black (1). (1) Help patients and caregivers prepare for care during crisis by communicating medical information directly and proactively. (2) Explain how a crisis might influence medical recommendations and impact on recovery from illness. (3) Use key messengers to improve communication between primary teams, patients, and caregivers. (4) Include caregivers and families in communication when they cannot be physically present. (5) Foster bidirectional communication with patients and families to engage them in shared decision-making during a vulnerable time. CONCLUSION: Communication is critical during a public health crisis yet overwhelmed clinicians may not be able to communicate effectively. Communicating with caregivers and family, transparent and timely communication, ensuring diverse providers are on the same page, and effective listening are known gaps even before the COVID-19 pandemic. Clinicians may need quick interventions, like education about goals of care, to remind them about what seriously ill patients and their caregivers want from communication and offer patient-centered care during crises.

"Diving in the deep-end and swimming": a mixed methods study using normalization process theory to evaluate a learning collaborative approach for the implementation of palliative care practices in hemodialysis centers.

BACKGROUND: Normalization Process Theory (NPT) is an implementation theory that can be used to explain how and why implementation strategies work or not in particular circumstances. We used it to understand the mechanisms that lead to the adoption and routinization of palliative care within hemodialysis centers. METHODS: We employed a longitudinal, mixed methods approach to comprehensively evaluate the implementation of palliative care practices among ten hemodialysis centers participating in an Institute for Healthcare Improvement Breakthrough- Series learning collaborative. Qualitative methods included longitudinal observations of collaborative activities, and interviews with implementers at the end of the study. We used an inductive and deductive approach to thematic analysis informed by NPT constructs (coherence, cognitive participation, collective action, reflexive monitoring) and implementation outcomes. The NoMAD survey, which measures NPT constructs, was completed by implementers at each hemodialysis center during early and late implementation. RESULTS: The four mechanisms posited in NPT had a dynamic and layered relationship during the implementation process. Collaborative participants participated because they believed in the value and legitimacy of palliative care for patients receiving hemodialysis and thus had high levels of cognitive participation at the start. Didactic Learning Sessions were important for building practice coherence, and sense-making was solidified through testing new skills in practice and first-hand observation during coaching visits by an expert. Collective action was hampered by limited time among team members and practical issues such as arranging meetings with patients. Reflexive monitoring of the positive benefit to patient and family experiences was key in shifting mindsets from disease-centric towards a patient-centered model of care. NoMAD survey scores showed modest improvement over time, with collective action having the lowest scores. CONCLUSIONS: NPT was a useful framework for understanding the implementation of palliative care practices within hemodialysis centers. We found a nonlinear relationship among the mechanisms which is reflected in our model of implementation of palliative care practices through a learning collaborative. These findings suggest that the implementation of complex practices such as palliative care may be more successful through iterative learning and practice opportunities as the mechanisms for change are layered and mutually reinforcing. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04125537 . Registered 14 October 2019 - Retrospectively registered.

Caregiver Experiences Participating in a Home-Based Primary Care Program: A Pragmatic Evaluation Including Qualitative Interviews and Quantitative Surveys.

The aim of this evaluation was to assess caregiver experience and burden during their first year in a geriatric home-based primary care (HBPC) program with qualitative interviews and surveys. HBPC included in-home visits for homebound, older adult patients. Seventeen caregivers, with varied amount of experience with HBPC, participated in semi-structured interviews. Change in caregiver burden from baseline was captured for 44 caregivers at 3 months post-enrollment, 27 caregivers at 6 months, and 22 caregivers at 12 months. Satisfaction survey was administered at these timepoints, but the last response of 48 caregivers was analyzed. Caregiver interviews revealed three themes: caregiving stressors, reliance on HBPC in relation to other medical care, and healthcare in the home. Surveyed caregivers were highly satisfied, but burden did not change substantially over the 1 year intervention. Caregivers appreciated HBPC reduced patient transportation and provided satisfactory primary care, but additional research is needed to tailor this care to reduce caregiver burden.

Effect of Perioperative Palliative Care on Health-Related Quality of Life Among Patients Undergoing Surgery for Cancer: A Randomized Clinical Trial.

Importance: Involvement of palliative care specialists in the care of medical oncology patients has been repeatedly observed to improve patient-reported outcomes, but there is no analogous research in surgical oncology populations. Objective: To determine whether surgeon-palliative care team comanagement, compared with surgeon team alone management, improves patient-reported perioperative outcomes among patients pursuing curative-intent surgery for high morbidity and mortality upper gastrointestinal (GI) cancers. Design, Setting, and Participants: From October 20, 2018, to March 31, 2022, a patient-randomized clinical trial was conducted with patients and clinicians nonblinded but the analysis team blinded to allocation. The trial was conducted in 5 geographically diverse academic medical centers in the US. Individuals pursuing curative-intent surgery for an upper GI cancer who had received no previous specialist palliative care were eligible. Surgeons were encouraged to offer participation to all eligible patients. Intervention: Surgeon-palliative care comanagement patients met with palliative care either in person or via telephone before surgery, 1 week after surgery, and 1, 2, and 3 months after surgery. For patients in the surgeon-alone group, surgeons were encouraged to follow National Comprehensive Cancer Network-recommended triggers for palliative care consultation. Main Outcomes and Measures: The primary outcome of the trial was patient-reported health-related quality of life at 3 months following the operation. Secondary outcomes were patient-reported mental and physical distress. Intention-to-treat analysis was performed. Results: In total, 359 patients (175 [48.7%] men; mean [SD] age, 64.6 [10.7] years) were randomized to surgeon-alone (n = 177) or surgeon-palliative care comanagement (n = 182), with most patients (206 [57.4%]) undergoing pancreatic cancer surgery. No adverse events were associated with the intervention, and 11% of patients in the surgeon-alone and 90% in the surgeon-palliative care comanagement groups received palliative care consultation. There was no significant difference between study arms in outcomes at 3 months following the operation in patient-reported health-related quality of life (mean [SD], 138.54 [28.28] vs 136.90 [28.96]; P = .62), mental health (mean [SD], -0.07 [0.87] vs -0.07 [0.84]; P = .98), or overall number of deaths (6 [3.7%] vs 7 [4.1%]; P > .99). Conclusions and Relevance: To date, this is the first multisite randomized clinical trial to evaluate perioperative palliative care and the earliest integration of palliative care into cancer care. Unlike in medical oncology practice, the data from this trial do not suggest palliative care-associated improvements in patient-reported outcomes among patients pursuing curative-intent surgeries for upper GI cancers. Trial Registration: ClinicalTrials.gov Identifier: NCT03611309.

Factors influencing pediatric transfusion: A complex decision impacting quality of care.

BACKGROUND: The risks of red blood cell transfusion may outweigh the benefits for many patients in pediatric intensive care units (PICUs), but guidelines from the Transfusion and Anemia eXpertise Initiative (TAXI) have not been consistently adopted. We sought to identify factors that influenced transfusion decision-making in PICUs to explore potential barriers and facilitators to implementing the guidelines. STUDY DESIGN AND METHODS: A total of 50 ICU providers working in eight US ICUs of different types (non-cardiac PICUs, cardiovascular ICUs, combined units) and variable sizes (11-32 beds) completed semi-structured interviews. Providers included ICU attendings and trainees, nurse practitioners, nurses, and subspecialty physicians. Interviews examined factors that influenced transfusion decisions, transfusion practices, and provider beliefs. Qualitative analysis utilized a Framework Approach. Summarized data was compared between provider roles and units with consideration to identify patterns and unique informative statements. RESULTS: Providers cited clinical, physiologic, anatomic, and logistic factors they considered in making transfusion decisions. Improving oxygen carrying capacity, hemodynamics and perfusion, respiratory function, volume deficits, and correcting laboratory values were among the reasons given for transfusion. Other sought-after benefits included alleviating symptoms of anemia, improving ICU throughput, and decreasing blood waste. Providers in different roles approached transfusion decisions differently, with the largest differences noted between nurses and subspecialists as compared with other ICU providers. While ICU attendings most often made the decision to transfuse, all providers influenced the decision-making. DISCUSSION: Implementation of transfusion guidelines requires multi-professional approaches that emphasize the known risks of transfusion, its limited benefits, and highlight evidence around the safety and benefit of restrictive approaches.

"Never waste a good crisis": A qualitative study of the impact of COVID-19 on palliative care in seven hospitals using the Dynamic Sustainability Framework.

BACKGROUND: The COVID-19 pandemic led to rapid adaptations among palliative care services, but it is unclear how these adaptations vary in relation to their unique organizational contexts. AIM: Understand how the pandemic impacted the implementation of new and existing palliative care programs in diverse hospital systems using the Dynamic Sustainability Framework. DESIGN: Twelve in-depth interviews with 15 key informants representing palliative care programs from seven hospital systems between April and June 2020. SETTING: Public, not-for-profit private, community, and academic teaching hospitals in the San Francisco Bay Area with existing palliative care programs that were expanding services to new clinical areas (e.g. new outpatient clinic or community-based care). RESULTS: Six themes characterized how palliative care programs were impacted and adapted during the early stages of the COVID-19 pandemic: palliative care involvement in preparing for surge, increased emphasis on advance care planning, advocating for visitors for dying patients, providing emotional support to clinicians, adopting virtual approaches to care, and gaps in chaplaincy support. There was variation in how new and existing programs were able to adapt to early pandemic stresses; systems with new outpatient programs struggled to utilize their programs effectively during the crisis onset. CONCLUSIONS: The fit between palliative care programs and practice setting was critical to program resiliency during the early stages of the pandemic. Reconceptualizing the Dynamic Sustainability Framework to reflect a bidirectional relationship between ecological system, practice setting, and intervention levels might better guide implementers and researchers in understanding how ecological/macro changes can influence interventions on the ground.

A 360 degree mixed-methods evaluation of a specialized COVID-19 outpatient clinic and remote patient monitoring program.

BACKGROUND: Our goals are to quantify the impact on acute care utilization of a specialized COVID-19 clinic with an integrated remote patient monitoring program in an academic medical center and further examine these data with stakeholder perceptions of clinic effectiveness and acceptability. METHODS: A retrospective cohort was drawn from enrolled and unenrolled ambulatory patients who tested positive in May through September 2020 matched on age, presence of comorbidities and other factors. Qualitative semi-structured interviews with patients, frontline clinician, and administrators were analyzed in an inductive-deductive approach to identify key themes. RESULTS: Enrolled patients were more likely to be hospitalized than unenrolled patients (N = 11/137 in enrolled vs 2/126 unenrolled, p = .02), reflecting a higher admittance rate following emergency department (ED) events among the enrolled vs unenrolled, though this was not a significant difference (46% vs 25%, respectively, p = .32). Thirty-eight qualitative interviews conducted June to October 2020 revealed broad stakeholder belief in the clinic's support of appropriate care escalation. Contrary to beliefs the clinic reduced inappropriate care utilization, no difference was seen between enrolled and unenrolled patients who presented to the ED and were not admitted (N = 10/137 in enrolled vs 8/126 unenrolled, p = .76). Administrators and providers described the clinic's integral role in allowing health services to resume in other areas of the health system following an initial lockdown. CONCLUSIONS: Acute care utilization and multi-stakeholder interviews suggest heightened outpatient observation through a specialized COVID-19 clinic and remote patient monitoring program may have contributed to an increase in appropriate acute care utilization. The clinic's role securing safe reopening of health services systemwide was endorsed as a primary, if unmeasured, benefit.

Technology-Enabled and Artificial Intelligence Support for Pre-Visit Planning in Ambulatory Care: Findings From an Environmental Scan.

PURPOSE: Pre-visit planning (PVP) is believed to improve effectiveness, efficiency, and experience of care, yet numerous implementation barriers exist. There are opportunities for technology-enabled and artificial intelligence (AI) support to augment existing human-driven PVP processes-from appointment reminders and pre-visit questionnaires to pre-visit order sets and care gap closures. This study aimed to explore the current state of PVP, barriers to implementation, evidence of impact, and potential use of non-AI and AI tools to support PVP. METHODS: We used an environmental scan approach involving: (1) literature review; (2) key informant interviews with PVP experts in ambulatory care; and (3) a search of the public domain for technology-enabled and AI solutions that support PVP. We then synthesized the findings using a qualitative matrix analysis. RESULTS: We found 26 unique PVP implementations in the literature and conducted 16 key informant interviews. Demonstration of impact is typically limited to process outcomes, with improved patient outcomes remaining elusive. Our key informants reported that many PVP barriers are human effort-related and see potential for non-AI and AI technologies to support certain aspects of PVP. We identified 8 examples of commercially available technology-enabled tools that support PVP, some with AI capabilities; however, few of these have been independently evaluated. CONCLUSIONS: As health systems transition toward value-based payment models in a world where the coronavirus disease 2019 pandemic has shifted patient care into the virtual space, PVP activities-driven by humans and supported by technology-may become more important and powerful and should be rigorously evaluated.

Predicting and Responding to Clinical Deterioration in Hospitalized Patients by Using Artificial Intelligence: Protocol for a Mixed Methods, Stepped Wedge Study.

BACKGROUND: The early identification of clinical deterioration in patients in hospital units can decrease mortality rates and improve other patient outcomes; yet, this remains a challenge in busy hospital settings. Artificial intelligence (AI), in the form of predictive models, is increasingly being explored for its potential to assist clinicians in predicting clinical deterioration. OBJECTIVE: Using the Systems Engineering Initiative for Patient Safety (SEIPS) 2.0 model, this study aims to assess whether an AI-enabled work system improves clinical outcomes, describe how the clinical deterioration index (CDI) predictive model and associated work processes are implemented, and define the emergent properties of the AI-enabled work system that mediate the observed clinical outcomes. METHODS: This study will use a mixed methods approach that is informed by the SEIPS 2.0 model to assess both processes and outcomes and focus on how physician-nurse clinical teams are affected by the presence of AI. The intervention will be implemented in hospital medicine units based on a modified stepped wedge design featuring three stages over 11 months-stage 0 represents a baseline period 10 months before the implementation of the intervention; stage 1 introduces the CDI predictions to physicians only and triggers a physician-driven workflow; and stage 2 introduces the CDI predictions to the multidisciplinary team, which includes physicians and nurses, and triggers a nurse-driven workflow. Quantitative data will be collected from the electronic health record for the clinical processes and outcomes. Interviews will be conducted with members of the multidisciplinary team to understand how the intervention changes the existing work system and processes. The SEIPS 2.0 model will provide an analytic framework for a mixed methods analysis. RESULTS: A pilot period for the study began in December 2020, and the results are expected in mid-2022. CONCLUSIONS: This protocol paper proposes an approach to evaluation that recognizes the importance of assessing both processes and outcomes to understand how a multifaceted AI-enabled intervention affects the complex team-based work of identifying and managing clinical deterioration. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/27532.

Implementation of clinical practice changes in the PICU: a qualitative study using and refining the iPARIHS framework.

BACKGROUND: Like in many settings, implementation of evidence-based practices often fall short in pediatric intensive care units (PICU). Very few prior studies have applied implementation science frameworks to understand how best to improve practices in this unique environment. We used the relatively new integrated Promoting Action on Research Implementation in Health Services (iPARIHS) framework to assess practice improvement in the PICU and to explore the utility of the framework itself for that purpose. METHODS: We used the iPARIHS framework to guide development of a semi-structured interview tool to examine barriers, facilitators, and the process of change in the PICU. A framework approach to qualitative analysis, developed around iPARIHS constructs and subconstructs, helped identify patterns and themes in provider interviews. We assessed the utility of iPARIHS to inform PICU practice change. RESULTS: Fifty multi-professional providers working in 8 U.S. PICUs completed interviews. iPARIHS constructs shaped the development of a process model for change that consisted of phases that include planning, a decision to adopt change, implementation and facilitation, and sustainability; the PICU environment shaped each phase. Large, complex multi-professional teams, and high-stakes work at near-capacity impaired receptivity to change. While the unit leaders made decisions to pursue change, providers' willingness to accept change was based on the evidence for the change, and provider's experiences, beliefs, and capacity to integrate change into a demanding workflow. Limited analytic structures and resources frustrated attempts to monitor changes' impacts. Variable provider engagement, time allocated to work on changes, and limited collaboration impacted facilitation. iPARIHS constructs were useful in exploring implementation; however, we identified inter-relation of subconstructs, unique concepts not captured by the framework, and a need for subconstructs to further describe facilitation. CONCLUSIONS: The PICU environment significantly shaped the implementation. The described process model for implementation may be useful to guide efforts to integrate changes and select implementation strategies. iPARIHS was adequate to identify barriers and facilitators of change; however, further elaboration of subconstructs for facilitation would be helpful to operationalize the framework. TRIAL REGISTRATION: Not applicable, as no health care intervention was performed.

Factors Influencing Implementation of Blood Transfusion Recommendations in Pediatric Critical Care Units.

Purpose: Risks of red blood cell transfusion may outweigh benefits for many patients in Pediatric Intensive Care Units (PICUs). The Transfusion and Anemia eXpertise Initiative (TAXI) recommendations seek to limit unnecessary and potentially harmful transfusions, but use has been variable. We sought to identify barriers and facilitators to using the TAXI recommendations to inform implementation efforts. Materials and Methods: The integrated Promoting Action on Research Implementation in Health Services (iPARIHS) framework guided semi-structured interviews conducted in 8 U.S. ICUs; 50 providers in multiple ICU roles completed interviews. Adapted Framework analysis, a form of content analysis, used the iPARIHS innovation, recipient, context and facilitation constructs and subconstructs to categorize data and identify patterns as well as unique informative statements. Results: Providers perceived that the TAXI recommendations would reduce transfusion rates and practice variability, but adoption faced challenges posed by attitudes around transfusion and care in busy and complex units. Development of widespread buy-in and inclusion in implementation, integration into workflow, designating committed champions, and monitoring outcomes data were expected to enhance implementation. Conclusions: Targeted activities to create buy-in, educate, and plan for use are necessary for TAXI implementation. Recognition of contextual challenges posed by the PICU environment and an approach that adjusts for barriers may optimize adoption.

Pathways Project: Development of a Multimodal Innovation To Improve Kidney Supportive Care in Dialysis Centers.

Current care models for older patients with kidney failure in the United States do not incorporate supportive care approaches. The absence of supportive care contributes to poor symptom management and unwanted forms of care at the end of life. Using an Institute for Healthcare Improvement Collaborative Model for Achieving Breakthrough Improvement, we conducted a focused literature review, interviewed implementation experts, and convened a technical expert panel to distill existing evidence into an evidence-based supportive care change package. The change package consists of 14 best-practice recommendations for the care of patients seriously ill with kidney failure, emphasizing three key practices: systematic identification of patients who are seriously ill, goals-of-care conversations with identified patients, and care options to respond to patient wishes. Implementation will be supported through a collaborative consisting of three intensive learning sessions, monthly learning and collaboration calls, site data feedback, and quality-improvement technical assistance. To evaluate the change package's implementation and effectiveness, we designed a mixed-methods hybrid study involving the following: (1) effectiveness evaluation (including patient outcomes and staff perception of the effectiveness of the implementation of the change package); (2) quality-improvement monitoring via monthly tracking of a suite of quality-improvement indicators tied to the change package; and (3) implementation evaluation conducted by the external evaluator using mixed methods to assess implementation of the collaborative processes. Ten dialysis centers across the country, treating approximately 1550 patients, will participate. This article describes the process informing the intervention design, components of the intervention, evaluation design and measurements, and preliminary feasibility assessments. Clinical Trial registry name and registration number: Pathways Project: Kidney Supportive Care, NCT04125537.

"Along for the Ride": A Qualitative Study Exploring Patient and Caregiver Perceptions of Decision Making in Cancer Care.

Background. Shared decision making is a cornerstone of an informed consent process for cancer treatment, yet there are often many physician and patient-related barriers to participation in the process. Decisions in cancer care are often perceived as relating to a discrete, treatment decision event, yet there is evidence that decisions are longitudinal in nature and reflect a multifactorial experience. Objective. To explore patient and caregiver perceptions of the choices and decision-making opportunities within cancer care. Design. Qualitative in-depth interviews with 37 cancer patients and 7 caregivers carried out as part of an evaluation of a cancer center's effort to improve patient experience. Results. Participants described decision making related to four distinct phases in complex cancer care, with physicians leading, and often limiting, decisions related to disease assessment and treatment options and access, and patients leading decisions related to physician selection. Though physicians led many decisions, patients had a moderating influence on treatment, such that if patients did not like options presented, they would reconsider their options and sometimes switch physicians. Patients had various strategies for dealing with uncertainty when faced with decisions, such as seeking additional information to make an informed choice or making a conscious choice to defer decision making to the physician. Limitations. Patients were sampled from one academic cancer center that serves a predominantly Caucasian, Asian, and Hispanic/Latino population and received complex treatment. Conclusion. Because of the complexity of cancer treatment, many patients felt as though they were a "passenger" in decision making about care and did not lead many of the decisions, though many patients trusted their doctors to make the best decisions and were comforted by their expertise.

The Stanford Lightning Report Method: A comparison of rapid qualitative synthesis results across four implementation evaluations.

BACKGROUND: Current evaluation methods are mismatched with the speed of health care innovation and needs of health care delivery partners. We introduce a qualitative approach called the lightning report method and its specific product-the "Lightning Report." We compare implementation evaluation results across four projects to explore report sensitivity and the potential depth and breadth of lightning report method findings. METHODS: The lightning report method was refined over 2.5 years across four projects: team-based primary care, cancer center transformation, precision health in primary care, and a national life-sustaining decisions initiative. The novelty of the lightning report method is the application of Plus/Delta/Insight debriefing to dynamic implementation evaluation. This analytic structure captures Plus ("what works"), Delta ("what needs to be changed"), and Insights (participant or evaluator insights, ideas, and recommendations). We used structured coding based on implementation science barriers and facilitators outlined in the Consolidated Framework for Implementation Research (CFIR) applied to 17 Lightning Reports from four projects. RESULTS: Health care partners reported that Lighting Reports were valuable, easy to understand, and they implied reports supported "corrective action" for implementations. Comparative analysis revealed cross-project emphasis on the domains of Inner Setting and Intervention Characteristics, with themes of communication, resources/staffing, feedback/reflection, alignment with simultaneous interventions and traditional care, and team cohesion. In three of the four assessed projects, the largest proportion of coding was to the clinic-level domain of Inner Setting-ranging from 39% for the cancer center project to a high of 56% for the life-sustaining decisions project. CONCLUSIONS: The lightning report method can fill a gap in rapid qualitative approaches and is generalizable with consistent but flexible core methods. Comparative analysis suggests it is a sensitive tool, capable of uncovering differences and insights in implementation across projects. The Lightning Report facilitates partnered evaluation and communication with stakeholders by providing real-time, actionable insights in dynamic health care implementations.

Adapting rapid assessment procedures for implementation research using a team-based approach to analysis: a case example of patient quality and safety interventions in the ICU.

BACKGROUND: Innovations to improve quality and safety in healthcare are increasingly complex, targeting multiple disciplines and organizational levels, and often requiring significant behavior change by those delivering care. Learning health systems must tackle the crucial task of understanding the implementation and effectiveness of complex interventions, but may be hampered in their efforts by limitations in study design imposed by business-cycle timelines and implementation into fast-paced clinical environments. Rapid assessment procedures are a pragmatic option for producing timely, contextually rich evaluative information about complex interventions implemented into dynamic clinical settings. METHODS: We describe our adaptation of rapid assessment procedures and introduce a rapid team-based analysis process using an example of an evaluation of an intensive care unit (ICU) redesign initiative aimed at improving patient safety in four academic medical centers across the USA. Steps in our approach included (1) iteratively working with stakeholders to develop evaluation questions; (2) integration of implementation science frameworks into field guides and analytic tools; (3) selecting and training a multidisciplinary site visit team; (4) preparation and trust building for 2-day site visits; (5) engaging sites in a participatory approach to data collection; (6) rapid team analysis and triangulation of data sources and methods using a priori charts derived from implementation frameworks; and (7) validation of findings with sites. RESULTS: We used the rapid assessment approach at each of the four ICU sites to evaluate the implementation of the sites' innovations. Though the ICU projects all included three common components, they were individually developed to suit the local context and had mixed implementation outcomes. We generated in-depth case summaries describing the overall implementation process for each site; implementation barriers and facilitators for all four sites are presented. One of the site case summaries is presented as an example of findings generated using the method. CONCLUSIONS: A rapid team-based approach to qualitative analysis using charts and team discussion using validation techniques, such as member-checking, can be included as part of rapid assessment procedures. Our work demonstrates the value of including rapid assessment procedures for implementation research when time and resources are limited.

Negotiating Lay and Clinical Issues: Implementing a Lay Navigation Program in Cancer Care.

PURPOSE: Patients with cancer face daunting coordination problems at a vulnerable time. Lay navigation programs offer 1 approach to address these problems, but how to best implement these programs presents challenges. We sought to describe those implementation challenges at 1 academic cancer center to inform future efforts. METHODS: We performed a mixed methods study using standard implementation outcomes 1 year after program initiation. Quantitative data from the electronic medical record and qualitative data from in-depth interviews, focus groups, and ethnographic observations were included in analyses. The study took place at a National Cancer Institute-designated comprehensive cancer center across 12 tumor-specific clinics. RESULTS: Supportive care concerns, scheduling, and clinical-related issues were the most frequent issues navigators encountered. Effective navigation required continuous, time-consuming, invisible work, including building and maintaining a broad knowledge base of resources and health system processes, as well as cultivating relationships with diverse and changing clinical teams. The acceptability and appropriateness of lay navigator activities were mixed among clinic and social work staff, related to negotiating lines between clinical and nonclinical care. CONCLUSION: After 1 year of implementation, lay navigators still found it difficult to interpret and prioritize complex patient needs in a way that all clinical staff found appropriate. Negotiating these issues has made it difficult to develop the strong relationships with clinical teams that are needed for an integrated approach to patient care. To successfully coordinate patient care, it seems that lay navigation programs should be integrated with clinical teams to provide more seamless patient care.