"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.

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.

"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.

"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.

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.

Palliative Care Disincentives in CKD: Changing Policy to Improve CKD Care.

The dominant health delivery model for advanced chronic kidney disease (CKD) and end-stage renal disease (ESRD) in the United States, which focuses on provision of dialysis, is ill-equipped to address many of the needs of seriously ill patients. Although palliative care may address some of these gaps in care, its integration into advanced CKD care has been suboptimal due to several health system barriers. These barriers include uneven access to specialty palliative care services, underdeveloped models of care for seriously ill patients with advanced CKD, and misaligned policy incentives. This article reviews policies that affect the delivery of palliative care for this population, discusses reforms that could address disincentives to palliative care, identifies quality measurement issues for palliative care for individuals with advanced CKD and ESRD, and considers potential pitfalls in the implementation of new models of integrated palliative care. Reforming health care delivery in ways that remove policy disincentives to palliative care for patients with advanced CKD and ESRD will fill a critical gap in care.

Bereaved carers' accounts of the end of life and the role of care providers in a 'good death': A qualitative study.

BACKGROUND: The way that people die is particularly important to those who are left behind and this memory is not limited to the moment of death, but encompasses the entire end-of-life phase. While a number of attributes for a 'good death' have been identified, less is known about how care providers feature within these conceptualisations. AIM: The aim of this article is to describe the end-of-life experience from the point of view of bereaved family carers with particular reference to the role that care providers play in shaping this experience. DESIGN: Qualitative interviews carried out as part of a study to evaluate a new rapid response hospice at home service. An interpretive thematic analysis using the Framework approach was used to examine how family carers judge a 'good death' and how care providers feature in the attributes of a 'good death'. PARTICIPANTS AND SETTING: A total of 44 interviews with bereaved family carers from a hospice population in the South East of England. RESULTS: Six themes were identified as attributes of a good death in which care providers had a key role: social engagement and connection to identity, care provider characteristics and actions, carer's confidence and ability to care, preparation and awareness of death, presentation of the patient at death and support after death for protected grieving. CONCLUSION: Care providers played a much wider role in social aspects of care at the end of life than previously considered.

A quasi-experimental controlled evaluation of the impact of a hospice rapid response community service for end-of-life care on achievement of preferred place of death.

BACKGROUND: Rapid response services operating 24 h a day have been advocated in UK health policy to support dying patients at home, though there is limited evidence of their effectiveness. AIM: To assess the impact of a rapid response hospice at home service (intervention) on people dying in their preferred place, and carer quality of life, compared to usual care (control). DESIGN: Quasi-experimental multi-centred controlled evaluation. Patient data were collected from hospice records; carers completed postal questionnaires to report quality of life, anxiety and depression. SETTING AND PARTICIPANTS: Community served by one hospice (three contiguous sites) in South East England; 953 patients who died with a preferred place of death recorded and 64 carers who completed questionnaires. RESULTS: There was no significant difference between control and intervention groups in proportions achieving preferred place of death (61.9% vs 63.0% (odds ratio: 0.949; 95% confidence interval: 0.788-1.142)). People living at home alone were less likely to die where they wanted (0.541; 95% confidence interval: 0.438-0.667). Carers in the intervention group reported worse mental health component summary scores (short form-12, p = 0.03) than those in the control group; there were no differences in other carer outcomes. CONCLUSION: The addition of a rapid response hospice at home service did not have a significant impact on helping patients to die where they wanted in an area already well served by community palliative care. Recording preferences, and changes over time, is difficult and presented challenges for this study.

Impact of a hospice rapid response service on preferred place of death, and costs.

BACKGROUND: Many people with a terminal illness would prefer to die at home. A new palliative rapid response service (RRS) provided by a large hospice provider in South East England was evaluated (2010) to provide evidence of impact on achieving preferred place of death and costs. The RRS was delivered by a team of trained health care assistants and available 24/7. The purpose of this study was to (i) compare the characteristics of RRS users and non-users, (ii) explore differences in the proportions of users and non-users dying in the place of their choice, (iii) monitor the whole system service utilisation of users and non-users, and compare costs. METHODS: All hospice patients who died with a preferred place of death recorded during an 18 month period were included. Data (demographic, preferences for place of death) were obtained from hospice records. Dying in preferred place was modelled using stepwise logistic regression analysis. Service use data (period between referral to hospice and death) were obtained from general practitioners, community providers, hospitals, social services, hospice, and costs calculated using validated national tariffs. RESULTS: Of 688 patients referred to the hospice when the RRS was operational, 247 (35.9%) used it. Higher proportions of RRS users than non-users lived in their own homes with a co-resident carer (40.3% vs. 23.7%); more non-users lived alone or in residential care (58.8% vs. 76.3%). Chances of dying in the preferred place were enhanced 2.1 times by being a RRS user, compared to a non-user, and 1.5 times by having a co-resident carer, compared to living at home alone or in a care home. Total service costs did not differ between users and non-users, except when referred to hospice very close to death (users had higher costs). CONCLUSIONS: Use of the RRS was associated with increased likelihood of dying in the preferred place. The RRS is cost neutral. TRIAL REGISTRATION: Current controlled trials ISRCTN32119670, 22 June 2012.

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.

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.

Patient Experiences of Specialty Palliative Care in the Perioperative Period for Cancer Surgery.

CONTEXT: Though patients undergoing treatment for upper gastrointestinal (GI) cancers frequently experience a range of sequelae and disease recurrence, patients often do not receive specialty palliative care soon after diagnosis and it is unknown in what ways they may benefit. OBJECTIVES: To understand patient experiences of specialty palliative care in the perioperative period for patients seeking curative intent upper GI oncologic surgery. METHODS: As part of a randomized controlled trial, we conducted in-depth interviews between November 2019 and July 2021 with 23 patients in the intervention arm who were undergoing curative intent treatment for upper GI cancers and who were also followed by the specialty palliative care team. RESULTS: We found five themes that characterized patient experiences and perceptions of specialty palliative care. Patients typically had limited prior awareness of palliative care (theme 1), but during the study, came to understand it as a "talking" intervention (theme 2). Patients whose concerns aligned with palliative care described it as being impactful on their care (theme 3). However, most patients expressed a focus on cure from their cancer and less perceived relevance for integration of palliative care (theme 4). Integrating specialist palliative care practitioners with surgical teams made it difficult for some patients to identify how palliative care practitioners differed from other members of their care team (theme 5). CONCLUSION: While receipt of specialty palliative care in the perioperative period was generally perceived positively and patients appreciated palliative care visits, they did not describe many needs typically met by palliative care practitioners. TRIAL REGISTRATION: clinicaltrials.gov registration: NCT03611309.

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.

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.

Evaluation of a hospice rapid response community service: a controlled evaluation.

BACKGROUND: While most people faced with a terminal illness would prefer to die at home, less than a third in England are enabled to do so with many dying in National Health Service hospitals. Patients are more likely to die at home if their carers receive professional support. Hospice rapid response teams, which provide specialist palliative care at home on a 24/7 on-call basis, are proposed as an effective way to help terminally ill patients die in their preferred place, usually at home. However, the effectiveness of rapid response teams has not been rigorously evaluated in terms of patient, carer and cost outcomes. METHODS/DESIGN: The study is a pragmatic quasi-experimental controlled trial. The primary outcome for the quantitative evaluation for patients is dying in their preferred place of death. Carers' quality of life will be evaluated using postal questionnaires sent at patient intake to the hospice service and eight months later. Carers' perceptions of care received and the patient's death will be assessed in one to one interviews at 6 to 8 months post bereavement. Service utilisation costs including the rapid response intervention will be compared to those of usual care. DISCUSSION: The study will contribute to the development of the evidence base on outcomes for patients and carers and costs of hospice rapid response teams operating in the community. TRIAL REGISTRATION: Current controlled trials ISRCTN32119670.

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.

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.

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.

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.