Adapting Behavioral Treatments for Primary Care Using a Theory-Based Framework: The Case of Adolescent Eating Disorders.

Evidence-based treatments have been developed for a range of pediatric mental health conditions. These interventions have proven efficacy but require trained pediatric behavioral health specialists for their administration. Unfortunately, the widespread shortage of behavioral health specialists leaves few referral options for primary care providers. As a result, primary care providers are frequently required to support young patients during their lengthy and often fruitless search for specialty treatment. One solution to this treatment-access gap is to draw from the example of integrated behavioral health and adapt brief evidence-based treatments for intra-disciplinary delivery by primary care providers in consultation with mental health providers. This solution has potential to expand access to evidence-based interventions and improve patient outcomes. We outline how an 8-step theory-based process for adapting evidence-based interventions, developed from a scoping review of the wide range of implementation science frameworks, can guide treatment development and implementation for pediatric behavioral health care delivery in the primary care setting, using an example of our innovative treatment adaptation for child and adolescent eating disorders. After reviewing the literature, obtaining input from leaders in eating disorder treatment research, and engaging community stakeholders, we adapted Family-Based Treatment for delivery in primary care. Pilot data suggest that the intervention is feasible to implement in primary care and preliminary findings suggest a large effect on adolescent weight gain. Our experience using this implementation framework provides a model for primary care providers looking to develop intra-disciplinary solutions for other areas where specialty services are insufficient to meet patient needs.

Implementing cancer symptom management interventions utilizing patient-reported outcomes: a pre-implementation evaluation of barriers and facilitators.

PURPOSE: Symptoms can negatively impact quality of life for patients with a history of cancer. Digital, electronic health record (EHR)-integrated approaches to routine symptom monitoring accompanied by evidence-based interventions for symptom management have been explored as a scalable way to improve symptom management, particularly between clinic visits. However, little research has evaluated barriers and facilitators to implementing these approaches in real-world settings, particularly during the pre-implementation phase. Pre-implementation assessment is critical for informing the selection and sequencing of implementation strategies and intervention adaptation. Thus, this study sought to understand pre-implementation perceptions of a remote cancer symptom monitoring and management intervention that uses electronic patient-reported outcome measures for symptom assessment. METHODS: We interviewed 20 clinical and administrative stakeholders from 4 geographic regions within an academic medical center and its affiliated health system during the months prior to initiation of a stepped-wedge, cluster randomized pragmatic trial. Transcripts were coded using the Consolidated Framework for Implementation Research [CFIR] 2.0. Two study team members reviewed coded transcripts to understand how determinants were relevant in the pre-implementation phase of the trial and prepared analytic memos to identify themes. RESULTS: Findings are summarized in four themes: (1) ability of the intervention to meet patient needs [recipient characteristics], (2) designing with care team needs in mind [innovation design and adaptability], (3) fit of the intervention with existing practice workflows [compatibility], and (4) engaging care teams early [engaging deliverers]. CONCLUSION: Attention to these aspects when planning intervention protocols can promote intervention compatibility with patients, providers, and practices thereby increasing implementation success.

Implementation of a Virtual Interprofessional ICU Learning Collaborative: Successes, Challenges, and Initial Reactions From the Structured Team-Based Optimal Patient-Centered Care for Virus COVID-19 Collaborators.

Initial Society of Critical Care Medicine Discovery Viral Infection and Respiratory illness Universal Study (VIRUS) Registry analysis suggested that improvements in critical care processes offered the greatest modifiable opportunity to improve critically ill COVID-19 patient outcomes. OBJECTIVES: The Structured Team-based Optimal Patient-Centered Care for Virus COVID-19 ICU Collaborative was created to identify and speed implementation of best evidence based COVID-19 practices. DESIGN SETTING AND PARTICIPANTS: This 6-month project included volunteer interprofessional teams from VIRUS Registry sites, who received online training on the Checklist for Early Recognition and Treatment of Acute Illness and iNjury approach, a structured and systematic method for delivering evidence based critical care. Collaborators participated in weekly 1-hour videoconference sessions on high impact topics, monthly quality improvement (QI) coaching sessions, and received extensive additional resources for asynchronous learning. MAIN OUTCOMES AND MEASURES: Outcomes included learner engagement, satisfaction, and number of QI projects initiated by participating teams. RESULTS: Eleven of 13 initial sites participated in the Collaborative from March 2, 2021, to September 29, 2021. A total of 67 learners participated in the Collaborative, including 23 nurses, 22 physicians, 10 pharmacists, nine respiratory therapists, and three nonclinicians. Site attendance among the 11 sites in the 25 videoconference sessions ranged between 82% and 100%, with three sites providing at least one team member for 100% of sessions. The majority reported that topics matched their scope of practice (69%) and would highly recommend the program to colleagues (77%). A total of nine QI projects were initiated across three clinical domains and focused on improving adherence to established critical care practice bundles, reducing nosocomial complications, and strengthening patient- and family-centered care in the ICU. Major factors impacting successful Collaborative engagement included an engaged interprofessional team; an established culture of engagement; opportunities to benchmark performance and accelerate institutional innovation, networking, and acclaim; and ready access to data that could be leveraged for QI purposes. CONCLUSIONS AND RELEVANCE: Use of a virtual platform to establish a learning collaborative to accelerate the identification, dissemination, and implementation of critical care best practices for COVID-19 is feasible. Our experience offers important lessons for future collaborative efforts focused on improving ICU processes of care.

Patient- and Provider-Level Factors Associated With Telehealth Utilization Across a Multisite, Multiregional Cancer Practice From 2019 to 2021.

PURPOSE: In response to the COVID-19 pandemic, many cancer practices rapidly adopted telehealth services. However, there is a paucity of data regarding ongoing telehealth visit utilization beyond this initial response. The purpose of this study was to assess changes in variables associated with telehealth visit utilization over time. METHODS: This is a cross-sectional, year-over-year, retrospective analysis of telehealth visits conducted across a multisite, multiregional cancer practice in the United States. Multivariable models examined the association of patient- and provider-level variables with telehealth utilization across outpatient visits conducted over three 8-week periods from July to August in 2019 (n = 32,537), 2020 (n = 33,399), and 2021 (n = 35,820). RESULTS: The rate of telehealth utilization increased from <0.01% (2019) to 11% (2020) to 14% (2021). The most significant patient-level factors associated with increased telehealth utilization included nonrural residence and age ≤65 years. Among patients residing in rural settings, video visit utilization rates were significantly lower and phone visit utilization rates were significantly higher compared with patients from nonrural residences. Regarding provider-level factors, widening differences in telehealth utilization were observed at tertiary versus community-based practice settings. Increased telehealth utilization was not associated with duplicative care as per-patient and per-physician visit volumes in 2021 remained consistent with prepandemic levels. CONCLUSION: We observed continuous expansion in telehealth visit utilization from 2020 to 2021. Our experiences suggest that telehealth can be integrated into cancer practices without evidence of duplicative care. Future work should examine sustainable reimbursement structures and policies to ensure accessibility of telehealth as a means to facilitate equitable, patient-centered cancer care.

A multisite exploration of the association between critical care implementation factors and clinical outcomes during the COVID-19 pandemic.

Background: Little is known about strategies to implement new critical care practices in response to COVID-19. Moreover, the association between differing implementation climates and COVID-19 clinical outcomes has not been examined. The purpose of this study was to evaluate the relationship between implementation determinants and COVID-19 mortality rates. Methods: We used mixed methods guided by the Consolidated Framework for Implementation Research (CFIR). Semi-structured qualitative interviews were conducted with critical care leaders and analyzed to rate the influence of CFIR constructs on the implementation of new care practices. Qualitative and quantitative comparisons of CFIR construct ratings were performed between hospital groups with low- versus high-mortality rates. Results: We found associations between various implementation factors and clinical outcomes of critically ill COVID-19 patients. Three CFIR constructs (implementation climate, leadership engagement, and engaging staff) had both qualitative and statistically significant quantitative correlations with mortality outcomes. An implementation climate governed by a trial-and-error approach was correlated with high COVID-19 mortality, while leadership engagement and engaging staff were correlated with low mortality. Another three constructs (needs of patient; organizational incentives and rewards; and engaging implementation leaders) were qualitatively different across mortality outcome groups, but these differences were not statistically significant. Conclusions: Improving clinical outcomes during future public health emergencies will require reducing identified barriers associated with high mortality and harnessing salient facilitators associated with low mortality. Our findings suggest that collaborative and engaged leadership styles that promote the integration of new yet evidence-based critical care practices best support COVID-19 patients and contribute to lower mortality.

Facilitators and barriers to the implementation of new critical care practices during COVID-19: a multicenter qualitative study using the Consolidated Framework for Implementation Research (CFIR).

BACKGROUND: The COVID-19 pandemic produced unprecedented demands and rapidly changing evidence and practices within critical care settings. The purpose of this study was to identify factors and strategies that hindered and facilitated effective implementation of new critical care practices and policies in response to the pandemic. METHODS: We used a cross-sectional, qualitative study design to conduct semi-structured in-depth interviews with critical care leaders across the United States. The interviews were audio-taped and professionally transcribed verbatim. Guided by the Consolidated Framework for Implementation Research (CFIR), three qualitative researchers used rapid analysis methods to develop relevant codes and identify salient themes. RESULTS: Among the 17 hospitals that agreed to participate in this study, 31 clinical leaders were interviewed. The CFIR-driven rapid analysis of the interview transcripts generated 12 major themes, which included six implementation facilitators (i.e., factors that promoted the implementation of new critical care practices) and six implementation barriers (i.e., factors that hindered the implementation of new critical care practices). These themes spanned the five CFIR domains (Intervention Characteristics, Outer Setting, Inner Setting, Characteristics of Individuals, and Process) and 11 distinct CFIR constructs. Salient facilitators to implementation efforts included staff resilience, commitment, and innovation, which were supported through collaborative feedback and decision-making mechanisms between leadership and frontline staff. Major identified barriers included lack of access to reliable and transferable information, available resources, uncollaborative leadership and communication styles. CONCLUSIONS: Through applying the CFIR to organize and synthesize our qualitative data, this study revealed important insights into implementation determinants that influenced the uptake of new critical care practices during COVID-19. As the pandemic continues to burden critical care units, clinical leaders should consider emulating the effective change management strategies identified. The cultivation of streamlined, engaging, and collaborative leadership and communication mechanisms not only supported implementation of new care practices across sites, but it also helped reduce salient implementation barriers, particularly resource and staffing shortages. Future critical care implementation studies should seek to capitalize on identified facilitators and reduce barriers.

Contributors to Diagnostic Error or Delay in the Acute Care Setting: A Survey of Clinical Stakeholders.

Diagnostic error or delay (DEOD) is common in the acute care setting and results in poor patient outcomes. Many factors contribute to DEOD, but little is known about how contributors may differ across acute care areas and professional roles. As part of a sequential exploratory mixed methods research study, we surveyed acute care clinical stakeholders about the frequency with which different factors contribute to DEOD. Survey respondents could also propose solutions in open text fields. N = 220 clinical stakeholders completed the survey. Care Team Interactions, Systems and Process, Patient, Provider, and Cognitive factors were perceived to contribute to DEOD with similar frequency. Organization and Infrastructure factors were perceived to contribute to DEOD significantly less often. Responses did not vary across acute care setting. Physicians perceived Cognitive factors to contribute to DEOD more frequently compared to those in other roles. Commonly proposed solutions included: technological solutions, organization level fixes, ensuring staff know and are encouraged to work to the full scope of their role, and cultivating a culture of collaboration and respect. Multiple factors contribute to DEOD with similar frequency across acute care areas, suggesting the need for a multi-pronged approach that can be applied across acute care areas.

Receptivity to a Nurse-Led Symptom Management Intervention Among Highly Symptomatic Patients With Cancer.

BACKGROUND: The symptom burden associated with cancer and its treatment can negatively affect patients' quality of life and survival. Symptom-focused collaborative care model (CCM) interventions can improve outcomes, but only if patients engage with them. We assessed the receptivity of severely symptomatic oncology patients to a remote nurse-led CCM intervention. METHODS: In a pragmatic, cluster-randomized, stepped-wedge trial conducted as part of the National Cancer Institute IMPACT Consortium (E2C2, NCT03892967), patients receiving cancer care were asked to rate their sleep disturbance, pain, anxiety, emotional distress, fatigue, and limitations in physical function. Patients reporting at least 1 severe symptom (≥7/10) were offered phone consultation with a nurse symptom care manager (RN SCM). Initially, patients had to "opt-in" to receive a call, but the protocol was later modified so they had to "opt-out" if they did not want a call. We assessed the impact of opt-in vs opt-out framing and patient characteristics on receptiveness to RN SCM calls. All statistical tests were 2-sided. RESULTS: Of the 1204 symptom assessments (from 864 patients) on which at least 1 severe symptom was documented, 469 (39.0%) indicated receptivity to an RN SCM phone call. The opt-out period (odds ratio [OR] = 1.61, 95% confidence interval [CI] = 1.12 to 2.32, P = .01), receiving care at a tertiary care center (OR = 3.59, 95% CI = 2.18 to 5.91, P < .001), and having severe pain (OR = 1.80, 95% CI = 1.24 to 2.62, P = .002) were associated with statistically significantly greater willingness to receive a call. CONCLUSIONS: Many severely symptomatic patients were not receptive to an RN SCM phone call. Better understanding of reasons for refusal and strategies for improving patient receptivity are needed.

Connecting community-delivered evidence-based programs and the healthcare system: Piloting a learning "wellcare" system.

INTRODUCTION: Many evidence-based programs (EBPs) have been determined in randomized controlled trials to be effective, but few studies explore the real-world effectiveness of EBPs implemented in the natural community setting. Our study evaluated whether a novel linked infrastructure would enable such insights and continuous improvement as part of a learning healthcare-community bridged "wellcare" ecosystem. METHODS: We created a secure, web-based data entry and storage platform with a network of Minnesota community-based organizations to record EBP participants' demographics and attendance, and program details. We then linked participant's information to their Rochester Epidemiology Project (REP) medical records. With this infrastructure, we conducted a proof of concept, retrospective cohort study by matching EBP participants to REP controls and comparing medical record-documented outcomes over 1 year follow-up. RESULTS: We successfully linked EBP participant records with medical records in 77.6% of cases, and the infrastructure proved feasible and scalable. Still, key challenges remain in obtaining participant consent for data sharing. Upfront resource investments and the availability of REP-like warehouses limit generalizability. Optimal learning will be improved by enhancements that better track program fidelity. Our pilot study established a proof-of-concept, but sample sizes (n = 99 for falls prevention and n = 97 chronic disease/pain management EBP completers) were too small to detect significant differences in hospital admittance as compared to matched controls for either EBP group, (OR = 0.66[0.36, 1.19]) and (OR = 0.81[0.43, 1.54]), respectively. Events were too rare to gather meaningful information about effects on fall rates. CONCLUSIONS: Our pilot demonstrates the feasibility of developing an online infrastructure that connects information from community leaders with medical record documented health outcomes, bridging the knowledge gap between community programs and the health care system. Insights gleaned from our infrastructure can be used to continuously shape community program delivery to reduce the need for formal health care services.

Teaching for implementation: A framework for building implementation research and practice capacity within the translational science workforce.

Implementation science offers a compelling value proposition to translational science. As such, many translational science stakeholders are seeking to recruit, teach, and train an implementation science workforce. The type of workforce that will make implementation happen consists of both implementation researchers and practitioners, yet little guidance exists on how to train such a workforce. We-members of the Advancing Dissemination and Implementation Sciences in CTSAs Working Group-present the Teaching For Implementation Framework to address this gap. We describe the differences between implementation researchers and practitioners and demonstrate what and how to teach them individually and in co-learning opportunities. We briefly comment on educational infrastructures and resources that will be helpful in furthering this type of approach.

Integrating dissemination and implementation sciences within Clinical and Translational Science Award programs to advance translational research: Recommendations to national and local leaders.

The National Center for Advancing Translational Sciences (NCATS) has defined translation as the process of turning observations into interventions that are adopted, sustained, and improve health. Translation must attend to research and community systems and context at multiple levels, and to key stakeholders. Dissemination and implementation (D&I) sciences are informed by an understanding of the critical role of people and systems in disseminating, adopting, and sustaining innovations within real-world settings. Thus, the D&I sciences provides a set of principles that can guide the translational work of Clinical and Translational Science Award (CTSA) programs from basic research to public health. In this special communication, our cross-domain working group of the CTSA consortium, comprised of experts in methods and processes, workforce development, evaluation, stakeholder engagement, and D&I sciences, share a vision of how CTSAs can enhance translation across the translational spectrum through the integration of D&I sciences into the critical areas of methods and processes, workforce development, and evaluation. We propose a set of recommendations for NCATS national and local leaders that are intended to move D&I sciences out of a position of unfamiliarity and ancillary value and into the core identity of who CTSAs are, how they think, and what they do, to advance translation and health.

Increasing risk-concordant cardiovascular care in diverse health systems: a mixed methods pragmatic stepped wedge cluster randomized implementation trial of shared decision making (SDM4IP).

BACKGROUND: The primary prevention of cardiovascular (CV) events is often less intense in persons at higher CV risk and vice versa. Clinical practice guidelines recommend that clinicians and patients use shared decision making (SDM) to arrive at an effective and feasible prevention plan that is congruent with each person's CV risk and informed preferences. However, SDM does not routinely happen in practice. This study aims to integrate into routine care an SDM decision tool (CV PREVENTION CHOICE) at three diverse healthcare systems in the USA and study strategies that foster its adoption and routine use. METHODS: This is a mixed method, hybrid type III stepped wedge cluster randomized study to estimate (a) the effectiveness of implementation strategies on SDM uptake and utilization and (b) the extent to which SDM results in prevention plans that are risk-congruent. Formative evaluation methods, including clinician and stakeholder interviews and surveys, will identify factors likely to impact feasibility, acceptability, and adoption of CV PREVENTION CHOICE as well as normalization of CV PREVENTION CHOICE in routine care. Implementation facilitation will be used to tailor implementation strategies to local needs, and implementation strategies will be systematically adjusted and tracked for assessment and refinement. Electronic health record data will be used to assess implementation and effectiveness outcomes, including CV PREVENTION CHOICE reach, adoption, implementation, maintenance, and effectiveness (measured as risk-concordant care plans). A sample of video-recorded clinical encounters and patient surveys will be used to assess fidelity. The study employs three theoretical approaches: a determinant framework that calls attention to categories of factors that may foster or inhibit implementation outcomes (the Consolidated Framework for Implementation Research), an implementation theory that guides explanation or understanding of causal influences on implementation outcomes (Normalization Process Theory), and an evaluation framework (RE-AIM). DISCUSSION: By the project's end, we expect to have (a) identified the most effective implementation strategies to embed SDM in routine practice and (b) estimated the effectiveness of SDM to achieve feasible and risk-concordant CV prevention in primary care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04450914 . Posted June 30, 2020 TRIAL STATUS: This study received ethics approval on April 17, 2020. The current trial protocol is version 2 (approved February 17, 2021). The first subject had not yet been enrolled at the time of submission.

What Contributes to Diagnostic Error or Delay? A Qualitative Exploration Across Diverse Acute Care Settings in the United States.

OBJECTIVES: Diagnostic error and delay is a prevalent and impactful problem. This study was part of a mixed-methods approach to understand the organizational, clinician, and patient factors contributing to diagnostic error and delay among acutely ill patients within a health system, as well as recommendations for the development of tailored, targeted, feasible, and effective interventions. METHODS: We did a multisite qualitative study using focus group methodology to explore the perspectives of key clinician stakeholders. We used a conceptual framework that characterized diagnostic error and delay as occurring within 1 of 3 stages of the patient's diagnostic journey-critical information gathering, synthesis of key information, and decision making and communication. We developed our moderator guide based on the sociotechnical frameworks previously described by Holden and Singh for understanding noncognitive factors that lead to diagnostic error and delay. Deidentified focus group transcripts were coded in triplicate and to consensus over a series of meetings. A final coded data set was then uploaded into NVivo software. The data were then analyzed to generate overarching themes and categories. RESULTS: We recruited a total of 64 participants across 4 sites from emergency departments, hospital floor, and intensive care unit settings into 11 focus groups. Clinicians perceive that diverse organizational, communication and coordination, individual clinician, and patient factors interact to impede the process of making timely and accurate diagnoses. CONCLUSIONS: This study highlights the complex sociotechnical system within which individual clinicians operate and the contributions of systems, processes, and institutional factors to diagnostic error and delay.

Evidence-Based Strategies for Clinical Organizations to Address COVID-19 Vaccine Hesitancy.

The success of vaccination programs is contingent upon irrefutable scientific safety data combined with high rates of public acceptance and population coverage. Vaccine hesitancy, characterized by lack of confidence in vaccination and/or complacency about vaccination that may lead to delay or refusal of vaccination despite the availability of services, threatens to undermine the success of coronavirus disease 2019 (COVID-19) vaccination programs. The rapid pace of vaccine development, misinformation in popular and social media, the polarized sociopolitical environment, and the inherent complexities of large-scale vaccination efforts may undermine vaccination confidence and increase complacency about COVID-19 vaccination. Although the experience of recent lethal surges of COVID-19 infections has underscored the value of COVID-19 vaccines, ensuring population uptake of COVID-19 vaccination will require application of multilevel, evidence-based strategies to influence behavior change and address vaccine hesitancy. Recent survey research evaluating public attitudes in the United States toward the COVID-19 vaccine reveals substantial vaccine hesitancy. Building upon efforts at the policy and community level to ensure population access to COVID-19 vaccination, a strong health care system response is critical to address vaccine hesitancy. Drawing on the evidence base in social, behavioral, communication, and implementation science, we review, summarize, and encourage use of interpersonal, individual-level, and organizational interventions within clinical organizations to address this critical gap and improve population adoption of COVID-19 vaccination.

Erratum: Integrating dissemination and implementation sciences within Clinical and Translational Science Award programs to advance translational research: Recommendations to national and local leaders - ERRATUM.

[This corrects the article DOI: 10.1017/cts.2021.815.].

A New Standard in Graft-versus-Host Disease Prophylaxis? An Introduction to Blood and Marrow Transplant Clinical Trials Network 1703.

Effective immunosuppressive regimens to prevent the development of graft-versus-host disease (GVHD) are essential to the success of allogeneic hematopoietic cell transplantation (HCT). After revolutionizing haploidentical transplantation, post-transplantation cyclophosphamide (PTCy) is now being evaluated for HCT performed from related and unrelated donors. In this setting, 2 recent randomized studies have demonstrated lower rates of GVHD and superior GVHD-free, relapse-free survival with PTCy compared with conventional GVHD prophylaxis. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) is currently conducting a large, randomized phase III, multicenter trial (BMT CTN 1703) comparing PTCy/tacrolimus/mycophenolate mofetil to tacrolimus/methotrexate as GVHD prophylaxis regimens in reduced-intensity allogeneic HCT. Here we review the ongoing study, highlight its importance to the field, and explore the possible implications of its results on clinical practice.

Hospital to Community Transitions for Older Adults: An Update for the Practicing Clinician.

Spurred by changes in both population demographics and health care reimbursement, health care providers are responding by using new models to more fully support the posthospital transition. This paper reviews common models for posthospital transition and also describes the Mayo Clinic model for care transition. Models are designed with the intent of managing the cost of health care by reducing 30-day hospital readmissions and improving management of chronic disease. Meta-analyses have proved helpful in identifying the most effective program elements designed to reduce 30-day hospital readmissions. These elements include a bundled and multidisciplinary approach to best meet the needs of patients. Successful care teams also emphasize self-empowerment for both patients and caregivers. There are 2 general types of practice. In 1 model, introduced by Mary Naylor, an advanced-practice provider cares for the patient for a set period of time, which includes home visits. In the second model, introduced by Eric Coleman, a transitions coach, who can be an RN, a social worker, or a trained volunteer, serves as the health care coach, while improving self-efficacy. Both models have been successful. At Mayo Clinic, the Mayo Clinic Care Transitions program has encompassed a 7-year experience, using the services of an advanced practice provider. In previous studies, this model demonstrated a 20.1% (95% confidence interval [CI], 15.8 to 24.1%) decrease in 30-day readmission in controls compared with 12.4% (95% CI, 8.9 to 15.7%) in the control group. Although this model was successful in reducing 30-day readmissions, there was no difference between groups at 180 days. In patients experiencing the highest deciles of cost (8th decile), enrollment in a care transitions program reduced their overall cost by $2700. This cost savings was statistically significant. Both patients and caregivers participating in the program appreciated the home visits and felt more comfortable communicating at home.

Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2).

BACKGROUND: The prevalence of inadequate symptom control among cancer patients is quite high despite the availability of definitive care guidelines and accurate and efficient assessment tools. METHODS: We will conduct a hybrid type 2 stepped wedge pragmatic cluster randomized clinical trial to evaluate a guideline-informed enhanced, electronic health record (EHR)-facilitated cancer symptom control (E2C2) care model. Teams of clinicians at five hospitals that care for patients with various cancers will be randomly assigned in steps to the E2C2 intervention. The E2C2 intervention will have two levels of care: level 1 will offer low-touch, automated self-management support for patients reporting moderate sleep disturbance, pain, anxiety, depression, and energy deficit symptoms or limitations in physical function (or both). Level 2 will offer nurse-managed collaborative care for patients reporting more intense (severe) symptoms or functional limitations (or both). By surveying and interviewing clinical staff, we will also evaluate whether the use of a multifaceted, evidence-based implementation strategy to support adoption and use of the E2C2 technologies improves patient and clinical outcomes. Finally, we will conduct a mixed methods evaluation to identify disparities in the adoption and implementation of the E2C2 intervention among elderly and rural-dwelling patients with cancer. DISCUSSION: The E2C2 intervention offers a pragmatic, scalable approach to delivering guideline-based symptom and function management for cancer patients. Since discrete EHR-imbedded algorithms drive defining aspects of the intervention, the approach can be efficiently disseminated and updated by specifying and modifying these centralized EHR algorithms. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03892967. Registered on 25 March 2019.