Cultural challenges for adapting behavioral intervention frameworks: A critical examination from a cultural psychology perspective.

We introduce the bias and equivalence framework to highlight how concepts, methods, and tools from cultural psychology can contribute to successful cultural adaptation and implementation of behavioral interventions. To situate our contribution, we provide a review of recent cultural adaptation research and existing frameworks. We identified 68 different frameworks that have been cited when reporting cultural adaptations and highlight three major adaptation dimensions that can be used to differentiate adaptations. Regarding effectiveness, we found an average effect size of zr = 0.24 (95%CI 0.20, 0.29) in 24 meta-analyses published since 2014, but also substantive differences across domains and unclear effects of the extent of cultural adaptations. To advance cultural adaptation efforts, we outline a framework that integrates key steps from previous cultural adaptation frameworks and highlight how cultural bias and equivalence considerations in conjunction with community engagement help a) in the diagnosis of behavioral or psychological problems, b) identification of possible interventions, c) the selection of specific mechanisms of behavior change, d) the specification and documentation of dose effects and thresholds for diagnosis, e) entry and exit points within intervention programs, and f) cost-benefit-sustainability discussions. We provide guiding questions that may help researchers when adapting interventions to novel cultural contexts.

Medicine plus mindset: A mixed-methods evaluation of a novel mindset-focused training for primary care teams.

OBJECTIVES: Patient mindsets influence health outcomes; yet trainings focused on care teams' understanding, recognizing, and shaping patient mindsets do not exist. This paper aims to describe and evaluate initial reception of the "Medicine Plus Mindset" training program. METHODS: Clinicians and staff at five primary care clinics (N = 186) in the San Francisco Bay Area received the Medicine Plus Mindset Training. The Medicine Plus Mindset training consists of a two-hour training program plus a one-hour follow-up session including: (a) evidence to help care teams understand patients' mindsets' influence on treatment; (b) a framework to support care teams in identifying specific patient mindsets; and (c) strategies to shape patient mindsets. RESULTS: We used a common model (Kirkpatrick) to evaluate the training based on participants' reaction, learnings, and behavior. Reaction: Participants rated the training as highly useful and enjoyable. Learnings: The training increased the perceived importance of mindsets in healthcare and improved self-reported efficacy of using mindsets in practice. Behavior: The training increased reported frequency of shaping patient mindsets. CONCLUSIONS: Development of this training and the study's results introduce a promising and feasible approach for integrating mindset into clinical practice. Practice Implications Mindset training can add a valuable dimension to clinical care and should be integrated into training and clinical practice.

Organizational and community resilience for COVID-19 and beyond: Leveraging a system for health and social services integration.

OBJECTIVE: To examine how a preexisting initiative to align health care, public health, and social services influenced COVID-19 pandemic response. DATA SOURCES AND STUDY SETTING: In-depth interviews with administrators and frontline staff in health care, public health, and social services in Contra Costa County, California from October, 2020, to May, 2021. STUDY DESIGN: Qualitative, semi-structured interviews examined how COVID-19 response used resources developed for system alignment prior to the pandemic. DATA COLLECTION: We interviewed 31 informants including 14 managers in public health, health care, or social services and 17 social needs case managers who coordinated services across these sectors on behalf of patients. An inductive-deductive qualitative coding approach was used to systematically identify recurrent themes. PRINCIPAL FINDINGS: We identified four distinct components of the county's system alignment capabilities that supported COVID-19 response, including (1) an organizational culture of adaptability fostered through earlier system alignment efforts, which included the ability and willingness to rapidly implement new organizational processes, (2) trusting relationships among organizations based on prior, positive experiences of cross-sector collaboration, (3) capacity to monitor population health of historically marginalized community members, including information infrastructures, data analytics, and population monitoring and outreach, and (4) frontline staff with flexible skills to support health and social care who had built relationships with the highest risk community members. CONCLUSIONS: Prior investments in aligning systems provided unanticipated benefits for organizational and community resilience during the COVID-19 pandemic. Our results illustrate a pathway for investment in system alignment efforts that build capacity within organizations and relationships between organizations to enhance resilience to crisis. Our findings suggest the usefulness of an integrated concept of organizational and community resilience that understands the resilience of systems of care as a vital resource for community resilience during crisis.

Addressing Social Needs in Clinical Settings: Implementation and Impact on Health Care Utilization, Costs, and Integration of Care.

In recent years, health care policy makers have focused increasingly on addressing social drivers of health as a strategy for improving health and health equity. Impacts of social, economic, and environmental conditions on health are well established. However, less is known about the implementation and impact of approaches used by health care providers and payers to address social drivers of health in clinical settings. This article reviews current efforts by US health care organizations and public payers such as Medicaid and Medicare to address social drivers of health at the individual and community levels. We summarize the limited available evidence regarding intervention impacts on health care utilization, costs, and integration of care and identify key lessons learned from current implementation efforts. Expected final online publication date for the Annual Review of Public Health, Volume 45 is April 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

Using Participatory Implementation Science to Advance Health Equity.

Participatory approaches to implementation science (IS) offer an inclusive, collaborative, and iterative perspective on implementing and sustaining evidence-based interventions (EBIs) to advance health equity. This review provides guidance on the principles and practice of participatory IS, which enables academic researchers, community members, implementers, and other actors to collaboratively integrate practice-, community-, and research-based evidence into public health and health care services. With a foundational focus on supporting academics in coproducing knowledge and action, participatory IS seeks to improve health, reduce inequity, and create transformational change. The three main sections of this review provide (a) a rationale for participatory approaches to research in implementation science, (b) a framework for integrating participatory approaches in research utilizing IS theory and methods, and (c) critical considerations for optimizing the practice and impact of participatory IS. Ultimately, participatory approaches can move IS activities beyond efforts to make EBIs work within harmful systems toward transformative solutions that reshape these systems to center equity. Expected final online publication date for the Annual Review of Public Health, Volume 45 is April 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

Between health care and social services: Boundary objects and cross-sector collaboration.

Health care systems throughout the United States are initiating collaborations with social services agencies. These cross-sector collaborations aim to address patients' social needs-such as housing, food, income, and transportation-in health care settings. However, such collaborations can be challenging as health care and social service sectors are composed of distinct missions, institutions, professional roles, and modes of distributing resources. This paper examines how the "high-risk" patient with both medical and social needs is constructed as a shared object of intervention across sectors. Using the concept of boundary object, we illustrate how the high-risk patient category aggregates and represents multiple types of information-medical, social, service utilization, and cost-in ways that facilitate its use across sectors. The high-risk patient category works as a boundary object, in part, by the differing interpretations of "risk" available to collaborators. During 2019-2021, we conducted 75 semi-structured interviews and 31 field observations to investigate a relatively large-scale, cross-sector collaboration effort in California known as CommunityConnect. This program uses a predictive algorithm and big data sets to assign risk scores to the population and directs integrated health care and social services to patients identified as high risk. While the high-risk patient category worked well to foster collaboration in administrative and policy contexts, we find that it was less useful for patient-level interactions, where frontline case managers were often hesitant or unable to communicate information about the risk-based eligibility process. We suggest that the predominance of health care utilization (and its impacts on costs) in constructing the high-risk patient category may be medicalizing social services, with the potential to deepen inequities.

Melanoma awareness and prevention among latinx and non-latinx white adults in urban and rural California: A qualitative exploration.

BACKGROUND: Melanoma mortality rates in the US are highest among older men, individuals of lower socioeconomic status (SES), and people of color. To better understand these inequities, a qualitative exploratory study was conducted in Northern and Southern California to generate knowledge about barriers and facilitators of awareness, prevention, and early detection of melanoma in lower SES Latinx and non-Latinx White (NLW) individuals living in urban and semi-rural areas. METHODS: Nineteen focus groups were conducted (N = 176 adult participants), stratified by race/ethnicity (Latinx, low-income NLW), geography (semi-rural, urban), and language (English and Spanish). Inductive and deductive thematic analysis was conducted, and the findings were organized using the socioecological model framework: individual, interpersonal, community, and health system/policy levels. RESULTS: Four socioecological themes describe how key factors affect knowledge, perceived risk, preventive behaviors, and melanoma screening. Individual level findings revealed that many participants were not familiar with melanoma, yet were willing to learn through trusted sources. Having brown or darker skin tone was perceived as being associated with lower risk for skin cancer. Interpersonally, social relationships were important influences for skin cancer prevention practice. However, for several Latinx and semi-rural participants, conversations about melanoma prevention did not occur with family and peers. At the community level, semi-rural participants reported distance or lack of transportation to a clinic as challenges for accessing dermatology care. Healthcare systems barriers included burdens of additional healthcare costs for dermatology visits and obtaining referral. CONCLUSIONS: Varying factors influence the awareness levels, beliefs, and behaviors associated with knowledge, prevention, and early detection of melanoma among low-income Latinx and NLW individuals and in semi-rural areas. Results have implications for health education interventions. Navigation strategies that target individuals, families, and health care settings can promote improved prevention and early detection of melanoma in these communities.

Conceptualizing the effective mechanisms of a social needs case management program shown to reduce hospital use: a qualitative study.

BACKGROUND: Social needs case management programs are a strategy to coordinate social and medical care for high-risk patients. Despite widespread interest in social needs case management, not all interventions have shown effectiveness. A lack of evidence about the mechanisms through which these complex interventions benefit patients inhibits effective translation to new settings. The CommunityConnect social needs case management program in Contra Costa County, California recently demonstrated an ability to reduce inpatient hospital admissions by 11% in a randomized study. We sought to characterize the mechanisms through which the Community Connect social needs case management program was effective in helping patients access needed medical and social services and avoid hospitalization. An in-depth understanding of how this intervention worked can support effective replication elsewhere. METHODS: Using a case study design, we conducted semi-structured, qualitative interviews with case managers (n = 30) and patients enrolled in social needs case management (n = 31), along with field observations of patient visits (n = 31). Two researchers coded all interview transcripts and observation fieldnotes. Analysis focused on program elements identified by patients and staff as important to effectiveness. RESULTS: Our analyses uncovered three primary mechanisms through which case management impacted patient access to needed medical and social services: [1] Psychosocial work, defined as interpersonal and emotional support provided through the case manager-patient relationship, [2] System mediation work to navigate systems, coordinate resources, and communicate information and [3] Addressing social needs, or working to directly mitigate the impact of social conditions on patient health. CONCLUSIONS: These findings highlight that the system mediation tasks which are the focus of many social needs assistance interventions offered by health care systems may be necessary but insufficient. Psychosocial support and direct assistance with social needs, enabled by a relationship-focused program, may also be necessary for effectiveness.

Patient and Health Professional Perceptions of Telemonitoring for Hypertension Management: Qualitative Study.

BACKGROUND: Hypertension is the most prevalent and important risk factor for cardiovascular disease, affecting nearly 50% of the US adult population; however, only 30% of these patients achieve controlled blood pressure (BP). Incorporating strategies into primary care that take into consideration individual patient needs, such as remote BP monitoring, may improve hypertension management. OBJECTIVE: From March 2018 to December 2018, Stanford implemented a precision health pilot called Humanwide, which aimed to leverage high-technology and high-touch medicine to tailor individualized care for conditions such as hypertension. We examined multi-stakeholder perceptions of hypertension management in Humanwide to evaluate the program's acceptability, appropriateness, feasibility, and sustainability. METHODS: We conducted semistructured interviews with 16 patients and 15 health professionals to assess their experiences with hypertension management in Humanwide. We transcribed and analyzed the interviews using a hybrid approach of inductive and deductive analysis to identify common themes around hypertension management and consensus methods to ensure reliability and validity. RESULTS: A total of 63% (10/16) of the patients and 40% (6/15) of the health professionals mentioned hypertension in the context of Humanwide. These participants reported that remote BP monitoring improved motivation, BP control, and overall clinic efficiency. The health professionals discussed feasibility challenges, including the time needed to analyze BP data and provide individualized feedback, integration of BP data, technological difficulties with the BP cuff, and decreased patient use of remote BP monitoring over time. CONCLUSIONS: Remote BP monitoring for hypertension management in Humanwide was acceptable to patients and health professionals and appropriate for care. Important challenges need to be addressed to improve the feasibility and sustainability of this approach by leveraging team-based care, engaging patients to sustain remote BP monitoring, standardizing electronic medical record integration of BP measurements, and finding more user-friendly BP cuffs.

The Presence 5 for Racial Justice Framework for anti-racist communication with Black patients.

OBJECTIVE: To identify communication practices that clinicians can use to address racism faced by Black patients, build trusting relationships, and empower Black individuals in clinical care. DATA SOURCES: Qualitative data (N = 112 participants, August 2020-March 2021) collected in partnership with clinics primarily serving Black patients in Leeds, AL; Memphis, TN; Oakland, CA; and Rochester, NY. STUDY DESIGN: This multi-phased project was informed by human-centered design thinking and community-based participatory research principles. We mapped emergent communication and trust-building strategies to domains from the Presence 5 framework for fostering meaningful connection in clinical care. DATA COLLECTION METHODS: Interviews and focus group discussions explored anti-racist communication and patient-clinician trust (n = 36 Black patients; n = 40 nonmedical professionals; and n = 24 clinicians of various races and ethnicities). The Presence 5 Virtual National Community Advisory Board guided analysis interpretation. PRINCIPAL FINDINGS: The emergent Presence 5 for Racial Justice (P5RJ) practices include: (1) Prepare with intention by reflecting on identity, bias, and power dynamics; and creating structures to address bias and structural determinants of health; (2) Listen intently and completely without interruption and listen deeply for the potential impact of anti-Black racism on patient health and interactions with health care; (3) Agree on what matters most by having explicit conversations about patient goals, treatment comfort and consent, and referral planning; (4) Connect with the patient's story, acknowledging socioeconomic factors influencing patient health and focusing on positive efforts; (5) Explore emotional cues by noticing and naming patient emotions, and considering how experiences with racism might influence emotions. CONCLUSION: P5RJ provides a framework with actionable communication practices to address pervasive racism experienced by Black patients. Effective implementation necessitates clinician self-reflection, personal commitment, and institutional support that offers time and resources to elicit a patient's story and to address patient needs.

Primary Care 2.0: A Prospective Evaluation of a Novel Model of Advanced Team Care With Expanded Medical Assistant Support.

PURPOSE: Assess effectiveness of Primary Care 2.0: a team-based model that incorporates increased medical assistant (MA) to primary care physician (PCP) ratio, integration of advanced practice clinicians, expanded MA roles, and extended the interprofessional team. METHODS: Prospective, quasi-experimental evaluation of staff/clinician team development and wellness survey data, comparing Primary Care 2.0 to conventional clinics within our academic health care system. We surveyed before the model launch and every 6-9 months up to 24 months post implementation. Secondary outcomes (cost, quality metrics, patient satisfaction) were assessed via routinely collected operational data. RESULTS: Team development significantly increased in the Primary Care 2.0 clinic, sustained across all 3 post implementation time points (+12.2, +8.5, + 10.1 respectively, vs baseline, on the 100-point Team Development Measure) relative to the comparison clinics. Among wellness domains, only "control of work" approached significant gains (+0.5 on a 5-point Likert scale, P = .05), but was not sustained. Burnout did not have statistically significant relative changes; the Primary Care 2.0 site showed a temporal trend of improvement at 9 and 15 months. Reversal of this trend at 2 years corresponded to contextual changes, specifically, reduced MA to PCP staffing ratio. Adjusted models confirmed an inverse relationship between team development and burnout (P <.0001). Secondary outcomes generally remained stable between intervention and comparison clinics with suggestion of labor cost savings. CONCLUSIONS: The Primary Care 2.0 model of enhanced team-based primary care demonstrates team development is a plausible key to protect against burnout, but is not sufficient alone. The results reinforce that transformation to team-based care cannot be a 1-time effort and institutional commitment is integral.

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.

Inpatient Telemedicine Implementation as an Infection Control Response to COVID-19: Qualitative Process Evaluation Study.

BACKGROUND: The COVID-19 pandemic created new challenges to delivering safe and effective health care while minimizing virus exposure among staff and patients without COVID-19. Health systems worldwide have moved quickly to implement telemedicine in diverse settings to reduce infection, but little is understood about how best to connect patients who are acutely ill with nearby clinical team members, even in the next room. OBJECTIVE: To inform these efforts, this paper aims to provide an early example of inpatient telemedicine implementation and its perceived acceptability and effectiveness. METHODS: Using purposive sampling, this study conducted 15 semistructured interviews with nurses (5/15, 33%), attending physicians (5/15, 33%), and resident physicians (5/15, 33%) on a single COVID-19 unit within Stanford Health Care to evaluate implementation outcomes and perceived effectiveness of inpatient telemedicine. Semistructured interview protocols and qualitative analysis were framed around the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework, and key themes were identified using a rapid analytic process and consensus approach. RESULTS: All clinical team members reported wide reach of inpatient telemedicine, with some use for almost all patients with COVID-19. Inpatient telemedicine was perceived to be effective in reducing COVID-19 exposure and use of personal protective equipment (PPE) without significantly compromising quality of care. Physician workflows remained relatively stable, as most standard clinical activities were conducted via telemedicine following the initial intake examination, though resident physicians reported reduced educational opportunities given limited opportunities to conduct physical exams. Nurse workflows required significant adaptations to cover nonnursing duties, such as food delivery and facilitating technology connections for patients and physicians alike. Perceived patient impact included consistent care quality, with some considerations around privacy. Reported challenges included patient-clinical team communication and personal connection with the patient, perceptions of patient isolation, ongoing technical challenges, and certain aspects of the physical exam. CONCLUSIONS: Clinical team members reported inpatient telemedicine encounters to be acceptable and effective in reducing COVID-19 exposure and PPE use. Nurses adapted their workflows more than physicians in order to implement the new technology and bore a higher burden of in-person care and technical support. Recommendations for improved inpatient telemedicine use include information technology support and training, increased technical functionality, and remote access for the clinical team.

An App-Based Intervention to Support First Responders and Essential Workers During the COVID-19 Pandemic: Needs Assessment and Mixed Methods Implementation Study.

BACKGROUND: The COVID-19 pandemic has created unprecedented challenges for first responders (eg, police, fire, and emergency medical services) and nonmedical essential workers (eg, workers in food, transportation, and other industries). Health systems may be uniquely suited to support these workers given their medical expertise, and mobile apps can reach local communities despite social distancing requirements. Formal evaluation of real-world mobile app-based interventions is lacking. OBJECTIVE: We aimed to evaluate the adoption, acceptability, and appropriateness of an academic medical center-sponsored app-based intervention (COVID-19 Guide App) designed to support access of first responders and essential workers to COVID-19 information and testing services. We also sought to better understand the COVID-19-related needs of these workers early in the pandemic. METHODS: To understand overall community adoption, views and download data of the COVID-19 Guide App were described. To understand the adoption, appropriateness, and acceptability of the app and the unmet needs of workers, semistructured qualitative interviews were conducted by telephone, by video, and in person with first responders and essential workers in the San Francisco Bay Area who were recruited through purposive, convenience, and snowball sampling. Interview transcripts and field notes were qualitatively analyzed and presented using an implementation outcomes framework. RESULTS: From its launch in April 2020 to September 2020, the app received 8262 views from unique devices and 6640 downloads (80.4% conversion rate, 0.61% adoption rate across the Bay Area). App acceptability was mixed among the 17 first responders interviewed and high among the 10 essential workers interviewed. Select themes included the need for personalized and accurate information, access to testing, and securing personal safety. First responders faced additional challenges related to interprofessional coordination and a "culture of heroism" that could both protect against and exacerbate health vulnerability. CONCLUSIONS: First responders and essential workers both reported challenges related to obtaining accurate information, testing services, and other resources. A mobile app intervention has the potential to combat these challenges through the provision of disease-specific information and access to testing services but may be most effective if delivered as part of a larger ecosystem of support. Differentiated interventions that acknowledge and address the divergent needs between first responders and non-first responder essential workers may optimize acceptance and adoption.

Implementation outcomes of Humanwide: integrated precision health in team-based family practice primary care.

BACKGROUND: Humanwide was precision health embedded in primary care aiming to leverage high-tech and high-touch medicine to promote wellness, predict and prevent illness, and tailor treatment to individual medical and psychosocial needs. METHODS: We conducted a study assessing implementation outcomes to inform spread and scale, using mixed methods of semi-structured interviews with diverse stakeholders and chart reviews. Humanwide included: 1) health coaching; 2) four digital health tools for blood-pressure, weight, glucose, and activity; 3) pharmacogenomic testing; and 4) genetic screening/testing. We examined implementation science constructs: reach/penetration, acceptability, feasibility, and sustainability. Chart reviews captured preliminary clinical outcomes. RESULTS: Fifty of 69 patients (72%) invited by primary care providers participated in the Humanwide pilot. We performed chart reviews for the 50 participating patients. Participants were diverse overall (50% non-white, 66% female). Over half of the participants were obese and 58% had one or more major cardiovascular risk factor: dyslipidemia, hypertension, diabetes. Reach/penetration of Humanwide components varied: pharmacogenomics testing 94%, health coaching 80%, genetic testing 72%, and digital health 64%. Interview participants (n=27) included patients (n=16), providers (n=9), and the 2 staff who were allocated dedicated time for Humanwide patient intake and orientation. Patients and providers reported Humanwide was acceptable; it engaged patients holistically, supported faster medication titration, and strengthened patient-provider relationships. All patients benefited clinically from at least one Humanwide component. Feasibility challenges included: low provider self-efficacy for interpreting genetics and pharmacogenomics; difficulties with data integration; patient technology challenges; and additional staffing needs. Patient financial burden concerns surfaced with respect to sustainability. CONCLUSION: This is the first report of implementation of a multi-component precision health model embedded in team-based primary care. We found acceptance from both patients and providers; however, feasibility barriers must be overcome to enable broad spread and sustainability. We found that barriers to implementation of precision health in a team-based primary care clinic are mundane and straightforward, though not necessarily easy to overcome. Future implementation endeavors should invest in basics: education, workflow, and reflection/evaluation. Strengthening fundamentals will enable healthcare systems to more nimbly accept the responsibility of meeting patients at the crossroads of innovative science and routinized clinical systems.

Approach to Human-Centered, Evidence-Driven Adaptive Design (AHEAD) for Health Care Interventions: a Proposed Framework.

Human-centered design (HCD), an empathy-driven approach to innovation that focuses on user needs, offers promise for the rapid design of health care interventions that are acceptable to patients, clinicians, and other stakeholders. Reviews of HCD in healthcare, however, note a need for greater rigor, suggesting an opportunity for integration of elements from traditional research and HCD. A strategy that combines HCD principles with evidence-grounded health services research (HSR) methods has the potential to strengthen the innovation process and outcomes. In this paper, we review the strengths and limitations of HCD and HSR methods for intervention design, and propose a novel Approach to Human-centered, Evidence-driven Adaptive Design (AHEAD) framework. AHEAD offers a practical guide for the design of creative, evidence-based, pragmatic solutions to modern healthcare challenges.

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.

CFIR simplified: Pragmatic application of and adaptations to the Consolidated Framework for Implementation Research (CFIR) for evaluation of a patient-centered care transformation within a learning health system.

INTRODUCTION: The Consolidated Framework for Implementation Research (CFIR) is a commonly used implementation science framework to facilitate design, evaluation, and implementation of evidence-based interventions. Its comprehensiveness is an asset for considering facilitators and barriers to implementation and also makes the framework cumbersome to use. We describe adaptations we made to CFIR to simplify its pragmatic application, for use in a learning health system context, in the evaluation of a complex patient-centered care transformation. METHODS: We conducted a qualitative study and structured our evaluation questions, data collection methods, analysis, and reporting around CFIR. We collected qualitative data via semi-structured interviews and observations with key stakeholders throughout. We identified and documented adaptations to CFIR throughout the evaluation process. RESULTS: We analyzed semi-structured interviews with key stakeholders (n = 23) from clinical observations (n = 5). We made three key adaptations to CFIR: (a) promoted "patient needs and resources," a subconstruct of the outer setting, to its own domain within CFIR during data analysis; (b) divided the "inner setting" domain into three layers that account for the hierarchy of health care systems (i. pilot clinic, ii. peer clinics, and iii. overarching health care system); and (c) tailored several construct definitions to fit a patient-centered, primary care setting. Analysis yielded qualitative findings concentrated in the CFIR domains "intervention characteristics" and "outer setting," with a robust number of findings in the new domain "patient needs and resources." CONCLUSIONS: To make CFIR more accessible and relevant for wider use in the context of patient-centered care transformations within a learning health system, a few adaptations are key. Specifically, we found success by teasing apart interactions across the inner layers of a health system, tailoring construct definitions, and placing additional focus on patient needs.