A structured approach to applying systems analysis methods for examining implementation mechanisms.

BACKGROUND: It is challenging to identify and understand the specific mechanisms through which an implementation strategy affects implementation outcomes, as implementation happens in the context of complex, multi-level systems. These systems and the mechanisms within each level have their own dynamic environments that change frequently. For instance, sequencing may matter in that a mechanism may only be activated indirectly by a strategy through another mechanism. The dosage or strength of a mechanism may vary over time or across different health care system levels. To elucidate the mechanisms relevant to successful implementation amidst this complexity, systems analysis methods are needed to model and manage complexity. METHODS: The fields of systems engineering and systems science offer methods-which we refer to as systems analysis methods-to help explain the interdependent relationships between and within systems, as well as dynamic changes to systems over time. When applied to studying implementation mechanisms, systems analysis methods can help (i) better identify and manage unknown conditions that may or may not activate mechanisms (both expected mechanisms targeted by a strategy and unexpected mechanisms that the methods help detect) and (ii) flexibly guide strategy adaptations to address contextual influences that emerge after the strategy is selected and used. RESULTS: In this paper, we delineate a structured approach to applying systems analysis methods for examining implementation mechanisms. The approach includes explicit steps for selecting, tailoring, and evaluating an implementation strategy regarding the mechanisms that the strategy is initially hypothesized to activate, as well as additional mechanisms that are identified through the steps. We illustrate the approach using a case example. We then discuss the strengths and limitations of this approach, as well as when these steps might be most appropriate, and suggest work to further the contributions of systems analysis methods to implementation mechanisms research. CONCLUSIONS: Our approach to applying systems analysis methods can encourage more mechanisms research efforts to consider these methods and in turn fuel both (i) rigorous comparisons of these methods to alternative mechanisms research approaches and (ii) an active discourse across the field to better delineate when these methods are appropriate for advancing mechanisms-related knowledge.

Advancing rapid cycle research in cancer care delivery: a National Cancer Institute workshop report.

Generating actionable research findings quickly and efficiently is critical for improving the delivery of cancer-related care and outcomes. To address this issue, the National Cancer Institute convened subject matter experts, researchers, clinicians, and patients for a 2-day virtual meeting in February 2022. The purpose of this meeting was to identify how rapid cycle interventional research methods can be used to generate findings useful in improving routine clinical practice. The meeting yielded an initial conceptualization of rapid cycle interventional research as being comprised of 6 key elements: use of iterative study designs; reliance on proximal primary outcomes; early and continued engagement with community and clinical partners; use of existing data sources to measure primary outcomes; facilitative features of the study setting and context; and consideration of appropriate rigor relative to intended use of findings. The meeting also identified the types of study designs that can be leveraged to conduct rapid cycle interventional research and provided examples of these; considered this approach from the perspective of key partners; described the clinical and data infrastructure, research resources, and key collaborations needed to support this work; identified research topics best addressed using this approach; and considered needed methodological advances. The National Cancer Institute is committed to exploring opportunities to encourage further development and application of this research approach as a means for better promoting improvements in the delivery of cancer-related care.

A study protocol for a cluster randomized pragmatic trial for comparing strategies for implementing primary HPV testing for routine cervical cancer screening in a large health care system.

BACKGROUND: Limited guidance exists regarding implementation strategies that best facilitate cancer screening practice substitution and achieve optimal stakeholder-centered outcomes. Here we describe the protocol for a randomized pragmatic trial comparing two implementation strategies to facilitate substitution of primary HPV screening for Pap and HPV co-testing to perform routine cervical cancer screening of women aged 30-65 years at Kaiser Permanente Southern California (KPSC). METHODS: Twelve service areas within KPSC will be randomized to a "centrally-administered system-wide implementation + local-tailored implementation" strategy or a "centrally-administered system-wide implementation only" strategy. The centrally-administered strategy comprises clinician and staff educational activities. Sites in the local-tailored arm will then conduct a structured local needs assessment followed by site-specific selection and deployment of implementation interventions. Surveys and interviews will be conducted among women and providers from the primary care and ob/gyn departments prior to the system-wide transition, shortly after the transition, and after the completion of local-tailored interventions. A stakeholder advisory committee will assist with study design, defining stakeholder-centered outcomes, and developing data collection tools. RESULTS: The primary outcome of interest is uptake of primary HPV screening. Secondary provider-centered outcomes include provider knowledge, delivery of patient education, satisfaction with the practice substitution process, and resistance to primary HPV screening. Secondary patient-centered outcomes include patient knowledge, stigma, and satisfaction with the screening process. Intervention fidelity will also be measured via surveys. CONCLUSIONS: Findings from this study will help inform future use of a local-tailored implementation strategy for adopting primary HPV screening at large health care systems. Findings may also be applicable to other types of practice substitution.

Trends in HPV vaccine administration and HPV vaccine coverage in children by race/ethnicity and socioeconomic status during the COVID-19 pandemic in an integrated health care system in California.

BACKGROUND: We sought to evaluate the trends of HPV vaccination between 03/2019-09/2021 and whether the impact of the COVID pandemic on HPV vaccination varied by race/ethnicity and neighborhood deprivation index (NDI). METHODS: Electronic medical records at Kaiser Permanente Southern California were used to assess monthly volume of HPV vaccine doses administered among children aged 9-12.9yrs, and up-to-date coverage (% vaccinated) by age 13 between 03/2019-09/2021. Modified Poisson models were used to evaluate the interactions between race/ethnicity, NDI and the pandemic periods on HPV vaccine coverage. RESULTS: HPV vaccine doses administered in 2020/2021 have returned to the 2019 level after the initial drop. The average up-to-date coverage in 05/2021-09/2021 (54.8%) remained lower than the pre-pandemic level (58.5%). The associations between race/ethnicity, NDI and HPV vaccine coverage did not vary due to the pandemic. CONCLUSION: HPV vaccine promotion efforts are needed to address COVID-19 pandemic's lasting impact on HPV vaccination coverage.

How successful was the use of a community of practice for the implementation of evidence-based practices for heart failure within the United States Department of Veterans Affairs: Insights from a formative evaluation.

BACKGROUND: Communities of Practice (CoPs) are a promising approach to facilitate the implementation of evidence-based practices (EBPs) to improve care for chronic conditions like heart failure (HF). CoPs involve a complex process of acquiring and converting both explicit and tacit knowledge into clinical activities. This study describes the conceptualization, creation, capacity-building and dissemination of a CoP sustained over 9 years, and evaluates its value and impact on EBP. METHODS: In July 2006, a CoP called the Heart Failure Provider Network (HF Network) was established within the United States Department of Veterans Affairs (VA) with the overarching goal of improving the quality of care for HF patients. We assessed (formative) the HF Network in terms of its various activities (inputs) and proximal impacts (mediators) at the individual level, and its distal impacts (outcomes) at the site level including implementation of new/improved EBPs at the systemwide level. RESULTS: The HF Network membership grew steadily over the 9 years. The CoP has involved a total of 1341 multidisciplinary and multilevel members at all 144 VA Health Care Systems (sites). Most members were practising clinicians (n = 891, 66.4%), followed by administrators (n = 342, 25.5%), researchers (n = 70, 5.2%) and others (n = 38, 2.8%). Participation was assessed to be "active" for 70.6% versus "passive" for 29.4% of members. The distribution of active members (clinicians 64.7%, administrators 21.6%) was similar to the distribution of overall membership. CONCLUSIONS: Survey respondents perceived the HF Network as useful in terms of its varied activities and resources relevant for patient care. Strong evidence shows that these members, particularly those who considered themselves influential in improving quality of care, noted multiple benefits of membership, which included confirmation of their own clinical practices, evidence-based changes to their practice and help in understanding facilitators and barriers in setting up or running HF clinics and other programmes. Such CoPs have strong impacts on the quality of care being delivered for both mandated and non-mandated initiatives.

The Knowledge Assessment of Renal Transplantation (KART) 2.0: Development and Validation of CKD and Transplant Knowledge Scales.

BACKGROUND AND OBJECTIVES: Many individuals with kidney disease, particularly those belonging to racial and ethnic minority groups and whose primary language is not English, lack knowledge related to kidney disease symptoms, physiologic functions of the kidney, and benefits and risks of kidney transplantation. Valid instruments to assess patients' knowledge of CKD and kidney transplantation are needed. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Using a sample of 977 patients with stages 3-5 CKD in the Kaiser Permanente health system, we developed the Knowledge Assessment of Renal Transplantation (KART) 2.0 instrument. We conducted cognitive interviews followed by item response theory (IRT) to reduce 48 candidate items. Construct validity was tested by examining differences in scores between patients who spent <1 and ≥1 hour receiving CKD and transplant education. RESULTS: Cognitive interviews modified four items and omitted 11. IRT analyses resulted in two scales: the KART 2.0-Transplant Knowledge Scale (16 items; Cronbach's α=0.8) and the KART 2.0-CKD Knowledge Scale (nine items; Cronbach's α=0.79). Differential item functioning showed that the scales were unbiased to capture knowledge across self-identified race, primary language, CKD stage, and sex. Both scales distinguished patients who had spent <1 and ≥1 hour speaking with health professionals (effect size [ES]=0.33 [transplant], 0.54 [CKD]; P<0.001 for both), reading about kidney disease (ES=0.45 [transplant], 0.62 [CKD]; P<0.001), reading about kidney transplantation (ES=0.67 [transplant], 0.69 [CKD]; P<0.001), and reading about living donor kidney transplant (ES=0.76 [transplant], 0.62 [CKD]; P<0.001). CONCLUSIONS: The KART 2.0 is a valid tool to assess patients' knowledge of CKD and kidney transplantation.

Potentially Harmful Medication Dispenses After a Fall or Hip Fracture: A Mixed Methods Study of a Commonly Used Quality Measure.

BACKGROUND: High-risk medication dispenses to patients with a prior fall or hip fracture represent a potentially dangerous disease-drug interaction among older adults. The research team quantified the prevalence, identified risk factors, and generated patient and provider insights into high-risk medication dispenses in a large, community-based integrated health system using a commonly used quality measure. METHODS: This was a mixed methods study with a convergent design combining a retrospective cohort study using electronic health record (EHR) data, individual interviews of primary care physicians, and a focus group of patient advisors. RESULTS: Of 113,809 patients ≥ 65 years with a fall/fracture in 2009-2015, 35.4% had a potentially harmful medication dispensed after their fall/fracture. Most medications were prescribed by primary care providers. Older age, male gender, and race/ethnicity other than non-Hispanic White were associated with a reduced risk of high-risk medication dispenses. Patients with a pre-fall/fracture medication dispense were substantially more likely to have a post-fall/fracture medication dispense (hazard ratio [HR] = 13.26, 95% confidence interval [CI] = 12.91-13.61). Both patients and providers noted that providers may be unaware of patient falls due to inconsistent assessments and patient reluctance to disclose falls. Providers also noted the lack of a standard location to document falls and limited decision support alerts within the EHR. CONCLUSION: High-risk medication dispenses are common among older patients with a history of falls/fractures. Future interventions should explore improved assessment and documentation of falls, decision support, clinician training strategies, patient educational resources, building trusting patient-clinician relationships to facilitate long-term medication discontinuation among persistent medication users, and a focus on fall prevention.

Implementation fidelity of a nurse-led RCT-tested complex intervention, care coordination for health promotion and activities in Parkinson's disease (CHAPS) in meeting challenges in care management.

BACKGROUND: Parkinson's disease (PD) complexity poses challenges for individuals with Parkinson's, providers, and researchers. A recent multisite randomized trial of a proactive, telephone-based, nurse-led care management intervention - Care Coordination for Health Promotion and Activities in Parkinson's Disease (CHAPS) - demonstrated improved PD care quality. Implementation details and supportive stakeholder feedback were subsequently published. To inform decisions on dissemination, CHAPS Model components require evaluations of their fidelity to the Chronic Care Model and to their implementation. Additionally, assessment is needed on whether CHAPS addresses care challenges cited in recent literature. METHODS: These analyses are based on data from a subset of 140 intervention arm participants and other CHAPS data. To examine CHAPS Model fidelity, we identified CHAPS components corresponding to the Chronic Care Model's six essential elements. To assess implementation fidelity of these components, we examined data corresponding to Hasson's modified implementation fidelity framework. Finally, we identified challenges cited in current Parkinson's care management literature, grouped these into themes using open card sorting techniques, and examined CHAPS data for evidence that CHAPS met these challenges. RESULTS: All Chronic Care Model essential elements were addressed by 17 CHAPS components, thus achieving CHAPS Model fidelity. CHAPS implementation fidelity was demonstrated by adherence to content, frequency, and duration with partial fidelity to telephone encounter frequency. We identified potential fidelity moderators for all six of Hasson's moderator types. Through card sorting, four Parkinson's care management challenge themes emerged: unmet needs and suggestions for providers (by patient and/or care partner), patient characteristics needing consideration, and standardizing models for Parkinson's care management. CHAPS activities and stakeholder perceptions addressed all these themes. CONCLUSIONS: CHAPS, a supportive nurse-led proactive Parkinson's care management program, improved care quality and is designed to be reproducible and supportive to clinicians. Findings indicated CHAPS Model fidelity occurred to the Chronic Care Model and fidelity to implementation of the CHAPS components was demonstrated. Current Parkinson's care management challenges were met through CHAPS activities. Thus, dissemination of CHAPS merits consideration by those responsible for implementing changes in clinical practice and reaching people in need. TRIAL REGISTRATION: ClinicalTrials.gov as NCT01532986 , registered on January 13, 2012.

Reflections on 10 years of effectiveness-implementation hybrid studies.

This article provides new reflections and recommendations from authors of the initial effectiveness-implementation hybrid study manuscript and additional experts in their conceptualization and application. Given the widespread and continued use of hybrid studies, critical appraisals are necessary. The article offers reflections across five conceptual and methodological areas. It begins with the recommendation to replace the term "design" in favor of "study." The use of the term "design" and the explicit focus on trial methodology in the original paper created confusion. The essence of hybrid studies is combining research questions concerning intervention effectiveness and implementation within the same study, and this can and should be achieved by applying a full range of research designs. Supporting this recommendation, the article then offers guidance on selecting a hybrid study type based on evidentiary and contextual information and stakeholder concerns/preferences. A series of questions are presented that have been designed to help investigators select the most appropriate hybrid type for their study situation. The article also provides a critique on the hybrid 1-2-3 typology and offers reflections on when and how to use the typology moving forward. Further, the article offers recommendations on research designs that align with each hybrid study type. Lastly, the article offers thoughts on how to integrate costs analyses into hybrid studies.

Performance of Patient-Reported Outcome Measures in a Large Pragmatic Trial of Home-Based Palliative Care (HomePal): Methodological and Practical Considerations for Embedded Patient-Centered Design.

Background: The research enterprise has embraced patient centeredness in embedded efficient pragmatic trials, but limited data exist on using patient-reported outcomes (PROs) collected as part of usual clinical care for research. Objectives: We sought to assess the performance of different assessment methods for obtaining PROs in a pragmatic cluster randomized trial (HomePal study) designed to compare two models of home-based palliative care (HBPC). Design: Descriptive analytics, comparative trends, and psychometric performance of PROs collected in the HomePal study; measures included Edmonton Symptom Assessment System (ESAS), PROMIS-10, and others administered at baseline, 1, and 6 months. Setting/Subjects: HomePal was conducted in the Southern California and Northwest Kaiser Permanente regions in the United States; subjects were patients receiving HBPC and their caregivers. Measurements: We specifically compared ESAS obtained by research staff with those obtained by clinical HBPC nurses at the time of HBPC enrollment. We also compared ESAS completed by patients versus if done or assisted by a caregiver (proxy). Results: We enrolled 3533 patients and had 2205 ESAS measurements that met the criteria for analysis at baseline and 1447 at the one-month follow-up assessment. Research staff-obtained ESAS at admission to HBPC was higher overall (indicating more symptoms) than the clinically collected measure whether symptoms were reported by patients (31.7 ± 15.4 vs. 26.0 ± 13.4) or by proxies (36.9 ± 15.6 vs. 26.5 ± 13.5). These differences persisted with follow-up ESAS measures. Conclusions: We identified significant variability in PRO responses between different surveyors and whether proxy interaction was needed suggesting complex issues around PRO measure performance for pragmatic embedded trials. ClinicalTrials.gov Identifier: NCT03694431.

Influencing Factors Associated with Implementation of INTERACT (Interventions to Reduce Acute Care Transfers) in VA Community Living Centers (CLCs) Using the Consolidated Framework.

Our objective was to identify the influencing factors associated with the implementation of the INTERACT (Interventions to Reduce Acute Care Transfers) Quality Improvement program within a national healthcare system. INTERACT focuses on early identification and management of changes in residents' condition leading to a reduction in potentially preventable hospital transfers. The Consolidated Framework was used to evaluate implementation data from eight VA Community Living Centers. Qualitative implementation data suggest two influencing Consolidated Framework domains had a strong influence: 1) key attributes of the intervention (e.g., adaptability or complexity) and 2) internal organizational factors (e.g., culture or compatibility). Using the Consolidated Framework can assist future adaptations to this and other complex quality improvement initiatives.

Effects of Different Transitional Care Strategies on Outcomes after Hospital Discharge-Trust Matters, Too.

BACKGROUND: As health systems shift toward value-based care, strategies to reduce readmissions and improve patient outcomes become increasingly important. Despite extensive research, the combinations of transitional care (TC) strategies associated with best patient-centered outcomes remain uncertain. METHODS: Using an observational, prospective cohort study design, Project ACHIEVE sought to determine the association of different combinations of TC strategies with patient-reported and postdischarge health care utilization outcomes. Using purposive sampling, the research team recruited a diverse sample of short-term acute care and critical access hospitals in the United States (N = 42) and analyzed data on eligible Medicare beneficiaries (N = 7,939) discharged from their medical/surgical units. Using both hospital- and patient-reported TC strategy exposure data, the project compared patients "exposed" to each of five overlapping groups of TC strategies to their "control" counterparts. Primary outcomes included 30-day hospital readmissions, 7-day postdischarge emergency department (ED) visits and patient-reported physical and mental health, pain, and participation in daily activities. RESULTS: Participants averaged 72.3 years old (standard deviation =10.1), 53.4% were female, and most were White (78.9%). Patients exposed to one TC group (Hospital-Based Trust, Plain Language, and Coordination) were less likely to have 30-day readmissions (risk ratio [RR], 0.72; 95% confidence interval [CI] = 0.57-0.92, p < 0.001) or 7-day ED visits (RR, 0.72; 95% CI, 0.55-0.93, p < 0.001) and more likely to report excellent physical and mental health, greater participation in daily activities, and less pain (RR ranged from 1.11 to 1.15, p < 0.01). CONCLUSION: In concert with care coordination activities that bridge the transition from hospital to home, hospitals' clear communication and fostering of trust with patients were associated with better patient-reported outcomes and reduced health care utilization.

Laboratory monitoring to reduce adverse drug-related events: a mixed methods study.

BACKGROUND: Therapy with angiotensinconverting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) requires laboratory monitoring to avoid hyperkalemia and acute kidney failure. OBJECTIVE: To assess the frequency of recommended annual serum potassium and creatinine monitoring and determine potential factors associated with care gaps among adults dispensed an ACEI or ARB. METHODS: This mixed-methods study integrated findings from a retrospective cohort study and individual patient interviews. Adults aged 21 years and over within Kaiser Permanente Southern California with at least 180 treatment days of an ACEI and/or ARB in 2015 were included. Patients invited for qualitative interviews included those who did and did not complete the recommended laboratory tests. We assessed the proportion of patients completing both recommended laboratory tests, factors associated with not receiving laboratory monitoring, and patients' insights into barriers and facilitators of recommended monitoring. RESULTS: Of 437,544 patients who received an ACEI or ARB, 9.0% did not receive both a serum potassium and creatinine laboratory test during treatment (defined as a care gap). Lower risk of a care gap was observed for patients with increasing age (rate ratio [RR] per 10-year increase = 0.78, 95% CI = 0.77-0.79); diabetes mellitus (RR = 0.62, 95% CI = 0.60-0.64); hypertension (RR = 0.71, 95% CI = 0.71-0.74); Charlson Comorbidity Index score of at least 2 (RR = 0.62, 95% CI = 0.60-0.64); those who changed medication classes (RR = 0.53, 95% CI = 0.51-0.56); and patients with a cardiologist (RR = 0.81, 95% CI = 0.73-0.90) or nephrologist (RR = 0.60, 95% CI = 0.52-0.69) as their prescribing provider. Twenty-five patients completed the qualitative interviews. Patients often lacked knowledge about the need for laboratory monitoring, cited logistical barriers to accessing the laboratory, and deemed the reminders they received through an outpatient safety program as a facilitator to completing tests. CONCLUSIONS: Given the large patient population on ACEI and ARB medications, monitoring and support strategies such as electronic clinical surveillance could be important in addressing care gaps and potentially reducing adverse drug effects. DISCLOSURES: This project was supported by grant number R01HS024437 from the Agency for Healthcare Research and Quality. The funder had no role in the design of the study; collection, analyses, or interpretation of the data, or decision to submit this manuscript for publication. Harrison, Reynolds, Hahn, Munoz-Plaza, Yi, Fischer, Luong, Sim, Brettler, Handler, and Mittman are employees of the Southern California Permanente Medical Group. Danworth was employed by the Southern California Permanente Medical Group at the time of this study. Singh was partially supported by the Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (CIN13-413). Reynolds reports grants from Novartis, Amgen Inc., and Vital Strategies, Resolve to Save Lives, unrelated to this work. Yi reports grants from Novartis unrelated to this work. Kanter has nothing to disclose.

Trauma Communications Center Coordinated Severity-Based Stroke Triage: Protocol of a Hybrid Type 1 Effectiveness-Implementation Study.

Background: Mechanical thrombectomy (MT) can improve the outcomes of patients with large vessel occlusion (LVO), but a minority of patients with LVO are treated and there are disparities in timely access to MT. In part, this is because in most regions, including Alabama, the emergency medical service (EMS) transports all patients with suspected stroke, regardless of severity, to the nearest stroke center. Consequently, patients with LVO may experience delayed arrival at stroke centers with MT capability and worse outcomes. Alabama's trauma communications center (TCC) coordinates EMS transport of trauma patients by trauma severity and regional hospital capability. Our aims are to develop a severity-based stroke triage (SBST) care model based on Alabama's trauma system, compare the effectiveness of this care pathway to current stroke triage in Alabama for improving broad, equitable, and timely access to MT, and explore stakeholder perceptions of the intervention's feasibility, appropriateness, and acceptability. Methods: This is a hybrid type 1 effectiveness-implementation study with a multi-phase mixed methods sequential design and an embedded observational stepped wedge cluster trial. We will extend TCC guided stroke severity assessment to all EMS regions in Alabama; conduct stakeholder interviews and focus groups to aid in development of region and hospital specific prehospital and inter-facility stroke triage plans for patients with suspected LVO; implement a phased rollout of TCC Coordinated SBST across Alabama's six EMS regions; and conduct stakeholder surveys and interviews to assess context-specific perceptions of the intervention. The primary outcome is the change in proportion of prehospital stroke system patients with suspected LVO who are treated with MT before and after implementation of TCC Coordinated SBST. Secondary outcomes include change in broad public health impact before and after implementation and stakeholder perceptions of the intervention's feasibility, appropriateness, and acceptability using a mixed methods approach. With 1200 to 1300 total observations over 36 months, we have 80% power to detect a 15% improvement in the primary endpoint. Discussion: This project, if successful, can demonstrate how the trauma system infrastructure can serve as the basis for a more integrated and effective system of emergency stroke care.

Advancing mechanisms of implementation to accelerate sustainable evidence-based practice integration: protocol for generating a research agenda.

INTRODUCTION: Mechanisms explain how implementation strategies work. Implementation research requires careful operationalisation and empirical study of the causal pathway(s) by which strategies effect change, and factors that may amplify or weaken their effects. Understanding mechanisms is critically important to replicate findings, learn from negative studies or adapt an implementation strategy developed in one setting to another. Without understanding implementation mechanisms, it is difficult to design strategies to produce expected effects across contexts, which may have disproportionate effects on settings in which priority populations receive care. This manuscript outlines the protocol for an Agency for Healthcare Research and Quality-funded initiative to: (1) establish priorities for an agenda to guide research on implementation mechanisms in health and public health, and (2) disseminate the agenda to research, policy and practice audiences. METHODS AND ANALYSIS: A network of scientific experts will convene in 'Deep Dive' meetings across 3 years. A research agenda will be generated through analysis and synthesis of information from six sources: (1) systematic reviews, (2) network members' approaches to studying mechanisms, (3) new proposals presented in implementation proposal feedback sessions, (4) working group sessions conducted in a leading implementation research training institute, (5) breakout sessions at the Society for Implementation Research Collaboration's (SIRC) 2019 conference and (6) SIRC conference abstracts. Two members will extract mechanism-relevant text segments from each data source and a third member will generate statements as an input for concept mapping. Concept mapping will generate unique clusters of challenges, and the network will engage in a nominal group process to identify priorities for the research agenda. ETHICS AND DISSEMINATION: This initiative will yield an actionable research agenda to guide research to identify and test mechanisms of change for implementation strategies. The agenda will be disseminated via multiple channels to solicit feedback and promote rigorous research on implementation mechanisms.

Combining Improvement and Implementation Sciences and Practices for the Post COVID-19 Era.

Health services made many changes quickly in response to the SARS-CoV-2 pandemic. Many more are being made. Some changes were already evaluated, and there are rigorous research methods and frameworks for evaluating their local implementation and effectiveness. But how useful are these methods for evaluating changes where evidence of effectiveness is uncertain, or which need adaptation in a rapidly changing situation? Has implementation science provided implementers with tools for effective implementation of changes that need to be made quickly in response to the demands of the pandemic? This perspectives article describes how parts of the research and practitioner communities can use and develop a combination of implementation and improvement to enable faster and more effective change in the future, especially where evidence of local effectiveness is limited. We draw on previous reviews about the advantages and disadvantages of combining these two domains of knowledge and practice. We describe a generic digitally assisted rapid cycle testing (DA-RCT) approach that combines elements of each in order to better describe a change, monitor outcomes, and make adjustments to the change when implemented in a dynamic environment.

De-implementation and substitution of clinical care processes: stakeholder perspectives on the transition to primary human papillomavirus (HPV) testing for cervical cancer screening.

BACKGROUND: New cervical cancer screening guidelines recommend primary human papillomavirus (HPV) testing for women age 30-65 years. Healthcare organizations are preparing to de-implement the previous recommended strategies of Pap testing or co-testing (Pap plus HPV test) and substitute primary HPV testing. However, there may be significant challenges to the replacement of this entrenched clinical practice, even with an evidence-based substitution. We sought to identify stakeholder-perceived barriers and facilitators to this substitution within a large healthcare system, Kaiser Permanente Southern California. METHODS: We conducted semi-structured qualitative interviews with clinician, administrative, and patient stakeholders regarding (a) acceptability and feasibility of the planned substitution; (b) perceptions of barriers and facilitators, with an emphasis on those related to the de-implementation/implementation cycle of substitution; and (c) perceived readiness to change. Our interview guide was informed by the Consolidated Framework for Implementation Research (CFIR). Using a team coding approach, we developed an initial coding structure refined during iterative analysis; the data were subsequently organized thematically into domains, key themes, and sub-themes using thematic analysis, followed by framework analysis informed by CFIR. RESULTS: We conducted 23 interviews: 5 patient and 18 clinical/administrative. Clinicians perceived that patients feel more tests equals better care, and clinicians and patients expressed fear of missed cancers ("…it'll be more challenging convincing the patient that only one test is…good enough to detect cancer."). Patients perceived practice changes resulting in "less care" are driven by the desire to cut costs. In contrast, clinicians/administrators viewed changing from two tests to one as acceptable and a workflow efficiency ("…It's very easy and half the work."). Stakeholder-recommended strategies included focusing on the increased efficacy of primary HPV testing and developing clinician talking points incorporating national guidelines to assuage "cost-cutting" fears. CONCLUSIONS: Substitution to replace an entrenched clinical practice is complex. Leveraging available facilitators is key to ease the process for clinical and administrative stakeholders-e.g., emphasizing the efficiency of going from two tests to one. Identifying and addressing clinician and patient fears regarding cost-cutting and perceived poorer quality of care is critical for substitution. Multicomponent and multilevel strategies for engagement and education will be required. TRIAL REGISTRATION: ClinicalTrials.gov, # NCT04371887.

A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders.

BACKGROUND: Treatment of a child who has an anxiety disorder usually begins with the question of which treatment to start first, medication or psychotherapy. Both have strong empirical support, but few studies have compared their effectiveness head-to-head, and none has investigated what to do if the treatment tried first isn't working well-whether to optimize the treatment already begun or to add the other treatment. METHODS: This is a single-blind Sequential Multiple Assignment Randomized Trial (SMART) of 24 weeks duration with two levels of randomization, one in each of two 12-week stages. In Stage 1, children will be randomized to fluoxetine or Coping Cat Cognitive Behavioral Therapy (CBT). In Stage 2, remitters will continue maintenance-level therapy with the single-modality treatment received in Stage 1. Non-remitters during the first 12 weeks of treatment will be randomized to either [1] optimization of their Stage 1 treatment, or [2] optimization of Stage 1 treatment and addition of the other intervention. After the 24-week trial, we will follow participants during open, naturalistic treatment to assess the durability of study treatment effects. Patients, 8-17 years of age who are diagnosed with an anxiety disorder, will be recruited and treated within 9 large clinical sites throughout greater Los Angeles. They will be predominantly underserved, ethnic minorities. The primary outcome measure will be the self-report score on the 41-item youth SCARED (Screen for Child Anxiety Related Disorders). An intent-to-treat analysis will compare youth randomized to fluoxetine first versus those randomized to CBT first ("Main Effect 1"). Then, among Stage 1 non-remitters, we will compare non-remitters randomized to optimization of their Stage 1 monotherapy versus non-remitters randomized to combination treatment ("Main Effect 2"). The interaction of these main effects will assess whether one of the 4 treatment sequences (CBT➔CBT; CBT➔med; med➔med; med➔CBT) in non-remitters is significantly better or worse than predicted from main effects alone. DISCUSSION: Findings from this SMART study will identify treatment sequences that optimize outcomes in ethnically diverse pediatric patients from underserved low- and middle-income households who have anxiety disorders. TRIAL REGISTRATION: This protocol, version 1.0, was registered in ClinicalTrials.gov on February 17, 2021 with Identifier: NCT04760275 .

Effect of a Coordinated Community and Chronic Care Model Team Intervention vs Usual Care on Systolic Blood Pressure in Patients With Stroke or Transient Ischemic Attack: The SUCCEED Randomized Clinical Trial.

Importance: Few stroke survivors meet recommended cardiovascular goals, particularly among racial/ethnic minority populations, such as Black or Hispanic individuals, or socioeconomically disadvantaged populations. Objective: To determine if a chronic care model-based, community health worker (CHW), advanced practice clinician (APC; including nurse practitioners or physician assistants), and physician team intervention improves risk factor control after stroke in a safety-net setting (ie, health care setting where all individuals receive care, regardless of health insurance status or ability to pay). Design, Setting, and Participants: This randomized clinical trial included participants recruited from 5 hospitals serving low-income populations in Los Angeles County, California, as part of the Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities (SUCCEED) clinical trial. Inclusion criteria were age 40 years or older; experience of ischemic or hemorrhagic stroke or transient ischemic attack (TIA) no more than 90 days prior; systolic blood pressure (BP) of 130 mm Hg or greater or 120 to 130 mm Hg with history of hypertension or using hypertensive medications; and English or Spanish language proficiency. The exclusion criterion was inability to consent. Among 887 individuals screened for eligibility, 542 individuals were eligible, and 487 individuals were enrolled and randomized, stratified by stroke type (ischemic or TIA vs hemorrhagic), language (English vs Spanish), and site to usual care vs intervention in a 1:1 fashion. The study was conducted from February 2014 to September 2018, and data were analyzed from October 2018 to November 2020. Interventions: Participants randomized to intervention were offered a multimodal coordinated care intervention, including hypothesized core components (ie, ≥3 APC clinic visits, ≥3 CHW home visits, and Chronic Disease Self-Management Program workshops), and additional telephone visits, protocol-driven risk factor management, culturally and linguistically tailored education materials, and self-management tools. Participants randomized to the control group received usual care, which varied by site but frequently included a free BP monitor, self-management tools, and linguistically tailored information materials. Main Outcomes and Measures: The primary outcome was change in systolic BP at 12 months. Secondary outcomes were non-high density lipoprotein cholesterol, hemoglobin A1c, and C-reactive protein (CRP) levels, body mass index, antithrombotic adherence, physical activity level, diet, and smoking status at 12 months. Potential mediators assessed included access to care, health and stroke literacy, self-efficacy, perceptions of care, and BP monitor use. Results: Among 487 participants included, the mean (SD) age was 57.1 (8.9) years; 317 (65.1%) were men, and 347 participants (71.3%) were Hispanic, 87 participants (18.3%) were Black, and 30 participants (6.3%) were Asian. A total of 246 participants were randomized to usual care, and 241 participants were randomized to the intervention. Mean (SD) systolic BP improved from 143 (17) mm Hg at baseline to 133 (20) mm Hg at 12 months in the intervention group and from 146 (19) mm Hg at baseline to 137 (22) mm Hg at 12 months in the usual care group, with no significant differences in the change between groups. Compared with the control group, participants in the intervention group had greater improvements in self-reported salt intake (difference, 15.4 [95% CI, 4.4 to 26.0]; P = .004) and serum CRP level (difference in log CRP, -0.4 [95% CI, -0.7 to -0.1] mg/dL; P = .003); there were no differences in other secondary outcomes. Although 216 participants (89.6%) in the intervention group received some of the 3 core components, only 35 participants (14.5%) received the intended full dose. Conclusions and Relevance: This randomized clinical trial of a complex multilevel, multimodal intervention did not find vascular risk factor improvements beyond that of usual care; however, further studies may consider testing the SUCCEED intervention with modifications to enhance implementation and participant engagement. Trial Registration: ClinicalTrials.gov Identifier: NCT01763203.

Impact of COVID-19 on Cervical Cancer Screening Rates Among Women Aged 21-65 Years in a Large Integrated Health Care System - Southern California, January 1-September 30, 2019, and January 1-September 30, 2020.

On March 19, 2020, the governor of California issued a statewide stay-at-home order to contain the spread of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19).* The order reduced accessibility to and patient attendance at outpatient medical visits,† including preventive services such as cervical cancer screening. In-person clinic visits increased when California reopened essential businesses on June 12, 2020.§ Electronic medical records of approximately 1.5 million women served by Kaiser Permanente Southern California (KPSC), a large integrated health care system, were examined to assess cervical cancer screening rates before, during, and after the stay-at-home order. KPSC policy is to screen women aged 21-29 years every 3 years with cervical cytology alone (Papanicolaou [Pap] test); those aged 30-65 years were screened every 5 years with human papillomavirus (HPV) testing and cytology (cotesting) through July 15, 2020, and after July 15, 2020, with HPV testing alone, consistent with the latest recommendations from U.S. Preventive Services Task Force.¶ Compared with the 2019 baseline, cervical cancer screening rates decreased substantially during the stay-at-home order. Among women aged 21-29 years, cervical cytology screening rates per 100 person-months declined 78%. Among women aged 30-65 years, HPV test screening rates per 100 person-months decreased 82%. After the stay-at-home order was lifted, screening rates returned to near baseline, which might have been aided by aspects of KPSC's integrated, organized screening program (e.g., reminder systems and tracking persons lost to follow-up). As the pandemic continues, groups at higher risk for developing cervical cancers and precancers should be evaluated first. Ensuring that women receive preventive services, including cancer screening and appropriate follow-up in a safe and timely manner, remains important.