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To assess the effectiveness of the ICAN Discussion Aid in improving patients' experience of receiving care for their chronic conditions and health professionals' experience of providing their care. We conducted a pragmatic, mixed-methods, cluster-randomized trial of the ICAN Discussion Aid at 8 clinics in 4 independent health systems in the US from January 2017 and to August 2018. Sites were randomized 1:1 in pairs. Participants were primary care health professionals and their adult patients with ≥1 chronic condition. Quantitative outcomes were health professional assessment of chronic illness care and relational coordination and patient-reported self-efficacy to manage chronic disease, self-efficacy to communicate with clinician, treatment burden, assessment of chronic illness care, general health, and disruption from illness and treatment. Uptake of ICAN was assessed with patient qualitative interviews, clinician focus groups/interviews, visit video recordings, and chart review. 98 clinicians and 1733 patients participated. We found no significant differences between ICAN and usual care sites in mixed effect models on main outcome measures. In adjusted difference-in-differences analyses, we found patient self-efficacy to manage chronic disease (mean difference 0.61 (SE 0.27), p = 0.023), patient self-efficacy to communicate with their clinician (mean difference 0.31 (SE 0.14), p = 0.032), and health professional assessment of chronic illness care (1.42 (SE 0.52), p = 0.007) were significantly better at ICAN sites. Chart review indicated the aid was implemented in 19% of eligible encounters. Qualitative analyses highlighted limited implementation of ICAN as intended overall due to varying clinic challenges but showed that ICAN use as intended was a valued addition to the visit. When patients and clinicians use ICAN as intended, which seldom occurred, important conversations emerge. This qualitative finding did not parlay into statistically significant effects on most outcomes of interest. The trial was registered at clinicaltrials.gov (# NCT03017196).

Background Sepsis survivors experience high morbidity and mortality. Though recommended best practices have been established to address the transition and early post hospital needs and promote recovery for sepsis survivors, few patients receive recommended post-sepsis care. Our team developed the Sepsis Transition and Recovery (STAR) program, a multicomponent transition intervention that leverages virtually-connected nurses to coordinate the application of evidence-based recommendations for post-sepsis care with additional clinical support from hospitalist and primary care physicians. In this paper, we present findings from a qualitative pre-implementation study, guided by the Consolidated Framework for Implementation Research (CFIR), of factors to inform successful STAR implementation at a large learning health system prior to effectiveness testing as part of a Type I Hybrid trial. Methods We conducted semi-structured qualitative interviews ( n  = 16) with 8 administrative leaders and 8 clinicians. Interviews were transcribed and analyzed in ATLAS.ti using a combination deductive/inductive strategy based on CFIR domains and constructs and the Constant Comparison Method. Results Six facilitators and five implementation barriers were identified spanning all five CFIR domains (Intervention Characteristics, Outer Setting, Inner Setting, Characteristics of Individuals and Process). Facilitators of STAR included alignment with health system goals, fostering stakeholder engagement, sharing STAR outcomes data, good communication between STAR navigators and patient care teams/PCPs, clinician promotion of STAR with patients, and good rapport and effective communication between STAR navigators and patients, caregivers, and family members. Barriers of STAR included competing demands for staff time and resources, insufficient communication and education of STAR’s value and effectiveness, underlying informational and technology gaps among patients, lack of patient access to community resources, and patient distrust of the program and/or health care. Conclusions CFIR proved to be a robust framework for examining facilitators and barriers for pre-implementation planning of post-sepsis care programs within diverse hospital and community settings in a large LHS. Conducting a structured pre-implementation evaluation helps researchers design with implementation in mind prior to effectiveness studies and should be considered a key component of Type I hybrid trials when feasible. Trial registration Clinicaltrials.gov, NCT04495946 . Registered August 3, 2020.

Asthma is a highly prevalent, chronic disease with significant morbidity, cost, and disparities in health outcomes. While adherence to asthma treatment guidelines can improve symptoms and decrease exacerbations, most patients receive care that is not guideline-based. New approaches that incorporate shared decision-making (SDM) and health information technology (IT) are needed to positively impact asthma management. Despite the promise of health IT to improve efficiency and outcomes in health care, new IT solutions frequently suffer from a lack of widespread adoption and do not achieve desired results, as a consequence of not involving end-users in design. To describe a case study of a pediatric asthma SDM health IT solution's development and demonstrate a methodology for engaging actual patients and families in IT development. Perspectives are shared from the vantage point of the research team and a parent of a child with asthma, who participated on the development team. We adapted user-centric design principles to engage actual users across three main development phases: project initiation, ideation, and usability testing. To facilitate the necessary level of user engagement, our approach included: (1) a Development Workgroup consisting of patients, caregivers, and providers who met regularly with the research team; and (2) \"real-world users\" consisting of patients, caregivers, and providers recruited from a variety of care locations, including safety-net clinics. Using this methodology, we successful partnered with asthma patients and families to create an interactive, digital solution called Carolinas Asthma Coach. Carolinas Asthma Coach incorporates SDM principles to elicit patient information, including goals and preferences, and provides health-literate, tailored education with specific guideline-based recommendations for patients and their providers. Of the patients, caregivers, and providers surveyed, 100% (n=60) said they would recommend Carolinas Asthma Coach to a friend or colleague. Qualitative feedback from users provided support for the usability and engaging nature of the app. This project demonstrates the feasibility and benefits of deploying user-centric design methods that engage real patients and caregivers throughout the health IT design process.

Background Asthma is a prevalent chronic disease that is difficult to manage and associated with marked disparities in outcomes. One promising approach to addressing disparities is shared decision making (SDM), a method by which the patient and provider cooperatively make a decision about asthma care. SDM is associated with improved outcomes for patients; however, time constraints and staff availability are noted implementation barriers. Use of health information technology (IT) solutions may facilitate the utilization of SDM. Coach McLungs SM is a collaborative web-based application that involves pediatric patients, their caregivers, and providers in a personalized experience while gathering patient-reported data. Background logic provides decision support so both audiences can develop a well-informed treatment plan together. The goal of this study is to evaluate the implementation of the Coach McLungs SM intervention into primary care. Methods Implementation will be evaluated using a stepped wedge randomized control study design at 21 pediatric and family medicine practices within a large, integrated, nonprofit healthcare system. We will measure changes in emergency department visits, hospitalizations, and oral steroid use, which serve as surrogate measures for patient-centered asthma outcomes. We will use a generalized linear mixed models with logit link to test the hypothesis for the reduction in exacerbation rates specifying the fixed effects of intervention and time and random effects for practice and practice*time. This design achieves 84% power to detect the hypothesized effect size difference of 10% in overall exacerbation between control (40%) and intervention (30%) periods (two-sided, p  = 0.05). Implementation will be guided using the Expert Recommendations for Implementing Change (ERIC), a compilation of implementation strategies, and evaluated using the CFIR (Consolidated Framework for Implementation Research) and RE-AIM (Reach Effectiveness, Adoption, Implementation, Maintenance). Discussion We anticipate that a tailored implementation of Coach McLungs SM across diverse primary care practices will lead to a decrease in emergency department visits, hospitalizations, and oral steroid use for patients in the intervention group as compared to the control condition. Trial Registration : Clincaltrials.gov, NCT05059210. Registered 28 September 2021, https://www.clinicaltrials.gov/ct2/show/NCT05059210

Background Sepsis survivors experience high morbidity and mortality, and healthcare systems lack effective strategies to address patient needs after hospital discharge. The Sepsis Transition and Recovery (STAR) program is a navigator-led, telehealth-based multicomponent strategy to provide proactive care coordination and monitoring of high-risk patients using evidence-driven, post-sepsis care tasks. The purpose of this study is to evaluate the effectiveness of STAR to improve outcomes for sepsis patients and to examine contextual factors that influence STAR implementation. Methods This study uses a hybrid type I effectiveness-implementation design to concurrently test clinical effectiveness and gather implementation data. The effectiveness evaluation is a two-arm, pragmatic, stepped-wedge cluster randomized controlled trial at eight hospitals in North Carolina comparing clinical outcomes between sepsis survivors who receive Usual Care versus care delivered through STAR. Each hospital begins in a Usual Care control phase and transitions to STAR in a randomly assigned sequence (one every 4 months). During months that a hospital is allocated to Usual Care, all eligible patients will receive usual care. Once a hospital transitions to STAR, all eligible patients will receive STAR during their hospitalization and extending through 90 days from discharge. STAR includes centrally located nurse navigators using telephonic counseling and electronic health record-based support to facilitate best-practice post-sepsis care strategies including post-discharge review of medications, evaluation for new impairments or symptoms, monitoring existing comorbidities, and palliative care referral when appropriate. Adults admitted with suspected sepsis, defined by clinical criteria for infection and organ failure, are included. Planned enrollment is 4032 patients during a 36-month period. The primary effectiveness outcome is the composite of all-cause hospital readmission or mortality within 90 days of discharge. A mixed-methods implementation evaluation will be conducted before, during, and after STAR implementation. Discussion This pragmatic evaluation will test the effectiveness of STAR to reduce combined hospital readmissions and mortality, while identifying key implementation factors. Results will provide practical information to advance understanding of how to integrate post-sepsis management across care settings and facilitate implementation, dissemination, and sustained utilization of best-practice post-sepsis management strategies in other heterogeneous healthcare delivery systems. Trial registration NCT04495946 . Submitted July 7, 2020; Posted August 3, 2020.

The primary assessment tool used by hospitals to measure the outcomes of pain management programs is the 0-10 numerical pain rating scale. However, it is unclear if this assessment should be used as the sole indicator of positive outcomes by pain management programs. Although it is assumed that pain intensity scores would be correlated with patient satisfaction, few studies have evaluated the association between pain intensity scores and patient satisfaction. In this pilot study, we investigated the relationship between pain intensity and patient satisfaction by evaluating 88 patients who received opioid analgesics at a 1018-bed acute care institution. A 14-question survey was adapted from a questionnaire developed by the American Pain Society to assess patient pain control and overall satisfaction with our institution's pain management strategies. This study found no association between pain intensity score and patient satisfaction with overall pain management (Spearman's rank correlation coefficient = -0.31; 95% confidence interval = -0.79 to 0.39). The majority of the surveyed patients were satisfied or very satisfied with their overall pain management, regardless of their pain intensity score. These findings contribute to the general understanding that institutions should use pain intensity scores together with a measure of patient pain satisfaction when assessing regulatory and quality control programs.

Objectives/Goals: The Wake Forest Clinical and Translational Science Institute (CTSI) has integrated academic goals of T0-T4 translation, scholarship, and education into our Academic Learning Health System (aLHS) framework. Our Translation Research Academy (TRA) provides rigorous training for outstanding and diverse K12 and early-career faculty to develop LHS core competencies. Methods/Study Population: The TRA Forum is the main vehicle for delivering an aLHS-oriented curriculum. Currently, the program includes six K12 scholars and 18 other early-career research faculty with facilitated access to CTSI resources. The TRA Forum is a 2-year seminar series that meets twice a month to discuss topics relevant to the aLHS, leadership, and career development. Inclusion of first- and second-year scholars facilitates peer mentorship, allowing Year 2 scholars to share insights with new scholars. Forum sessions are developed around adult learning theory: Each participant is asked to contribute their experience to discussions, and sessions focus on real-world examples. Results/Anticipated Results: Scholar and faculty commitment is very high. For the first 30 min., scholars present their work in small groups. This extends the range of disciplines exposed (64% of TRA graduates found this very helpful) and promotes translational traits of boundary crosser, team player, and systems thinker. Participants view the TRA as an opportunity to form internal peer networks, promote peer mentoring, and establish new collaborations. The remaining 60 minutes are used for education. Sessions include nominated topics and those providing a solid foundation in core aLHS competencies and characteristics of translational scientists. Educational sessions (97%) were rated as helpful or very helpful. Discussion/Significance of Impact: TRA scholars receive rigorous training in a highly supportive environment to produce aLHS researchers with skills to transcend boundaries, innovate systems, create new knowledge, and rigorously evaluate results.

ObjectiveTo qualitatively analyse different types of dissemination of information during monthly group calls between researchers, providers and clinical staff used to establish best practices for implementing an asthma shared decision-making (SDM) intervention. Evaluating dissemination of information can provide a better understanding of how best practices are shared, informing implementation approaches to improve the uptake of new evidence and overcome barriers.Setting10 primary care practices in North Carolina.ParticipantsProviders and clinical staff participated in monthly group phone calls with researchers to share best practices during implementation of a SDM intervention for asthma patients.DesignThe research team transcribed and coded statements using content analysis into three different knowledge types: Knowledge Position, Knowledge Form and Knowledge Object. Knowledge Objects were further classified using directed content analysis where the research team interpreted the content objects through a classification process of identifying themes or patterns to describe three different types of dissemination of information: (A) Confirmation of Existing Knowledge, (B) Generation of New Knowledge and (C) Spreading of New Knowledge.ResultsAcross the 8 transcripts, 4 Knowledge Positions, 7 Knowledge Forms and 18 types of Knowledge Objects were identified. From the Knowledge Objects, Confirmation of Existing Knowledge occurred during the training of participating practices. The review also identified Generation of New Knowledge by providers and clinical staff raised in these calls. This Generation of New Knowledge was later documented being used by other practices with the identification of Spreading of New Knowledge.ConclusionThe research team described the types of dissemination of information that occurred between researchers, providers and clinical staff during implementation of an asthma SDM intervention. Both Confirmation of Existing Knowledge and Generation of New Knowledge in response to barriers occurred. These exploratory dissemination of information results provide additional mechanisms for evaluating implementation science.Trial registration numberNCT02047929; Post-results

Background Asthma is a chronic lung disease that affects more than 23 million people in the United States, including 7 million children. Asthma is a difficult to manage chronic condition associated with disparities in health outcomes, poor medical compliance, and high healthcare costs. The research network coordinating this project includes hospitals, urgent care centers, and outpatient clinics within Carolinas Healthcare System that share a common electronic medical record and billing system allowing for rapid collection of clinical and demographic data. This study investigates the impact of three interventions on clinical outcomes for patients with asthma. Interventions are: an integrated approach to care that incorporates asthma management based on the chronic care model; a shared decision making intervention for asthma patients in underserved or disadvantaged populations; and a school based care approach that examines the efficacy of school-based programs to impact asthma outcomes including effectiveness of linkages between schools and the healthcare providers. Methods/Design This study will include 95 Practices, 171 schools, and over 30,000 asthmatic patients. Five groups (A-E) will be evaluated to determine the effectiveness of three interventions. Group A is the usual care control group without electronic medical record (EMR). Group B practices are a second control group that has an EMR with decision support, asthma action plans, and population reports at baseline. A time delay design during year one converts practices in Group B to group C after receiving the integrated approach to care intervention. Four practices within Group C will receive the shared decision making intervention (and become group D). Group E will receive a school based care intervention through case management within the schools. A centralized database will be created with the goal of facilitating comparative effectiveness research on asthma outcomes specifically for this study. Patient and community level analysis will include results from patient surveys, focus groups, and asthma patient density mapping. Community variables such as income and housing density will be mapped for comparison. Outcomes to be measured are reduced hospitalizations and emergency department visits; improved adherence to medication; improved quality of life; reduced school absenteeism; improved self-efficacy and improved school performance. Discussion Identifying new mechanisms that improve the delivery of asthma care is an important step towards advancing patient outcomes, avoiding preventable Emergency Department visits and hospitalizations, while simultaneously reducing overall healthcare costs.

Background Self-monitoring of blood glucose (SMBG) is a low value health care practice that does not benefit most patients with non-insulin treated type 2 diabetes (T2DM). This paper evaluates Re-Think the Strip (RTS), a multi-component study aimed at de-implementing SMBG among non-insulin treated T2DM patients in primary care. Methods This study used a pre-post design to evaluate the effectiveness and implementation of Re-Think the Strip in 20 primary care clinics with a comparison group of 34 clinics within one health system. De-implementation strategies were implemented over 12 months and practices were followed for 18 months. Results There was an overall decrease in the odds of receiving a prescription for diabetes testing supplies (i.e., test strips and/or lancets) between the baseline and 12-month intervention follow-up for intervention and comparison clinics (OR 0.96, 95% CI 0.94, 0.98). However, there was no statistically significant difference in prescribing between the intervention and comparison clinics. In sensitivity analyses, a small intervention effect was observed for those patients newly diagnosed with T2DM or newly assigned to a study clinic (OR = 0.97, 95% CI 0.95, 1.00). Conclusions De-implementation strategies are feasible in primary care practices. Although prescriptions for SMBG decreased in intervention practices, they also decreased in the comparison practices. Newly diagnosed patients or new patients may be more receptive to de-implementation. Other factors, including the COVID-19 pandemic and baseline prescribing rates may have limited the effectiveness of the RTS de-implementation strategy.