How engagement of a diverse set of stakeholders shaped the design, implementation, and dissemination of a multicenter pragmatic trial of stroke transitional care: The COMPASS study.
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SUBMITTER: Gesell SB
PROVIDER: S-EPMC8057438 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe COMprehensive Post-Acute Stroke Services (COMPASS) pragmatic trial compared the effectiveness of comprehensive transitional care (COMPASS-TC) versus usual care among stroke and transient ischemic attack (TIA) patients discharged home from North Carolina hospitals. We evaluated implementation of COMPASS-TC in 20 hospitals randomized to the intervention using the RE-AIM framework.MethodsWe evaluated hospital-level Adoption of COMPASS-TC; patient Reach (meeting transitional care management requirements of timely telephone and face-to-face follow-up); Implementation using hospital quality measures (concurrent enrollment, two-day telephone follow-up, 14-day clinic visit scheduling); and hospital-level sustainability (Maintenance). Effectiveness compared 90-day physical function (Stroke Impact Scale-16), between patients receiving COMPASS-TC versus not. Associations between hospital and patient characteristics with Implementation and Reach measures were estimated with mixed logistic regression models.ResultsAdoption: Of 95 eligible hospitals, 41 (43%) participated in the trial. Of the 20 hospitals randomized to the intervention, 19 (95%) initiated COMPASS-TC. Reach: A total of 24% (656/2751) of patients enrolled received a billable TC intervention, ranging from 6 to 66% across hospitals.ImplementationOf eligible patients enrolled, 75.9% received two-day calls (or two attempts) and 77.5% were scheduled/offered clinic visits. Most completed visits (78% of 975) occurred within 14 days. Effectiveness: Physical function was better among patients who attended a 14-day visit versus those who did not (adjusted mean difference: 3.84, 95% CI 1.42-6.27, p = 0.002). Maintenance: Of the 19 adopting hospitals, 14 (74%) sustained COMPASS-TC.ConclusionsCOMPASS-TC implementation varied widely. The greatest challenge was reaching patients because of system difficulties maintaining consistent delivery of follow-up visits and patient preferences to pursue alternate post-acute care. Receiving COMPASS-TC was associated with better functional status.Trial registrationClinicalTrials.gov number: NCT02588664. Registered 28 October 2015.
| S-EPMC6923985 | biostudies-literature
Project description:Background and objectivesStroke is a chronic, complex condition that disproportionally affects older adults. Health systems are evaluating innovative transitional care (TC) models to improve outcomes in these patients. The Comprehensive Post-Acute Stroke Services (COMPASS) Study, a large cluster-randomized pragmatic trial, tested a TC model for patients with stroke or transient ischemic attack discharged home from the hospital. The implementation of COMPASS-TC in complex real-world settings was evaluated to identify successes and challenges with integration into the clinical workflow.Research design and methodsWe conducted a concurrent process evaluation of COMPASS-TC implementation during the first year of the trial. Qualitative data were collected from 4 sources across 19 intervention hospitals. We analyzed transcripts from 43 conference calls with hospital clinicians, individual and group interviews with leaders and clinicians from 9 hospitals, and 2 interviews with the COMPASS-TC Director of Implementation using iterative thematic analysis. Themes were compared to the domains of the RE-AIM framework.ResultsOrganizational, individual, and community factors related to Reach, Adoption, and Implementation were identified. Organizational readiness was an additional key factor to successful implementation, in that hospitals that were not "organizationally ready" had more difficulty addressing implementation challenges.Discussion and implicationsMultifaceted TC models are challenging to implement. Facilitators of implementation were organizational commitment and capacity, prioritizing implementation of innovative delivery models to provide comprehensive care, being able to address challenges quickly, implementing systems for tracking patients throughout the intervention, providing clinicians with autonomy and support to address challenges, and adequately resourcing the intervention.Clinical trial registrationNCT02588664.
| S-EPMC7427484 | biostudies-literature
Project description:IntroductionThere has been an increasing focus on disseminating research findings, but less about practices specific to disseminating and engaging non-researchers. The present project sought to describe dissemination practices and engagement of stakeholders among dissemination & implementation (D&I) scientists.MethodsMethods to disseminate to and engage non-research stakeholders were assessed using an online survey sent to a broad, diverse sample of D&I scientists.ResultsSurveys were received from 210 participants. The majority of respondents were from university or research settings in the United States. (69%) or Canada (13%), representing a mix of clinical (28%) and community settings (34%). 26% had received formal training in D&I. Respondents indicated routinely engaging in a variety of dissemination-related activities, with academic journal publications (88%), conference presentations (86%), and reports to funders (74%) being the most frequent. Journal publication was identified as the most impactful on respondents' careers (94%), but face-to-face meetings with stakeholders were rated as most impactful on practice or policy (40%). Stakeholder involvement in research was common, with clinical and community-based researchers engaging stakeholder groups in broadly similar ways, but with critical differences noted between researchers with greater seniority, those with more D&I training, those based in the United States vs. Canada, and those in community vs. clinical research settings.ConclusionsThere have been increases in stakeholder engagement, but few other practices since the 2012 survey, and some differences across subgroups. Methods to engage different stakeholders deserve more in-depth investigation. D&I researchers report substantial misalignment of incentives and behaviors related to dissemination to non-research audiences.
| S-EPMC6853327 | biostudies-literature
Project description:BackgroundDissemination of research findings to past study participants and the community-at-large is important. Yet, a standardized process for research dissemination is needed to report results to the community.ObjectiveWe developed a framework and strategies to guide community-academic partnerships in community-targeted, dissemination efforts.MethodsFrom 2017 to 2019, a community-academic partnership was formed in Nashville, Tennessee, and iteratively developed a framework and strategies for research dissemination using cognitive interviews. A deductive, constant comparative analysis was conducted on interview responses to examine framework and strategy content. Feedback was used to finalize the framework and strategies for the evaluation. Using existing data, the framework's utility was evaluated in seven town hall meetings (n = 117). Bivariate analyses determined its effect on community members' trust and willingness to participate in research using pre- and post-surveys. Evaluation results were used to finalize the framework.ResultsThe Community-Engaged Research Dissemination (CERD) framework has two phases. Phase one is a preliminary planning phase with two steps, and phase two is the four-step dissemination process. There are five standards to be upheld conducting these phases. We provide competencies for each component. Three feasible, culturally adapted strategies were developed as exemplars to disseminate research findings. Using pre- and post-surveys for intervention evaluation, there was a significant difference in trust in medical research and researchers (P = .006) and willingness to participate in research (P = .013).Discussion and conclusionThe CERD framework can potentially standardize the process and compare the effect of dissemination efforts on the community's trust and willingness to participate in research.
| S-EPMC7495063 | biostudies-literature
Project description:BackgroundNumerous transitional care innovations (TCIs) are being developed and implemented to optimize care continuity for older persons when transferring between multiple care settings, help meet their care needs, and ultimately improve their quality of life. Although the implementation of TCIs is influenced by contextual factors, the use of effective implementation strategies is largely lacking. Thus, to improve the implementation of TCIs targeting older persons receiving long-term care services, we systematically developed a set of viable strategies selected to address the influencing factors.MethodsAs part of the TRANS-SENIOR research network, a stepwise approach following Implementation Mapping (steps 1 to 3) was applied to select implementation strategies. Building on the findings of previous studies, existing TCIs and factors influencing their implementation were identified. A combination of four taxonomies and overviews of change methods as well as relevant evidence on their effectiveness were used to select the implementation strategies targeting each of the relevant factors. Subsequently, individual consultations with scientific experts were performed for further validation of the process of mapping strategies to implementation factors and for capturing alternative ideas on relevant implementation strategies.ResultsTwenty TCIs were identified and 12 influencing factors (mapped to the Consolidated Framework for Implementation Research) were designated as priority factors to be addressed with implementation strategies. A total of 40 strategies were selected. The majority of these target factors at the organizational level, e.g., by using structural redesign, public commitment, changing staffing models, conducting local consensus discussions, and organizational diagnosis and feedback. Strategies at the level of individuals included active learning, belief selection, and guided practice. Each strategy was operationalized into practical applications.ConclusionsThis project developed a set of theory and evidence-based implementation strategies to address the influencing factors, along further tailoring for each context, and enhance the implementation of TCIs in daily practice settings. Such work is critical to advance the use of implementation science methods to implement innovations in long-term care successfully.
| S-EPMC10463528 | biostudies-literature
Project description:Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the feasibility of upholding ethical standards without imposing undue burden on clinical workflows, staff members or patients who may participate in the research by virtue of their presence in a cluster randomised facility. The COMPASS study included 40 randomised sites and compared the effectiveness of a postacute stroke intervention with standard care. Each site provided either the comprehensive postacute stroke intervention or standard care according to the randomisation assignment. Working together, the study team, institutional review board and members of the community designed an ethically appropriate and operationally reasonable consent process which was carried out successfully at all randomised sites. This achievement is noteworthy because it demonstrates how to effectively conduct appropriate informed consent in cluster randomised trials, and because it provides a model that can easily be adapted for other pragmatic studies. With this innovative approach to informed consent, patients have access to the information they need about research occurring where they are seeking care, and medical researchers can conduct their studies without ethical concerns or unreasonable logistical impediments.NCT02588664, recruiting. This article covers the development of consent process that is currentlty being employed in the study.
| S-EPMC6073919 | biostudies-other
Project description:BackgroundTo have population-level impact, physical activity (PA) interventions must be effectively implemented and sustained under real-world conditions. Adequate Fundamental Movement Skills (FMS) is integral to children being able to actively participate in play, games, and sports. Yet, few FMS interventions have been implemented at scale, nor sustained in routine practice, and thus it is important to understand the influences on sustained implementation. The study's aim was to use Collective Intelligence (CI)-an applied systems science approach-with stakeholder groups to understand barriers to the implementation of FMS interventions, interdependencies between these barriers, and options to overcome the system of barriers identified.MethodsThree CI sessions were conducted with three separate groups of experienced FMS intervention researchers/practitioners (N = 22) in the United Kingdom and Ireland. Participants generated and ranked barriers they perceive most critical in implementing FMS interventions. Each group developed a structural model describing how highly ranked barriers are interrelated in a system. Participants then conducted action mapping to solve the problem based on the logical relations between barriers reflected in the model.ResultsThe top ranked barriers (of 76) are those related to policy, physical education curriculum, and stakeholders' knowledge and appreciation. As reflected in the structural model, these barriers have influences over stakeholders' efficacy in delivering and evaluating interventions. According to this logical structure, 38 solutions were created as a roadmap to inform policy, practice, and research. Collectively, solutions suggest that efforts in implementation and sustainability need to be coordinated (i.e., building interrelationship with multiple stakeholders), and a policy or local infrastructure that supports these efforts is needed.ConclusionsThe current study is the first to describe the complexity of barriers to implementing and sustaining FMS interventions and provide a roadmap of actions that help navigate through the complexity. By directing attention to the ecological context of FMS intervention research and participation, the study provides researchers, policy makers, and practitioners with a framework of critical components and players that need to be considered when designing and operationalising future projects in more systemic and relational terms.
| S-EPMC8565647 | biostudies-literature
Project description:BackgroundEarly Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium-long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and the NHS. This study will evaluate the effectiveness, cost-effectiveness and implementation of a team-based motivational Early Youth Engagement (EYE-2) intervention.MethodThe study design is a cluster randomised controlled trial (RCT) with economic evaluation, comparing the EYE-2 intervention + standardised EIP service to standardised EIP service alone, with randomisation at the team level. A process evaluation will evaluate the delivery of the intervention qualitatively and quantitatively across contexts. The setting is 20 EIP teams in 5 sites: Manchester, South London, East Anglia, Thames Valley and Hampshire. Participants are young people (14-35 years) with first episode psychosis, and EIP staff. The intervention is the team-based motivational engagement (EYE-2) intervention, delivered alongside standardised EIP services, and supported by additional training, website, booklets and social groups. The comparator is the standardised EIP service. Both interventions are delivered by EIP clinicians. The primary outcome is time to disengagement (time in days from date of allocation to care coordinator to date of last contact following refusal to engage with EIP service, or lack of response to EIP contact for a consecutive 3-month period). Secondary outcomes include mental and physical health, deaths, social and occupational function, recovery, satisfaction and service use at 6, 12, 18 and 24 months. A 12-month within-trial economic evaluation will investigate cost-effectiveness from a societal perspective and from an NHS perspective.DiscussionThe trial will provide the first test of an engagement intervention in standardised care, with the potential for significant impact on the mental health and wellbeing of young people and their families, and economic benefits for services. The intervention will be highly scalable, supported by the toolkit including manuals, commissioning guide, training and resources, adapted to meet the needs of the diverse EIP population, and based on an in-depth process evaluation.Trial registrationISRCTN 51629746 prospectively registered 7th May 2019. Date assigned 10th May 2019.
| S-EPMC8042707 | biostudies-literature
Project description:Visual representations, such as pathway models, are increasingly being used to both communicate higher education science, technology, engineering, and mathematics (STEM) education program evaluation plans as well as accurately represent complex programs and the systems within which the educational programs reside. However, these representations can be overwhelming to audiences that are not familiar with the program's structure or engaged in the evaluation process. The goal of this methods essay is to help both evaluators and discipline-based education researchers improve communication about program evaluation with a variety of stakeholders. We propose a three-stage method for developing progressively less complex visualizations to build affordances that help make the program evaluation process and statements of program impact more meaningful to a wider range of audiences. The creation of less complex visualizations can facilitate understanding by allowing a stakeholder to more easily "see" the structure of the program and thereby may evoke a greater willingness to take action and make meaningful programmatic changes based on strategic evaluation planning. To aid readers, we describe how we modified the Systems Evaluation Protocol (SEP) to develop simplified visualizations when evaluating a long-standing college science faculty development program, the Summer Institutes on Scientific Teaching.
| S-EPMC8697662 | biostudies-literature
Project description:BACKGROUND:Meaningful patient engagement (PE) in medicines development and during the life cycle of a product requires all stakeholders have a clear understanding of respective expectations. OBJECTIVE:A qualitative survey was undertaken to understand stakeholder expectations. DESIGN:The survey explored 4 themes from the perspective of each stakeholder group: meaning, views, expectations and priorities for PE. Participants were grouped into 7 categories: policymakers/regulators; health-care professionals (HCPs); research funders; payers/purchasers/HTA; patients/patient representatives; pharmaceutical/life sciences industry; and academic researchers. RESULTS:Fifty-nine interviews were conducted across a range of geographies, PE experience and job seniority/role. There was consensus across stakeholders on meaning of PE; importance of promoting PE to a higher level than currently; need for a more structured process and guidance. There was little consensus on stakeholder expectations and roles. Policymakers/regulators were expected by others to drive PE, create a framework and facilitate PE, provide guidelines of good practice and connect stakeholders, but this expectation was not shared by the policymakers/regulators group. HCPs were seen as the link between patients and other stakeholders, but HCPs did not necessarily share this view. DISCUSSION AND CONCLUSIONS:Despite broad stakeholder categories, clear themes emerged: there is no "leader"; no stakeholder has a clear view on how to meaningfully engage with patients; there are educational gaps; and a structure and guidance for PE is urgently required. Given the diversity of stakeholders, there needs to be multistakeholder collaborative leadership. Effective collaboration requires consensus on roles, responsibilities and expectations to synergize efforts to deliver meaningful PE in medicines life cycle.
| S-EPMC6250871 | biostudies-other