Multi-tiered external facilitation: the role of feedback loops and tailored interventions in supporting change in a stepped-wedge implementation trial

Background: Facilitation is a complex, relational implementation strategy that guides change processes. Facilitators engage in multiple activities and tailor efforts to local contexts. How this work is coordinated and shared among multiple, external actors and the contextual factors that prompt and moderate facilitators to tailor activities have not been well-described. Methods: We conducted a mixed methods evaluation of a trial to improve the quality of transient ischemic attack care. Six sites in the Veterans Health Administration received external facilitation (EF) before and during a 1-year active implementation period. We examined how EF was employed and activated. Data analysis included prospective logs of facilitator correspondence with sites (160 site-directed episodes), stakeholder interviews (a total of 78 interviews, involving 42 unique individuals), and collaborative call debriefs (n=22) spanning implementation stages. Logs were descriptively analyzed across facilitators, sites, time periods, and activity types. Interview transcripts were coded for content related to EF and themes were identified. Debriefs were reviewed to identify instances of and utilization of EF during site critical junctures. Results: Multi-tiered EF was supported by two groups (site-facing quality improvement [QI] facilitators and the implementation support team) that were connected by feedback loops. Each site received an average of 24 episodes of site-directed EF; most of the EF was delivered by the QI nurse. For each site, site-directed EF frequently involved networking (45%), preparation and planning (44%), process monitoring (44%), and/or education (36%). EF less commonly involved audit and feedback (20%), brainstorming solutions (16%), and/or stakeholder engagement (5%). However, site-directed EF varied widely across sites and time periods in terms of these facilitation types. Site participants recognized the responsiveness of the QI nurse and valued her problem-solving, feedback, and accountability support. External facilitators used monitoring and dialogue to intervene by facilitating redirection during challenging periods of uncertainty about project direction and feasibility for sites. External facilitators, in collaboration with the implementation support team, successfully used strategies tailored to diverse local contexts, including networking, providing data, and brainstorming solutions. Conclusions: Multi-tiered facilitation capitalizing on emergent feedback loops allowed for tailored, site-directed facilitation. Critical juncture cases illustrate the complexity of EF and the need to often try multiple strategies in combination to facilitate implementation progress

Correction to: The “State of Implementation” Progress Report (SIPREP): a pilot demonstration of a navigation system for implementation

Following publication of the original article [1], it was reported that the incorrect version of a reviewer’s comments were published. The correct version has now been uploaded and the original article has been corrected

The "State of Implementation" Progress Report (SIPREP): a pilot demonstration of a navigation system for implementation

BACKGROUND: Implementation of new clinical programs across diverse facilities in national healthcare systems like the Veterans Health Administration (VHA) can be extraordinarily complex. Implementation is a dynamic process, influenced heavily by local organizational context and the individual staff at each medical center. It is not always clear in the midst of implementation what issues are most important to whom or how to address them. In recognition of these challenges, implementation researchers within VHA developed a new systemic approach to map the implementation work required at different stages and provide ongoing, detailed, and nuanced feedback about implementation progress. METHODS: This observational pilot demonstration project details how a novel approach to monitoring implementation progress was applied across two different national VHA initiatives. Stage-specific grids organized the implementation work into columns, rows, and cells, identifying specific implementation activities at the site level to be completed along with who was responsible for completing each implementation activity. As implementation advanced, item-level checkboxes were crossed off and cells changed colors, offering a visual representation of implementation progress within and across sites across the various stages of implementation. RESULTS: Applied across two different national initiatives, the SIPREP provided a novel navigation system to guide and inform ongoing implementation within and across facilities. The SIPREP addressed different needs of different audiences, both described and explained how to implement the program, made ample use of visualizations, and revealed both what was happening and not happening within and across sites. The final SIPREP product spanned distinct stages of implementation. CONCLUSIONS: The SIPREP made the work of implementation explicit at the facility level (i.e., who does what, and when) and provided a new common way for all stakeholders to monitor implementation progress and to help keep implementation moving forward. This approach could be adapted to a wide range of settings and interventions and is planned to be integrated into the national deployment of two additional VHA initiatives within the next 12 months

Seeding Structures for a Community of Practice Focused on Transient Ischemic Attack (TIA): Implementing Across Disciplines and Waves

Background: The Community of Practice (CoP) model represents one approach to address knowledge management to support effective implementation of best practices. Objective: We sought to identify CoP developmental strategies within the context of a national quality improvement project focused on improving the quality for patients receiving acute transient ischemic attack (TIA) care. Design: Stepped wedge trial. Participants: Multidisciplinary staff at six Veterans Affairs medical facilities. Interventions: To encourage site implementation of a multi-component quality improvement intervention, the trial included strategies to improve the development of a CoP: site kickoff meetings, CoP conference calls, and an interactive website (the "Hub"). Approach: Mixed-methods evaluation included data collected through a CoP attendance log; semi-structured interviews with site participants at 6 months (n = 32) and 12 months (n = 30), and CoP call facilitators (n = 2); and 22 CoP call debriefings. Key results: The critical seeding structures that supported the cultivation of the CoP were the kickoffs which fostered relationships (key to the community element of CoPs) and provided the evidence base relevant to TIA care (key to the domain element of CoPs). The Hub provided the forum for sharing quality improvement plans and other tools which were further highlighted during the CoP calls (key to the practice element of CoPs). CoP calls were curated to create a positive context around participants' work by recognizing team successes. In addition to improving care at their local facilities, the community created a shared set of tools which built on their collective knowledge and could be shared within and outside the group. Conclusions: The PREVENT CoP advanced the mission of the learning healthcare system by successfully providing a forum for shared learning. The CoP was grown through seeding structures that included kickoffs, CoP calls, and the Hub. A CoP expands upon the learning collaborative implementation strategy as an effective implementation practice

Acceptability of a complex team-based quality improvement intervention for transient ischemic attack: a mixed-methods study

Background: The Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurologic Symptoms (PREVENT) program was a complex quality improvement (QI) intervention targeting transient ischemic attack (TIA) evidence-based care. The aim of this study was to evaluate program acceptability among the QI teams and factors associated with degrees of acceptability. Methods: QI teams from six Veterans Administration facilities participated in active implementation for a one-year period. We employed a mixed methods study to evaluate program acceptability. Multiple data sources were collected over implementation phases and triangulated for this evaluation. First, we conducted 30 onsite, semi-structured interviews during active implementation with 35 participants at 6 months; 27 interviews with 28 participants at 12 months; and 19 participants during program sustainment. Second, we conducted debriefing meetings after onsite visits and monthly virtual collaborative calls. All interviews and debriefings were audiotaped, transcribed, and de-identified. De-identified files were qualitatively coded and analyzed for common themes and acceptability patterns. We conducted mixed-methods matrix analyses comparing acceptability by satisfaction ratings and by the Theoretical Framework of Acceptability (TFA). Results: Overall, the QI teams reported the PREVENT program was acceptable. The clinical champions reported high acceptability of the PREVENT program. At pre-implementation phase, reviewing quality data, team brainstorming solutions and development of action plans were rated as most useful during the team kickoff meetings. Program acceptability perceptions varied over time across active implementation and after teams accomplished actions plans and moved into sustainment. We observed team acceptability growth over a year of active implementation in concert with the QI team's self-efficacy to improve quality of care. Guided by the TFA, the QI teams' acceptability was represented by the respective seven components of the multifaceted acceptability construct. Conclusions: Program acceptability varied by time, by champion role on QI team, by team self-efficacy, and by perceived effectiveness to improve quality of care aligned with the TFA. A complex quality improvement program that fostered flexibility in local adaptation and supported users with access to data, resources, and implementation strategies was deemed acceptable and appropriate by front-line clinicians implementing practice changes in a large, national healthcare organization

Assessment of the Protocol-Guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) Program for Improving Quality of Care for Transient Ischemic Attack: A Nonrandomized Cluster Trial

Importance Patients with transient ischemic attack (TIA) are at high risk of recurrent vascular events. Timely management can reduce that risk by 70%; however, gaps in TIA quality of care exist. Objective To assess the performance of the Protocol-Guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) intervention to improve TIA quality of care. Design, Setting, and Participants This nonrandomized cluster trial with matched controls evaluated a multicomponent intervention to improve TIA quality of care at 6 diverse medical centers in 6 geographically diverse states in the US and assessed change over time in quality of care among 36 matched control sites (6 control sites matched to each PREVENT site on TIA patient volume, facility complexity, and quality of care). The study period (defined as the data period) started on August 21, 2015, and extended to May 12, 2019, including 1-year baseline and active implementation periods for each site. The intervention targeted clinical teams caring for patients with TIA. Intervention The quality improvement (QI) intervention included the following 5 components: clinical programs, data feedback, professional education, electronic health record tools, and QI support. Main Outcomes and Measures The primary outcome was the without-fail rate, which was calculated as the proportion of veterans with TIA at a specific facility who received all 7 guideline-recommended processes of care for which they were eligible (ie, anticoagulation for atrial fibrillation, antithrombotic use, brain imaging, carotid artery imaging, high- or moderate-potency statin therapy, hypertension control, and neurological consultation). Generalized mixed-effects models with multilevel hierarchical random effects were constructed to evaluate the intervention associations with the change in the mean without-fail rate from the 1-year baseline period to the 1-year intervention period. Results Six facilities implemented the PREVENT QI intervention, and 36 facilities were identified as matched control sites. The mean (SD) age of patients at baseline was 69.85 (11.19) years at PREVENT sites and 71.66 (11.29) years at matched control sites. Most patients were male (95.1% [154 of 162] at PREVENT sites and 94.6% [920 of 973] at matched control sites at baseline). Among the PREVENT sites, the mean without-fail rate improved substantially from 36.7% (58 of 158 patients) at baseline to 54.0% (95 of 176 patients) during a 1-year implementation period (adjusted odds ratio, 2.10; 95% CI, 1.27-3.48; P = .004). Comparing the change in quality at the PREVENT sites with the matched control sites, the improvement in the mean without-fail rate was greater at the PREVENT sites than at the matched control sites (36.7% [58 of 158 patients] to 54.0% [95 of 176 patients] [17.3% absolute improvement] vs 38.6% [345 of 893 patients] to 41.8% [363 of 869 patients] [3.2% absolute improvement], respectively; absolute difference, 14%; P = .008). Conclusions and Relevance The implementation of this multifaceted program was associated with improved TIA quality of care across the participating sites. The PREVENT QI program is an example of a health care system using QI strategies to improve performance, and may serve as a model for other health systems seeking to provide better care. Trial Registration ClinicalTrials.gov Identifier: NCT02769338 Go to: Introduction Approximately 8500 veterans with transient ischemic attack (TIA) or ischemic stroke are cared for in Department of Veterans Affairs (VA) emergency departments (EDs) or inpatient wards annually in the United States.1 Patients with TIA generally present with transient neurological symptoms of a presumed ischemic cause.2 Patients with TIA are at a high risk of recurrent vascular events3,4,5; however, delivery of timely TIA care can reduce that risk by up to 70%.6,7,8,9 Despite the known benefits of timely TIA care, gaps in TIA quality of care exist in both private-sector US hospitals10 and VA facilities.11,12 In a learning health care system, “clinical informatics, incentives, and culture are aligned to promote continuous improvement and innovation, with best practices seamlessly embedded in the delivery process and new knowledge captured as an integral by-product of the delivery experience.”13(p136) Within a learning health care system, health care teams respond to quality problems by using quality improvement (QI) strategies and systems redesign approaches to improve performance, depending on the complexity and scope of the problem.14 The objective of the Protocol-Guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) trial was to evaluate a multicomponent QI intervention to improve the quality of TIA care.15 The PREVENT intervention was designed to align with the learning health care system model.13,1

Implementation Evaluation of a Complex Intervention to Improve Timeliness of Care for Veterans with Transient Ischemic Attack

Background: The Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurologic Symptoms (PREVENT) program was designed to address systemic barriers to providing timely guideline-concordant care for patients with transient ischemic attack (TIA). Objective: We evaluated an implementation bundle used to promote local adaptation and adoption of a multi-component, complex quality improvement (QI) intervention to improve the quality of TIA care Bravata et al. (BMC Neurology 19:294, 2019). Design: A stepped-wedge implementation trial with six geographically diverse sites. Participants: The six facility QI teams were multi-disciplinary, clinical staff. Interventions: PREVENT employed a bundle of key implementation strategies: team activation; external facilitation; and a community of practice. This strategy bundle had direct ties to four constructs from the Consolidated Framework for Implementation Research (CFIR): Champions, Reflecting & Evaluating, Planning, and Goals & Feedback. Main measures: Using a mixed-methods approach guided by the CFIR and data matrix analyses, we evaluated the degree to which implementation success and clinical improvement were associated with implementation strategies. The primary outcomes were the number of completed implementation activities, the level of team organization and > 15 points improvement in the Without Fail Rate (WFR) over 1 year. Key results: Facility QI teams actively engaged in the implementation strategies with high utilization. Facilities with the greatest implementation success were those with central champions whose teams engaged in planning and goal setting, and regularly reflected upon their quality data and evaluated their progress against their QI plan. The strong presence of effective champions acted as a pre-condition for the strong presence of Reflecting & Evaluating, Goals & Feedback, and Planning (rather than the other way around), helping to explain how champions at the +2 level influenced ongoing implementation. Conclusions: The CFIR-guided bundle of implementation strategies facilitated the local implementation of the PREVENT QI program and was associated with clinical improvement in the national VA healthcare system

Genome-wide association study of classical Hodgkin lymphoma identifies key regulators of disease susceptibility

Several susceptibility loci for classical Hodgkin lymphoma (cHL) have been reported, however much of the heritable risk is unknown. Here, we perform a meta-analysis of two existing genome-wide association studies (GWAS), a new GWAS, and replication totalling 5,314 cases and 16,749 controls. We identify risk loci for all cHL at 6q22.33 (rs9482849, P=1.52 × 10-8) and for nodular sclerosis HL (NSHL) at 3q28 (rs4459895, P=9.43 × 10-17), 6q23.3 (rs6928977, P=4.62 × 10-55 11), 10p14 (rs3781093, P=9.49 × 10-13), 13q34 (rs112998813, P=4.58 × 10-8) and 16p13.13 (rs34972832, P=2.12 × 10-8). Additionally, independent loci within the HLA region are observed for NSHL (rs9269081, HLA-DPB1*03:01, Val86 in HLA-DRB1) and mixed cellularity HL (rs1633096, rs13196329, Val86 in HLA-DRB1). The new and established risk loci localise to areas of active chromatin and show an over-representation of transcription factor binding for determinants of B-cell development and immune response.In the United Kingdom, Bloodwise (LLR; 10021) provided principal funding for the study. Support from Cancer Research UK (C1298/A8362 supported by the Bobby Moore Fund) and the Lymphoma Research Trust is also acknowledged. A.S. is supported by a clinical fellowship from Cancer Research UK. For the UK-GWAS, sample and data acquisition were supported by Breast Cancer Now, the European Union and the Lymphoma Research Trust. The UK-GWAS made use of control genotyping data generated by the WTCCC. For further information, please visit the publishr's website

Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial.

BACKGROUND: Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months. METHODS: We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed. FINDINGS: Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91-1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed. INTERPRETATION: Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI. FUNDING: British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden