J Clin Epidemiol. ------------------------------------------------------------------------------------------------------- To Collection of Lump Sum Item LSE11.5 *** ---------- *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Quality improvement activities include trimestral committee meetings with chart review and discussions with clinical and administrative leads locally and at referring centers to identify improvement strategies such as the development of local care protocols. Moore L, Lavoie A, LeSage N, et al. https://www.hse.ie/eng/services/publications/national-review-of-clinical-audit-report-2019.pdf. From waste to value in health care. 2017;29(1):322. Level 1 trauma center means a regional resource trauma center that has the capability of providing leadership and comprehensive, definitive care for every aspect of injury from prevention through rehabilitation. UCDH is the sole Level 1 trauma center serving the Sacramento-Sierra area and the primary tertiary care referral center for a 32-county area of more than five million residents. Reilly BM, Evans AT. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. Consolidated Framework for Implementation Research-Experts Recommendations for Implementing Change, Consolidated Standards of Reporting Trials, Institut dExcellence en Sant et en Services Sociaux, Pragmatic Explanatory Continuum Indicator Summary, Standard Protocol Items: Recommendations for Interventional Trials. Qual Res Psychol. This protocol is reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (Additional file 1) [38] and the Consolidated Standards of Reporting Trials (CONSORT) extension for cluster trials (Additional File 2) [39]. S-4.2, r. 27 - Rglement sur la transmission de renseignements concernant les usagers victimes de traumatismes majeurs. Am J Community Psychol. 2012;6:Cd000259. In line with recommendations [54] and to avoid contamination, we have embedded the refinement phase in the intervention (Additional file 3: Figure S1, Table S3, Fig. Malloum Boukar K, Moore L, Tardif PA, et al. Implement Sci. 2015;5(2):27281. Pediatric Behavioral Health and Development, Pediatric Physical Medicine & Rehabilitation, Pediatric Radiology and Diagnostic Imaging, Winnie Palmer Hospital for Women & Babies, Orlando Health Heart & Vascular Institute, Orlando Health Institute for Learning Online. Accessed 1 Sept 2022. Level I is the highest designation, indicating that the most advanced care is available. Low-value injury care in the adult orthopaedic trauma population: a systematic review. Critical Care Services Ontario. Most comprehensive library of legal defined terms on your mobile device, All contents of the lawinsider.com excluding publicly sourced documents are Copyright 2013-, Non-Administrator Skilled Nursing Facility. BMJ. Cookies policy. Campbell MK, Piaggio G, Elbourne DR, Altman DG, Group C. Consort 2010 statement: extension to cluster randomised trials. Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Formal letters of agreement are signed by heads of clinical departments to operate changes in their services when required. Trauma centers vary in their specific capabilities and are identified by "Level" designation: Level I (Level-1) being the highest and Level III (Level-3) being the lowest (some states have five designated levels, in which case Level V (Level-5) is the lowest). Process evaluation data collected at the end of the first cycle will be analyzed to inform intervention refinements for the second cycle, and data collected at the end of the trial will be used to refine the intervention prior to upscaling. Int J Qual Health Care. Your US state privacy rights, Our dissemination plan was designed using published guidelines [91] and includes (i) one-page visual summaries on partner organization websites, (ii) peer-reviewed publications, (iii) presentations at clinical and academic (de/implementation science) conferences and to end users (patient support groups, clinicians, accreditation authorities), (iv) media channels and policy briefs, and (v) half-day workshop with implementation science and accreditation stakeholders on the development multifaceted interventions targeting de-implementation. Kahan BC, Li F, Copas AJ, Harhay MO. A Level I Trauma Center offers the highest level of trauma care available, ensuring that patients receive the best possible care regardless of the severity of their injury. Clin Trials. 2019;86(6):98393. 2017;12(1):144. To obtain correct type I error rates, variables used in the covariate-constrained allocation will be included as covariates (volume, designation level, and baseline proportion), and to improve power and precision [75], the analysis will adjust for prespecified patient risk factors: age, comorbidities, and injury severity (anatomical and physiological parameters). I want the best for them, and in the case of a traumatic injury, a Pediatric Level One Trauma Center is the best. Implementation Sci 18, 27 (2023). We will use descriptive statistics to report on the sex and gender, experience, and discipline of participants and to assess intervention fidelity. The Trauma Audit & Research Network. We will modify the intervention in the presence of problems considered important by end users (e.g., difficulty in interpreting quality indicators) or in the presence of more minor problems (e.g., aesthetic details regarding the presentation of materials) reported frequently (by5/8 end users). What this means in Alaska is: The hospital has demonstrated commitment to providing the best trauma care possible by allowing experts to review staffing and qualifications, procedures, protocols and resources; BMJ Open. Research design: qualitative, quantitative, and mixed methods approaches. Regional trauma network development. LCC-300 Cost Centre E Terminus Building - Structure Lump Sum Breakdown E11 : Immigration (GL C-M/9-19, 21.96m-28.87m) Lump Sum Item LSE11.5 E11.5 : BWIC with Services Contractor's Other Charges The Contractor shall enter hereunder any specific item of work or obligation or thing which is necessary for the execution of the Works, as required by the Contract, which has been omitted from or has not been separately itemised in this Lump Sum Breakdown and for which a separate charge is required. Accessed September 13th, 2022. Evaluating the validity of multiple imputation for missing physiological data in the national trauma data bank. 2018;18(1):148. Lorencatto F, Gould NJ, McIntyre SA, et al. However, there may be differences in engagement that will be explored through process evaluation. Sites will be followed up over the 18-month interval (6 to 24months) after implementation over two evaluation cycles using these data (Fig. We chose thematic analysis because it allows for data organization and reduction, which facilitates a comprehensible description and interpretation of relevant elements [82]. Fortunately, only a few patients have injuries severe enough to need these services. 2018;172(9):8079. Braun V, Clarke V. Using thematic analysis in psychology. Victorian State Trauma Outcomes Registry and Monitoring Group (VSTORM). We will repeat this process with 58 additional end users until no major or frequent problems remain [61]. Ministre du Travail de l'Emploi et de la Solidarit sociale. 2015;78(6):116875. BMC Med Res Methodol. American College of Surgeons. https://www.albertahealthservices.ca/info/page13243.aspx. Secondary outcomes measured as continuous variables (i.e., ICU and hospital length of stay) will be analyzed using linear regression after log transformation. Newbury Park: SAGE Publications; 2017. Following the trial, we will update the simulation model with trial data to evaluate the cost-effectiveness of the true intervention. The authors approved the final version of the manuscript. The trial scored 5/5 on 6 of the 9 domains of the PRagmatic Explanatory Continuum Indicator Summary (PRECIS 2) tool, 3/5 for organization intervention and 4/5 for the outcome, indicating a high level of pragmatism (Additional file 3: Table S1) [40]. 24-hour in-house coverage by general surgeons, and prompt availability of care in specialties such as orthopedic surgery, neurosurgery, anesthesiology, emergency medicine, radiology, internal medicine, plastic surgery, oral and maxillofacial, pediatric and critical care. Guideline on adjustment for baseline covariates in clinical trials. Canadian Institute for Health Information. Committees include the program medical director (chair), the program manager, heads of critical care, emergency and surgical departments, and multidisciplinary services, and a hospital administrator. 2020;15(1):2. . The authors would like to thank Xavier Neveu for his help with the statistical analysis plan. Skivington K, Matthews L, Simpson SA, et al. Trauma Services BC. We will ensure transferability using purposive sampling to maximize the chances of obtaining information that is relevant to the research objectives [83]. The committee will oversee trial conduct and knowledge translation activities and ensure we meet project deliverables according to timelines. Evidence for overuse of medical services around the world. PubMed PubMedGoogle Scholar. Trauma centers take emergency care to the next level. Guidance on how to develop complex interventions to improve health and healthcare. Supporting material will be made available through the research program website. Berwick DM, Hackbarth AD. Which facilities are capable of treating the most severe injuries? And more importantly, what difference does it make in the life of your family? Sample size calculation for primary and selected secondary outcomes. Canadian Institutes of Health Research (CIHR). Google Scholar. Evaluating the effectiveness of a multifaceted intervention to reduce low-value care in adults hospitalized following trauma: a protocol for a pragmatic cluster randomized controlled trial. What is a Level One Trauma Center? Ann Fam Med. Burton CR, Williams L, Bucknall T, et al. . Operates an organized teaching and research effort to help direct new innovations in trauma care. Eur J Trauma Emerg Surg. Twenty-four hour staffing is vital for these critically . The unit of measurement for any Contractor's Other Charge shall be "sum", with Quantity and Rate columns entered with "N/A". https://www.tarn.ac.uk/. We will test a low-cost, pragmatic de-implementation intervention that can be adapted to other trauma systems in high-income countries. Table S5. PubMed Provides continuing education of the trauma team members. Accessed 29 March 2021. Impact of trauma centre accreditation on mortality and complications in a Canadian trauma system: an interrupted time series analysis. Gray-Burrows KA, Willis TA, Foy R, et al. Process evaluation of complex interventions: Medical Research Council guidance. Key components include: 24-hour in-hospital access to general surgeons If the intervention is effective and cost-effective, we will upscale across Canada with national and provincial trauma authorities and promote uptake in other healthcare domains. Study Centre means a centre established and maintained or recognized by the University for the purpose of advising, counselling or for rendering any other assistance required by the students in the context of distance education; Birth center means a facility or institution, which is not an ambulatory surgical center or a hospital or in a hospital, in which births are planned to occur following a normal, uncomplicated, low-risk pregnancy. https://ipam.ca/. BMJ. Providing care to trauma patients in Alberta. A small sample correction will be applied to control for the small number of clusters [73]. https://www.legisquebec.gouv.qc.ca/fr/document/rc/S-4.2,%20r.%2027. A stepped wedge design will not be used as the minimum 1-year rollout period is unacceptably long for stakeholders and parallel arm cRCTs have fewer risks of bias than stepped wedge cRCTs [42]. It could also free up resources, reduce delays to care, and reduce clinician workload, ultimately improving efficiency at a time of unprecedented strain on healthcare resources. We will first conduct four 60-min focus groups with 810 local trauma committee members [58] in trauma centers randomized to the intervention arm (stratified by designation level), with additional focus groups to obtain informational redundancy if required [59]. 2020;76(2):67686. Weve already shared with you why its imperative to choose a specialized pediatric emergency department for your children when they need emergency care. Accessed 22 Aug 2022. Evidence-based de-implementation for contradicted, unproven, and aspiring healthcare practices. These centers typically serve as a referral resource for the region and usually include: For the purposes of the rule, a trauma center is defined as a hospital that is verified by the American College of Surgeons (ACS), a hospital that is state designated as a trauma center - such as in Illinois who doesn't use the ACS to verify trauma centers, or a hospital that is "in the process" of becoming a trauma center. However, as a parent trying to make the best decision for your kids it becomes really difficult to discern which healthcare entity truly offers the best care because healthcare marketing and messaging get all mixed up with the facts. 2009;2(2):739. Organizations such as National Audit Commissioners advocate for enhancing A&F to support clinicians in their use of feedback data [13, 14]. With the largest 24-hour Level 1 trauma center in New England, the Emergency Department had more than 129,169 visits in 2008. Anney V. Ensuring the quality of the findings of qualitative research: looking at trustworthiness criteria. No members of the general public are involved. To produce the intervention effect as a relative risk with a 95% confidence interval, we will use modified robust Poisson regression for clustered data [74]. Level One Trauma Center criteria vary somewhat from state to state, but commonly include these elements, according to the American Trauma Society: We hope and pray that our children never require trauma care, but sometimes unfortunate accidents and injuries do occur. Moulton LH. 2012;307(14):15136. Schedule of enrolment, interventions, and assessments. JETERAPS. Low-value clinical practices in injury care: a scoping review and expert consultation survey. An official website of the State of Georgia. Maximising the quality improvement potential of the National Clinical Audit and Patient Outcomes Programme. The economic evaluation will be conducted according to Canadian Agency Guidelines for Economic Evaluation of Health Technologies [88] and results will be reported according to the Consolidated Health Economic Evaluation Reporting Standards 2022 statement [89]. Provided by the Springer Nature SharedIt content-sharing initiative. UCDMC is the sole Level 1 trauma center serving the Sacramento-Sierra area and the primary tertiary care referral center for a 32-county area of more than five million residents. Based on this work, we developed a multifaceted intervention with clinical and implementation science experts, patientpartners, and accreditation professionals using UK Medical Research Council guidelines for the Development of Complex Interventions (Additional file 3: Figure S1)[53, 54]. Hemming K, Kasza J, Hooper R, Forbes A, Taljaard M. A tutorial on sample size calculation for multiple-period cluster randomized parallel, cross-over and stepped-wedge trials using the Shiny CRT Calculator. [STAMP]. http://www.phsa.ca/our-services/programs-services/trauma-services-bc. Together with its Level 1 Pediatric Trauma Center at Comer Children's Hospital and its Burn and Complex Wound Center, UChicago Medicine is able to provide the community a comprehensive system of care to treat the full range of trauma injuries in patients of all ages. That sounds impressive, but what does it mean exactly? 2020;10(10):e040025. Squires JE, Sullivan K, Eccles MP, Worswick J, Grimshaw JM. We will also evaluate the download of educational materials (e.g., case revision tool, clinical decision rules, shared decision-making tools) using Google Analytics [68] and examine submitted action plans to document whether they address feedback and describe strategies to facilitate de-implementation based on a local assessment of barriers and facilitators [69]. Audit and feedback: effects on professional practice and healthcare outcomes. There are missing data on covariables in the registry, which will be handled with multiple imputation, shown to lead to accurate effect estimates for trauma quality indicators in simulations [77,78,79]. Evaluating the effectiveness of a multifaceted intervention to reduce low-value care in adults hospitalized following trauma: a protocol for a pragmatic cluster randomized controlled trial, https://doi.org/10.1186/s13012-023-01279-y, The Canadian Traumatic Brain Injury Research Consortium (CTRC), https://www.amq.ca/fr/publications/nos-communiques-de-presse/communiques-2013/item/502-plus-de-cinq-milliards-mal-depenses-dans-le-systeme-de-sante, https://www.cihi.ca/sites/default/files/document/choosing-wisely-baseline-report-en-web.pdf, https://www.hqip.org.uk/wp-content/uploads/2021/11/Maximising-the-QI-potential-of-the-national-clinical-audit-and-outcome-review-programme.pdf, https://www.hse.ie/eng/services/publications/national-review-of-clinical-audit-report-2019.pdf, http://www.parachutecanada.org/downloads/research/Cost_of_Injury-2015.pdf, https://www.albertahealthservices.ca/info/page13243.aspx, https://criticalcareontario.ca/wp-content/uploads/2020/10/Regional-Trauma-Network-Development-Guide.pdf, https://www.inesss.qc.ca/thematiques/sante/traumatologie/continuum-de-services-en-traumatologie-cst/evaluation-du-reseau.html, http://www.phsa.ca/our-services/programs-services/trauma-services-bc, https://www.facs.org/quality-programs/trauma/quality/trauma-quality-improvement-program/, https://www.monash.edu/medicine/sphpm/vstorm/home, https://www.msss.gouv.qc.ca/professionnels/soins-et-services/guide-urgences-trajectoire-traumatologie/, https://www.connexiontccqc.ca/wp-content/uploads/INESSS_Reseau_traumatologie_adulte-3.pdf, https://cfirguide.org/choosing-strategies/, https://www.usability.gov/sites/default/files/documents/guidelines_book.pdf, https://www.legisquebec.gouv.qc.ca/fr/document/rc/S-4.2,%20r.%2027, https://www.datadrivenu.com/track-downloads-google-analytics/, https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-adjustment-baseline-covariates-clinical-trials_en.pdf, https://provalisresearch.com/products/qualitative-data-analysis-software/, https://www.cadth.ca/guidelines-economic-evaluation-health-technologies-canada-0, https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=467919&lang=en, http://creativecommons.org/licenses/by/4.0/, http://creativecommons.org/publicdomain/zero/1.0/. De-implementation is defined here as discontinuing or abandoning practices that are not proven to be effective, are less effective or less cost-effective than an alternative practice, or are potentially harmful[10, 11]. We will conduct a pragmatic cluster randomized controlled trial (cRCT) embedded in a Canadian provincial quality assurance program. Value Health. Hooper R, Forbes A, Hemming K, Takeda A, Beresford L. Analysis of cluster randomised trials with an assessment of outcome at baseline. 2018;62(12):189202. Table S3. Boat TF, Chao SM, ONeill PH. First, we identified 63 potentially low-value practices through a scoping review and clinician survey [47]. On completion of the cRCT, if the intervention is effective and cost-effective, the multifaceted intervention will be integrated into trauma systems across Canada. This project will advance de-implementation science through the application of knowledge on barriers and facilitators to intervention design and on the incremental effectiveness of a multifaceted de-implementation intervention over simple A&F in a pragmatic setting. While simple Audit & Feedback (A&F) has shown modest effectiveness in reducing low-value care, there is a knowledge gap on the effectiveness of multifaceted interventions to support de-implementation efforts. Admissions with a primary diagnosis of thermal injuries, foreign bodies, drowning, or late effects of injuries will be excluded as diagnostic and therapeutic approaches for these diagnoses are distinct [44]. 2015;13:255. ALL RIGHTS RESERVED, Get to know a member of our trauma team, nursing operations manager Jenn Thelen. Covariate-based constrained randomization of group-randomized trials. Given the need to make rapid decisions in a context of multiple diagnostic and therapeutic options, trauma is a high-risk setting for low-value care. 2012;345:e5661. BMC Med. Furthermore, investigators cannot be blinded to group allocation and there is a possibility of contamination bias that will be minimized by conducting intervention refinement only with participants in the intervention arm and will be assessed in process evaluations. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Trauma quality assurance programs in place in Canada [25,26,27,28,29] and worldwide [30,31,32] have been associated with improvements in quality of care [33,34,35], but they are based on simple A&F and exclusively target adherence to high-valueclinical practices. Level I trauma centers also have technology and equipment Level II trauma centers don't. The ECMO machine is a prime example. They will also be responsible for liaising with trauma program managers in each center and coordinating the collection of qualitative data for the process evaluation. Trauma NB. Supervision by a data manager, on-going training, an electronic forum, and quarterly meetings with stakeholders are used to ensure data quality. Finally, at the end of the trial (months 27 to 30; Fig. Chan AW, Tetzlaff JM, Altman DG, et al. To assess the influence of multiple imputation, we will conduct complete case analyses. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Any trial modifications will be submitted to the trial steering committee for approval, recorded in our registered protocol, and reported in final manuscripts. https://choosingwiselycanada.org/about/. Ann Intern Med. Cochrane Database Syst Rev. Are there any other Level I trauma centers in Missouri? 2020;32(10):67784. Our advisory committee recommended evaluation over two cycles as identifying problems, implementing solutions and operating change takes place over more than one cycle [65]. arterial road means a road which in the opinion of the municipality functions as a main carrier of traffic within an urban area; Seaplane means an aircraft that is capable of landing and taking off on the water. The multifaceted intervention was developed using extensive background work, conducted according to recommended steps for de-implementation [16, 45, 46]. Provalis Research. If contamination is present, we will use an instrumental variable adjustment method [87] in sensitivity analyses. Choosing Wisely Canada. Where can I find experts in any and all of the specialty services I may need? Summer session assignments shall be governed by Article 26 of this Agreement. All sample size parameter values were accurately estimated by historical data from four 18-month observation periods between April 1, 2017, and March 31, 2020, using trauma registry data from the 30 level IIII trauma centers in the Qubec Trauma Care Continuum[36]. de La Mdecine, Qubec, Qc, Canada, Population Health and Optimal Health Practices Research Unit, Centre de Recherche du CHU de Qubec (Hpital de LEnfant-Jsus), Universit Laval, 1050 Av. European Medicines Agency. Building an evidence base for nonprobability sample sizes. Castleview Hospital Press Release. Can J Nurs Res. BMJ Qual Saf. Designated as a Level 1 trauma center by the American College of Surgeons, Ohio State's Wexner Medical Center is widely recognized as a regional resource to care for the most critically ill and injured patients. Trajectoire - Traumatologie. All patients participated in the meeting and voted on practices to be retained. Secondary outcomes will be low-value specialist consultation, low-value repeat imaging after a patient transfer, unintended consequences, determinants for successful implementation, and incremental cost-effectiveness ratios. 2015;350:h2147. Niven DJ, Mrklas KJ, Holodinsky JK, et al. Are multifaceted interventions more effective than single-component interventions in changing health-care professionals behaviours? Husereau D, Drummond M, Augustovski F, et al. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. Cite this article. Unnecessary Care in Canada. 2009;150(4):2701. Audit & Feedback (A&F), a summary of the clinical performance of healthcare provided over a specified period of time, has been shown to have a modest effect on the de-implementation of low-value practices [12]. When children need emergency medical treatment they need specialized equipment suited to their size, expert medical providers who are experienced in treating children, medications tailored for their growing bodies, and many other special considerations. Accessed 22 Aug 2022. Summer Session means the intersession between academic years.