Clinical Behavior Change Research Articles

Implementation of a behavioral medicine approach in physiotherapy: impact and sustainability

Purpose: To explore the effects on and sustainability of physiotherapists’ clinical behavior when using facilitation to support the implementation of a behavioral medicine approach in primary health care for patients with persistent musculoskeletal pain.Methods: A quasi-experimental pre-/post-test trial was conducted. Fifteen physiotherapists were included in the experimental group, and nine in the control group. Based on social cognitive theory and the Promoting Action on Research Implementation in Health Services framework, facilitation with multifaceted implementation methods was used during a six-month period. Clinical behaviors were investigated with a study-specific questionnaire, structured observations, self-reports and patient records. Descriptive and non-parametric statistical methods were used for analyzing differences over time and effect size.Results: A sustained increase in self-efficacy for applying the behavioral medicine approach was found. Clinical actions and verbal expressions changed significantly, and the effect size was large; however, changes were not sustained at follow-ups. The behavioral changes were mainly related to the goal setting, self-monitoring and functional behavioral analysis components. No changes in clinical behavior were found in the control group.Conclusion: Tailored multifaceted facilitation can support the implementation of a behavioral medicine approach in physiotherapy in primary health care, but more comprehensive actions targeting sustainability are needed.Implications for rehabilitationTailored multifaceted facilitation can support the implementation of an evidence based behavioral medicine approach in physiotherapy.Facilitation can be useful for increasing self-efficacy beliefs for using behavioral medicine approach in physiotherapist’s clinical practice.Further research is required to establish strategies that are effective in sustaining behavioral changes.

Implementation of Recommendations for Long-Acting Contraception Among Women Aged 13 to 18 Years in Primary Care

ObjectiveClinical specialty societies recommend long-acting reversible contraceptives (LARCs) as first-line contraception for adolescent women. We evaluated whether a combined educational and process improvement intervention enhanced LARC placement in primary care within an integrated health care system. MethodsThe intervention included journal clubs, live continuing education, point-of-care guidelines, and new patient materials. We conducted a retrospective cohort study across 3 time periods: baseline (January 2013−September 2015), early implementation (October 2015–March 2016), and full implementation (April 2016–June 2017). The primary outcome was the proportion of LARCs placed by primary care clinicians among women aged 13 to 18 years compared with gynecology clinicians. ResultsKaiser Foundation Health Plan of Colorado cared for approximately 20,000 women aged 13 to 18 years in each calendar quarter between 2013 and 2017. Overall, LARC placement increased from 7.0 per 1000 members per quarter at baseline to 13.0 per 1000 during the full intervention. Primary care clinicians placed 6.2% of all LARCs in 2013, increasing to 32.1% by 2017 (P < .001), including 45.5% of contraceptive implants. Clinicians who attended educational sessions were more likely to adopt LARCs than those who did not (17.9% vs 6.4% respectively, P = .009). Neither overall LARC placement rates (relative risk, 1.9; 95% confidence interval, 0.7−5.6) nor contraceptive implant rates (relative risk, 3.0; 95% confidence interval, 0.9−9.8) increased significantly in clinicians who attended educational activities. ConclusionsThis multimodal intervention was associated with increased LARC placement for adolescent women in primary care. The combination of education and process improvement is a promising strategy to promote clinician behavior change.

Longitudinal survey of clinician behavior change in CKD management.

To assess longitudinal improvement for a simple intervention to teach physician assistants (PAs) and NPs management of patients with diabetes and chronic kidney disease (CKD). The original cohort from the Kidneys in a Box quality improvement project was revisited at the 3-year mark and asked about patient statin use, A1C measurement, urine albumin-creatinine ratio (UACR), CKD staging, distribution of over-the-counter (OTC) medication caution lists, and documentation of smoking history. A statistically significant increase in quality metrics was seen at 3 months postintervention for the original cohort. At the 3-year mark, these improvements were sustained. For UACR and smoking quality metrics, performance increased beyond the gains initially seen at 3 months. This study demonstrates that a single-intervention quality improvement program can affect sustained improvements in clinical care of patients with diabetes and CKD. The results provide evidence that one-time quality improvement interventions have the power to promote longitudinal practice changes associated with reduced rates of CKD progression and potentially reduced healthcare costs.

A clinical process redesign project to improve outcomes and reduce care variance for people with Parkinson's disease

BackgroundRedesigning clinical processes is an iterative process that seeks to reduce care variance and improve quality, safety and satisfaction for patients. The aim of this project was to optimise multidisciplinary collaboration, management and integration of clinical processes for people with Parkinson's Disease (PD) in one Emergency Department (ED). MethodsThe retrospective evaluation study design explored the outcomes of a clinical process redesign project. The project included: a pre-post medical record audit, a nurse survey and patient and carer telephone interviews. ResultsThe pre-post ED medical record audit revealed in favour of the post group a median reduction of 175 minutes (IQR 0:40 - 19:40) in length of stay, a 21% improvement in timely PD medication administration and 13% improvement in correctly prescribed PD medications. Patients and carers (n=47) were satisfied with their ED experience, clinicians' knowledge and management and healthcare decision engagement. Nurses (n=30) reported improved knowledge, confidence and management in caring for PD patients. ConclusionThis project led to enhanced multidisciplinary engagement and positive patient, clinician and service outcomes. Redesign principles can provide a pragmatic approach to improve the integration of care, change clinician behaviour, and reduce adverse outcomes within any clinical setting.

A basic anesthesia training program for nurses in Chad: first steps for a south-south academic cooperation program.

Safe perioperative care remains a large public healthcare problem in low- and middle-income countries. Anesthesia care provided by trained professionals is one of the essential determinants to address this situation. This article reports the design and implementation of a focused anesthesia educational program for nurses in Chad. This program consisted of four full-time courses of one month each, taught in a local hospital. The program included supervised practice in the operating room and post-anesthesia recovery room, skills lab simulation training, high fidelity crisis simulation, theoretical classes, integration sessions, evaluations, and structured feedback sessions. Seven male nurses, aged 28-40 yr, were accepted and successfully completed the program. The median [interquartile range] students' global satisfaction with the program was high (86 [85-93]%). Cognitive and skills assessment improved significantly after the program. Students subsequently worked in city and district hospitals performing essential and emergency surgical interventions. This is a novel south-south academic cooperation program for nurses in Chad. The program evaluation indicated a high level of satisfaction, effective cognitive and skills learning, and changes in clinical behaviour. Addressing the lack of adequate provision of anesthesia care is a task still to be faced, and this program depicts a bridge alternative until formal educational programs are implemented in the country.

A circulating tumor cell RNA assay for dynamic assessment of androgen receptor signaling inhibitors sensitivity in metastatic castration-resistant prostate cancer.

157 Background: Tissue-based gene signatures can predict clinical behavior in prostate cancer (PC). Our objective was to extend their application to circulating tumor cells (CTCs) and to show that changes in the signature were associated with changes in clinical behavior. Methods: Our approach combined the Thermoresponsive(TR)-NanoVelcro CTC purification system with the Nanostring nCounter system for cellular purification and transcriptomic analysis. The Prostate Cancer Classification System (PCS) panel was modified for use in CTCs. We selected 31 blood samples from 23 PC patients receiving androgen receptor signaling inhibitors (ARSI) and measured the PCS1 Z score (probability). These findings were compared with clinical outcome data (responsiveness/resistance). Results: A modified, 16-gene PCS1 signature was established and validated through a rigorous bioinformatics process. We performed analytical validation of our combined CTC-RNA system to ensure reproducibility and specificity. In patient bloods, ARSI-resistant samples (ARSI-R, n = 14) had significantly higher PCS1 Z scores as compared with ARSI-sensitive samples (ARSI-S, n = 17) (Rank-sum test, P = 0.003). The analyzed bloods contained samples from 8 patients who developed resistance to an ARSI allowing for dynamic measurement of gene expression. Our analysis found that the PCS1 Z score increased at the time that ARSI-resistance emerged (Pairwise T-test, P = 0.016). Conclusions: Using this new methodology, contemporary, clinically-relevant gene signatures such as PCS could be measured non-invasively in CTCs. These findings can be used to relate gene expression to clinical drug response. This approach also allowed for measurement of dynamic variations of gene expression in individual patients over time that correlated to ARSI sensitivity.

P002 WHEN THE PATIENT VOICE IS HEARD IN EDUCATION, DOES THE CLINICIAN LISTEN? DUAL TRACK PATIENT/PROVIDER EDUCATION IN IBD INCORPORATING PATIENTS AS LEARNERS AND FACULTY

It is postulated that patient inclusion in planning/execution of continuing medical education (CME) activities may better engage providers, reinforce learning, and improve outcomes. RMEI Medical Education’s (RMEI’s) proprietary Clinical Convergence® format, launched in 2014 and spanning 30 activities in multiple disease states, utilizes interactive case-based discussion centered on real patients to contextualize didactic learning. In the final third of the program, the patients discussed join the clinical faculty panel for a guided discussion. This series in inflammatory bowel disease (IBD) was endured and offered as a web-based educational activity, concurrent with a patient education program. This study examined the efficacy of this format on improving provider proficiency and empowering patients. The Crohn’s & Colitis Foundation (Foundation) and RMEI developed a Clinical Convergence® curriculum, comprising a series of half-day regional meetings, aimed at gastroenterology/primary care providers who manage patients with IBD; patients with IBD and their caregivers were also invited to participate in concurrent patient education. The patient/caregiver track included a workshop (led by the Foundation and faculty) focused on facilitating meaningful engagement with clinicians. Participants from both tracks then converged to discuss lessons learned. The provider track was endured online, expanding the reach to a national cohort of community clinicians. Outcomes were measured via ARS keypads (live) and web-based testing (enduring and follow-up). For patients, a composite Wellness Index measured the degree to which they felt able to actively participate in their care before and after the education. Learners’ performance changes on these metrics were used to evaluate changes in proficiency. 818 providers (92% physicians) participated in the four activities (61% gastroenterology providers), with N=103 completers. 102 patients participated in the live meetings. Analysis of learning objectives (Figure 1) revealed improved clinician proficiency and behavior change in key clinical areas in both live and online formats. Patients/caregivers showed improvements in knowledge regarding symptoms and treatments with commensurate improvements in confidence and intent to change ratings (Figure 2). Patients showed universal improvement across the Wellness Index. These findings demonstrate the applied efficacy of this program for both clinicians and patients/caregivers. Specifically, working with real patients as faculty, who are presented as case scenarios and able to discuss their perspectives on treatment, represents a unique opportunity for meaningful collaboration and conversation. It also improves professional proficiency and patient engagement.

Virtual Reality for Health Professions Education: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration.

BackgroundVirtual reality (VR) is a technology that allows the user to explore and manipulate computer-generated real or artificial three-dimensional multimedia sensory environments in real time to gain practical knowledge that can be used in clinical practice.ObjectiveThe aim of this systematic review was to evaluate the effectiveness of VR for educating health professionals and improving their knowledge, cognitive skills, attitudes, and satisfaction.MethodsWe performed a systematic review of the effectiveness of VR in pre- and postregistration health professions education following the gold standard Cochrane methodology. We searched 7 databases from the year 1990 to August 2017. No language restrictions were applied. We included randomized controlled trials and cluster-randomized trials. We independently selected studies, extracted data, and assessed risk of bias, and then, we compared the information in pairs. We contacted authors of the studies for additional information if necessary. All pooled analyses were based on random-effects models. We used the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach to rate the quality of the body of evidence.ResultsA total of 31 studies (2407 participants) were included. Meta-analysis of 8 studies found that VR slightly improves postintervention knowledge scores when compared with traditional learning (standardized mean difference [SMD]=0.44; 95% CI 0.18-0.69; I2=49%; 603 participants; moderate certainty evidence) or other types of digital education such as online or offline digital education (SMD=0.43; 95% CI 0.07-0.79; I2=78%; 608 participants [8 studies]; low certainty evidence). Another meta-analysis of 4 studies found that VR improves health professionals’ cognitive skills when compared with traditional learning (SMD=1.12; 95% CI 0.81-1.43; I2=0%; 235 participants; large effect size; moderate certainty evidence). Two studies compared the effect of VR with other forms of digital education on skills, favoring the VR group (SMD=0.5; 95% CI 0.32-0.69; I2=0%; 467 participants; moderate effect size; low certainty evidence). The findings for attitudes and satisfaction were mixed and inconclusive. None of the studies reported any patient-related outcomes, behavior change, as well as unintended or adverse effects of VR. Overall, the certainty of evidence according to the GRADE criteria ranged from low to moderate. We downgraded our certainty of evidence primarily because of the risk of bias and/or inconsistency.ConclusionsWe found evidence suggesting that VR improves postintervention knowledge and skills outcomes of health professionals when compared with traditional education or other types of digital education such as online or offline digital education. The findings on other outcomes are limited. Future research should evaluate the effectiveness of immersive and interactive forms of VR and evaluate other outcomes such as attitude, satisfaction, cost-effectiveness, and clinical practice or behavior change.

Driving Organizational Change in Serious Illness Communication: Successes and Challenges of Implementing the Serious Illness Care Program (QI729)

1.Describe different approaches to the use of clinical tools, clinician training, and systems-changes to improve serious illness communication throughout a system.2.Examine aggregate implementation data across three health systems on structures and processes of implementing a primary palliative care program focused on communication.3.Explore strategies to maximize clinician behavior change and factors that may influence uptake of serious illness communication on the frontlines. Clinicians commonly miss opportunities to engage seriously ill patients in conversations about values and goals, or do so late in the illness course. Achieving more, earlier, and better serious illness communication requires system-level change. Examine early learnings about successes and challenges of implementing a communication quality-improvement initiative in three health systems. Three U.S. systems have adapted and implemented the Serious Illness Care Program (SICP), which includes tools, training, and systems-changes, in partnership with Ariadne Labs (AL) using a system-level implementation model. We combined and analyzed structure and process data from the three systems and routinely collected coaching notes to understand early successes and challenges. From 2016-present, AL trained and coached 24 champions (including 20 palliative care specialists) at the 3 systems. Champions launched SICP in cardiology, oncology, geriatrics, surgery, and primary care; Champions have trained 330 clinicians. EMRs have been modified to include an accessible template; 1,852 patients have a documented conversation thus far. Preliminary analysis of coaching notes revealed: 1) Structures and capabilities (e.g. clinician training, EHR template) can be replicated, yet clinician uptake of serious illness conversations varies and may depend on factors not captured in the model, e.g. attitudes toward palliative or end-of-life care; 2) Uncertainties about the role of inter-professionals (e.g. nurses) and specialists vs. generalists in serious illness communication may contribute to workflow challenges; 3) Supportive coaching, leadership/peer engagement, and/or data-reporting are likely to enhance practice change but require time and resources. Successful adaptation and adoption of SICP structures and processes in three health systems suggests the promise of a systems-level implementation model to improve serious illness communication. More effective workflows that activate the care team and a better understanding of the mechanisms and contextual factors that support practice change are likely to enhance efforts.

Accounting for Healthcare-Seeking Behaviours and Testing Practices in Real-Time Influenza Forecasts.

For diseases such as influenza, where the majority of infected persons experience mild (if any) symptoms, surveillance systems are sensitive to changes in healthcare-seeking and clinical decision-making behaviours. This presents a challenge when trying to interpret surveillance data in near-real-time (e.g., to provide public health decision-support). Australia experienced a particularly large and severe influenza season in 2017, perhaps in part due to: (a) mild cases being more likely to seek healthcare; and (b) clinicians being more likely to collect specimens for reverse transcription polymerase chain reaction (RT-PCR) influenza tests. In this study, we used weekly Flutracking surveillance data to estimate the probability that a person with influenza-like illness (ILI) would seek healthcare and have a specimen collected. We then used this estimated probability to calibrate near-real-time seasonal influenza forecasts at each week of the 2017 season, to see whether predictive skill could be improved. While the number of self-reported influenza tests in the weekly surveys are typically very low, we were able to detect a substantial change in healthcare seeking behaviour and clinician testing behaviour prior to the high epidemic peak. Adjusting for these changes in behaviour in the forecasting framework improved predictive skill. Our analysis demonstrates a unique value of community-level surveillance systems, such as Flutracking, when interpreting traditional surveillance data. These methods are also applicable beyond the Australian context, as similar community-level surveillance systems operate in other countries.

Behavioural change in primary care professionals undertaking online education in dementia care in general practice.

A challenge facing general practice is improving the diagnosis, management and care of people with dementia. Training and education for primary care professionals about knowledge and attitudes about dementia is needed. Online resources can provide educational opportunities for health professionals with limited access to dementia training. An online educational resource (four modules over 3 h) was designed to assist primary care practitioners to develop a systematic framework to identify, diagnose and manage patients with dementia within their practice. Interviews and questionnaires (knowledge, attitudes, confidence and behavioural intentions), with practice nurses and international medical graduates working in general practices, were used to evaluate the resource. Participants' knowledge, confidence and attitudes about dementia increased after completing the modules. Participants had strong intentions to apply a systematic framework to identify and manage dementia. In post-module interviews, participants reported increased awareness, knowledge and confidence in assessing and managing people with dementia, corroborating the questionnaire results. This project has demonstrated some early changes in clinical behaviour around dementia care in general practice. Promoting the value of applying a systematic framework with colleagues and co-workers could increase awareness of, and participation in, dementia assessment by other primary care professionals within general practices.

Chromothripsis and Chromoplexy Are Associated with DNA Instability and Adverse Clinical Outcome in Multiple Myeloma

Introduction: Chromothripsis and chromoplexy are gross structural events that deregulate multiple genes simultaneously and may help explain rapid changes in clinical behavior. Previous screening studies in multiple myeloma (MM) using copy number arrays have identified chromothripsis at a low frequency (1.3%) and suggested it adversely impacts prognosis. Here, using whole genome sequencing (WGS) data we have identified a higher frequency of these events, suggesting they are more common than previously thought.Methods: 10X ChromiumWGS (10XWGS) from 76 newly diagnosed MM (NDMM) patients were analyzed for structural rearrangements using Longranger. Oxford Nanopore long read sequencing was performed on 2 samples. Long insert WGS data from 813 NDMM patient samples from the Myeloma Genome Project (MGP) were analyzed for structural rearrangements using Manta. Whole exome sequencing was available for 712 samples. RNA-seq was available for 643 samples. Chromothripsis was determined by manual curation of breakpoint and copy number data. Chromoplexy was defined as rearrangements within 1 Mb of one another involving 3 or more chromosomes.Results: Chromoplexy was detected in 33/76 (46%) cases using 10XWGS data, and cross validated in the MGP WGS dataset being found in 30% (247/813) of samples and was most frequent on chromosomes 8 (11.7% of samples), 14 (10.6%), 11 (9.6%), 1 (9.5%), 6 (8.0%), 22 (7.6%), 12 (6.7%), and 17 (6.7%). The gene regions most involved in chromoplexy events were MYC (chr8; 7.3%), IGH (chr14, 8.8%), IGL (chr22; 4.6%), CCND1 (chr11; 3.9%), TXNDC5 (chr6; 1.7%), FCHSD2 (chr11; 1.4%), FAM46C (chr1; 1.2%), MMSET (chr4; 1.2%), and MAP3K14 (chr17; 0.7%).Chromoplexy samples involved pairings of super-enhancer donors (IGH, IGL, FAM46C, TXNDC5) and oncogenic receptors (CCND1, MMSET, MAP3K14, MYC) implicating transcriptional deregulation. To confirm, RNASeq showed an elevation of expression over median in the oncogenic receptors when paired with a donor: CCND1 (median expression = 12.0 vs. median expression with donor = 17.9), MAP3K14 (10.8 vs. 14.7), MYC (12.7 vs. 14.1) and MMSET (11.9 vs. 16.7). We also identified elevated expression of PAX5 (8.23 vs. 13.79) and two cases where BCL2 (13.32 vs. 14.68) partnered with MYC, one involved IGH similar to follicular lymphoma.To determine if chromoplexy events were happening on the same allele, we performed long read sequencing using Oxford Nanopore on a sample with a t(2;6;8;11) event. We observed a read mapped to chromosome 2, with secondary alignment to chromosomes 6 and 8. This single 32 kb read was a continuous t(2;6;8) event, proving these events occurred on the same allele. However, despite close proximity, the data did not put the t(8;11) in the same read meaning this event occurred on a different allele or sub-clone, suggesting ongoing genomic instability.Chromothripsis was detected in 16/76 (21%) cases using 10XWGS, and was consistent in MGP data, (170/813; 21%). Chromothripsis occurred on all chromosomes but at different frequencies where chromosome 1 had most events (5.1%), followed by 14 (2.4%), 11 (2.3%), 12 (2.2%), 20 (1.9%), 17 (1.9%), and 8 (1.9%).We hypothesized the presence of both chromoplexy and chromothripsis could be associated with ineffective DNA repair and indeed, using WES data, patients with both events show more mutations in TP53 (19% vs. 5%) and ATM (10% vs. 4%) implicating homologous recombination deficiency as an etiologic mechanism. Gene set enrichment analysis showed significant enrichment and positive normalized enrichment score (NES) for the DNA Repair (P = 0.01; NES = 1.7) and MYC pathways (P = 0.01; NES = 3.2) consistent with previous results.In relation to prognosis, chromoplexy and chromothripsis have a negative impact on progression free survival (28.6 months vs. 42.8 months, P=0.03 and 28.6 months vs. 40.7 months P=0.01, respectively). When patients with both chromoplexy and chromothripsis (9%) were examined there was a pronounced effect on PFS (40.7 months vs. 22.7 months, P<0.001).Conclusion: Complex structural events are seen frequently in MM and could help explain disease progression. Severe cases with both chromoplexy and chromothripsis are associated with acquired genomic instability and an adverse impact on prognosis either directly or due to their association with DNA repair abnormalities. This opens the possibility of specifically therapeutically targeting the underlying DNA abnormalities. DisclosuresFlynt:Celgene Corporation: Employment, Equity Ownership. Ortiz:Celgene Research SL (Spain), part of Celgene Corporation: Employment, Equity Ownership. Dervan:Celgene Corporation: Employment, Equity Ownership. Gockley:Celgene Corporation: Employment. Davies:Janssen: Consultancy, Honoraria; TRM Oncology: Honoraria; Abbvie: Consultancy; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; ASH: Honoraria; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; MMRF: Honoraria; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees. Thakurta:Celgene Corporation: Employment, Equity Ownership. Morgan:Celgene: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Janssen: Research Funding.

Brief teaching sessions change behaviour in A&E.

The Accident and Emergency Department (A&E) is a busy environment that requires time- and resource-efficient teaching. Managing cervical spine (c-spine) trauma is often an unfamiliar skill for new doctors starting work in A&E. This study investigated the efficacy of brief teaching interventions in changing clinician behaviour within A&E. The Accident and Emergency Department is a busy environment that requires time- and resource-efficient teaching METHODS: Data for 482 patients receiving c-spine computed tomography (CT) imaging in two Gloucestershire A&Es before and after multimodal departmental teaching were compared. Time taken to CT, indication for CT scan and presence of bony injury were manually recorded from patient management software. Following the provision of teaching, the proportion of CT scans performed within 1hour did not significantly change, from 31% before teaching to 37.6% after teaching (p=0.133); however, the mean number of c-spine CT scans performed per week rose from 14.50 to 23.25 (p=0.0001), and the mean number of CT scans performed per week within 1hour rose from 4.50 to 8.75 (p ≤0.001). There was no reduction in the quality of these scans, with the proportion detecting bony injury remaining constant, and there was no increase in the proportion of scans not indicated by National Institute for Health and Care Excellence guidelines. This study demonstrates that brief, low-resource teaching can be associated with a positive change in clinician behaviour. This intervention was straightforward to implement and is likely to be transferable to other guideline-driven investigations. Limitations include the patient cohort being proportionately older than that found in major trauma centres, and a lack of data on patients in whom CT scans were indicated but not performed.

Implementation of Guideline-Based Clinical Practice at Ocean Road Cancer Institute in Tanzania

Purpose Low-income countries (LICs) face a growing cancer burden and a pressing need to strengthen cancer care delivery systems. Overall case fatality from cancer is estimated to be 30% higher in LICs than in high-income countries, and adherence to standard treatment guidelines is a critical component of addressing this disparity. Despite several recent international efforts to develop resource-stratified cancer treatment guidelines, little research has been done on their implementation. In 2018, Tanzania’s Ministry of Health will publish a new set of national cancer treatment guidelines for all cancers. The objective of this work is to evaluate the feasibility, adoption, and effectiveness of a theory-informed implementation strategy to facilitate the uptake of guideline-based clinical practice at the national referral center, Ocean Road Cancer Institute (ORCI). Our central hypothesis is that this implementation strategy will be undertaken with fidelity and context-appropriate adaptations and will effectively increase guideline-concordant treatment at ORCI. Methods Qualitative data demonstrate that major barriers to guideline-based practice at ORCI include a lack of familiarity with standard treatment guidelines and a culture that prioritizes experience-based expertise over guidelines. We developed a multifaceted intervention to target these barriers using the Capability, Opportunity, Motivation and Behavior/Behavior Change Wheel framework. Our intervention has three phases: distribution of national cancer treatment guidelines in hard and soft copy, with an accompanying publicity campaign; dedicated multidisciplinary trainings for oncology providers and implementation champions; and reinforcement strategies, such as environmental restructuring and point-of-care clinical forms, to promote guideline-based practice. We will use a pre–post design that uses a mixed-methods approach to measure process and outcomes, including clinical data collection, survey administration, and qualitative interviews, focus groups, and field observation. Conclusion In Tanzania and other LICs, shifting to guideline-based practice entails a change in clinical culture and behavior, and guideline publication alone is unlikely to result in meaningful change. A theory-informed implementation strategy is the optimal way to ensure the adoption and sustained use of guideline-based practice. Systematic evaluation will allow us to make necessary modifications, disseminate findings, and advance knowledge in the field of cancer treatment guideline implementation in LICs. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/site/ifc . Li Zhang Consulting or Advisory Role: Dendreon, Unity

ALS-specific cognitive and behavior changes associated with advancing disease stage in ALS.

ObjectiveTo elucidate the relationship between disease stage in amyotrophic lateral sclerosis (ALS), as measured with the King's Clinical Staging System, and cognitive and behavioral change, measured with the Edinburgh Cognitive and Behavioural ALS Screen (ECAS).MethodsA large multicenter observational cohort of 161 cross-sectional patients with ALS and 80 healthy matched controls were recruited across 3 research sites (Dublin, Edinburgh, and London). Participants were administered the ECAS and categorized into independent groups based on their King's clinical disease stage at time of testing.ResultsSignificant differences were observed between patients and controls on all subtests of the ECAS except for visuospatial functioning. A significant cross-sectional effect was observed across disease stages for ALS-specific functions (executive, language, letter fluency) and ECAS total score but not for ALS-nonspecific functions (memory, visuospatial). Rates of ALS-specific impairment and behavioral change were also related to disease stage. The relationship between cognitive function and disease stage may be due to letter fluency impairment, whereas higher rates of all behavioral domains were seen in later King's stage. The presence of bulbar signs, but not site of onset, was significantly related to ALS-specific, ECAS total, and behavioral scores.ConclusionALS-specific cognitive deficits and behavioral impairment are more frequent with more severe disease stage. By end-stage disease, only a small percentage of patients are free of neuropsychological impairment. The presence of bulbar symptoms exaggerates the differences observed between disease stages. These findings suggest that cognitive and behavioral change should be incorporated into ALS diagnostic criteria and should be included in future staging systems.

System-integrated technology-enabled model of care to improve the health of stroke patients in rural China: protocol for SINEMA—a cluster-randomized controlled trial

Despite the significant burden of stroke in rural China, secondary prevention of stroke is suboptimal. This study aims to develop a SINEMA for the secondary prevention of stroke in rural China and to evaluate the effectiveness of the model compared with usual care. The SINEMA model is being implemented and evaluated through a 1-year cluster-randomized controlled trial in Nanhe County, Hebei Province in China. Fifty villages from 5 townships are randomized in a 1:1 ratio to either the intervention or the control arm (usual care) with a target to enroll 25 stroke survivors per village. Village doctors in the intervention arm (1) receive systematic cascade training by stroke specialists on clinical guidelines, essential medicines and behavior change; (2) conduct monthly follow-up visits with the support of a mobile phone application designed for this study; (3) participate in virtual group activities with other village doctors; 4) receive performance feedback and payment. Stroke survivors participate in a health education and project briefing session, receive monthly follow-up visits by village doctors and receive a voice message call daily as reminders for medication use and physical activities. Baseline and 1-year follow-up survey will be conducted in all villages by trained staff who are blinded of the randomized allocation of villages. The primary outcome will be systolic blood pressure and the secondary outcomes will include diastolic blood pressure, medication adherence, mobility, physical activity level and quality of life. Process and economic evaluation will also be conducted. This study is one of very few that aim to promote secondary prevention of stroke in resource-constrained settings and the first to incorporate mobile technologies for both healthcare providers and patients in China. The SINEMA model is innovative as it builds the capacity of primary healthcare workers in the rural area, uses mobile health technologies at the point of care, and addresses critical health needs for a vulnerable community-dwelling patient group. The findings of the study will provide translational evidence for other resource-constrained settings in developing strategies for the secondary prevention of stroke.

In Reply.

We thank our colleagues for their interest in the published work1 and their thoughtful comments. The study of clinical decision support, process of care measures, and clinical outcomes is a complex area that demands increased attention from the peer-reviewed literature, academic institutions, and industry.We concur with Dr. Freundlich et al. that multicenter studies of clinical decision support are necessary to advance the field. To maximize generalizability and reproducibility, multicenter research is a natural step in the evolution of evidence-based practice change. Donabedian’s classic “ structure-process-outcomes” framework clearly identifies that the context within which care is delivered must be incorporated into clinical and health services research.2 A decision support system that is associated with clinical impact in one health system or structure of care may demonstrate no value in another setting, or vice versa. Multicenter pragmatic clinical trials and Randomized, Embedded, Multifactorial, Adaptive Platform (also known as “REMAP”) trial designs are potential cost-effective avenues to study clinical decision support.3 With support from a multitude of national and international anesthesiology organizations, the Multicenter Perioperative Outcomes Group, on behalf of its more than 40 contributing member organizations, has invested in the Initiative for Multicenter Perioperative Clinical Trials (IMPACT).4 We look forward to working with centers and investigators from around the world that wish to use this infrastructure for pragmatic perioperative trials.We also share Doctoral Candidate Patel’s interest in the complexity of data elements and factors involved in clinical research. We struggle, however, to identify a specific way forward offered by Patel et al., or any recommendation underlying their correspondence. The “curse of dimensionality” is not unique to the study of decision support systems or healthcare research in general. Nor is pharmaceutical research, and the billions of dollars expended each year on unsuccessful drug targets, an appropriate model for future work. In fact, much of current drug development involves the use of hypothesis-generating phenome-wide or genome-wide association studies that provide hundreds of candidate targets for a given disease state; these potential targets are then evaluated at scale using computational, theoretical models. Although increased sample size and data breadth may address some issues with analyses of multifactorial clinical outcomes, data heterogeneity and quality issues often arise in concert. Increased sample size may have allowed adequate power to detect a difference in infrequent outcomes such as stage 2 acute kidney injury.In summary, we concur that new data types and approaches are needed to advance the science of decision support system evaluation. Although our current analysis demonstrated process of care impact, it could not evaluate the impact on many crucial clinical outcomes inconsistently recorded in the electronic health record, such as surgical site infection, pulmonary complications, delirium, or patient satisfaction. Finally, the positive impact upon process of care measures and some resource outcomes should offer encouragement to clinicians and researchers seeking to advance care for their patients. Changing clinician behavior remains a goal almost as elusive as improving clinical outcomes.Support provided by the Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, Michigan.Dr. Tremper is the founder of, and has an equity interest in, AlertWatch (Ann Arbor, Michigan), the company that developed the decision support system being evaluated.

Undergraduate education in anaesthesia, intensive care, pain, and perioperative medicine: The development of a national curriculum framework

Introduction: The study describes the development of the first UK national framework to guide undergraduate education in anesthesia, perioperative medicine, critical care, and pain medicine.Methods: We followed an inclusive process of curriculum design aiming to promote high-level learning amongst students. We conducted telephone interviews with senior anesthetic educators at 33 UK medical schools to establish current provision and practice. We then held a consultative national workshop for educators, using focus group interviews to set broad aims for the final framework and gather information.Result: Anesthesia undergraduate educators demonstrated a conceptual focus that moves beyond simple acquisition of knowledge to one geared to encouraging clinical behavioral change in learners to equip them for practice as new doctors. Respondents also highlighted the opportunities for promoting spiral, integrated, and longitudinal learning within the undergraduate curriculum. We also formulated eight key domains of practice in anesthesia and critical care and mapped 63 of the 106 General Medical Council’s Outcomes for Graduates against these domains, and created a brief suggested syllabus.Conclusions: The framework aims to provide support and guidance for medical schools in the development of competent, well-rounded doctors who are able to provide safe, patient-centered care in all areas of medical practice.

Selected abstracts from the 24th Annual Meeting of the Society in Europe for the Simulation Applied to Medicine

Ethics statement: The authors declare that they have followed the guidelines for scientific integrity and professional ethics. The article does not contain any studies with human or animal subjects. Introduction & Aim: Stroke is one of the leading causes of morbidity and mortality worldwide. In eligible patients with acute ischemic stroke, early treatment with intravenous thrombolysis is crucial for a good patient outcome. We introduced simulation training sessions in conjunction with an improved treatment protocol as part of a quality improvement project to reduce door-to-needle times in stroke thrombolysis. Methods: A questionnaire assessing our preexisting treatment protocol was sent to all members of the stroke team. A panel of experts reviewed the responses and suggested potential changes to streamline the treatment protocol. In February 2017, we introduced the new protocol along with weekly videotaped in-situ scenario based simulation sessions with all stroke team members as participants. Previous stroke patients acted as markers. Kirkpatrick’s four-level training evaluation model was used for assessment. Here we present 1) Participant reactions (level 1) on a Likert item from 0-10, and 2) Median door-to-needle times in stroke thrombolysis, a measure of clinical behavioral change (level 3), using a statistical process control method. Simulated performance and long term patient outcomes will be assessed in future analysis. Results & Discussion: Participant reactions were predominantly positive. Self-perceived learning scored a median of 8 (IQR 7-9). We compared door-to-needle times for 478 prospectively included patients with acute ischemic stroke treated with intravenous thrombolysis at our hospital from January 2014 – July 2017. There was a significant reduction in median door-to-needle time from 27 (IQR 19-41) to 13 minutes (IQR 9-21, p<0.001) for the 78 patients in the post-intervention group. The results remained significant regardless of time of admission. There were no significant changes in the rate of stroke mimics, prehospital time or fatal intracranial hemorrhage. Simulation training in conjunction with protocol improvement led to an immediate and significant reduction of median door-to-needle time in stroke thrombolysis (Fig. 1). To our knowledge, no other published data have shown lower median treatment times. Combining simulation training with protocol change holds promise as a method both for effective implementation and significant results in attempts to reduce in-hospital delays in stroke thrombolysis. Effects on non-technical skills, provider variability and long term patient outcomes are yet to be evaluated.

Education of healthcare professionals for preventing pressure ulcers.

Pressure ulcers, also known as bed sores or pressure sores, are localised areas of tissue damage arising due to excess pressure and shearing forces. Education of healthcare staff has been recognised as an integral component of pressure ulcer prevention. These educational programmes are directed towards influencing behaviour change on the part of the healthcare professional, to encourage preventative practices with the aim of reducing the incidence of pressure ulcer development. To assess the effects of educational interventions for healthcare professionals on pressure ulcer prevention. In June 2017 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. We included randomised controlled trials (RCTs) and cluster-RCTs, that evaluated the effect of any educational intervention delivered to healthcare staff in any setting to prevent pressure ulceration. Two review authors independently assessed titles and abstracts of the studies identified by the search strategy for eligibility. We obtained full versions of potentially relevant studies and two authors independently screened these against the inclusion criteria. We identified five studies that met the inclusion criteria for this review: four RCTs and one cluster-RCT. The study characteristics differed in terms of healthcare settings, the nature of the interventions studied and outcome measures reported. The cluster-RCT, and two of the RCTs, explored the effectiveness of education delivered to healthcare staff within residential or nursing home settings, or nursing home and hospital wards, compared to no intervention, or usual practices. Educational intervention in one of these studies was embedded within a broader, quality improvement bundle. The other two individually randomised controlled trials explored the effectiveness of educational intervention, delivered in two formats, to nursing staff cohorts.Due to the heterogeneity of the studies identified, pooling was not appropriate and we have presented a narrative overview. We explored a number of comparisons (1) education versus no education (2) components of educational intervention in a number of combinations and (3) education delivered in different formats. There were three primary outcomes: change in healthcare professionals' knowledge, change in healthcare professionals' clinical behaviour and incidence of new pressure ulcers.We are uncertain whether there is a difference in health professionals' knowledge depending on whether they receive education or no education on pressure ulcer prevention (hospital group: mean difference (MD) 0.30, 95% confidence interval (CI) -1.00 to 1.60; 10 participants; nursing home group: MD 0.30, 95% CI -0.77 to 1.37; 10 participants). This was based on very low-certainty evidence from one study, which we downgraded for serious study limitations, indirectness and imprecision.We are uncertain whether there is a difference in pressure ulcer incidence with the following comparisons: training, monitoring and observation, versus monitoring and observation (risk ratio (RR) 0.63, 95% CI 0.37 to 1.05; 345 participants); training, monitoring and observation, versus observation alone (RR 1.21, 95% CI 0.60 to 2.43; 325 participants) or, monitoring and observation versus observation alone (RR 1.93, 95% CI 0.96 to 3.88; 232 participants). This was based on very low-certainty evidence from one study, which we downgraded for very serious study limitations and imprecision. We are uncertain whether multilevel intervention versus attention control makes any difference to pressure ulcer incidence. The report presented insufficient data to enable further interrogation of this outcome.We are uncertain whether education delivered in different formats such as didactic education versus video-based education (MD 4.60, 95% CI 3.08 to 6.12; 102 participants) or e-learning versus classroom education (RR 0.92, 95% CI 0.80 to 1.07; 18 participants), makes any difference to health professionals' knowledge of pressure ulcer prevention. This was based on very low-certainty evidence from two studies, which we downgraded for serious study limitations and study imprecision.None of the included studies explored our other primary outcome: change in health professionals' clinical behaviour. Only one study explored the secondary outcomes of interest, namely, pressure ulcer severity and patient and carer reported outcomes (self-assessed quality of life and functional dependency level respectively). However, this study provided insufficient information to enable our independent assessment of these outcomes within the review. We are uncertain whether educating healthcare professionals about pressure ulcer prevention makes any difference to pressure ulcer incidence, or to nurses' knowledge of pressure ulcer prevention. This is because the included studies provided very low-certainty evidence. Therefore, further information is required to clarify the impact of education of healthcare professionals on the prevention of pressure ulcers.