A Cost Analysis of Rethink the Strip: De-implementing a Low-value Practice in Primary Care.

BACKGROUND: Routine self-monitoring of blood glucose is a low-value practice that provides limited benefit for patients with non-insulin-treated type 2 diabetes mellitus. OBJECTIVES: We estimated the costs of Rethink the Strip (RTS), a multistrategy approach to the de-implementation of self-monitoring of blood glucose in primary care. RESEARCH DESIGN: RTS was conducted among 20 primary care clinics in North Carolina. We estimated the non-site-based and site-based costs of the 5 RTS strategies (practice facilitation, audit and feedback, provider champions, educational meetings, and educational materials) from the analytic perspective of an integrated health care system for 12 and 27-month time horizons. Material costs were tracked through project records, and personnel costs were assessed using activity-based costing. We used nationally based wage estimates. RESULTS: Total RTS costs equaled $68,941 for 12 months. Specifically, non-site-based costs comprised $16,560. Most non-site-based costs ($11,822) were from the foundational programming and coding updates to the electronic health record data to develop the audit and feedback reports. The non-site-based costs of educational meetings, practice facilitation, and educational materials were substantially lower, ranging between ~$400 and $1000. Total 12-month site-based costs equaled $2569 for a single clinic (or $52,381 for 20 clinics). Educational meetings were the most expensive strategy, averaging $1401 per clinic. The site-based costs for the 4 other implementation strategies were markedly lower, ranging between $51 for educational materials and $555 for practice facilitation per clinic. CONCLUSIONS: This study provides detailed cost information for implementation strategies used to support evidence-based programs in primary care clinics.

Implementing practice facilitation in research: how facilitators spend their time guiding practices to improve blood pressure control.

BACKGROUND: Practice facilitators (PFs) coach practices through quality improvement (QI) initiatives aimed at enhancing patient outcomes and operational efficiencies. Practice facilitation is a dynamic intervention that, by design, is tailored to practices' unique needs and contexts. Little research has explored the amount of time PFs spend with practices on QI activities. This short report expands on previously published work that detailed a 12-month practice facilitation intervention as part of the Southeastern Collaboration to Improve Blood Pressure Control (SEC) trial, which focused on improving hypertension control among people living in rural settings in the southeastern USA. This report analyzes data on the time PFs spent to guide 32 primary care practices in implementing QI activities to support enhanced outcomes in patients with high blood pressure. METHODS: The SEC trial employed four certified PFs across all practice sites, who documented time spent: (1) driving to support practices; (2) working on-site with staff and clinicians; and (3) communicating remotely (phone, email, or video conference) with practice members. We analyzed the data using descriptive statistics to help understand time devoted to individual and aggregated tasks. Additionally, we explored correlations between practice characteristics and time spent with PFs. RESULTS: In aggregate, the PFs completed 416 visits to practices and spent an average of 130 (SD 65) min per visit driving to and from practices. The average time spent on-site per visit with practices was 87 (SD 37) min, while an average of 17 (SD 12) min was spent on individual remote communications. During the 12-month intervention, 1131 remote communications were conducted with practices. PFs spent most of their time with clinical staff members (n = 886 instances) or with practice managers alone (n = 670 instances) while relatively few on-site visits were conducted with primary care providers alone (n = 15). In 19 practices, no communications were solely with providers. No significant correlations were found between time spent on PF activities and a practices' percent of Medicaid and uninsured patients, staff-provider ratio, or federally qualified health center (FQHC) status. CONCLUSIONS: PFs working with practices serving rural patients with hypertension devote substantial time to driving, highlighting the importance of optimizing a balance between time spent on-site vs. communicating remotely. Most time spent was with clinical staff, not primary care providers. These findings may be useful to researchers and business leaders who design, test, and implement efficient facilitation services. TRIAL REGISTRATION: NIH ClinicalTrials.gov NCT02866669 . Registered on 15 August 2016. NHLBI AWARD number: PCS-1UH3HL130691.

Decoupling between leaf nitrogen and radiation use efficiency in vegetative and early reproductive stages in high-yielding soybean.

Ontogenic changes in soybean radiation use efficiency (RUE) have been attributed to variation in specific leaf nitrogen (SLN) based only on data collected during seed filling. We evaluated this hypothesis using data on leaf area, absorbed radiation (ARAD), aboveground dry matter (ADM), and plant nitrogen (N) concentration collected during the entire crop season from seven field experiments conducted in a stress-free environment. Each experiment included a full-N treatment that received ample N fertilizer and a zero-N treatment that relied on N fixation and soil N mineralization. We estimated RUE based on changes in ADM between sampling times and associated ARAD, accounting for changes in biomass composition. The RUE and SLN exhibited different seasonal patterns: a bell-shaped pattern with a peak around the beginning of seed filling, and a convex pattern followed by an abrupt decline during late seed filling, respectively. Changes in SLN explained the decline in RUE during seed filling but failed to predict changes in RUE in earlier stages and underestimated the maximum RUE observed during pod setting. Comparison between observed and simulated RUE using a process-based crop simulation model revealed similar discrepancies. The decoupling between RUE and SLN during early crop stages suggests that leaf N is above that needed to maximize crop growth but may play a role in storing N that can be used in later reproductive stages to meet the large seed N demand associated with high-yielding crops.

Implementation fidelity of the Promoting First Relationships intervention program in a Native community.

Promoting First Relationship (PFR) is an evidence-based intervention designed to promote positive, supportive relationships between primary caregivers and their young children. Implementing and testing the efficacy of PFR in a remote Native community is especially challenging and requires methods and tools for ensuring implementation fidelity. Tribal members of a Native community were successfully trained and certified to deliver PFR by university-based personnel. During PFR delivery, they achieved very high scores on adherence to intervention content (M = 0.99, SD = 0.02), and their quality of delivery uniformly exceeded established criteria. High attrition occurred before PFR was delivered. However, participants who remained in the study completed all 10 sessions of PFR content. Participants' satisfaction with the program was very high (M = 3.90 [of 4 points], SD = 0.19). High implementation fidelity was attained in the face of many inherent challenges. The suite of methods and tools used for training, monitoring, and evaluating implementation fidelity in this study provides an example that may be useful in the evaluation of evidence-based programs more generally.

When Less Is More: Identifying Patients With Type 2 Diabetes Engaging in Unnecessary Blood Glucose Monitoring.

This study examined whether certain patient characteristics are associated with the prescribing of self-monitoring of blood glucose for patients with type 2 diabetes who are not using insulin and have well-controlled blood glucose. Against recommendations, one-third of the patient sample from a large health network in North Carolina (N = 9,338) received a prescription for testing supplies (i.e., strips or lancets) within the prior 18 months. Women, African Americans, individuals prescribed an oral medication, nonsmokers, and those who were underweight or normal weight all had greater odds of receiving such a prescription. These results indicate that providers may have prescribing tendencies that are potentially biased against more vulnerable patient groups and contrary to guidelines.

The Key Driver Implementation Scale (KDIS) for practice facilitators: Psychometric testing in the "Southeastern collaboration to improve blood pressure control" trial.

BACKGROUND: Practice facilitators (PFs) provide tailored support to primary care practices to improve the quality of care delivery. Often used by PFs, the "Key Driver Implementation Scale" (KDIS) measures the degree to which a practice implements quality improvement activities from the Chronic Care Model, but the scale's psychometric properties have not been investigated. We examined construct validity, reliability, floor and ceiling effects, and a longitudinal trend test of the KDIS items in the Southeastern Collaboration to Improve Blood Pressure Control trial. METHODS: The KDIS items assess a practice's progress toward implementing: a clinical information system (using their own data to drive change); standardized care processes; optimized team care; patient self-management support; and leadership support. We assessed construct validity and estimated reliability with a multilevel confirmatory factor analysis (CFA). A trend test examined whether the KDIS items increased over time and estimated the expected number of months needed to move a practice to the highest response options. RESULTS: PFs completed monthly KDIS ratings over 12 months for 32 primary care practices, yielding a total of 384 observations. Data was fitted to a unidimensional CFA model; however, parameter fit was modest and could be improved. Reliability was 0.70. Practices started scoring at the highest levels beginning in month 5, indicating low variability. The KDIS items did show an upward trend over 12 months (all p < .001), indicating that practices were increasingly implementing key activities. The expected time to move a practice to the highest response category was 9.1 months for standardized care processes, 10.2 for clinical information system, 12.6 for self-management support, 13.1 for leadership, and 14.3 months for optimized team care. CONCLUSIONS: The KDIS items showed acceptable reliability, but work is needed in larger sample sizes to determine if two or more groups of implementation activities are being measured rather than one.

Clinical Team Response to the Impact of COVID-19 on Diabetes Self-Management: Findings From a Qualitative Study.

The aims of this study were to explore providers' perceptions of how COVID-19 affected patients' psychological wellbeing and diabetes self-care and discover how providers responded to sustain and improve patients' psychological health and diabetes management during the pandemic. Twenty-four semi-structured interviews were completed with primary care providers (n=14) and endocrine specialty clinicians (n=10) across sixteen clinics in North Carolina. Interview topics included: (1) current glucose monitoring approaches and diabetes management strategies for people with diabetes (2) barriers and unintended consequences encountered with respect to diabetes self-management, and (3) innovative strategies developed to overcome barriers. Interview transcripts were coded using qualitative analysis software and analyzed to identify cross-cutting themes and differences between participants. Primary care providers and endocrine specialty clinicians reported that people with diabetes experienced increased mental health symptoms, increased financial challenges and positive and negative changes in self-care routines due to COVID-19. To offer support, primary care providers and endocrine specialty providers focused discussions on lifestyle management and utilized telemedicine to connect with patients. Additionally, endocrine specialty clinicians helped patients access financial assistance programs. Findings indicate that people with diabetes experienced unique challenges to self-management during the pandemic and providers responded with targeted support strategies. Future research should explore the effectiveness of these provider interventions as the pandemic continues to evolve.

Developing a Primary Care-Focused Intervention to Engage Patients With Osteoarthritis in Physical Activity: A Stakeholder Engagement Qualitative Study.

Physical activity (PA) is important for managing osteoarthritis (OA), but many patients are inactive. Research is needed on strategies to leverage clinical encounters to engage patients in PA. Guided by the socioecological model of health behavior, this study aimed to engage stakeholders in the process of refining an Osteoarthritis Physical Activity Care Pathway (OA-PCP). Six focus groups and seven individual interviews were conducted with key stakeholders. Focus groups were specific to stakeholder roles and included patients with OA, support partners, and clinic personnel (n = 6 focus groups). Interview participants were local and national PA program representatives (n = 7 interviews). Data were analyzed by thematic analysis. Themes identified in the data included ways the OA-PCP can help patients with OA address challenges to PA engagement, strategies for connecting patients with PA resources, methods for implementing OA-PCP into clinical settings and potential use of PA trackers in the OA-PCP program. Stakeholders' comments were summarized into key recommendations for OA-PCP. Some recommendations reinforced and led to refinements in planned aspects of OA-PCP, including tailoring to individual patients, involvement of a support partner, and addressing pain with PA. Other recommendations resulted in larger changes for OA-PCP, including the addition of three email- or mail-based contacts and not requiring use of a PA tracker. The refined OA-PCP program is being evaluated in an exploratory trial, with the ultimate goal of establishing a PA program for OA that can be successfully implemented in clinical settings.

Successful Trial of Practice Facilitation for Plan, Do, Study, Act Quality Improvement.

BACKGROUND: Practice facilitation (PF) is a promising but relatively new intervention supporting data-driven practice change. There is a need to better detail research-based facilitation methods, which must balance intervention fidelity and time restrictions with the flexibility required for the intervention. As part of a multi-level 4-armed cluster randomized clinical trial (RCT), 32 rural primary care practices received PF for 1 year. We evaluated the feasibility of having facilitators guide practices to perform 4 key driver domain activities, implemented as Plan-Do-Study-Act (PDSA) cycles, to better understand facilitation "exposure." We describe the intervention and activity length such that our experiences may be useful to other PF research efforts. METHODS: Thirty-two practices serving rural patients involved in the Southeastern Collaboration to Improvement Blood Pressure Control engaged with a facilitator to develop and implement PDSAs nested within key drivers of change domains. Numbers of months practices worked on activities deemed most likely to be sustained were captured along with practice satisfaction data. RESULTS: All practices engaged in at least 4 domain-level activities, and 59% of the PDSAs were active for at least 3 months. There was variation by domain in the average length of the PDSA activities. Ninety-seven percent (31 of 32) of practices recommended similarly structured facilitation services to other primary care practices, and 84% (27 of 32) noted substantive changes in their care processes. CONCLUSION: In this trial, it was feasible for PFs to engage practices in at least 4 Key Driver quality improvement activities within 1 year, which will inform PF methods and protocol development in future trials.

Using the Consolidated Framework for Implementation Research (CFIR) to evaluate implementation effectiveness of a facilitated approach to an asthma shared decision making intervention.

OBJECTIVE: To describe the evaluation of implementation effectiveness of an asthma shared decision making (SDM) intervention at the 10 individual facilitator-led primary care practices in the ADAPT-NC Study using the Consolidated Framework for Implementation Research (CFIR). METHODS: Practices were scored across 40 CFIR constructs within 5 domains using a previously published scoring system of -2 to +2. Based on overall construct scores, practices were then classified as high, medium, or low adopters. To evaluate clinical outcomes, changes in asthma exacerbations were assessed for emergency department (ED) visits, hospitalizations, and oral steroid prescription orders. Using regression analysis, the absolute change in percent for each outcome relative to the CFIR score for each practice was analyzed. (Trial registration #NCT02047929). RESULTS: Implementation effectiveness was reflected in CFIR score differences with 7 high, 1 medium, and 2 low adopter practices. High adopters mostly scored well across all domains. Weaknesses were consistent amongst the 2 low adopters with lower scores in the Inner Setting, Characteristics of Individuals, and Process domains. While no significant correlations were seen between the practices' CFIR scores and the absolute change in ED visits, hospitalizations, or oral steroid prescription orders, practices with higher percentages of children had greater improvements in clinical outcomes. CONCLUSIONS: The CFIR was used to evaluate the asthma SDM intervention implementation at 10 facilitator-led practices. While there was no significant correlation between higher implementation effectiveness and greater improvement in clinical outcomes, practices with a higher proportion of pediatric patients did experience a significant reduction in overall exacerbations post-implementation.

Research nurses as practice facilitators to disseminate an asthma shared decision making intervention.

BACKGROUND: Practice facilitation is a method of introducing and sustaining organizational change. It involves the use of skilled healthcare professionals called practice facilitators (PFs) to help address the challenges associated with implementing evidence-based guidelines and complex interventions into practice. PFs provide a framework for translating research into practice by building relationships, improving communication, fostering change, and sharing resources. Nurses are well positioned to serve as PFs for the implementation of complex interventions, however, there is little evidence currently available to describe nurses in this role. Additionally, the best strategies to implement complex interventions into practices are still not fully understood. Combining practice facilitation with the train-the-trainer model has the potential to spread knowledge and skills. Shared decision making (SDM), which involves patients and providers jointly engaging in decisions around treatment options, has been shown to improve outcomes for patients with asthma. The goal of this manuscript is to describe and evaluate the practice facilitation process from the ADAPT-NC Study which successfully utilized research nurses to implement a complex asthma SDM toolkit intervention into primary care practices. METHODS: As part of a larger study, 10 primary care practices were recruited for a facilitator-led dissemination intervention involving a 12-week rollout of an asthma SDM toolkit (trial registration: 1.28.2014, #NCT02047929). An experienced lead PF trained research nurses as PFs from each of the 4 participating practice-based research networks (PBRNs) in a train-the-trainer model utilizing a one-day training event and subsequent remote meetings. Evaluation of PF engagement was measured through process improvement surveys. RESULTS: Overall, the asthma SDM intervention was successfully implemented within the 4 PBRNs. All 10 facilitator-led practices remained engaged with their PFs, with 8 out of the 10 practices able to incorporate and sustain SDM visits or clinics. Responses from the surveys for process improvement yielded improved PF communication and team dynamics over time. CONCLUSIONS: This study demonstrated effective use of research nurses as practice facilitators during the dissemination of an asthma SDM intervention into primary care practices, adding to the knowledge of best practices by describing a model of large-scale implementation of a complex intervention through practice facilitation with nurses. TRIAL REGISTRATION: "Comparing Traditional and Participatory Dissemination of a Shared Decision Making Intervention" was retrospectively registered at https://clinicaltrials.gov/ on January 28th, 2014 (NCT02047929).

Osteoarthritis physical activity care pathway (OA-PCP): results of a feasibility trial.

BACKGROUND: To obtain information on feasibility and acceptability, as well as preliminary data on efficacy, of an Osteoarthritis Physical activity Care Pathway (OA-PCP). METHODS: This was a single group pilot study involving 60 participants with symptomatic, physician diagnosed knee or hip OA, recruited from primary care clinics. Participants self-reported completing less than 150 min per week of moderate-to-vigorous physical activity (MVPA) at baseline. The 3-month OA-PCP intervention involved 3 physical activity (PA) coaching calls (focused on goal setting), three check-in emails and linkage with community-based or online resources to support PA. Efficacy outcomes were collected at baseline and 4-month follow-up. The primary efficacy outcome was minutes of MVPA, assessed via accelerometer. Secondary outcomes included minutes of light intensity activity, sedentary minutes, step counts, and Western Ontario and McMaster Universities (WOMAC) pain and function subscales. Participants were also asked to rate the helpfulness of the OA-PCP intervention on a scale of 0-10. Differences in efficacy outcomes between baseline and 4-month follow-up were assessed using paired t-tests. RESULTS: Among participants beginning the study, 88% completed follow-up assessments and ≥ 90% completed each of the intervention calls. Average daily minutes of MVPA was 8.0 at baseline (standard deviation (SD) = 9.9) and 8.9 at follow-up (SD = 12.1, p = 0.515). There were no statistically significant changes in light intensity activity, sedentary time or step counts. The mean WOMAC pain score improved from 8.1 (SD = 3.6) at baseline to 6.2 (SD = 3.8) at follow-up (p < 0.001); the mean WOMAC function score improved from 26.2 (SD = 13.2) to 20.2 (SD = 12.5; p < 0.001). The mean rating of helpfulness was 7.6 (SD = 2.5). CONCLUSIONS: Results supported the feasibility and acceptability of the study, and participants reported clinically relevant improvements in pain and function. PA metrics did not improve substantially. Based on these results and participant feedback, modifications including enhanced self-monitoring are being made to increase the impact of the OA-PCP intervention on PA behavior. TRIAL REGISTRATION: NCT03780400, December 19, 2018.

Sodium Nitroprusside-Enhanced Cardiopulmonary Resuscitation Improves Blood Flow by Pulmonary Vasodilation Leading to Higher Oxygen Requirements.

Sodium nitroprusside-enhanced cardiopulmonary resuscitation has shown superior resuscitation rates and neurologic outcomes in large animal models supporting the need for a randomized human clinical trial. This study is the first to show nonselective pulmonary vasodilation as a potential mechanism for the hemodynamic benefits. The pulmonary shunting that is created requires increased oxygen treatment, but the overall improvement in blood flow increases minute oxygen delivery to tissues. In this context, hypoxemia is an important safety endpoint and a 100% oxygen ventilation strategy may be necessary for the first human clinical trial.

Patient and provider perspectives on uptake of a shared decision making intervention for asthma in primary care practices.

OBJECTIVE: Poor outcomes and health disparities related to asthma result in part from difficulty disseminating new evidence such as shared decision making (SDM) into clinical practice. As part of a three-arm cluster randomized dissemination study, evaluation of the impact of different dissemination methods was studied. Here we evaluate themes from patient and provider focus groups to assess the impact of a facilitated, traditional dissemination approach, or no intervention, on patient and provider perspectives of asthma care. METHODS: Using semi-structured questions, twenty-four pre- and post-intervention focus groups with patients and providers took place across primary care practices. Discussions were held in all three arms both before and after the time of intervention rollout. Audio recordings were transcribed and analyzed for themes. RESULTS: Across all sites patients and providers discussed themes of communication, asthma self-management, barriers, education, and patient awareness. After the intervention, compared to traditional sites, facilitated practices were more likely to discuss themes related to SDM, such as patient-centered communication, patient-provider negotiation on treatment plan, planning, goal-setting, and solutions to barriers. CONCLUSIONS: Emergent themes allowed for further understanding of how the SDM implementation was perceived at the patient and provider level. The facilitated implementation was associated with higher adoption of the SDM intervention. These themes and supporting quotes add to knowledge of best practices associated with implementing an evidence-based SDM intervention for asthma into primary care and will inform researchers, practices, and providers as they work to improve adoption of evidence-based interventions into practice.

Health Literacy, Glycemic Control, and Physician-Advised Glucose Self-Monitoring Use in Type 2 Diabetes.

OBJECTIVE: To measure the association between health literacy and both patient-reported and clinical outcomes in patients with non-insulin-treated type 2 diabetes. RESEARCH DESIGN AND METHODS: We surveyed patients with non-insulin-treated type 2 diabetes (n = 448) from 15 primary care practices. The association between health literacy and patient-reported and clinical outcomes, including numeracy of self-monitoring of blood glucose (SMBG) use, how often physicians advised patients to conduct SMBG testing, and glycemic control (as measured by A1C), was investigated. RESULTS: Study participants included 448 patients with non-insulin-treated type 2 diabetes located within central North Carolina. Participants with limited health literacy had poorer glycemic control (A1C 7.7 ± 1.1% vs. 7.5 ± 1.0%, P = 0.016) despite using SMBG testing more frequently (daily SMBG testing 49.3 vs. 30.7%, P = 0.001) compared to individuals with adequate health literacy. The difference in how often physicians advised patients to conduct SMBG testing between limited and adequate health literacy groups was not significant (P = 0.68). CONCLUSION: Limited health literacy was associated with poorer glycemic control and an increased frequency of SMBG testing in patients with non-insulin-treated type 2 diabetes. There was no significant difference in how often physicians advised patients to conduct SMBG testing between patients with limited and adequate health literacy.

Patient and family engagement in Alberta Health Services: Improving care delivery and research outcomes.

Engaging patients and families in research and the design of quality improvement is an essential component of Patient and Family Centred Care (PFCC). Alberta Health Services (AHS) has been engaging patients and families to promote a cultural shift towards PFCC. The AHS trains patient and family advisors to share their experiences and encourages staff to work with advisors to co-design improvements in care. This article briefly describes the role and growth of patient and family advisors, advisory groups, and the participation of advisors in research initiatives through AHS' Strategic Clinical NetworksTM. It also describes recent efforts to build AHS' patient and family engagement capacity by introducing standard patient engagement training, supporting the creation of the innovative Patient and Community Engagement Research internship program, and by developing tools to measure the impact of patient and advisors on AHS. And finally, this article provides key learnings for health leaders.

Ensuring Implementation Fidelity of a 10-Week Home Visiting Program in Two Randomized Clinical Trials.

Introduction Implementation fidelity is a challenge for the adoption of evidence-based programs within social service broadly and child welfare specifically. However, implementation fidelity is critical for maintaining the integrity of clinical trials and for ensuring successful delivery of services in public health settings. Methods Promoting First Relationships ® (PFR), a 10-week home visiting parenting intervention, was evaluated in two randomized clinical trials with populations of families in child welfare. Seven providers from community agencies participated in the trials and administered PFR. Fidelity data collected included observational measures of provider behavior, provider records, and input from clients to assess training uptake, adherence to content, quality of delivery, program dosage, and participant satisfaction. Results In mock cases to assess training uptake, providers demonstrated an increase in PFR verbalization strategies and a decrease non-PFR verbalizations from pre to post PFR training, and overall this was maintained a year later (Mann-Whitney U's = 0, p's < .01). Adherence to content in actual cases was high, with M = 97% of the program elements completed. Quality of delivery varied across providers, indicated by PFR consultation strategies (Wilks' Lambda F = 18.24, df = 15, p < .001) and global ratings (F = 13.35, df = 5, p < .001). Program dosage was high in both trials (71 and 86% receiving 10 sessions), and participant satisfaction was high (M = 3.9, SD = 0.2; 4 = greater satisfaction). Discussion This system of training and monitoring provides an example of procedures that can be used effectively to achieve implementation fidelity with evidence-based programs in social service practice.

Role of epinephrine and extracorporeal membrane oxygenation in the management of ischemic refractory ventricular fibrillation: a randomized trial in pigs.

xtracorporeal membrane oxygenation (ECMO) is used in cardiopulmonary resuscitation (CPR) of refractory cardiac arrest. We used a 2×2 study design to compare ECMO versus CPR and epinephrine versus placebo in a porcine model of ischemic refractory ventricular fibrillation (VF). Pigs underwent 5 minutes of untreated VF, 10 minutes of CPR, and were randomized to receive epinephrine versus placebo for another 35 minutes. Animals were further randomized to LAD reperfusion at minute 45 with ongoing CPR versus veno-arterial ECMO cannulation at minute 45 of CPR and subsequent LAD reperfusion. Four-hour survival was improved with ECMO while epinephrine showed no effect.

Glucose Self-monitoring in Non-Insulin-Treated Patients With Type 2 Diabetes in Primary Care Settings: A Randomized Trial.

Importance: The value of self-monitoring of blood glucose (SMBG) levels in patients with non-insulin-treated type 2 diabetes has been debated. Objective: To compare 3 approaches of SMBG for effects on hemoglobin A1c levels and health-related quality of life (HRQOL) among people with non-insulin-treated type 2 diabetes in primary care practice. Design, Setting, and Participants: The Monitor Trial study was a pragmatic, open-label randomized trial conducted in 15 primary care practices in central North Carolina. Participants were randomized between January 2014 and July 2015. Eligible patients with type 2 non-insulin-treated diabetes were: older than 30 years, established with a primary care physician at a participating practice, had glycemic control (hemoglobin A1c) levels higher than 6.5% but lower than 9.5% within the 6 months preceding screening, as obtained from the electronic medical record, and willing to comply with the results of random assignment into a study group. Of the 1032 assessed for eligibility, 450 were randomized. Interventions: No SMBG, once-daily SMBG, and once-daily SMBG with enhanced patient feedback including automatic tailored messages delivered via the meter. Main Outcomes and Measures: Coprimary outcomes included hemoglobin A1c levels and HRQOL at 52 weeks. Results: A total of 450 patients were randomized and 418 (92.9%) completed the final visit. There were no significant differences in hemoglobin A1c levels across all 3 groups (P = .74; estimated adjusted mean hemoglobin A1c difference, SMBG with messaging vs no SMBG, -0.09%; 95% CI, -0.31% to 0.14%; SMBG vs no SMBG, -0.05%; 95% CI, -0.27% to 0.17%). There were also no significant differences found in HRQOL. There were no notable differences in key adverse events including hypoglycemia frequency, health care utilization, or insulin initiation. Conclusions and Relevance: In patients with non-insulin-treated type 2 diabetes, we observed no clinically or statistically significant differences at 1 year in glycemic control or HRQOL between patients who performed SMBG compared with those who did not perform SMBG. The addition of this type of tailored feedback provided through messaging via a meter did not provide any advantage in glycemic control. Trial Registration: clinicaltrials.gov Identifier: NCT02033499.

Three approaches to glucose monitoring in non-insulin treated diabetes: a pragmatic randomized clinical trial protocol.

BACKGROUND: For the nearly 75% of patients living with type 2 diabetes (T2DM) that do not use insulin, decisions regarding self-monitoring of blood glucose (SMBG) can be especially problematic. While in theory SMBG holds great promise for sparking favorable behavior change, it is a resource intensive activity without firmly established patient benefits. This study describes our study protocol to assess the impact of three different SMBG testing approaches on patient-centered outcomes in patients with non-insulin treated T2DM within a community-based, clinic setting. METHODS/DESIGN: Using stakeholder engagement approach, we developed and implemented a pragmatic trial of patient with non-insulin treated T2DM patients from five primary care practices randomized to one of three SMBG regimens: 1) no testing; 2) once daily testing with standard feedback consisting of glucose values being immediately reported to the patient through the glucose meter; and 3) once daily testing with enhanced patient feedback consisting of glucose values being immediately reported to the patient PLUS automated, tailored feedback messaging delivered to the patient through the glucose meter following each testing. Main outcomes assessed at 52 weeks include quality of life and glycemic control. DISCUSSION: This pragmatic trial seeks to better understand the value of SMBG in non-insulin treated patients with T2DM. This paper outlines the protocol used to implement this study in fifteen community-based primary care practices and highlights the impact of stakeholder involvement from the earliest stages of project conception and implementation. Plans for stakeholder involvement for result dissemination are also discussed. TRIAL REGISTRATION: ClinicalTrials.gov NCT02033499 , January 9, 2014.