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Project #162: Nurse Driven NSTEMI Protocol
Get PDFhttps://scholarlycommons.henryford.com/qualityexpo2025/1033/thumbnail.jp
Project #049: Forum-Beyond the Bedside: How Interdisciplinary Rounds Streamline ICU Care and Transitions
No full texthttps://scholarlycommons.henryford.com/qualityexpo2025/1005/thumbnail.jp
A Framework for Exception From Informed Consent in Trials Enrolling Patients With ST-Segment-Elevation Myocardial Infarction and Cardiogenic Shock.
No full textCardiogenic shock (CS) is critical end-organ hypoperfusion attributable to reduced cardiac output. Acute ST-segment-elevation myocardial infarction with CS (AMI-CS) has high mortality. Clinical research is challenging in such patients as they often cannot provide consent, lack available legal representatives, and require initiation of therapy. Multiple trials have enrolled patients with AMI-CS outside the United States under deferred consent. Trials in the United States have enrolled patients with out-of-hospital cardiac arrest under exception from informed consent (EFIC). However, AMI-CS has a longer therapeutic window to initiate treatment than out-of-hospital cardiac arrest, and more patients or their representatives can engage in treatment decisions. We provide a rationale for how a trial enrolling patients with AMI-CS could qualify for conduct using EFIC by meeting each criterion specified in US human subject regulations. AMI-CS is a life-threatening situation, available treatments are unsatisfactory, and collection of valid evidence is necessary. Obtaining informed consent is often not feasible, and trial participation could benefit subjects. Only enrolling consented patients is impracticable and could reduce the study\u27s generalizability. We propose a therapeutic window of 30 minutes within the study intervention must be initiated, with consent sought within 15 minutes, respecting any refusal or objection to enrollment, and otherwise enrollment under EFIC. A trial could enroll patients with AMI-CS under EFIC and can involve both patients and their representatives. Successful use of EFIC in trials of other interventions in patients with CS or enrolling patients with other acute cardiovascular conditions could increase the available evidence base to improve care
A cluster randomized stepped wedge implementation trial of scale-up approaches to ending pregnancy-related and -associated morbidity and mortality disparities in 12 Michigan counties: rationale and study protocol
No full textBACKGROUND: Hospital-focused maternal health safety and quality guidelines have been found to reduce pregnancy-related and -associated morbidity and mortality (PRAMM). Unfortunately, quality of obstetric care can improve without affecting disparities. This project is the first controlled implementation trial to test approaches to implementing safety guidelines that: (1) target PRAMM disparities; and (2) focus on community care (care provided outside hospitals in outpatient and other community settings, and coordination among care settings), where most deaths occur. It is also one of the first to test scale-up or sustainment implementation approaches to addressing maternal morbidity and mortality disparities.
METHODS: This project, one of three in the federally funded Multilevel Interventions for Raci.a.l Equity (MIRACLE) Maternal Health Research Center of Excellence, will develop and evaluate an implementation approach for scaling up bundled equity-focused maternal health safety guidelines in community care settings county-wide. The scale-up approach will be co-developed with partners, and then tested using a cluster randomized stepped-wedge trial of 12 Michigan counties with a total population of nearly 6 million. Randomization occurs at the county level; birthing people and providers are clustered within counties. PRAMM outcomes (individual level; primary) will be extracted from a pre-existing statewide linked dataset that includes Medicaid claims and vital records data. The sample will include all Medicaid insured individuals in the 12 counties observed during pregnancy, at birth, and up to 1 year postpartum during the project period (~ 151,920 births, including ~ 49,110 births to Black and/or Hispanic mothers). Implementation outcomes (provider level) will be collected using annual provider (n = 600) surveys and will include scale-up (penetration, reach, control for delivery, and intervention effectiveness at scale) and sustainment (maintenance of fidelity to core elements, health benefits, and capacity to deliver core elements over time) of bundles and cost-effectiveness of implementation approaches.
DISCUSSION: This implementation trial will be the first to evaluate an implementation approach to scaling community health equity-focused maternal safety guidelines, addressing an understudied aspect of implementation science (i.e., scale-up). The study will also provide information about implementation cost-effectiveness needed to drive policy decisions
Editorial for Influence of Multiband Technique on Temporal Diffusion Spectroscopy and Its Diagnostic Value in Breast Tumors
No full textAutomated Insulin Delivery in Adults With Type 2 Diabetes: A Nonrandomized Clinical Trial
No full textIMPORTANCE: There is a need for additional treatment options for people with type 2 diabetes treated with insulin. Given the limited data on the use of automated insulin delivery (AID) systems in type 2 diabetes, studies evaluating their safety and efficacy are important.
OBJECTIVE: To evaluate the association of AID with hemoglobin A1c (HbA1c) levels in a diverse cohort of adults with type 2 diabetes.
DESIGN, SETTING, AND PARTICIPANTS: This single-arm prospective trial was conducted at 21 clinical centers in the United States among individuals aged 18 to 75 years with type 2 diabetes who had been using insulin for at least 3 months prior to screening. Participants with AID system use were excluded. The study started with a 14-day standard therapy phase, followed by 13 weeks of treatment with the investigational device. The first participant was enrolled April 11, 2023, and the last participant follow-up visit was February 29, 2024.
INTERVENTION: Participants used the Omnipod 5 AID System for 13 weeks following the 14-day standard therapy phase.
MAIN OUTCOMES AND MEASURES: Primary outcome was change in HbA1c level at 13 weeks, tested sequentially for noninferiority (0.3% margin) and superiority, compared with baseline.
RESULTS: Among 305 participants (mean [SD] age, 57 [11] years; 175 [57%] female; 72 [24%] Black, 66 [22%] Hispanic or Latino, and 153 [50%] White), 289 (95%) completed the trial. At baseline, 223 (73%) were using multiple daily injections, 63 (21%) were using basal insulin without bolus, 17 (6%) were using an insulin pump, 188 (62%) were using continuous glucose monitoring, 168 (55%) were using glucagon-like peptide-1 receptor agonists (GLP-1RAs), and 134 (44%) were using sodium-glucose transport protein 2 inhibitors (SGLT-2is). Following AID use, HbA1c levels decreased from a mean (SD) of 8.2% (1.3) at baseline to 7.4% (0.9) at 13 weeks (mean difference, -0.8 [95% CI, -1.0 to -0.7] percentage points; P \u3c .001 for noninferiority and superiority). Improvement was seen across various subgroups (age, sex, race and ethnicity, insurance), and notably with or without use of GLP-1RAs or SGLT-2is and regardless of pretrial mealtime insulin regimen. Time in target glucose range (70-180 mg/dL) increased from a mean (SD) of 45% (25) to 66% (17) (mean difference, 20 [95% CI, 18 to 22] percentage points; P \u3c .001). Percentage of time in hypoglycemic ranges of less than 54 mg/dL and less than 70 mg/dL was noninferior compared with standard therapy. There was 1 episode of severe hypoglycemia and none of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.
CONCLUSIONS AND RELEVANCE: In this nonrandomized clinical trial, HbA1c levels were lower in a diverse cohort of adults with type 2 diabetes following AID initiation, suggesting that AID may be a beneficial and safe option for people with type 2 diabetes using insulin.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05815342
The impact of integrated care on clinical outcomes in patients with alcohol-associated liver disease: Early outcomes from a multidisciplinary clinic
No full textBACKGROUND: We analyzed early outcomes regarding the impact of our integrated alcohol-associated liver disease (ALD) clinic on patients with ALD and alcohol use.
METHODS: We conducted a retrospective study of patients with ALD who were evaluated in our integrated clinic from May 1, 2022, to December 31, 2023. Primary outcomes included differences in baseline clinical/demographic data between patients who accepted versus declined an appointment and changes in the severity of ALD, alcohol consumption, functional status, hospital utilization, and remission in alcohol use disorder for evaluated patients.
RESULTS: Patients who declined appointments (n=66) had higher median no-show rates (15.0 [8.0,30.0] vs. 8.5 [3.25,15.0], p\u3c 0.001), social vulnerability index (0.53 [0.26,0.79] vs. 0.38 [0.17,0.63], p=0.033), and proportions of cirrhosis (78.8% vs. 59.8%, p=0.017) versus evaluated patients. Comparison of baseline to first follow-up visit for evaluated patients (n=102) demonstrated significant reductions in median AST (59.5 [41.75, 89] vs. 44.5 [33.5, 56.25], p\u3c 0.001), alanine-aminotransferase (33.5 [20,45.25] vs. 26.5 [18.75,33.0], p=0.017), total bilirubin (1.6 [0.7,3.3] vs. 1 [0.5,1.9], p=0.001), phosphatidylethanol (263 [35, 784] vs. 0 [0, 163], p\u3c 0.001), MELD-3.0 and Sodium scores for patients with alcohol-associated hepatitis and cirrhosis (16 [11, 18.75] vs. 12 [9, 14], p\u3c 0.001), 14 [9.25, 17.75] vs. 11 [8.5, 14], p\u3c 0.001), and Child-Turcotte-Pugh scores for patients with cirrhosis (9 [6, 10.5] vs. 7 [6, 9], p\u3c 0.001). The proportion of patients with active-severe alcohol use disorder significantly decreased (85.2% vs. 51.9%, p\u3c 0.001). Additionally, patients had significant reductions in emergency department utilization (incidence rate ratio of 0.64 emergency department visits/month (p=0.002) and 0.71 hospital admissions/month (p=0.025). However, after considering the false discovery rate, the reduction in hospitalization admissions/month was not statistically significant (False Discovery Rate adjusted p=0.056).
CONCLUSIONS: Our integrated approach led to reductions in liver injury, degree of liver decompensation, alcohol use, and ED utilization, and remission in AUD in a population of both non-transplant ALD and post-transplant patients
A nursing and midwifery training program in Kathmandu on antimicrobial resistance and stewardship and infection prevention and control: a qualitative and quantitative outcomes and process evaluation
No full textBACKGROUND: Low- and middle-income countries (LMICs) are disproportionately affected by antimicrobial resistance (AMR). Nurses and midwives are essential to a holistic approach to AMR stewardship (AMS) and IPC within LMICs.
OBJECTIVE: (1) Adapt AMS and IPC training programs and practice guidelines for community- and hospital-based nurses and midwives in Nepal; (2) pilot and conduct training outcome and process evaluations.
DESIGN: A one-day training was developed through partnerships between Henry Ford Health and nursing and midwifery organizations and teaching facilities in Nepal. Quantitative outcome and process evaluations were conducted. Qualitative process evaluation interviews were conducted with purposefully selected trainees.
SETTINGS: Trainees worked in healthcare facilities in Kathmandu Valley.
PARTICIPANTS: A total of 126 nurses and midwives participated in the training and the quantitative evaluation. Eighteen trainees participated in the process evaluation interviews.
METHODS: The 10-module program was adapted from AMS and IPC materials from the World Health Organization and the Nepal Ministry of Health and Population, and curricula from previous AMS studies in Nepal. Key outcomes were AMS and IPC knowledge, and decision-making about empirical dispensing of antibiotics. The process evaluation focused on training content, integration into practice, implementation barriers, and recommendations for dissemination. Quantitative data analysis included descriptive and bivariate analysis. Qualitative data analysis included coding, searches, review of coded texts, and identification of patterns and themes.
RESULTS: AMS and AMR knowledge increased at immediate [1.40 (1.06-1.74) CI 95%] and six-month post-training [0.71 (0.35-1.08) CI 95%]. IPC knowledge also increased at immediate [0.79 (0.55-1.03) CI 95%] and six-month post-training [0.72 (0.49-0.96) CI 95%]. At immediate post-training, an increasing number of respondents indicated that they would not dispense antibiotics for adults [14.74% (4.88, 24.60%) CI 95%] and children [8.13% (-1.88, 18.14%) CI 95%] with fever and sore throats, and for non-pregnant women with burning sensation when urinating [10.69% (0.68%, 20.71%) CI 95%]. Process evaluation data indicated positive responses to the training content and relevancy to practice.
CONCLUSION: The AMS-IPC training increased knowledge and decreased intentions for dispensing antibiotics. Participants provided concrete examples of implementation of learnings into practice. Trainings will be adapted to address identified content needs and challenges to implementation
Circulating miR-126-3p is a mechanistic biomarker for knee osteoarthritis
No full textOsteoarthritis is a major contributor to pain and disability worldwide, yet there are currently no validated soluble biomarkers or disease-modifying treatments. Given that microRNAs are promising mechanistic biomarkers that can be therapeutically targeted, in this study, we aimed to identify and prioritize reproducible circulating microRNAs associated with radiographic knee osteoarthritis. Across four independent cohorts, we find circulating miR-126-3p is elevated in knee osteoarthritis versus controls. Across six primary human knee osteoarthritis tissues, miR-126-3p is highest in subchondral bone, fat pad and synovium, and lowest in cartilage. Following both intravenous and intra-articular miR-126-3p mimic treatment in a surgical mouse model of knee osteoarthritis, we show reduced disease severity in males. In human knee osteoarthritis biospecimens, miR-126-3p mimic treatment reduces genes and markers associated with angiogenesis, as well as genes linked to osteogenesis, adipogenesis, and synovitis-processes secondary to angiogenesis. Our findings indicate that miR-126-3p is elevated in knee osteoarthritis and mitigates disease severity, supporting its potential as a biomarker and therapeutic target
Unvaccinated and Unprepared: A COVID-19 Saga of Diffuse Alveolar Hemorrhage
No full textDiffuse alveolar hemorrhage (DAH) is a severe complication that can arise from various conditions, including COVID-19. This case report describes a 37-year-old Caucasian male with mild asthma and obesity who developed diffuse alveolar hemorrhage (DAH) following a COVID-19 infection. Despite initial treatment, his respiratory status deteriorated, leading to intubation and venovenous extracorporeal membrane oxygenation (VV ECMO). Multiple complications followed, culminating in multi-organ failure and his death. This case highlights the complexity of managing DAH in severe COVID-19 and underscores the importance of early recognition and a multidisciplinary approach. Additionally, a literature review compares similar cases to analyze outcomes and management strategies