Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.

BACKGROUND: Despite the availability of effective therapies for patients with chronic kidney disease, type 2 diabetes, and hypertension (the kidney-dysfunction triad), the results of large-scale trials examining the implementation of guideline-directed therapy to reduce the risk of death and complications in this population are lacking. METHODS: In this open-label, cluster-randomized trial, we assigned 11,182 patients with the kidney-dysfunction triad who were being treated at 141 primary care clinics either to receive an intervention that used a personalized algorithm (based on the patient's electronic health record [EHR]) to identify patients and practice facilitators to assist providers in delivering guideline-based interventions or to receive usual care. The primary outcome was hospitalization for any cause at 1 year. Secondary outcomes included emergency department visits, readmissions, cardiovascular events, dialysis, and death. RESULTS: We assigned 71 practices (enrolling 5690 patients) to the intervention group and 70 practices (enrolling 5492 patients) to the usual-care group. The hospitalization rate at 1 year was 20.7% (95% confidence interval [CI], 19.7 to 21.8) in the intervention group and 21.1% (95% CI, 20.1 to 22.2) in the usual-care group (between-group difference, 0.4 percentage points; P = 0.58). The risks of emergency department visits, readmissions, cardiovascular events, dialysis, or death from any cause were similar in the two groups. The risk of adverse events was also similar in the trial groups, except for acute kidney injury, which was observed in more patients in the intervention group (12.7% vs. 11.3%). CONCLUSIONS: In this pragmatic trial involving patients with the triad of chronic kidney disease, type 2 diabetes, and hypertension, the use of an EHR-based algorithm and practice facilitators embedded in primary care clinics did not translate into reduced hospitalization at 1 year. (Funded by the National Institutes of Health and others; ICD-Pieces ClinicalTrials.gov number, NCT02587936.).

Multi-species outbreak of SARS-CoV-2 Delta variant in a zoological institution, with the detection in two new families of carnivores.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has a worldwide distribution in humans and many other mammalian species. In late September 2021, 12 animals maintained by the Chicago Zoological Society's Brookfield Zoo were observed with variable clinical signs. The Delta variant of SARS-CoV-2 was detected in faeces and nasal swabs by qRT-PCR, including the first detection in animals from the families Procyonidae and Viverridae. Test positivity rate was 12.5% for 35 animals tested. All animals had been vaccinated with at least one dose of a recombinant vaccine designed for animals and all recovered with variable supportive treatment. Sequence analysis showed that six zoo animal strains were closely correlated with 18 human SARS-CoV-2 strains, suggestive of potential human-to-animal transmission events. This report documents the expanding host range of COVID-19 during the ongoing pandemic.

Integrating diabetes technologies with team-based primary care for type 2 diabetes: A pilot trial.

This pilot trial studied a novel intervention that integrated diabetes technologies into team-based primary care for type 2 diabetes. We found clinically significant reductions in blood pressure, weight, and glucose. The latter two were statistically significant.

Metformin and risk of mortality in patients hospitalised with COVID-19: a retrospective cohort analysis.

BACKGROUND: Type 2 diabetes and obesity, as states of chronic inflammation, are risk factors for severe COVID-19. Metformin has cytokine-reducing and sex-specific immunomodulatory effects. Our aim was to identify whether metformin reduced COVID-19-related mortality and whether sex-specific interactions exist. METHODS: In this retrospective cohort analysis, we assessed de-identified claims data from UnitedHealth Group (UHG)'s Clinical Discovery Claims Database. Patient data were eligible for inclusion if they were aged 18 years or older; had type 2 diabetes or obesity (defined based on claims); at least 6 months of continuous enrolment in 2019; and admission to hospital for COVID-19 confirmed by PCR, manual chart review by UHG, or reported from the hospital to UHG. The primary outcome was in-hospital mortality from COVID-19. The independent variable of interest was home metformin use, defined as more than 90 days of claims during the year before admission to hospital. Covariates were comorbidities, medications, demographics, and state. Heterogeneity of effect was assessed by sex. For the Cox proportional hazards, censoring was done on the basis of claims made after admission to hospital up to June 7, 2020, with a best outcome approach. Propensity-matched mixed-effects logistic regression was done, stratified by metformin use. FINDINGS: 6256 of the 15 380 individuals with pharmacy claims data from Jan 1 to June 7, 2020 were eligible for inclusion. 3302 (52·8%) of 6256 were women. Metformin use was not associated with significantly decreased mortality in the overall sample of men and women by either Cox proportional hazards stratified model (hazard ratio [HR] 0·887 [95% CI 0·782-1·008]) or propensity matching (odds ratio [OR] 0·912 [95% CI 0·777-1·071], p=0·15). Metformin was associated with decreased mortality in women by Cox proportional hazards (HR 0·785, 95% CI 0·650-0·951) and propensity matching (OR 0·759, 95% CI 0·601-0·960, p=0·021). There was no significant reduction in mortality among men (HR 0·957, 95% CI 0·82-1·14; p=0·689 by Cox proportional hazards). INTERPRETATION: Metformin was significantly associated with reduced mortality in women with obesity or type 2 diabetes who were admitted to hospital for COVID-19. Prospective studies are needed to understand mechanism and causality. If findings are reproducible, metformin could be widely distributed for prevention of COVID-19 mortality, because it is safe and inexpensive. FUNDING: National Heart, Lung, and Blood Institute; Agency for Healthcare Research and Quality; Patient-Centered Outcomes Research Institute; Minnesota Learning Health System Mentored Training Program, M Health Fairview Institutional Funds; National Center for Advancing Translational Sciences; and National Cancer Institute.

Age at Human Papillomavirus Vaccine Initiation Among Adolescents and Young Adults From 22 Pediatric Practices in the Northeastern United States.

PURPOSE: To examine trends in human papillomavirus (HPV) vaccine initiation and its determinants. DESIGN: This retrospective correlational study involved 12,260 individuals born between 1996 and 2000 receiving care from one of 22 pediatric practices in the northeastern region of the United States between 2016 and 2017. METHODS: We extracted data about HPV vaccination status and date, birth year, race, ethnicity, language, and geographic regions. Mean age at initiation was estimated using descriptive statistics. Multiple linear regression with weighted least squares was used to examine its correlates. FINDINGS: Of 12,260 individuals, about 76% initiated the HPV vaccination series at 9 to 17 years of age. While the initiation age decreased overall for both females and males (e.g., 14.3 vs. 16.2 years and 13.8 vs. 14.4 years in the 1996 vs. 2000 birth cohorts, respectively), a greater reduction was noted for males. Individuals tended to delay initiation if they were non-Hispanic or Asian and resided in urban areas. CONCLUSIONS: Most adolescents in our sample started HPV vaccination later than the recommended age, with variations in different demographic groups. Rapid improvement in on-time HPV vaccination is occurring, especially for males. CLINICAL RELEVANCE: The findings of this analysis emphasize continuous efforts to increase on-time HPV vaccination rates for all groups, including non-Hispanic whites and female adolescents, to eliminate current and possible disparities.

Observational Study of Metformin and Risk of Mortality in Patients Hospitalized with Covid-19.

Background Type 2 diabetes (T2DM) and obesity are significant risks for mortality in Covid19. Metformin has been hypothesized as a treatment for COVID19. Metformin has sex specific immunomodulatory effects which may elucidate treatment mechanisms in COVID-19. In this study we sought to identify whether metformin reduced mortality from Covid19 and if sex specific interactions exist. Methods De-identified claims data from UnitedHealth were used to identify persons with at least 6 months continuous coverage who were hospitalized with Covid-19. Persons in the metformin group had at least 90 days of metformin claims in the 12 months before hospitalization. Unadjusted and multivariate models were conducted to assess risk of mortality based on metformin as a home medication in individuals with T2DM and obesity, controlling for pre-morbid conditions, medications, demographics, and state. Heterogeneity of effect was assessed by sex. Results 6,256 persons were included; 52.8% female; mean age 75 years. Metformin was associated with decreased mortality in women by logistic regression, OR 0.792 (0.640, 0.979); mixed effects OR 0.780 (0.631, 0.965); Cox proportional-hazards: HR 0.785 (0.650, 0.951); and propensity matching, OR of 0.759 (0.601, 0.960). TNF-alpha inhibitors were associated with decreased mortality in the 38 persons taking them, by propensity matching, OR 0.19 (0.0378, 0.983). Conclusions Metformin was significantly associated with reduced mortality in women with obesity or T2DM in observational analyses of claims data from individuals hospitalized with Covid-19. This sex-specific finding is consistent with metformin reducing TNF-alpha in females over males, and suggests that metformin conveys protection in Covid-19 through TNF-alpha effects. Prospective studies are needed to understand mechanism and causality.

The impact of telemedicine on patient self-management processes and clinical outcomes for patients with Types I or II Diabetes Mellitus in the United States: A scoping review.

OBJECTIVE: The objective of this scoping review was to identify peer-reviewed medical literature on the use of telemedicine in patients with Types I or II DM in the United States, assess its impact on self-management processes and clinical outcomes of care, and to delineate research gaps. METHODS: We utilized a structured scoping review protocol to conduct this research. We searched the published medical literature utilizing two databases, PubMed and CINHAL, and we included all original research articles published prior to July 20th, 2018. Using a 4-step systematic approach, we identified, reviewed, extracted and summarized data from all relevant studies. RESULTS: We identified 47 articles overall. Telemedicine impact was reported as positive in articles addressing the following components of patient self-management: adherence to blood glucose monitoring, day-to-day decision-making related to self-care, and adherence with medications. The most commonly reported clinical outcome was HbA1c level. Few or no studies evaluated impact on long term clinical outcomes such as blindness, amputation, cardiovascular events, development of chronic kidney disease, or mortality. DISCUSSION: This scoping review provides important information about studies conducted in the United States evaluating the impact of telemedicine on patient self-management and on clinical outcomes in patients with DM. CONCLUSIONS: Results suggest that telemedicine has a positive impact on self-management processes and on HbA1c levels. However, future evaluative reviews are necessary to confirm and quantitate the impact of telemedicine on self-management processes and primary studies are necessary to evaluate its impact on long term clinical outcomes.

Cardiac disease is linked to adiposity in male gorillas (Gorilla gorilla gorilla).

Cardiac disease is a major cause of morbidity and mortality for adult gorillas. Previous research indicates a sex-based difference with predominantly males demonstrating evidence of left ventricular hypertrophy. To evaluate these findings, we analyzed serum markers with cardiac measures in a large sample of gorillas. The study sample included 44 male and 25 female gorillas housed at American Association of Zoo and Aquariums (AZA)-accredited zoos. Serum samples were collected from fasted gorillas during routine veterinary health exams and analyzed to measure leptin, adiponectin, IGF-1, insulin, ferritin, glucose, triglycerides, and cholesterol. Cardiac ultrasonography via transthoracic echocardiogram was performed simultaneously. Three echocardiographic parameters were chosen to assess cardiac disease according to parameters established for captive lowland gorillas: left ventricular internal diameter, inter-ventricular septum thickness, and left ventricular posterior wall thickness. Our data revealed that high leptin, low adiponectin, and lowered cholesterol were significantly and positively correlated with measures of heart thickness and age in males but not in females. Lowered cholesterol in this population would be categorized as elevated in humans. High leptin and low adiponectin are indicative of increased adiposity and suggests a potential parallel with human obesity and cardiovascular disease in males. Interestingly, while females exhibited increased adiposity with age, they did not progress to cardiac disease.

Feasibility of Implementing Patient Priorities Care for Older Adults with Multiple Chronic Conditions.

Older adults with multiple chronic conditions (MCCs) receive care that is fragmented and burdensome, lacks evidence, and most importantly is not focused on what matters most to them. An implementation feasibility study of Patient Priorities Care (PPC), a new approach to care that is based on health outcome goals and healthcare preferences, was conducted. This study took place at 1 primary care and 1 cardiology practice in Connecticut and involved 9 primary care providers (PCPs), 5 cardiologists, and 119 older adults with MCCs. PPC was implemented using methods based on a practice change framework and continuous plan-do-study-act (PDSA) cycles. Core elements included leadership support, clinical champions, priorities facilitators, training, electronic health record (EHR) support, workflow development and continuous modification, and collaborative learning. PPC processes for clinic workflow and decision-making were developed, and clinicians were trained. After 10 months, 119 older adults enrolled and had priorities identified; 92 (77%) returned to their PCP after priorities identification. In 56 (46%) of these visits, clinicians documented patient priorities discussions. Workflow challenges identified and solved included patient enrollment lags, EHR documentation of priorities discussions, and interprofessional communication. Time for clinicians to provide PPC remains a challenge, as does decision-making, including clinicians' perceptions that they are already doing so; clinicians' concerns about guidelines, metrics, and unrealistic priorities; and differences between PCPs and patients and between PCPs and cardiologists about treatment decisions. PDSA cycles and continuing collaborative learning with national experts and peers are taking place to address workflow and clinical decision-making challenges. Translating disease-based to priorities-aligned decision-making appears challenging but feasible to implement in a clinical setting.

Implementation of the Safewards model in public mental health facilities: A qualitative evaluation of staff perceptions.

BACKGROUND: The Safewards model is gaining increasing acceptance in the mental health field in Australia and overseas. One of the most important goals of inpatient psychiatric services is to provide a safe and therapeutic environment for both patients and staff. However, this goal can be difficult to achieve if staff-patient interaction is not conducive to preventing violence and aggression. OBJECTIVE: The purpose of this study was to explore nursing staff perceptions of the factors impacting on their capacity to establish Safewards in acute adult inpatient wards. DESIGN: This study was guided by a phenomenological approach to develop a rich understanding of staff perceptions using semi-structured interviews. SETTING AND SAMPLE: The setting was three acute mental health wards attached to general hospitals; one in a large provincial hospital and two in metropolitan hospitals in south-east Queensland. Interview participants were a purposive sample of fifteen registered nurses across each of the three wards. METHOD: Semi-structured interviews were conducted at 12 months post-implementation of Safewards. The study was underpinned by Michie's integrative framework of behaviour change that helped identify target areas in order to enhance successful implementation of this model. RESULTS: Content analysis of interview transcripts highlighted a range of factors including failure to address the difficulties encountered by some staff in engaging with Safewards interventions, lack of support from management, poor use of nurse educator time, the 'language' of Safewards, high acuity on the study wards, and staff and patient turnover. CONCLUSION: This study highlights some difficulties with implementing Safewards and maintaining fidelity of the Safewards interventions in busy acute inpatient wards. Although these findings are from a qualitative study consisting of only 15 staff, our results indicate that efforts to implement Safewards need to address challenges faced by staff in engaging with the interventions, ensure buy-in from management, ensure adequate training and support during implementation and review training materials to ensure they fit with the local (i.e. Australian) context. Safewards provides an opportunity for a change in attitudes and development of a more therapeutic ward environment.

Integrating Essential Components of Quality Improvement into a New Paradigm for Continuing Education.

Continuing education (CE) that strives to improve patient care in a complex health care system requires a different paradigm than CE that seeks to improve clinician knowledge and competence in an educational setting. A new paradigm for CE is necessary in order to change clinician behavior and to improve patient outcomes in an increasingly patient-centered, quality-oriented care context. The authors assert that a new paradigm should focus attention on an expanded and prioritized list of educational outcomes, starting with those that directly affect patients. Other important components of the paradigm should provide educational leaders with guidance about what interventions work, reasons why interventions work, and what contextual factors may influence the impact of interventions. Once fully developed, a new paradigm will be helpful to educators in designing and implementing more effective CE, an essential component of quality improvement efforts, and in supporting policy trends and in promoting CE scholarship. The purpose of this article is to rekindle interest in CE theory and to suggest key components of a new paradigm.

Description and Impact Evaluation of a Statewide Collaboration to Reduce Preventable Hospital Readmissions.

This article describes how a Medicare-funded Quality Improvement Organization collaborated with a hospital association and multiple cross-continuum partners on a statewide effort to reduce hospital readmissions. Interventions included statewide education on quality improvement strategies and community-specific technical assistance on collaboration approaches, data collection and analysis, and selection and implementation of interventions. Fifteen communities, comprising 16 acute care hospitals, 119 nursing homes, 70 home health agencies, and 32 other health care or social service providers, actively participated over a 4.5-year period. Challenges included problems with end-of-life discussions (80.0%), physician engagement (70.0%), staffing (70.0%), and communication between settings (60.0%). Thirty-day all-cause readmission rates in fee-for-service Medicare patients decreased in most hospital service areas across the state (22/24), and the aggregate statewide readmission rate dropped from 15.2/1000 to 12.1/1000, a relative decrease of 20.3% ( P < .001). Despite these positive findings, the specific impact of this collaboration could not be determined because of multiple confounding interventions.

Process Evaluation of a Quality Improvement Project to Decrease Hospital Readmissions From Skilled Nursing Facilities.

OBJECTIVE: To describe and evaluate the impact of quality improvement (QI) support provided to skilled nursing facilities (SNFs) by a Quality Improvement Organization (QIO). DESIGN: Retrospective, mixed-method, process evaluation of a QI project intended to decrease preventable hospital readmissions from SNFs. SETTING: Five SNFs in Connecticut. PARTICIPANTS: SNF Administrators, Directors of Nursing, Assistant Directors of Nursing, Admissions Coordinators, Registered Nurses, Certified Nursing Assistants, Receptionists, QIO Quality Improvement Consultant. INTERVENTION: QIO staff provided training and technical assistance to SNF administrative and clinical staff to establish or enhance QI infrastructure and implement an established set of QI tools [Interventions to Reduce Acute Care Transfers (INTERACT) tools]. MEASUREMENTS: Baseline SNF demographic, staffing, and hospital readmission data; baseline and follow-up SNF QI structure (QI Committee), processes (general and use of INTERACT tools), and outcome (30-day all-cause hospital readmission rates); details of QIO-provided training and technical assistance; QIO-perceived barriers to quality improvement; SNF leadership-perceived barriers, accomplishments, and suggestions for improvement of QIO support. RESULTS: Success occurred in establishing QI Committees and targeting preventable hospital readmissions, as well as implementing INTERACT tools in all SNFs; however, hospital readmission rates decreased in only 2 facilities. QIO staff and SNF leaders noted the ongoing challenge of engaging already busy SNF staff and leadership in QI activities. SNF leaders reported that they appreciated the training and technical assistance that their institutions received, although most noted that additional support was needed to bring about improvement in readmission rates. CONCLUSION: This process evaluation documented mixed clinical results but successfully identified opportunities to improve recruitment of and provision of technical support to participating SNFs. Recommendations are offered for others who wish to conduct similar projects.

National trends in patient safety for four common conditions, 2005-2011.

BACKGROUND: Changes in adverse-event rates among Medicare patients with common medical conditions and conditions requiring surgery remain largely unknown. METHODS: We used Medicare Patient Safety Monitoring System data abstracted from medical records on 21 adverse events in patients hospitalized in the United States between 2005 and 2011 for acute myocardial infarction, congestive heart failure, pneumonia, or conditions requiring surgery. We estimated trends in the rate of occurrence of adverse events for which patients were at risk, the proportion of patients with one or more adverse events, and the number of adverse events per 1000 hospitalizations. RESULTS: The study included 61,523 patients hospitalized for acute myocardial infarction (19%), congestive heart failure (25%), pneumonia (30%), and conditions requiring surgery (27%). From 2005 through 2011, among patients with acute myocardial infarction, the rate of occurrence of adverse events declined from 5.0% to 3.7% (difference, 1.3 percentage points; 95% confidence interval [CI], 0.7 to 1.9), the proportion of patients with one or more adverse events declined from 26.0% to 19.4% (difference, 6.6 percentage points; 95% CI, 3.3 to 10.2), and the number of adverse events per 1000 hospitalizations declined from 401.9 to 262.2 (difference, 139.7; 95% CI, 90.6 to 189.0). Among patients with congestive heart failure, the rate of occurrence of adverse events declined from 3.7% to 2.7% (difference, 1.0 percentage points; 95% CI, 0.5 to 1.4), the proportion of patients with one or more adverse events declined from 17.5% to 14.2% (difference, 3.3 percentage points; 95% CI, 1.0 to 5.5), and the number of adverse events per 1000 hospitalizations declined from 235.2 to 166.9 (difference, 68.3; 95% CI, 39.9 to 96.7). Patients with pneumonia and those with conditions requiring surgery had no significant declines in adverse-event rates. CONCLUSIONS: From 2005 through 2011, adverse-event rates declined substantially among patients hospitalized for acute myocardial infarction or congestive heart failure but not among those hospitalized for pneumonia or conditions requiring surgery. (Funded by the Agency for Healthcare Research and Quality and others.).

Using an expanded outcomes framework and continuing education evidence to improve facilitation of patient-centered medical home recognition and transformation.

BACKGROUND: The patient-centered medical home is a model for delivering primary care in the United States. Primary care clinicians and their staffs require assistance in understanding the innovation and in applying it to practice. PURPOSES: The purpose of this article is to describe and to critique a continuing education program that is relevant to, and will become more common in, primary care. METHODS: A multifaceted educational strategy prepared 20 primary care private practices to achieve National Committee for Quality Assurance Level 3 recognition as Patient-Centered Medical Homes. RESULTS: Eighteen (90%) practices submitted an application to the National Committee for Quality Assurance. On the first submission attempt, 13 of 18 (72%) achieved Level 3 recognition and 5 (28%) achieved Level 1 recognition. CONCLUSION: An interactive multifaceted educational strategy can be successful in preparing primary care practices for Patient-Centered Medical Homes recognition, but the strategy may not ensure transformation. Future educational activities should consider an expanded outcomes framework and the evidence of effective continuing education to be more successful with recognition and transformation.

The Path to Quality in Outpatient Practice: Meaningful Use, Patient-Centered Medical Homes, Financial Incentives, and Technical Assistance.

Adoption and meaningful use of electronic health records is considered an essential step to improve the quality of health care. The authors assessed whether a series of Connecticut primary care providers who achieved Stage I Meaningful Use of electronic health records used quality improvement strategies that are associated with improvements in care. Practice structural characteristics, quality improvement-related electronic health record processes, outcomes, and barriers were assessed in 14 primary care practices. Implementation of quality improvement-related electronic health record processes was variable and barriers were common. Only 4 practices used data consistently to assess their performance, and only 3 reported improvements in care. Practices that were patient-centered medical homes scored higher on all quality improvement domains and received financial rewards more commonly. These findings suggest that primary care quality may be improved by formal alignment of Meaningful Use and Patient-Centered Medical Home criteria and by ongoing technical assistance to practices.

The Mental Health Nurse Incentive Program: reactions of general practitioners and their patients.

OBJECTIVE: To evaluate reactions of general practitioners (GPs) and their patients to the Mental Health Nurse Incentive Program (MHNIP). METHOD: A descriptive, exploratory approach was employed using discussion groups with 25GPs and individual interviews with 19 patients receiving treatment through the MHNIP. All discussion groups and interviews were audio taped, transcribed and analysed using thematic content analysis. RESULTS: There was overwhelming support for the MHNIP across GP and patient groups. Patients noted that the treatment provided through the program was convenient, holistic and non-stigmatising. GPs valued the collaborative working arrangements with mental health nurses (MHNs) and highlighted the ability of these nurses to provide a wide range of interventions for patients with complex mental health problems. CONCLUSIONS: The collaborative working arrangement between GPs and MHNs promoted through the MHNIP was perceived to have significantly enhanced primary care services for those with mental health problems. What is known about the topic? The introduction of MHNs into GP practices under the MHNIP, a new primary care initiative, represents a major reform in the provision of primary care services for those with mental health problems. What does this paper add? This paper reports on the reactions of GPs and patients to the introduction of the MHNIP. What are the implications for practitioners? The collaborative model promoted through the program enables family doctors to play a greater role in the management of mental health conditions within the primary care setting. MHNs working with the program need considerable experience and skill in dealing with a broad range of mental health problems. In general, GPs require a better understanding of the overall program.

Do published studies of educational outreach provide documentation of potentially important characteristics?

Educational outreach is a common intervention used to translate research findings into practice; however, the intervention has a mixed effect on changing clinician behavior and improving patient outcomes. Based on a published set of characteristics aimed at standardizing the approach to educational outreach, the authors undertook a careful review of the literature to determine the consistency and completeness of documentation. Using a 25-item abstraction tool, the authors reviewed 68 published studies of a recent Cochrane meta-analysis to determine the extent to which educational outreach studies provide recommended documentation of important characteristics. The results indicate that studies are generally inconsistent (documentation range of 0% to 100% across characteristics) and incomplete (documentation average of 43.1% across studies) in their descriptions. Documentation shortcomings of educational outreach studies make understanding the intervention and interpreting its findings particularly challenging. The authors recommend the creation of a guideline to help improve documentation of educational outreach efforts.