Effect of depression treatment on health behaviors and cardiovascular risk factors in primary care patients with depression and elevated cardiovascular risk: data from the eIMPACT trial.

BACKGROUND: Depression is an independent risk factor for cardiovascular disease (CVD), but it is unknown if successful depression treatment reduces CVD risk. METHODS: Using eIMPACT trial data, we examined the effect of modernized collaborative care for depression on indicators of CVD risk. A total of 216 primary care patients with depression and elevated CVD risk were randomized to 12 months of the eIMPACT intervention (internet cognitive-behavioral therapy [CBT], telephonic CBT, and select antidepressant medications) or usual primary care. CVD-relevant health behaviors (self-reported CVD prevention medication adherence, sedentary behavior, and sleep quality) and traditional CVD risk factors (blood pressure and lipid fractions) were assessed over 12 months. Incident CVD events were tracked over four years using a statewide health information exchange. RESULTS: The intervention group exhibited greater improvement in depressive symptoms (p < 0.01) and sleep quality (p < 0.01) than the usual care group, but there was no intervention effect on systolic blood pressure (p = 0.36), low-density lipoprotein cholesterol (p = 0.38), high-density lipoprotein cholesterol (p = 0.79), triglycerides (p = 0.76), CVD prevention medication adherence (p = 0.64), or sedentary behavior (p = 0.57). There was an intervention effect on diastolic blood pressure that favored the usual care group (p = 0.02). The likelihood of an incident CVD event did not differ between the intervention (13/107, 12.1%) and usual care (9/109, 8.3%) groups (p = 0.39). CONCLUSIONS: Successful depression treatment alone is not sufficient to lower the heightened CVD risk of people with depression. Alternative approaches are needed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02458690.

Building the Infrastructure to Integrate Social Care in a Safety Net Health System.

A recent National Academies report recommended that health systems invest in new infrastructure to integrate social and medical care. Although many health systems routinely screen patients for social concerns, few health systems achieve the recommended model of integration. In this critical case study in an urban safety net health system, we describe the human capital, operational redesign, and financial investment needed to implement the National Academy recommendations. Using data from this case study, we estimate that other health systems seeking to build and maintain this infrastructure would need to invest $1 million to $3 million per year. While health systems with robust existing resources may be able to bootstrap short-term funding to initiate this work, we conclude that long-term investments by insurers and other payers will be necessary for most health systems to achieve the recommended integration of medical and social care. Researchers seeking to test whether integrating social and medical care leads to better patient and population outcomes require access to health systems and communities who have already invested in this model infrastructure. (Am J Public Health. 2024;114(6):619-625. https://doi.org/10.2105/AJPH.2024.307602).

Cultivating Food Safety Together: Insights About the Future of Produce Safety in the U.S. Controlled Environment Agriculture Sector.

Controlled environment agriculture (CEA) is a rapidly growing sector that presents unique challenges and opportunities in ensuring food safety. This manuscript highlights critical gaps and needs to promote food safety in CEA systems as identified by stakeholders (n=47) at the Strategizing to Advance Future Extension andResearch (S.A.F.E.R.) CEA conference held in April 2023 at The Ohio State University's Ohio CEA Research Center. Feedback collected at the conference was analyzed using an emergent thematic analysis approach to determine key areas of focus. Research-based guidance is specific to the type of commodity, production system type, and size. Themes include the need for improved supply chain control, cleaning, and sanitization practices, pathogen preventive controls and mitigation methods and training and education. Discussions surrounding supply chain control underscored the significance of the need for approaches to mitigate foodborne pathogen contamination. Effective cleaning and sanitization practices are vital to maintaining a safe production environment, with considerations such as establishing standard operating procedures, accounting for hygienic equipment design, and managing the microbial communities within the system. Data analysis further highlights the need for risk assessments, validated pathogen detection methods, and evidence-based guidance in microbial reduction. In addition, training and education were identified as crucial in promoting a culture of food safety within CEA. The development of partnerships between industry, regulatory, and research institutions are needed to advance data-driven guidance and practices across the diverse range of CEA operations and deemed essential for addressing challenges and advancing food safety practices in CEA. Considering these factors, the CEA industry can enhance food safety practices, foster consumer trust, and support its long-term sustainability.

Career development in pragmatic clinical trials to improve care for people living with dementia.

The growing number of people living with dementia (PLWD) requires a coordinated clinical response to deliver pragmatic, evidence-based interventions in frontline care settings. However, infrastructure to support such a response is lacking. Moreover, there are too few researchers conducting rigorous embedded pragmatic clinical trials (ePCTs) to make the vision of high quality, widely accessible dementia care a reality. National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer's disease and Related Dementias Clinical Trials (IMPACT) Collaboratory seeks to improve the pipeline of early career researchers qualified to lead ePCTs by funding career development awards. Even with support from the Collaboratory, awardees face practical and methodological challenges to success, recently exacerbated by the COVID-19 pandemic. We first describe the training opportunities and support network for the IMPACT CDA recipients. This report then describes the unique career development challenges faced by early-career researchers involved in ePCTs for dementia care. Topics addressed include challenges in establishing a laboratory, academic promotion, mentoring and professional development, and work-life balance. Concrete suggestions to address these challenges are offered for early-career investigators, their mentors, and their supporting institutions. While some of these challenges are faced by researchers in other fields, this report seeks to provide a roadmap for expanding the work of the IMPACT Collaboratory and initiating future efforts to recruit, train, and retain talented early-career researchers involved in ePCTs for dementia care.

Dementia care navigation: Building toward a common definition, key principles, and outcomes.

INTRODUCTION: As the complexity of medical treatments and patient care systems have increased, the concept of patient navigation is growing in both popularity and breadth of application. Patient navigators are trained personnel whose role is not to provide clinical care, but to partner with patients to help them identify their needs and goals and then overcome modifiable patient-, provider-, and systems-level barriers. Due to its high incidence, duration, and medical-social complexity, dementia is an ideal candidate for a patient-centric health care delivery model such as care navigation. METHODS: The Alzheimer's Association formed an expert workgroup of researchers in the field of dementia care navigation to identify evidence-based guidelines. RESULTS: Recognizing the unique and challenging needs of persons living with dementia and their care partners, several U.S. dementia care navigation programs have been developed and assessed in recent years. Collectively these programs demonstrate that persons living with dementia and their care partners benefit from dementia care navigation. Improved care system outcomes for the person living with dementia include reduced emergency department visits, lower hospital readmissions, fewer days hospitalized, and shorter delays in long-term care placement. Well-being is also increased, as there is decreased depression, illness, strain, embarrassment, and behavioral symptoms and increased self-reported quality of life. For care partners, dementia navigation resulted in decreased depression, burden, and unmet needs. DISCUSSION: This article presents principles of dementia care navigation to inform existing and emerging dementia care navigation programs. Highlights: Several U.S. dementia care navigation programs have demonstrated outcomes for persons living with dementia, care partners, and health systems.The Alzheimer's Association formed an expert workgroup of researchers in the field of dementia care navigation to create a shared definition and identify evidence-based guidelines or principles.These outlined principles of dementia care navigation can inform existing and emerging dementia care navigation programs.

Design and baseline characteristics of the Cognitive and Aerobic Resilience for the Brain (CARB) study.

BACKGROUND: Treatments that delay progression of cognitive impairment in older adults are of great public health significance. This manuscript outlines the protocol, recruitment, baseline characteristics, and retention for a randomized controlled trial of cognitive and aerobic physical training to improve cognition in individuals with subjective cognitive dysfunction, the "Cognitive and Aerobic Resilience for the Brain" (CARB) study. METHODS: Community-dwelling, older adults with self-reported memory loss were randomly assigned to receive either computer-based cognitive training, aerobic physical training, combined cognitive and physical training, or education control. Treatment was delivered 2- to 3-times per week in 45- to 90-min sessions for 12 weeks by trained facilitators videoconferencing into subject's home. Outcome assessments of were taken at the baseline, immediately following training, and 3-months after training. RESULTS: 191 subjects were randomized into the trial (mean age, 75.5 years; 68% female; 20% non-white; mean education, 15.1 years; 30% with 1+ APOE e4 allele). The sample was generally obese, hypertensive, and many were diabetic, while cognition, self-reported mood, and activities of daily living were in the normal range. There was excellent retention throughout the trial. Interventions were completed at high rates, participants found the treatments acceptable and enjoyable, and outcome assessments were completed at high rates. CONCLUSIONS: This study was designed to determine the feasibility of recruiting, intervening, and documenting response to treatment in a population at risk for progressive cognitive decline. Older adults with self-reported memory loss were enrolled in high numbers and were well engaged with the intervention and outcome assessments.

Effect of modernized collaborative care for depression on depressive symptoms and cardiovascular disease risk biomarkers: eIMPACT randomized controlled trial.

Although depression is a risk and prognostic factor for cardiovascular disease (CVD), clinical trials treating depression in patients with CVD have not demonstrated cardiovascular benefits. We proposed a novel explanation for the null results for CVD-related outcomes: the late timing of depression treatment in the natural history of CVD. Our objective was to determine whether successful depression treatment before, versus after, clinical CVD onset reduces CVD risk in depression. We conducted a single-center, parallel-group, assessor-blinded randomized controlled trial. Primary care patients with depression and elevated CVD risk from a safety net healthcare system (N = 216, Mage = 59 years, 78% female, 50% Black, 46% with income <$10,000/year) were randomized to 12 months of the eIMPACT intervention (modernized collaborative care involving internet cognitive-behavioral therapy [CBT], telephonic CBT, and/or select antidepressants) or usual primary care for depression (primary care providers supported by embedded behavioral health clinicians and psychiatrists). Outcomes were depressive symptoms and CVD risk biomarkers at 12 months. Intervention participants, versus usual care participants, exhibited moderate-to-large (Hedges' g = -0.65, p < 0.01) improvements in depressive symptoms. Clinical response data yielded similar results - 43% of intervention participants, versus 17% of usual care participants, had a ≥ 50% reduction in depressive symptoms (OR = 3.73, 95% CI: 1.93-7.21, p < 0.01). However, no treatment group differences were observed for the CVD risk biomarkers - i.e., brachial flow-mediated dilation, high-frequency heart rate variability, interleukin-6, high-sensitivity C-reactive protein, ß-thromboglobulin, and platelet factor 4 (Hedges' gs = -0.23 to 0.02, ps ≥ 0.09). Our modernized collaborative care intervention - which harnessed technology to maximize access and minimize resources - produced clinically meaningful improvements in depressive symptoms. However, successful depression treatment did not lower CVD risk biomarkers. Our findings indicate that depression treatment alone may not be sufficient to reduce the excess CVD risk of people with depression and that alternative approaches are needed. In addition, our effective intervention highlights the utility of eHealth interventions and centralized, remote treatment delivery in safety net clinical settings and could inform contemporary integrated care approaches. Trial Registration:ClinicalTrials.gov Identifier: NCT02458690.

Persistent effect of El Niño on global economic growth.

The El Niño-Southern Oscillation (ENSO) shapes extreme weather globally, causing myriad socioeconomic impacts, but whether economies recover from ENSO events and how anthropogenic changes to ENSO will affect the global economy are unknown. Here we show that El Niño persistently reduces country-level economic growth; we attribute $4.1 trillion and $5.7 trillion in global income losses to the 1982-83 and 1997-98 El Niño events, respectively. In an emissions scenario consistent with current mitigation pledges, increased ENSO amplitude and teleconnections from warming are projected to cause $84 trillion in 21st-century economic losses, but these effects are shaped by stochastic variation in the sequence of El Niño and La Niña events. Our results highlight the sensitivity of the economy to climate variability independent of warming and the potential for future losses due to anthropogenic intensification of such variability.

Continuous Glucose Monitoring and Other Wearable Devices to Assess Hypoglycemia among Older Adult Outpatients with Diabetes Mellitus.

BACKGROUND: Hypoglycemia (HG) causes symptoms that can be fatal, and confers risk of dementia. Wearable devices can improve measurement and feedback to patients and clinicians about HG events and risk. OBJECTIVES: The aim of the study is to determine whether vulnerable older adults could use wearables, and explore HG frequency over 2 weeks. METHODS: First, 10 participants with diabetes mellitus piloted a continuous glucometer, physical activity monitor, electronic medication bottles, and smartphones facilitating prompts about medications, behaviors, and symptoms. They reviewed graphs of glucose values, and were asked about the monitoring experience. Next, a larger sample (N = 70) wore glucometers and activity monitors, and used the smartphone and bottles, for 2 weeks. Participants provided feedback about the devices. Descriptive statistics summarized demographics, baseline experiences, behaviors, and HG. RESULTS: In the initial pilot, 10 patients aged 50 to 85 participated. Problems addressed included failure of the glucometer adhesive. Patients sought understanding of graphs, often requiring some assistance with interpretation. Among 70 patients in subsequent testing, 67% were African-American, 59% were women. Nearly one-fourth (23%) indicated that they never check their blood sugars. Previous HG was reported by 67%. In 2 weeks of monitoring, 73% had HG (glucose ≤70 mg/dL), and 42% had serious, clinically significant HG (glucose under 54 mg/dL). Eight patients with HG also had HG by home-based blood glucometry. Nearly a third of daytime prompts were unanswered. In 24% of participants, continuous glucometers became detached. CONCLUSION: Continuous glucometry occurred for 2 weeks in an older vulnerable population, but devices posed wearability challenges. Most patients experienced HG, often serious in magnitude. This suggests important opportunities to improve wearability and decrease HG frequency among this population.

Hypoxia-induced pulmonary hypertension upregulates eNOS and TGF-ß contributing to sex-linked differences in BMPR2 +/R899X mutant mice.

Dysfunctional bone morphogenetic protein receptor 2 (BMPR2) and endothelial nitric oxide synthase (eNOS) have been largely implicated in the pathogenesis of pulmonary arterial hypertension (PAH); a life-threatening cardiopulmonary disease. Although the incident of PAH is about three times higher in females, males with PAH usually have a worse prognosis, which seems to be dependent on estrogen-associated cardiac and vascular protection. Here, we evaluated whether hypoxia-induced pulmonary hypertension (PH) in humanized BMPR2+/R899X loss-of-function mutant mice contributes to sex-associated differences observed in PAH by altering eNOS expression and inducing expansion of hyperactivated TGF-ß-producing pulmonary myofibroblasts. To test this hypothesis, male and female wild-type (WT) and BMPR2+/R899X mutant mice were kept under hypoxic or normoxic conditions for 4 weeks, and then right ventricular systolic pressure (RVSP) and right ventricular hypertrophy (RVH) were measured. Chronic hypoxia exposure elevated RVSP, inducing RVH in both groups, with a greater effect in BMPR2+/R899X female mice. Lung histology revealed no differences in vessel thickness/area between sexes, suggesting RVSP differences in this model are unlikely to be in response to sex-dependent vascular narrowing. On the other hand, hypoxia exposure increased vascular collagen deposition, the number of TGF-ß-associated α-SMA-positive microvessels, and eNOS expression, whereas it also reduced caveolin-1 expression in the lungs of BMPR2+/R899X females compared to males. Taken together, this brief report reveals elevated myofibroblast-derived TGF-ß and eNOS-derived oxidants contribute to pulmonary microvascular muscularization and sex-linked differences in incidence, severity, and outcome of PAH.

Globally unequal effect of extreme heat on economic growth.

Increased extreme heat is among the clearest impacts of global warming, but the economic effects of heat waves are poorly understood. Using subnational economic data, extreme heat metrics measuring the temperature of the hottest several days in each year, and an ensemble of climate models, we quantify the effect of extreme heat intensity on economic growth globally. We find that human-caused increases in heat waves have depressed economic output most in the poor tropical regions least culpable for warming. Cumulative 1992-2013 losses from anthropogenic extreme heat likely fall between $5 trillion and $29.3 trillion globally. Losses amount to 6.7% of Gross Domestic Product per capita per year for regions in the bottom income decile, but only 1.5% for regions in the top income decile. Our results have the potential to inform adaptation investments and demonstrate how global inequality is both a cause and consequence of the unequal burden of climate change.

Deprescribing anticholinergics in primary care older adults: Experience from two models and impact on a continuous measure of exposure.

Background: Deprescribing interventions delivered through the electronic medical record have not significantly reduced the use of high-risk anticholinergics in prior trials. Pharmacists have been identified as ideal practitioners to conduct deprescribing; however, little experience beyond collaborative consult models has been published. Objective: To evaluate the impact of two pilot pharmacist-based advanced practice models nested within primary care. Methods: Pilot studies of a collaborative clinic-based pharmacist deprescribing intervention and a telephone-based pharmacist deprescribing intervention were conducted. Patients receiving the clinic-based pharmacy model were aged 55 years and older and referred for deprescribing at a specialty clinic. Patients receiving the telephone-based pharmacy model were aged 65 years and older and called by a clinical pharmacist for deprescribing without referral. Deprescribing was defined as a discontinuation or dose reduction reported either in clinical records or through self-reporting. Results: The 18 patients receiving clinic-based deprescribing had a mean age of 68 years and 78% were female. Among 24 medications deemed eligible for deprescribing, 23 (96%) were deprescribed. The clinic-based deprescribing model resulted in a 93% reduction in median annualized total standardized dose (TSD), 56% lowered their annualized exposure below a cognitive risk threshold, and 4 (17%) of medications were represcribed within 6 months. The 24 patients receiving telephone-based deprescribing had a mean age of 73 years and 92% were female. Among 24 medications deemed eligible for deprescribing, 12 (50%) were deprescribed. There was no change in the median annualized TSD, the annualized TSD was lowered below a cognitive risk threshold in 46%, and no medications were represcribed within 6 months. Few withdrawal symptoms or adverse events were reported in both groups. Conclusions: Pharmacist-based deprescribing successfully reduced exposure to high-risk anticholinergics in primary care older adults, yet further work is needed to understand the impact on clinical outcomes.

Multicomponent behavioral intervention to reduce exposure to anticholinergics in primary care older adults.

OBJECTIVE: To test the impact of a multicomponent behavioral intervention to reduce the use of high-risk anticholinergic medications in primary care older adults. DESIGN: Cluster-randomized controlled trial. SETTING AND PARTICIPANTS: Ten primary care clinics within Eskenazi Health in Indianapolis. INTERVENTION: The multicomponent intervention included provider- and patient-focused components. The provider-focused component was computerized decision support alerting of the presence of a high-risk anticholinergic and offering dose- and indication-specific alternatives. The patient-focused component was a story-based video providing education and modeling an interaction with a healthcare provider resulting in a medication change. Alerts within the medical record triggered staff to play the video for a patient. Our design intended for parallel, independent priming of both providers and patients immediately before an outpatient face-to-face interaction. MEASUREMENT: Medication orders were extracted from the electronic medical record system to evaluate the prescribing behavior and population prevalence of anticholinergic users. The intervention was introduced April 1, 2019, through March 31, 2020, and a preintervention observational period of April 1, 2018, through March 31, 2019, facilitated difference in difference comparisons. RESULTS: A total of 552 older adults had visits at primary care sites during the study period, with mean age of 72.1 (SD 6.4) years and 45.3% African American. Of the 259 provider-focused alerts, only three (1.2%) led to a medication change. Of the 276 staff alerts, 4.7% were confirmed to activate the patient-focused intervention. The intervention resulted in no significant differences in either the number of discontinue orders for anticholinergics (intervention: two additional orders; control: five fewer orders, p = 0.7334) or proportion of the population using anticholinergics following the intervention (preintervention: 6.2% and postintervention: 5.1%, p = 0.6326). CONCLUSION: This multicomponent intervention did not reduce the use of high-risk anticholinergics in older adults receiving primary care. Improving nudges or a policy-focused component may be necessary to reduce use of high-risk medications.

Complex Transitions from Skilled Nursing Facility to Home: Patient and Caregiver Perspectives.

BACKGROUND: Patients who undergo the complex series of transitions from the hospital to a skilled nursing facility (SNF) back to home represent a unique patient population with multiple comorbidities and impaired functional abilities. The needs and outcomes of patients who are discharged from the hospital to SNF before returning home are understudied in care transitions scholarship. OBJECTIVE: To study the patient and caregiver challenges and perspectives on transitions from the hospital to the SNF and back to home. DESIGN: Between 48 h and 1 week after discharge from the SNF, semi-structured interviews were performed with a convenience sample of patients and caregivers in their homes. Within 1 to 2 weeks after the baseline interview, follow-up interviews were performed over the phone. PARTICIPANTS: A total of 39 interviewees comprised older adults undergoing the series of transitions from hospital to skilled nursing facility to home and their informal caregivers. MAIN MEASURES: A constructionist, grounded-theory approach was used to code the interviews, identify major themes and subthemes, and develop a theoretical model explaining the outcomes of the SNF to home transition. KEY RESULTS: The mean age of the patients was 76.6 years and 64.8 years for the caregivers. Four major themes were identified: comforts of home, information needs, post-SNF care, and independence. Patients noted an extended time away from home and were motivated to return to and remain in the home. Information needs were variably met and affected post-SNF care, including medication management, appointments, and therapy gains and setbacks. Interviewees identified independent function at home as the most important outcome of the transition home. CONCLUSIONS: Post-SNF in home support is needed rapidly after discharge from the SNF to prevent adverse outcomes. In-home support needs to be highly individualized based on a patient's and caregiver's unique situation and needs.

Training the Workforce to Conduct Embedded Pragmatic Clinical Trials to Improve Care for People Living with Dementia and Their Caregivers.

The National Institute on Aging IMbedded Pragmatic Alzheimer's Disease and Alzheimer's Disease-Related Dementias Clinical Trials (IMPACT) Collaboratory serves as a national resource for the conduct of embedded pragmatic clinical trials to improve the care of people living with dementia (PLWD) in partnership with the healthcare systems that serve them. Inherent in this objective is the need to train and support a cadre of investigators prepared to conduct this work now and in the future. The Training Core of the IMPACT Collaboratory supports the training of investigators to become experts in this field through three objectives: (1) curricula development and dissemination; (2) network generation and navigation; and (3) a career development award program. The innovative approach of the Training Core will require developing content and providing training experiences that recognize the unique challenges of research at the intersection of health systems, pragmatic trials, and PLWD and their caregivers. Ultimately, we seek to build the nation's capacity to conduct research that bridges the gaps between efficacy studies to effectiveness research to implementation science. Although foundational resources in the methods of each of these areas are already available, few actually focus on pragmatic trials embedded within healthcare systems that focus on PLWD. To bring new interventions for PLWD from efficacy to widespread implementation, researchers must build diffusability, adaptability, heterogeneity, and scalability into the design of the intervention. In achieving these objectives, the Training Core will utilize the network of investigators, institutions, and stakeholders represented in the IMPACT Collaboratory. J Am Geriatr Soc 68:S21-S27, 2020.