Multicomponent Intervention to Improve Acute Myocardial Infarction Care in Tanzania: Protocol for a Pilot Implementation Trial.

BACKGROUND: Although the incidence of acute myocardial infarction (AMI) is rising in sub-Saharan Africa, the uptake of evidence-based care for the diagnosis and treatment of AMI is limited throughout the region. In Tanzania, studies have revealed common misdiagnosis of AMI, infrequent administration of aspirin, and high short-term mortality rates following AMI. OBJECTIVE: This study aims to evaluate the implementation and efficacy outcomes of an intervention, the Multicomponent Intervention to Improve Acute Myocardial Infarction Care (MIMIC), which was developed to improve the delivery of evidence-based AMI care in Tanzania. METHODS: This single-arm pilot trial will be conducted in the emergency department (ED) at a referral hospital in northern Tanzania. The MIMIC intervention will be implemented by the ED staff for 1 year. Approximately 400 adults presenting to the ED with possible AMI symptoms will be enrolled, and research assistants will observe their care. Thirty days later, a follow-up survey will be administered to assess mortality and medication use. The primary outcome will be the acceptability of the MIMIC intervention, which will be measured by the Acceptability of Intervention Measurement (AIM) instrument. Acceptability will further be assessed via in-depth interviews with key stakeholders. Secondary implementation outcomes will include feasibility and fidelity. Secondary efficacy outcomes will include the following: the proportion of participants who receive electrocardiogram and cardiac biomarker testing, the proportion of participants with AMI who receive aspirin, 30-day mortality among participants with AMI, and the proportion of participants with AMI taking aspirin 30 days following enrollment. RESULTS: Implementation of MIMIC began on September 1, 2023. Enrollment is expected to be completed by September 1, 2024, and the first results are expected to be published by December 31, 2024. CONCLUSIONS: This study will be the first to evaluate an intervention for improving AMI care in sub-Saharan Africa. If MIMIC is found to be acceptable, the findings from this study will inform a future cluster-randomized trial to assess effectiveness and scalability. TRIAL REGISTRATION: ClinicalTrials.gov NCT04563546; https://clinicaltrials.gov/study/NCT04563546. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59917.

Nurse-Supported Self-Directed Cognitive Behavioral Therapy for Insomnia: A Randomized Clinical Trial.

Importance: Cognitive behavioral therapy for insomnia (CBTi) is the standard of care for treating insomnia disorder, but access is limited. Alternative approaches are needed to expand access to the standard of care. Objective: To examine the effectiveness of a nurse-supported, self-directed behavioral insomnia intervention for decreasing insomnia severity and improving sleep outcomes among veterans, a population with considerable mental health comorbidity. Design, Setting, and Participants: This randomized clinical trial included 178 patients with insomnia disorder who were recruited from a Veterans Affairs hospital (Durham VA Healthcare System) from September 2019 to April 2022 and randomized following baseline assessment; follow-ups were conducted at 8 weeks (primary end point) and 6 months. Data analysis was primarily conducted during the summer of 2023 and concluded in May 2024. Intervention: Six weekly phone calls from a nurse interventionist plus assigned treatment manual readings covering CBTi treatment components. The health education manual focused on health topics but not sleep. Main Outcomes and Measures: The primary outcome was the Insomnia Severity Index (score range, 0-28; remission <8; differential improvement of 3 points targeted) score assessed at 8 weeks postrandomization. Secondary outcomes were sleep outcomes, depression, fatigue, treatment response, and remission. Results: Of 178 study participants, the mean (SD) age was 55.1 (13.2) years, and 128 (71.9%) identified as men. At 8 weeks, Insomnia Severity Index scores decreased by an estimated mean (SE) of 5.7 (0.51) points in the intervention group and 2.0 (0.47) points in the control group, a differential mean improvement of 3.7 points (95% CI, -5.0 to -2.4; P < .001). Differences were sustained at 6 months (mean, -2.8; 95% CI, -4.4 to -1.3; P < .001). The intervention also resulted in greater improvements at 8 weeks postrandomization in diary sleep onset latency, wake after sleep onset, and sleep efficiency and actigraphy sleep efficiency; these differences were sustained at 6 months. At 8 weeks, depression and fatigue were significantly reduced, and the odds of treatment response and remission were greater in the intervention group compared with controls. Conclusions and Relevance: This randomized clinical trial found that despite greater prevalence of mental health conditions and sleep difficulties among veterans, a nurse-supported self-directed CBTi was more effective than health education control for reducing insomnia severity and improving sleep outcomes. Although less effective than therapist-delivered CBTi, findings were comparable with other trials using modified CBTi protocols. Trial Registration: ClinicalTrials.gov Identifier: NCT03727438.

The search for the missing link between health misinformation & health disparities.

Relative to the rapid increase in available health information, little has been published on the differential impact misinformation has on the health of communities. Observations during the height of the COVID-19 pandemic indicated there were communities that made decisions that negatively impacted health outcomes beyond expectations; we propose that health misinformation was a contributor to poor health outcomes. Health misinformation exposure varies across communities and preliminary research suggests that some communities are more vulnerable to the impact of health misinformation than others. However, few studies have evaluated the connection between health misinformation and healthcare disparities. In this paper, we (a) review the current literature on misinformation and its impact on health disparities, (b) expand on prior epidemiological models to explain the communal spread of misinformation and the link to disparate health outcomes, (c) identify gaps in knowledge about communal misinformation spread (d) review promising interventions to halt the adverse impact of misinformation.

Disclosure of HIV Status to Sexual Partners Among People With HIV in Singida Regional Referral Hospital of Tanzania: A Cross-Sectional Study.

ABSTRACT: HIV status nondisclosure to sexual partners remains a major challenge in Tanzania's health system. This hospital-based, descriptive, cross-sectional study design recruited 380 people living with HIV (PLWH) to assess voluntary HIV status disclosure to sexual partners, the associated factors, and outcomes among PLWH in Tanzania. Approximately 78% ( n = 297) of the study participants reported disclosing their HIV status to their sexual partners. Adjusted multivariable logistic regression analysis revealed that HIV status disclosure to sexual partners was significantly associated with living with a sexual partner (adjusted odds ratio [AOR] = 3.91, 95% CI [1.43-10.72]), knowledge of HIV disclosure (AOR = 11.71, 95% CI [2.88-47.63]), known serostatus of the sexual partner (AOR = 40.20, 95% CI [15.31-105.56]), and HIV disclosure-related stigma (AOR = 0.92, 95% CI [0.85-0.99]). Addressing these significant factors will maximize the magnitude of voluntary disclosure to sexual partners.

EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND): Protocol and Baseline Data for a Randomized Trial.

BACKGROUND: Approximately 10-15 % of individuals with type 2 diabetes have persistently poorly-controlled diabetes mellitus (PPDM) despite receiving available care, and frequently have comorbid hypertension. Mobile monitoring-enabled telehealth has the potential to improve outcomes in treatment-resistant chronic disease by supporting self-management and facilitating patient-clinician contact but must be designed in a manner amenable to real-world use. METHODS: Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) is an ongoing randomized trial comparing two 12-month interventions for comorbid PPDM and hypertension: 1) EXTEND, a mobile monitoring-enabled self-management intervention; and 2) EXTEND Plus, a comprehensive, nurse-delivered telehealth program incorporating mobile monitoring, self-management support, and pharmacist-supported medication management. Both arms leverage a novel platform that uses existing technological infrastructure to enable transmission of patient-generated health data into the electronic health record. The primary study outcome is difference in HbA1c change from baseline to 12 months. Secondary outcomes include blood pressure, weight, implementation barriers/facilitators, and costs. RESULTS: Enrollment concluded in June 2023 following randomization of 220 patients. Baseline characteristics are similar between arms; mean age is 54.5 years, and the cohort is predominantly female (63.6 %) and Black (68.2 %), with a baseline HbA1c of 9.81 %. CONCLUSION: The EXTEND trial is evaluating two mobile monitoring-enabled telehealth approaches that seek to improve outcomes for patients with PPDM and hypertension. Critically, these approaches are designed around existing infrastructure, so may be amenable to implementation and scaling. This study will promote real-world use of telehealth to maximize benefits for those with high-risk chronic disease.

Kidney and Cardiovascular Effectiveness of SGLT2 Inhibitors vs GLP-1 Receptor Agonists in Type 2 Diabetes.

BACKGROUND: Emerging data suggest that glucagon-like peptide-1 receptor agonists (GLP-1 RAs) improve kidney outcomes for people with type 2 diabetes (T2D). Direct comparisons of the kidney and cardiovascular effectiveness of GLP-1 RA with sodium-glucose cotransporter 2 inhibitors (SGLT2i), a first-line therapy for this population, are needed. OBJECTIVES: The authors compared kidney and cardiovascular outcomes for new users of SGLT2i and GLP-1 RAs with T2D. METHODS: Using propensity score overlap weighting, we analyzed electronic health record data from 20 U.S. health systems contributing to PCORnet between 2015 and 2020. The primary kidney outcome was a composite of sustained 40% estimated glomerular filtration rate (eGFR) decline, incident end-stage kidney disease, or all-cause mortality over 2 years or until censoring. In addition, we examined cardiovascular and safety outcomes. RESULTS: The weighted study cohort included 35,004 SGLT2i and 47,268 GLP-1 RA initiators. Over a median of 1.2 years, the primary outcome did not differ between treatments (HR: 0.91; 95% CI: 0.81-1.02), although SGLT2i were associated with a lower risk of 40% eGFR decline (HR: 0.77; 95% CI: 0.65-0.91). Risks of mortality (HR: 1.08; 95% CI: 0.92-1.27), a composite of stroke, myocardial infarction, or death (HR: 1.03; 95% CI: 0.93-1.14), and heart failure hospitalization (HR: 0.95; 95% CI: 0.80-1.13) did not differ. Genital mycotic infections were more common for SGLT2i initiators, but other safety outcomes did not differ. The results were similar regardless of chronic kidney disease status. CONCLUSIONS: SGLT2i and GLP-1 RAs led to similar kidney and cardiovascular outcomes in people with T2D, though SGLT2i initiation was associated with a lower risk of 40% eGFR decline. (Evaluating Comparative Effectiveness of Empagliflozin in Type 2 Diabetes Population With and Without Chronic Kidney Disease; NCT05465317).

Post-trial responsibilities in pragmatic clinical trials: Fulfilling the promise of research to drive real-world change.

While considerable scholarship has explored responsibilities owed to research participants at the conclusion of explanatory clinical trials, no guidance exists regarding responsibilities owed at the conclusion of a pragmatic clinical trial (PCT). Yet post-trial responsibilities in PCTs present distinct considerations from those emphasized in existing guidance and prior scholarship. Among these considerations include the responsibilities of the healthcare delivery systems in which PCTs are embedded, and decisions about implementation for interventions that demonstrate meaningful benefit following their integration into usual care settings-or deimplementation for those that fail to do so. In this article, we present an overview of prior scholarship and guidance on post-trial responsibilities, and then identify challenges for post-trial responsibilities for PCTs. We argue that, given one of the key rationales for PCTs is that they can facilitate uptake of their results by relevant decision-makers, there should be a presumptive default that PCT study results be incorporated into future care delivery processes. Fulfilling this responsibility will require prospective planning by researchers, healthcare delivery system leaders, institutional review boards, and sponsors, so as to ensure that the knowledge gained from PCTs does, in fact, influence real-world practice.

Clinical Outcomes Among High-Risk Primary Care Patients With Diabetic Kidney Disease: Methodological Challenges and Results From the STOP-DKD Study.

BACKGROUND/OBJECTIVE: Slowing the progression of diabetic kidney disease (DKD) is critical. We conducted a randomized controlled trial to target risk factors for DKD progression. METHODS: We evaluated the effect of a pharmacist-led intervention focused on supporting healthy behaviors, medication management, and self-monitoring on decline in estimated glomerular filtration rate (eGFR) for 36 months compared with an educational control. RESULTS: We randomized 138 individuals to the intervention group and 143 to control. At baseline, mean (SD) eGFR was 80.7 (21.7) mL/min/1.73m 2 , 56% of participants had chronic kidney disease and a history of uncontrolled hypertension with a baseline SBP of 134.3 mm Hg. The mean (SD) decline in eGFR by cystatin C from baseline to 36 months was 5.0 (19.6) and 5.9 (18.6) mL/min/1.73m 2 for the control and intervention groups, respectively, with no significant between-group difference ( P =0.75). CONCLUSIONS: We did not observe a significant difference in clinical outcomes by study arm. However, we showed that individuals with DKD will engage in a pharmacist-led intervention. The potential explanations for a lack of change in DKD risk factors can be attributed to 5 broad issues, challenges: (1) associated with enrolling patients with low eGFR and poor BP control; (2) implementing the intervention; (3) limited duration during which to observe any clinical benefit from the intervention; (4) potential co-intervention or contamination; and (5) low statistical power.

RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial: Study rationale and design.

Out-of-hospital cardiac arrest (OHCA) occurs in nearly 350,000 people each year in the United States (US). Despite advances in pre and in-hospital care, OHCA survival remains low and is highly variable across systems and regions. The critical barrier to improving cardiac arrest outcomes is not a lack of knowledge about effective interventions, but rather the widespread lack of systems of care to deliver interventions known to be successful. The RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial is a 7-year pragmatic, cluster-randomized trial of 62 counties (57 clusters) in North Carolina using an established registry and is testing whether implementation of a customized set of strategically targeted community-based interventions improves survival to hospital discharge with good neurologic function in OHCA relative to control/standard care. The multifaceted intervention comprises rapid cardiac arrest recognition and systematic bystander CPR instructions by 9-1-1 telecommunicators, comprehensive community CPR training and enhanced early automated external defibrillator (AED) use prior to emergency medical systems (EMS) arrival. Approximately 20,000 patients are expected to be enrolled in the RACE CARS Trial over 4 years of the assessment period. The primary endpoint is survival to hospital discharge with good neurologic outcome defined as a cerebral performance category (CPC) of 1 or 2. Secondary outcomes include the rate of bystander CPR, defibrillation prior to arrival of EMS, and quality of life. We aim to identify successful community- and systems-based strategies to improve outcomes of OHCA using a cluster randomized-controlled trial design that aims to provide a high level of evidence for future application.

Behavioral Engagement and Activation Model Study (BEAMS): A latent class analysis of adopters and non-adopters of digital health technologies among people with Type 2 diabetes.

Many people with Type 2 diabetes (T2D) who could benefit from digital health technologies (DHTs) are either not using DHTs or do use them, but not for long enough to reach their behavioral or metabolic goals. We aimed to identify subgroups within DHT adopters and non-adopters and describe their unique profiles to better understand the type of tailored support needed to promote effective and sustained DHT use across a diverse T2D population. We conducted latent class analysis of a sample of adults with T2D who responded to an internet survey between December 2021 and March 2022. We describe the clinical and psychological characteristics of DHT adopters and non-adopters, and their attitudes toward DHTs. A total of 633 individuals were characterized as either DHT "Adopters" (n = 376 reporting any use of DHT) or "Non-Adopters" (n = 257 reporting never using any DHT). Within Adopters, three subgroups were identified: 21% (79/376) were "Self-managing Adopters," who reported high health activation and self-efficacy for diabetes management, 42% (158/376) were "Activated Adopters with dropout risk," and 37% (139/376) were "Non-Activated Adopters with dropout risk." The latter two subgroups reported barriers to using DHTs and lower rates of intended future use. Within Non-Adopters, two subgroups were identified: 31% (79/257) were "Activated Non-Adopters," and 69% (178/257) were "Non-Adopters with barriers," and were similarly distinguished by health activation and barriers to using DHTs. Beyond demographic characteristics, psychological, and clinical factors may help identify different subgroups of Adopters and Non-Adopters.

In this study, we characterized subgroups of adopters and non-adopters of digital health technologies (DHTs) for managing Type 2 diabetes, such as apps to track nutrition, continuous glucose monitors, and activity monitors like Fitbit. Self-efficacy for diabetes management, health activation, and perceived barriers to use DHT emerged as characteristics that distinguished subgroups. Notably, subgroups of adopters differed in their interest to use these technologies in the next 3 months; groups with low levels of self-efficacy and health activation were least interested in using them and thus at risk of discontinuing use. The ability to identify these subgroups can inform strategies tailored to each subgroup that motivate adoption of DHTs and promote long-term engagement.

Concordance With Screening and Treatment Guidelines for Chronic Kidney Disease in Type 2 Diabetes.

Importance: Chronic kidney disease (CKD) is an often-asymptomatic complication of type 2 diabetes (T2D) that requires annual screening to diagnose. Patient-level factors linked to inadequate screening and treatment can inform implementation strategies to facilitate guideline-recommended CKD care. Objective: To identify risk factors for nonconcordance with guideline-recommended CKD screening and treatment in patients with T2D. Design, Setting, and Participants: This retrospective cohort study was performed at 20 health care systems contributing data to the US National Patient-Centered Clinical Research Network. To evaluate concordance with CKD screening guidelines, adults with an outpatient clinician visit linked to T2D diagnosis between January 1, 2015, and December 31, 2020, and without known CKD were included. A separate analysis reviewed prescription of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) and sodium-glucose cotransporter 2 (SGLT2) inhibitors in adults with CKD (estimated glomerular filtration rate [eGFR] of 30-90 mL/min/1.73 m2 and urinary albumin-to-creatinine ratio [UACR] of 200-5000 mg/g) and an outpatient clinician visit for T2D between October 1, 2019, and December 31, 2020. Data were analyzed from July 8, 2022, through June 22, 2023. Exposures: Demographics, lifestyle factors, comorbidities, medications, and laboratory results. Main Outcomes and Measures: Screening required measurement of creatinine levels and UACR within 15 months of the index visit. Treatment reflected prescription of ACEIs or ARBs and SGLT2 inhibitors within 12 months before or 6 months following the index visit. Results: Concordance with CKD screening guidelines was assessed in 316 234 adults (median age, 59 [IQR, 50-67] years), of whom 51.5% were women; 21.7%, Black; 10.3%, Hispanic; and 67.6%, White. Only 24.9% received creatinine and UACR screening, 56.5% received 1 screening measurement, and 18.6% received neither. Hispanic ethnicity was associated with lack of screening (relative risk [RR], 1.16 [95% CI, 1.14-1.18]). In contrast, heart failure, peripheral arterial disease, and hypertension were associated with a lower risk of nonconcordance. In 4215 patients with CKD and albuminuria, 3288 (78.0%) received an ACEI or ARB; 194 (4.6%), an SGLT2 inhibitor; and 885 (21.0%), neither therapy. Peripheral arterial disease and lower eGFR were associated with lack of CKD treatment, while diuretic or statin prescription and hypertension were associated with treatment. Conclusions and Relevance: In this cohort study of patients with T2D, fewer than one-quarter received recommended CKD screening. In patients with CKD and albuminuria, 21.0% did not receive an SGLT2 inhibitor or an ACEI or an ARB, despite compelling indications. Patient-level factors may inform implementation strategies to improve CKD screening and treatment in people with T2D.

Association Between Frailty and Management and Outcomes of Acute Myocardial Infarction Complicated by Cardiogenic Shock.

Background: Cardiogenic shock (CS) in the setting of acute myocardial infarction (AMI) is associated with high morbidity and mortality. Frailty is a common comorbidity in patients with cardiovascular disease and is also associated with adverse outcomes. The impact of preexisting frailty at the time of CS diagnosis following AMI has not been studied. Objectives: The purpose of this study was to examine the prevalence of frailty in patients admitted with AMI complicated by CS (AMI-CS) hospitalizations and its associations with in-hospital outcomes. Methods: We retrospectively analyzed the National Inpatient Sample from 2016 to 2020 and identified all hospitalizations for AMI-CS. We classified them into frail and nonfrail groups according to the hospital frailty risk score cut-off of 5 and compared in-hospital outcomes. Results: A total of 283,700 hospitalizations for AMI-CS were identified. Most (70.8%) occurred in the frail. Those with frailty had higher odds of in-hospital mortality (adjusted OR [aOR]: 2.17, 95% CI: 2.07 to 2.26, P < 0.001), do-not-resuscitate status, and discharge to a skilled nursing facility compared with those without frailty. They also had higher odds of in-hospital adverse events, including intracranial hemorrhage, gastrointestinal hemorrhage, acute kidney injury, and delirium. Importantly, AMI-CS hospitalizations in the frail had lower odds of coronary revascularization (aOR: 0.55, 95% CI: 0.53-0.58, P < 0.001) or mechanical circulatory support (aOR: 0.89, 95% CI: 0.85-0.93, P < 0.001). Lastly, hospitalizations for AMI-CS showed an overall increase from 53,210 in 2016 to 57,065 in 2020 (P trend <0.001), with this trend driven by a rise in the frail. Conclusions: A high proportion of hospitalizations for AMI-CS had concomitant frailty. Hospitalizations with AMI-CS and frailty had higher rates of in-hospital morbidity and mortality compared to those without frailty.

Implementation of a Clinician-led Medication Adherence Intervention Among Patients With Systemic Lupus Erythematosus.

OBJECTIVE: Medication nonadherence in systemic lupus erythematosus (SLE) leads to poor clinical outcomes. We developed a clinician-led adherence intervention that involves reviewing real-time pharmacy refill data and using effective communication to address nonadherence. Prior pilot testing showed promising effects on medication adherence. Here, we describe further evaluation of how clinicians implemented the intervention and identify areas for improvement. METHODS: We audio recorded encounters of clinicians with patients who were nonadherent (90-day proportion of days covered [PDC] < 80% for SLE medications). We coded recordings for intervention components performed, communication quality, and time spent discussing adherence. We also conducted semistructured interviews with patients and clinicians on their experiences and suggestions for improving the intervention. We assessed change in 90-day PDC post intervention. RESULTS: We included 25 encounters with patients (median age 39, 100% female, 72% Black) delivered by 6 clinicians. Clinicians performed most intervention components consistently and exhibited excellent communication, as coded by objective coders. Adherence discussions took an average of 3.8 minutes, and 44% of patients had ≥ 20% increase in PDC post intervention. In structured interviews, many patients felt heard and valued and described being more honest about nonadherence and more motivated to take SLE medications. Patients emphasized patient-clinician communication and financial and logistical assistance as areas for improvement. Some clinicians wanted additional resources and training to improve adherence conversations. CONCLUSION: We provide further evidence to support the feasibility, acceptability, and fidelity of the adherence intervention. Future work will optimize clinician training and evaluate the intervention's effectiveness in a large, randomized trial.

Kidney and Cardiovascular Effectiveness of Empagliflozin Compared With Dipeptidyl Peptidase-4 Inhibitors in Patients With Type 2 Diabetes.

Placebo-controlled trials of sodium-glucose co-transporter-2 inhibitors demonstrate kidney and cardiovascular benefits for patients with type 2 diabetes and chronic kidney disease (CKD). We used real-world data to compare the kidney and cardiovascular effectiveness of empagliflozin to dipeptidyl peptidase-4 inhibitors (DPP4is), a commonly prescribed antiglycemic medication, in a diverse population with and without CKD. Using electronic health record data from 20 large US health systems, we leveraged propensity overlap weighting to compare the outcomes for empagliflozin and DPP4i initiators with type 2 diabetes between 2016 and 2020. The primary composite kidney outcome included 40% estimated glomerular filtration rate decrease, incident end-stage kidney disease, or all-cause mortality through 2 years or censoring. We also assessed cardiovascular and safety outcomes. Of 62,197 new users, 20,279 initiated empagliflozin and 41,918 initiated DPP4i. Over a median follow-up of 1.1 years, empagliflozin prescription was associated with a lower risk of the primary outcome (hazard ratio [HR] 0.75, 95% confidence interval [CI] 0.65 to 0.87) than DPP4is. The risks for mortality (HR 0.76, 95% CI 0.62 to 0.92) and a cardiovascular composite of stroke, myocardial infarction, or all-cause mortality (HR 0.81, 95% CI 0.70 to 0.95) were also lower for empagliflozin initiators. No difference in heart failure hospitalization risk between groups was observed. Genital mycotic infections were more common in patients prescribed empagliflozin (HR 1.72, 95% CI 1.58 to 1.88). Empagliflozin was associated with a lower risk of the primary outcome in patients with CKD (HR 0.68, 95% CI 0.53 to 0.88) and those without CKD (HR 0.79, 95% CI 0.67 to 0.94). In conclusion, the initiation of empagliflozin was associated with a significantly lower risk of kidney and cardiovascular outcomes than DPP4is over a median of just over 1 year. The association with a lower risk for clinical outcomes was apparent even for patients without known CKD at baseline.

Understanding veterans' experiences with lung cancer and psychological distress: A multimethod approach.

Psychological distress while coping with cancer is a highly prevalent and yet underrecognized and burdensome adverse effect of cancer diagnosis and treatment. Left unaddressed, psychological distress can further exacerbate poor mental health, negatively influence health management behaviors, and lead to a worsening quality of life. This multimethod study primarily focused on understanding veterans' psychological distress and personal experiences living with lung cancer (an underrepresented patient population). In a sample of 60 veterans diagnosed with either nonsmall cell lung cancer (NSCLC) or small cell lung cancer (SCLC), we found that distress is common across clinical psychology measures of depression (37% [using the Patient Health Questionnaire, PHQ-9 measure]), anxiety (35% [using the Generalized Anxiety Disorder, GAD-7 measure]), and cancer-related posttraumatic stress (13% [using the Posttraumatic Stress Symptom Checklist measure]). A total of 23% of the sample endorsed distress scores on two or more mental health screeners. Using a broader cancer-specific distress measure (National Comprehensive Cancer Network), 67% of our sample scored above the clinical cutoff (i.e., ≥ 3), and in the follow-up symptom checklist of the National Comprehensive Cancer Network measure, a majority endorsed feeling sadness (75%), worry (73%), and depression (60%). Qualitative analysis with a subset of 25 veterans highlighted that psychological distress is common, variable in nature, and quite bothersome. Future research should (a) identify veterans at risk for distress while living with lung cancer and (b) test supportive mental health interventions to target psychological distress among this vulnerable veteran population. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Improving acute myocardial infarction care in northern Tanzania: barrier identification and implementation strategy mapping.

BACKGROUND: Evidence-based care for acute myocardial infarction (AMI) reduces morbidity and mortality. Prior studies in Tanzania identified substantial gaps in the uptake of evidence-based AMI care. Implementation science has been used to improve uptake of evidence-based AMI care in high-income settings, but interventions to improve quality of AMI care have not been studied in sub-Saharan Africa. METHODS: Purposive sampling was used to recruit participants from key stakeholder groups (patients, providers, and healthcare administrators) in northern Tanzania. Semi-structured in-depth interviews were conducted using a guide informed by the Consolidated Framework for Implementation Research (CFIR). Interview transcripts were coded to identify barriers to AMI care, using the 39 CFIR constructs. Barriers relevant to emergency department (ED) AMI care were retained, and the Expert Recommendations for Implementing Change (ERIC) tool was used to match barriers with Level 1 recommendations for targeted implementation strategies. RESULTS: Thirty key stakeholders, including 10 patients, 10 providers, and 10 healthcare administrators were enrolled. Thematic analysis identified 11 barriers to ED-based AMI care: complexity of AMI care, cost of high-quality AMI care, local hospital culture, insufficient diagnostic and therapeutic resources, inadequate provider training, limited patient knowledge of AMI, need for formal implementation leaders, need for dedicated champions, failure to provide high-quality care, poor provider-patient communication, and inefficient ED systems. Seven of these barriers had 5 strong ERIC recommendations: access new funding, identify and prepare champions, conduct educational meetings, develop educational materials, and distribute educational materials. CONCLUSIONS: Multiple barriers across several domains limit the uptake of evidence-based AMI care in northern Tanzania. The CFIR-ERIC mapping approach identified several targeted implementation strategies for addressing these barriers. A multi-component intervention is planned to improve uptake of evidence-based AMI care in Tanzania.

Nurse-Led Strategy to Improve Blood Pressure and Cholesterol Level Among People With HIV: A Randomized Clinical Trial.

Importance: Despite higher atherosclerotic cardiovascular disease (ASCVD) risk, people with HIV (PWH) experience unique barriers to ASCVD prevention, such as changing models of HIV primary care. Objective: To test whether a multicomponent nurse-led strategy would improve systolic blood pressure (SBP) and non-high-density lipoprotein (HDL) cholesterol level in a diverse population of PWH receiving antiretroviral therapy (ART). Design, Setting, and Participants: This randomized clinical trial enrolled PWH at 3 academic HIV clinics in the US from September 2019 to January 2022 and conducted follow-up for 12 months until January 2023. Included patients were 18 years or older and had a confirmed HIV diagnosis, an HIV-1 viral load less than 200 copies/mL, and both hypertension and hypercholesterolemia. Participants were stratified by trial site and randomized 1:1 to either the multicomponent EXTRA-CVD (A Nurse-Led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention) intervention group or the control group. Primary analyses were conducted according to the intention-to-treat principle. Intervention: The EXTRA-CVD group received home BP monitoring guidance and BP and cholesterol management from a dedicated prevention nurse at 4 in-person visits (baseline and 4, 8, and 12 months) and frequent telephone check-ins up to every 2 weeks as needed. The control group received general prevention education sessions from the prevention nurse at each of the 4 in-person visits. Main Outcomes and Measures: Study-measured SBP was the primary outcome, and non-HDL cholesterol level was the secondary outcome. Measurements were taken over 12 months and assessed by linear mixed models. Prespecified moderators tested were sex at birth, baseline ASCVD risk, and trial site. Results: A total of 297 PWH were randomized to the EXTRA-CVD arm (n = 149) or control arm (n = 148). Participants had a median (IQR) age of 59.0 (53.0-65.0) years and included 234 males (78.8%). Baseline mean (SD) SBP was 135.0 (18.8) mm Hg and non-HDL cholesterol level was 139.9 (44.6) mg/dL. At 12 months, participants in the EXTRA-CVD arm had a clinically significant 4.2-mm Hg (95% CI, 0.3-8.2 mm Hg; P = .04) lower SBP and 16.9-mg/dL (95% CI, 8.6-25.2 mg/dL; P < .001) lower non-HDL cholesterol level compared with participants in the control arm. There was a clinically meaningful but not statistically significant difference in SBP effect in females compared with males (11.8-mm Hg greater difference at 4 months, 9.6 mm Hg at 8 months, and 5.9 mm Hg at 12 months; overall joint test P = .06). Conclusions and Relevance: Results of this trial indicate that the EXTRA-CVD strategy effectively reduced BP and cholesterol level over 12 months and should inform future implementation of multifaceted ASCVD prevention programs for PWH. Trial Registration: ClinicalTrials.gov Identifier: NCT03643705.

Racial and ethnic disparities in genomic testing among lung cancer patients: a systematic review.

BACKGROUND: Racial and ethnic disparities in genomic testing could exacerbate disparities in access to precision cancer therapies and survival-particularly in the context of lung cancer where genomic testing has been recommended for the past decade. However, prior studies assessing disparities in genomic testing have yielded mixed results. METHODS: We conducted a systemic review to examine racial and ethnic disparities in the use of genomic testing among lung cancer patients in the United States. Two comprehensive searches in PubMed, Embase, and Scopus were conducted (September 2022, May 2023). Original studies that assessed rates of genomic testing by race or ethnicity were included. Findings were narratively synthesized by outcome. RESULTS: The search yielded 2739 unique records, resulting in 18 included studies. All but 1 study were limited to patients diagnosed with non-small cell lung cancer. Diagnosis years ranged from 2007 to 2022. Of the 18 studies, 11 found statistically significant differences in the likelihood of genomic testing by race or ethnicity; in 7 of these studies, testing was lower among Black patients compared with White or Asian patients. However, many studies lacked adjustment for key covariates and included patients with unclear eligibility for testing. CONCLUSIONS: A majority of studies, though not all, observed racial and ethnic disparities in the use of genomic testing among patients with lung cancer. Heterogeneity of study results throughout a period of changing clinical guidelines suggests that minoritized populations-Black patients in particular-have faced additional barriers to genomic testing, even if not universally observed at all institutions.

Factors influencing support for the implementation of community-based out-of-hospital cardiac arrest interventions in high- and low-performing counties.

Aim of the study: Survival to hospital discharge from out-of-hospital cardiac arrest (OHCA) after receiving treatment from emergency medical services (EMS) is less than 10% in the United States. Community-focused interventions improve survival rates, but there is limited information on how to gain support for new interventions or program activities within these populations. Using data from the RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial, we aimed to identify the factors influencing emergency response agencies' support in implementing an OHCA intervention. Methods: North Carolina counties were stratified into high-performing or low-performing counties based on the county's cardiac arrest volume, percent of bystander-cardiopulmonary resuscitation (CPR) performed, patient survival to hospital discharge, cerebral performance in patients after cardiac arrest, and perceived engagement in the RACE-CARS project. We randomly selected 4 high-performing and 3 low-performing counties and conducted semi-structured qualitative interviews with emergency response stakeholders in each county. Results: From 10/2021 to 02/2022, we completed 29 interviews across the 7 counties (EMS (n = 9), telecommunications (n = 7), fire/first responders (n = 7), and hospital representatives (n = 6)). We identified three themes salient to community support for OHCA intervention: (1) initiating support at emergency response agencies; (2) obtaining support from emergency response agency staff (senior leadership and emergency response teams); and (3) and maintaining support. For each theme, we described similarities and differences by high- and low-performing county. Conclusions: We identified techniques for supporting effective engagement of emergency response agencies in community-based interventions for OHCA improving survival rates. This work may inform future programs and initiatives around implementation of community-based interventions for OHCA.

Diabetes distress in Veterans with type 2 diabetes mellitus: Qualitative descriptive study.

Diabetes distress (DD) is a negative psychosocial response to living with type 2 diabetes mellitus (T2DM). We sought insight into Veterans' experiences with DD in the context of T2DM self-management. The four domains in the Diabetes Distress Scale (i.e. regimen, emotional, interpersonal, healthcare provider) informed the interview guide and analysis (structural coding using thematic analysis). The mean age of the cohort (n = 36) was 59.1 years (SD 10.4); 8.3% of patients were female and 63.9% were Black or Mixed Race; mean A1C was 8.8% (SD 2.0); and mean DDS score was 2.4 (SD 1.1), indicating moderate distress. Veterans described DD and challenges to T2DM self-management across the four domains in the Diabetes Distress Scale. We found that (1) Veterans' challenges with their T2DM self-management routines influenced DD and (2) Veterans experienced DD across a wide range of domains, indicating that clinical interventions should take a "whole-person" approach.Trial Registration: NCT04587336.