Social determinants of health and emergency department visits among older adults with multimorbidity: insight from 2010 to 2018 National Health Interview Survey.

BACKGROUND: Multimorbidity is prevalent among older adults and is associated with adverse health outcomes, including high emergency department (ED) utilization. Social determinants of health (SDoH) are associated with many health outcomes, but the association between SDoH and ED visits among older adults with multimorbidity has received limited attention. This study aimed to examine the association between SDoH and ED visits among older adults with multimorbidity. METHODS: A cross-sectional analysis was conducted among 28,917 adults aged 50 years and older from the 2010 to 2018 National Health Interview Survey. Multimorbidity was defined as the presence of two or more self-reported diseases among 10 common chronic conditions, including diabetes, hypertension, asthma, stroke, cancer, arthritis, chronic obstructive pulmonary disease, and heart, kidney, and liver diseases. The SDoH assessed included race/ethnicity, education level, poverty income ratio, marital status, employment status, insurance status, region of residence, and having a usual place for medical care. Logistic regression models were used to examine the association between SDoH and one or more ED visits. RESULTS: Participants' mean (± SD) age was 68.04 (± 10.66) years, and 56.82% were female. After adjusting for age, sex, and the number of chronic conditions in the logistic regression model, high school or less education (adjusted odds ratio [AOR]: 1.10, 95% confidence interval [CI]: 1.02-1.19), poverty income ratio below the federal poverty level (AOR: 1.44, 95% CI: 1.31-1.59), unmarried (AOR: 1.19, 95% CI: 1.11-1.28), unemployed status (AOR: 1.33, 95% CI: 1.23-1.44), and having a usual place for medical care (AOR: 1.46, 95% CI 1.18-1.80) was significantly associated with having one or more ED visits. Non-Hispanic Black individuals had higher odds (AOR: 1.28, 95% CI: 1.19-1.38), while non-Hispanic Asian individuals had lower odds (AOR: 0.71, 95% CI: 0.59-0.86) of one or more ED visits than non-Hispanic White individuals. CONCLUSION: SDoH factors are associated with ED visits among older adults with multimorbidity. Systematic multidisciplinary team approaches are needed to address social disparities affecting not only multimorbidity prevalence but also health-seeking behaviors and emergent healthcare access.

Effectiveness of implementing a standardized perioperative pain management protocol in children undergoing tonsillectomy: A quality improvement project.

BACKGROUND AND PURPOSE: Tonsillectomy procedures are commonly performed worldwide. At our academic tertiary care facility, we perform approximately 1000 tonsillectomy procedures annually. We have found inconsistent pain management strategies in pediatric tonsillectomy patients have contributed to variability in postoperative complications and the number and types of postoperative pain medications required in the Post Anesthesia Care Unit (PACU). This project aimed to assess the impact of implementing a standardized perioperative pain management protocol on reducing postoperative complications in pediatric patients who underwent a tonsillectomy procedure. METHODS: A pre-post-intervention design was utilized, comparing characteristics and outcomes of pediatric patients for whom a standardized perioperative pain management protocol was implemented over a 12-week period compared to those who did not. The standardized perioperative pain management protocol was utilized intraoperatively by the anesthesiologists, nurse anesthetists, and residents. A Qualtrics survey was used by the Post Anesthesia Care Unit (PACU) nurses to gather data as they cared for patients who underwent tonsillectomy. Four outcomes were measured: (1) postoperative pain medication administration, (2) rate of postoperative respiratory complications, (3) rate of adherence, and (4) usability of a standardized pain management protocol. Data were compared between pre and post-implementation groups. RESULTS: During the quality improvement project, 180 children underwent tonsillectomy, with 81 in the control group and 99 in the intervention group. The median age did not differ between groups. The control group had higher postoperative opioid medication usage (93.8% vs. 54.5%) and a higher number of opioids administered in the recovery room. Postoperative IV fentanyl was reduced in the intervention group (49.4% vs. 28.3% in the intervention, p = .004). Respiratory interventions were more frequent in the control group (24.7% vs. 7.1%), with increased respiratory team activation. Respiratory team activation in the Post Anesthesia Care Unit (PACU) includes a 511 page for anesthesia provider assistance. Respiratory interventions included bag-mask ventilation, lidocaine, propofol or succinylcholine administration, and reintubation. The intervention group had 100% adherence to the pain management protocol, and providers found it easy to use. CONCLUSION: The quality improvement project highlighted notable improvements in the intervention group for whom a standardized perioperative pain management protocol was used, including reduced opioid medication administration, lower incidence of respiratory interventions, and high adherence to the pain management protocol. These findings underscore the effectiveness and feasibility of standardized protocols in enhancing patient outcomes.

Association Between the Composite Cardiovascular Risk and mHealth Use Among Adults in the 2017-2020 Health Information National Trends Survey: Cross-Sectional Study.

BACKGROUND: Numerous studies have suggested that the relationship between cardiovascular disease (CVD) risk and the usage of mobile health (mHealth) technology may vary depending on the total number of CVD risk factors present. However, whether higher CVD risk is associated with a greater likelihood of engaging in specific mHealth use among US adults is currently unknown. OBJECTIVE: We aim to assess the associations between the composite CVD risk and each component of mHealth use among US adults regardless of whether they have a history of CVD or not. METHODS: This study used cross-sectional data from the 2017 to 2020 Health Information National Trends Survey. The exposure was CVD risk (diabetes, hypertension, smoking, physical inactivity, and overweight or obesity). We defined low, moderate, and high CVD risk as having 0-1, 2-3, and 4-5 CVD risk factors, respectively. The outcome variables of interest were each component of mHealth use, including using mHealth to make health decisions, track health progress, share health information, and discuss health decisions with health providers. We used multivariable logistic regression models to examine the association between CVD risk and mHealth use adjusted for demographic factors. RESULTS: We included 10,531 adults, with a mean age of 54 (SD 16.2) years. Among the included participants, 50.2% were men, 65.4% were non-Hispanic White, 41.9% used mHealth to make health decisions, 50.8% used mHealth to track health progress toward a health-related goal, 18.3% used mHealth to share health information with health providers, and 37.7% used mHealth to discuss health decisions with health providers (all are weighted percentages). Adults with moderate CVD risk were more likely to use mHealth to share health information with health providers (adjusted odds ratio 1.49, 95% CI 1.24-1.80) and discuss health decisions with health providers (1.22, 95% CI 1.04-1.44) compared to those with low CVD risk. Similarly, having high CVD risk was associated with higher odds of using mHealth to share health information with health providers (2.61, 95% CI 1.93-3.54) and discuss health decisions with health providers (1.56, 95% CI 1.17-2.10) compared to those with low CVD risk. Upon stratifying by age and gender, we observed age and gender disparities in the relationship between CVD risk and the usage of mHealth to discuss health decisions with health providers. CONCLUSIONS: Adults with a greater number of CVD risk factors were more likely to use mHealth to share health information with health providers and discuss health decisions with health providers. These findings suggest a promising avenue for enhancing health care communication and advancing both primary and secondary prevention efforts related to managing CVD risk factors through the effective usage of mHealth technology.

Living with multimorbidity: A qualitative exploration of shared experiences of patients, family caregivers, and healthcare professionals in managing symptoms in the United States.

AIMS: To elicit experiences of patients, family caregivers, and healthcare professionals in intermediate care units (IMCUs) in an academic medical centre in Baltimore, MD related to the challenges and intricacies of multimorbidity management to inform development of a multimorbidity symptom management toolkit. DESIGN: Experience-based co-design. METHODS: Between July and October 2021, patients aged 55 years and older with multimorbidity admitted to IMCUs at an academic medical centre in Baltimore, Maryland, USA were recruited and interviewed in person. Interdisciplinary healthcare professionals working in the IMCU were interviewed virtually. Participants were asked questions about their role in recognizing and treating symptoms, factors affecting the quality of life, symptom burden and trajectory over time, and strategies that have and have not worked for managing symptoms. An inductive thematic analysis approach was used for analysis. RESULTS: Twenty-three interviews were conducted: 9 patients, 2 family caregivers, and 12 healthcare professionals. Patients' mean age was 67.5 (±6.5) years, over half (n = 5) were Black or Hispanic, and the average number of comorbidities was 3.67. Five major themes that affect symptom management emerged: (1) the patient-provider relationship; (2) open and honest communication; (3) accessibility of resources during hospitalization and at discharge; (4) caregiver support, training, and education; and (5) care coordination and follow-up care. CONCLUSION: Patients, caregivers, and healthcare professionals often have similar goals but different priorities for multimorbidity management. It is imperative to identify shared priorities and target holistic interventions that consider patient and caregiver experiences to improve outcomes. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE AND IMPACT: This paper addresses the paucity of research related to the shared experience of disease trajectory and symptom management for people living with multimorbidity. We found that patients, caregivers, and healthcare professionals often have similar goals but different care and communication priorities. Understanding differing priorities will help better design interventions to support symptom management so people with multimorbidity can have the best possible quality of life. REPORTING METHOD: We have adhered to the Consolidated Criteria for Reporting Qualitative Studies (COREQ) guidelines in our reporting. PATIENT OR PUBLIC CONTRIBUTION: This study has been designed and implemented with patient and public involvement throughout the process, including community advisory board engagement in the project proposal phase and interview guide development, and member checking in the data collection and analysis phases. The method we chose, experience-based co-design, emphasizes the importance of engaging members of a community to act as experts in their own life challenges. In the coming phases of the study, the public will be involved in developing and testing a new intervention, informed by these qualitative interviews and co-design events, to support symptom management for people with multimorbidity.

Obesity paradox of cardiovascular mortality in older adults in the United States: A cohort study using 1997-2018 National Health Interview Survey data linked with the National Death Index.

BACKGROUND: Large-scale, population-based investigations primarily investigating the association between body mass index (BMI) and cardiovascular disease (CVD) mortality among older and younger adults in the United States (U.S.) are lacking. OBJECTIVE: To evaluate the relationship between BMI and CVD mortality in older (≥65 years) and younger (<65 years) adults and to identify the nadir for CVD mortality. DESIGN: This cohort study used serial cross-sectional data from the 1997 to 2018 National Health Interview Survey (NHIS) linked with the National Death Index. NHIS is an annual nationally representative household interview survey of the civilian noninstitutionalized U.S. SETTING: Residential units of the civilian noninstitutionalized population in the U.S. PARTICIPANTS: The target population for the NHIS is the civilian noninstitutionalized U.S. population at the time of the interview. We included all adults who had BMI data collected at 18 years and older and with mortality data being available. To minimize the risk of reverse causality, we excluded adults whose survival time was ≤2 years of follow-up after their initial BMI was recorded and those with prevalent cancer and/or CVD at baseline. METHODS: We used the BMI record obtained in the year of the NHIS survey. Total CVD mortality used the NHIS data linked to the latest National Death Index data from the survey inception to December 31, 2019. We performed multivariable Cox proportional hazards regression models to estimate adjusted hazard ratios (aHRs) and 95 % confidence intervals (CIs). RESULTS: The study included 425,394 adults; the mean (SD) age was 44 (16.7) years. During a median follow-up period of 11 years, 12,089 CVD-related deaths occurred. In older adults, having overweight was associated with a lower risk of CVD mortality (aHR 0.92 [95 % CI, 0.87-0.97]); having class I obesity (1.04 [0.97-1.12]) and class II obesity (1.12 [1.00-1.26]) was not significantly associated with an increased CVD mortality; and having class III obesity was associated with an increased risk of CVD mortality (1.63 [1.35-1.98]), in comparison with adults who had a normal BMI. Yet, in younger adults, having overweight, class I, II, and III obesity was associated with a progressively higher risk of CVD mortality. The nadir for CVD mortality is 28.2 kg/m2 in older adults and 23.6 kg/m2 in younger adults. CONCLUSION: This U.S. population-based cohort study highlights the significance of considering age as a crucial factor when providing recommendations and delivering self-care educational initiatives for weight loss to reduce CVD mortality.

Heterogeneity in the Prevalence of Cardiovascular Risk Factors by Ethnicity and Birthplace Among Asian Subgroups: Evidence From the 2010 to 2018 National Health Interview Survey.

BACKGROUND: Asian people in the United States have different sociodemographic and health-related characteristics that might affect cardiovascular disease (CVD) risk by ethnicity and birthplace. However, they are often studied as a monolithic group in health care research. This study aimed to examine heterogeneity in CVD risk factors on the basis of birthplace among the 3 largest Asian subgroups (Chinese, Asian Indian, and Filipino) compared with US-born non-Hispanic White (NHW) adults. METHODS AND RESULTS: A cross-sectional analysis was conducted using the 2010 to 2018 National Health Interview Survey data from 125 008 US-born and foreign-born Chinese, Asian Indian, Filipino, and US-born NHW adults. Generalized linear models with Poisson distribution were used to examine the prevalence and prevalence ratios of self-reported hypertension, diabetes, high cholesterol, physical inactivity, smoking, and overweight/obesity among Asian subgroups compared with US-born NHW adults. The study included 118 979 US-born NHW and 6029 Asian adults who self-identified as Chinese (29%), Asian Indian (33%), and Filipino (38%). Participants' mean (±SD) age was 49±0.1 years, and 53% were females. In an adjusted analysis, foreign-born Asian Indians had significantly higher prevalence of diabetes, physical inactivity, and overweight/obesity; foreign-born Chinese had higher prevalence of physical inactivity, and foreign-born Filipinos had higher prevalence of all 5 CVD risk factors except smoking compared with NHW adults. CONCLUSIONS: This study revealed significant heterogeneity in the prevalence of CVD risk factors among Asian subgroups by ethnicity and birthplace, stressing the necessity of disaggregating Asian subgroup data. Providers should consider this heterogeneity in CVD risk factors and establish tailored CVD prevention plans for Asian subgroups.

Palliative Care Research and Clinical Practice Priorities in the United States as Identified by an Interdisciplinary Modified Delphi Approach.

Background: Palliative care demands in the United States are growing amid a comparatively small workforce of palliative care clinicians and researchers. Therefore, determining research and clinical practice priorities is essential for streamlining initiatives to advance palliative care science and practice. Objectives: To identify and rank palliative care research and clinical practice priority areas through expert consensus. Design: Using a modified Delphi method, U.S. palliative care experts identified and ranked priority areas in palliative care research and clinical practice. Priorities were thematically grouped and analyzed for topic content and frequency; univariate analysis used the median of each priority item ranking, with a cutoff median of ≤8 indicating >76% agreement for an item's ranking. Results: In total, 27 interdisciplinary pediatric and adult palliative care experts representing 19 different academic institutions and medical centers participated in the preliminary survey and the first Delphi round, and 22 participated in the second Delphi round. The preliminary survey generated 78 initial topics, which were developed into 22 priority areas during the consensus meeting. The top five priorities were (1) access to palliative care, (2) equity in palliative care, (3) adequate financing of palliative care, (4) provision of palliative care in primary care settings, and (5) palliative care workforce challenges. Conclusions: These expert-identified priority areas provide guidance for researchers and practitioners to develop innovative models, policies, and interventions, thereby enriching the quality of life for those requiring palliative care services.

Multiethnic Perspectives of Shared Decision-Making in Hypertension: A Mixed-Methods Study.

BACKGROUND: Shared decision-making (SDM) has the potential to improve hypertension care quality and equity. However, research lacks diverse representation and evidence about how race and ethnicity affect SDM. Therefore, this study aims to explore SDM in the context of hypertension management. METHODS AND RESULTS: Explanatory sequential mixed-methods design was used. Quantitative data were sourced at baseline and 12-month follow up from RICH LIFE (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) participants (n=1212) with hypertension. Qualitative data were collected from semistructured individual interviews, at 12-month follow-up, with participants (n=36) selected based on their SDM scores and blood pressure outcome. Patients were cross- categorized based on high or low SDM scores and systolic blood pressure reduction of ≥10 or <10 mm Hg. Multinomial logistic regression analysis showed that predictors of SDM scores and blood pressure outcome were race and ethnicity (relative risk ratio [RRR], 1.64; P=0.029), age (RRR, 1.03; P=0.002), educational level (RRR, 1.87; P=0.016), patient activation (RRR, 0.98; P<0.001; RRR, 0.99; P=0.039), and hypertension knowledge (RRR, 2.2; P<0.001; and RRR, 1.57; P=0.045). Qualitative and mixed-methods findings highlight that provider-patient communication and relationship influenced SDM, being emphasized both as facilitators and barriers. Other facilitators were patients' understanding of hypertension; clinicians' interest in the patient, and clinicians' personality and attitudes; and barriers included perceived lack of compassion, relationship hierarchy, and time constraints. CONCLUSIONS: Participants with different SDM scores and blood pressure outcomes varied in determinants of decision and descriptions of contextual factors influencing SDM. Results provide actionable information, are novel, and expand our understanding of factors influencing SDM in hypertension.

Shared Decision-Making in Cardiovascular Risk Factor Management: A Systematic Review and Meta-Analysis.

Importance: The effect of shared decision-making (SDM) and the extent of its use in interventions to improve cardiovascular risk remain unclear. Objective: To assess the extent to which SDM is used in interventions aimed to enhance the management of cardiovascular risk factors and to explore the association of SDM with decisional outcomes, cardiovascular risk factors, and health behaviors. Data Sources: For this systematic review and meta-analysis, a literature search was conducted in the Medline, CINAHL, Embase, Cochrane, Web of Science, Scopus, and ClinicalTrials.gov databases for articles published from inception to June 24, 2022, without language restrictions. Study Selection: Randomized clinical trials (RCTs) comparing SDM-based interventions with standard of care for cardiovascular risk factor management were included. Data Extraction and Synthesis: The systematic search resulted in 9365 references. Duplicates were removed, and 2 independent reviewers screened the trials (title, abstract, and full text) and extracted data. Data were pooled using a random-effects model. The review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline. Main Outcomes and Measures: Decisional outcomes, cardiovascular risk factor outcomes, and health behavioral outcomes. Results: This review included 57 RCTs with 88 578 patients and 1341 clinicians. A total of 59 articles were included, as 2 RCTs were reported twice. Nearly half of the studies (29 [49.2%]) tested interventions that targeted both patients and clinicians, and an equal number (29 [49.2%]) exclusively focused on patients. More than half (32 [54.2%]) focused on diabetes management, and one-quarter focused on multiple cardiovascular risk factors (14 [23.7%]). Most studies (35 [59.3%]) assessed cardiovascular risk factors and health behaviors as well as decisional outcomes. The quality of studies reviewed was low to fair. The SDM intervention was associated with a decrease of 4.21 points (95% CI, -8.21 to -0.21) in Decisional Conflict Scale scores (9 trials; I2 = 85.6%) and a decrease of 0.20% (95% CI, -0.39% to -0.01%) in hemoglobin A1c (HbA1c) levels (18 trials; I2 = 84.2%). Conclusions and Relevance: In this systematic review and meta-analysis of the current state of research on SDM interventions for cardiovascular risk management, there was a slight reduction in decisional conflict and an improvement in HbA1c levels with substantial heterogeneity. High-quality studies are needed to inform the use of SDM to improve cardiovascular risk management.

Fear in general populations: A cross-sectional study on perceived fear of common diseases, COVID-19, life events, and environmental threats in 30 countries.

Background: In this study, we assessed the general population's fears towards various diseases and events, aiming to inform public health strategies that balance health-seeking behaviours. Methods: We surveyed adults from 30 countries across all World Health Organization (WHO) regions between July 2020 and August 2021. Participants rated their fear of 11 factors on an 11-point Likert scale. We stratified the data by age and gender and examined variations across countries and regions through multidimensional preference analysis. Results: Of the 16 512 adult participants, 62.7% (n = 10 351) were women. The most feared factor was the loss of family members, reported by 4232 participants (25.9%), followed by cancer (n = 2248, 13.7%) and stroke (n = 1416, 8.7%). The highest weighted fear scores were for loss of family members (mean (x̄) = 7.46, standard deviation (SD) = 3.04), cancer (x̄ = 7.00, SD = 3.09), and stroke (x̄ = 6.61, SD = 3.24). The least feared factors included animals/insects (x̄ = 3.72, SD = 2.96), loss of a mobile phone (x̄ = 4.27, SD = 2.98), and social isolation (x̄ = 4.83, SD = 3.13). Coronavirus disease 2019 (COVID-19) was the sixth most feared factor (x̄ = 6.23, SD = 2.92). Multidimensional preference analyses showed distinct fears of COVID-19 and job loss in Australia and Burundi. The other countries primarily feared loss of family members, cancer, stroke, and heart attacks; this ranking was consistent across WHO regions, economic levels, and COVID-19 severity levels. Conclusions: Fear of family loss can improve public health messaging, highlighting the need for bereavement support and the prevention of early death-causing diseases. Addressing cancer fears is crucial to encouraging the use of preventive services. Fear of non-communicable diseases remains high during health emergencies. Top fears require more resources and countries with similar concerns should collaborate internationally for effective fear management.

Key lifestyles and health outcomes across 16 prevalent chronic diseases: A network analysis of an international observational study.

Background: Central and bridge nodes can drive significant overall improvements within their respective networks. We aimed to identify them in 16 prevalent chronic diseases during the coronavirus disease 2019 (COVID-19) pandemic to guide effective intervention strategies and appropriate resource allocation for most significant holistic lifestyle and health improvements. Methods: We surveyed 16 512 adults from July 2020 to August 2021 in 30 territories. Participants self-reported their medical histories and the perceived impact of COVID-19 on 18 lifestyle factors and 13 health outcomes. For each disease subgroup, we generated lifestyle, health outcome, and bridge networks. Variables with the highest centrality indices in each were identified central or bridge. We validated these networks using nonparametric and case-dropping subset bootstrapping and confirmed central and bridge variables' significantly higher indices through a centrality difference test. Findings: Among the 48 networks, 44 were validated (all correlation-stability coefficients >0.25). Six central lifestyle factors were identified: less consumption of snacks (for the chronic disease: anxiety), less sugary drinks (cancer, gastric ulcer, hypertension, insomnia, and pre-diabetes), less smoking tobacco (chronic obstructive pulmonary disease), frequency of exercise (depression and fatty liver disease), duration of exercise (irritable bowel syndrome), and overall amount of exercise (autoimmune disease, diabetes, eczema, heart attack, and high cholesterol). Two central health outcomes emerged: less emotional distress (chronic obstructive pulmonary disease, eczema, fatty liver disease, gastric ulcer, heart attack, high cholesterol, hypertension, insomnia, and pre-diabetes) and quality of life (anxiety, autoimmune disease, cancer, depression, diabetes, and irritable bowel syndrome). Four bridge lifestyles were identified: consumption of fruits and vegetables (diabetes, high cholesterol, hypertension, and insomnia), less duration of sitting (eczema, fatty liver disease, and heart attack), frequency of exercise (autoimmune disease, depression, and heart attack), and overall amount of exercise (anxiety, gastric ulcer, and insomnia). The centrality difference test showed the central and bridge variables had significantly higher centrality indices than others in their networks (P < 0.05). Conclusion: To effectively manage chronic diseases during the COVID-19 pandemic, enhanced interventions and optimised resource allocation toward central lifestyle factors, health outcomes, and bridge lifestyles are paramount. The key variables shared across chronic diseases emphasise the importance of coordinated intervention strategies.

Study protocol for Care cOORDInatioN And sympTom managEment (COORDINATE) programme: a feasibility study.

INTRODUCTION: Sustainable approaches to support care coordination and symptom management needs of critically ill adults living with multimorbidity are needed to combat the challenges and complexity that multimorbidity presents. The study aims to test the feasibility of the Care cOORDInatioN And sympTom managEment (COORDINATE) intervention to improve health outcomes of adults living with multimorbidity. METHODS AND ANALYSIS: A multicomponent nurse-driven intervention was developed using experience-based co-design and human-centred design. Inclusion criteria include (1) age 55 years and older, (2) admitted to an intermediate care unit, (3) presence of two or more chronic health conditions and (4) signed informed consent. Data collection will occur at baseline (time of recruitment predischarge) and 6 weeks and 3 months following hospital discharge. Outcome of interest from this feasibility study is to evaluate the financial, technical and logistic feasibility of a full-scale study including data collection and protocol adherence. Additionally, Cohen's d effect sizes for the change in outcomes over time will be computed to establish power calculations required for a full-scale study. The protocol was prepared in accordance with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. ETHICS AND DISSEMINATION: The study has been reviewed and approved by the Institutional Review Board of Johns Hopkins Medical Institutions. Given the success of this feasibility study, the potential for the COORDINATE intervention to decrease the symptom burden and improve participant quality of life among critically ill people with multimorbidity will be tested in a full-scale study, and findings will be actively disseminated. TRIAL REGISTRATION NUMBER: NCT05985044.