Patient Satisfaction with Private Community Pharmacies versus Pharmacies in Primary Health Care Centers in Saudi Arabia.

Introduction: Saudi Arabia has begun reforming its government-run health care system to increase efficiency and reduce costs. One effort is the adoption of an electronic prescribing system (Wasfaty) and outsourcing pharmaceutical services from government-run clinics to community pharmacies (CP). This study aims to compare satisfaction with pharmaceutical services offered in the two systems. Materials and methods: This cross-sectional observational study used existing survey data collected from patients (≥15 years of age) visiting government primary health care centers from January 2022 to June 2022. Satisfaction with three pharmaceutical services (availability of medications, pharmacist's explanation of the prescription, and waiting time to get medications) were the main outcomes. Results: The study comprised 91,317 participants, 74.06 % of them were CP/Wasfaty users. CP/Wasfaty patients had lower odds of satisfaction with the three pharmaceutical services: availability of medications (OR = 0.49, 95 % CI = 0.47-0.51), pharmacists' explanation of prescription (OR = 0.55, 95 % CI = 0.53-0.58), and waiting time to get medications (OR = 0.81, 95 % CI = 0.75-0.88). Additional findings showed variations in satisfaction levels based on demographic factors and clinic types. Conclusions: The significant differences observed in satisfaction levels based on demographic characteristics and type of clinics visited emphasize the importance of tailoring pharmaceutical services to meet the specific needs and expectations of different patient populations.

Non-use and inadequate use of cervical cancer screening among a representative sample of women in the United States.

Introduction: Women's adherence to the United States (U.S.) Preventive Services Task Force guidelines for cervical cancer screening was determined by examining predisposing, enabling, and needs factors from Andersen's Behavioral Model of Health Services Use conceptual framework. Methods: The outcome was operationalized as cervical cancer screening use, non-use, and inadequate-use. Multinomial logistic regression was conducted on data from the 2019 National Health Interview Survey of 7,331 eligible women aged 21-65. Results: Compared with women who used cervical cancer screening services, women aged 30-65 were less likely to be Non-Users than those aged 21-29. Hispanic, Asian, and American Indian/Alaska Native (AIAN) women were more likely to be Non-Users than White women. More educated women were less likely to be Non-Users. Foreign-born women <10 years in the U.S. were more likely to be Non-Users than U.S.-born women. Women with financial hardship were less likely to be Non-Users. Poorer women and uninsured women were more likely to be Non-Users. Women with children in their household were less likely to be Non-Users than those without children. Women who had a well-visit in the past year were less likely to be Non-Users. Women with a history of human papillomavirus (HPV) vaccination were less likely to be Non-Users. Compared with women who used cervical cancer screening services, women aged 30-65 were less likely to be Inadequate-Users. AIAN women were more likely to be Inadequate-Users. Women of other races were less likely to be Inadequate-Users. Employed women were less likely to be Inadequate-Users. Uninsured women were more likely to be Inadequate-Users. Women who had a well-visit within a year were less likely to be Inadequate-Users. Women with past HPV vaccination were more likely to be Inadequate-Users. Smokers were less likely to be Inadequate-Users. Discussion: Predisposing, enabling, and needs factors are differently associated with non-use and inadequate use of cervical cancer screening. Understanding factors associated with the use, non-use, and inadequate use of cervical cancer screening is crucial to avoid or curb unnecessary tests, increased costs to both society and individuals, and the ill-allocation of limited resources.

Type 2 diabetes and health-related quality of life among older Medicare beneficiaries: The mediating role of sleep.

OBJECTIVE: To examine mediating effects of sleep quality and duration on the association between T2D and QoL among Medicare beneficiaries 65+. METHODS: Data from the Medicare Health Outcome Survey (2015-2020) were used. The outcome was QoL (physical and mental health component-summary scores [PCS and MCS]) measured by the Veterans-Rand-12. The main predictor was diagnosed T2D. Mediators were sleep duration and sleep quality. The effect modifier was race/ethnicity. Structural Equation Modeling was used to estimate moderated-mediating effects of sleep quality and duration across race/ethnicity. RESULTS: Of the 746,400 Medicare beneficiaries, 26.7% had T2D, and mean age was 76 years (SD ± 6.9). Mean PCS score was 40 (SD ± 12.2), and mean MCS score was 54.0 (SD ± 10.2). Associations of T2D with PCS and MCS were negative and significant. For all racial/ethnic groups, those with T2D reported lower PCS. For White, Black, Asian, and Hispanic beneficiaries only, those with T2D reported lower MCS. The negative impact of T2D on PCS and MCS was mediated through sleep quality, especially very bad sleep quality. CONCLUSION: Improving sleep may lead to improvement in QoL in elderly adults with T2D.

Healthy food delivery for type 2 diabetes management in rural clinics' patients: A comparative effectiveness randomized controlled trial protocol.

BACKGROUND: Rural populations experience a higher prevalence of both food insecurity and type 2 diabetes mellitus (T2DM) than metropolitan populations and face many challenges in accessing resources essential to optimal T2DM self-management. This study aims to address these challenges by delivering a T2DM-appropriate food box and recipes directly to rural participants' homes. METHODS: This is a comparative effectiveness randomized controlled trial including 400 English- or Spanish-speaking rural adult participants with T2DM (HbA1c ≥6.5%) experiencing food insecurity. Participants are randomly assigned to a 3-month Healthy Food Delivery Intervention (HFDI) plus one 60-min virtual consultation with a diabetes educator or consultation only. The HFDI includes a weekly food box delivery with recipes. Data are collected at pre-intervention, 3-months (post-intervention), 9-months, and 15-months. The primary outcome is change in HbA1c, with secondary measures including diet quality (Healthy Eating Index-2015, calculated from one 24-h dietary recall at each data collection time point), cardio-metabolic risk factors (i.e., blood pressure, lipids, body mass index, glucose), and patient-centered outcomes (e.g., T2DM self-efficacy, T2DM-related distress). Process evaluation data (e.g., successful food box deliveries, diabetes educator consultation attendance, intervention satisfaction) are collected during and post-intervention (3-months). A cost-effectiveness analysis based on traditional cost per quality-adjusted life year gain thresholds will be conducted to estimate the incremental cost-effectiveness between HFDI plus consultation and consultation alone. CONCLUSION: Findings from this study will provide evidence regarding the effectiveness of an intervention that promotes participant adherence and improves access to healthy food. CLINICAL TRIAL REGISTRATION: NCT04876053.

Identifying the process and agency characteristics associated with poor utilization outcomes in home healthcare.

This study identified the process and agency characteristics associated with poor utilization outcomes - higher percentages of patients (i) admitted to an acute care organization and (ii) visited an emergency room (ER) unplanned without hospitalization - for home health agencies (HHAs) in the United States. We conducted a secondary analysis of data about HHAs' various characteristics, process adherence levels, and utilization outcomes collected from disparate public repositories for 2010-2022. We developed descriptive tree-based models using HHAs' hospital admission or ER visit percentages as response variables. Across the board, hospital admission percentages have steadily improved while ER percentages deteriorated for an extended period. Recently, checking for fall risks and depression was associated with improved outcomes for urban agencies. In general, rural HHAs had worse utilization outcomes than urban HHAs. Targeted investments and improvement initiatives can help rural HHAs close the urban-rural gap in the future.

Association Between Physical Activity and Physical Function in a Marshallese Population with Type 2 Diabetes.

Physical activity can delay functional decline in people with type 2 diabetes (T2D), but these associations have not been studied within a sample of Native Hawaiian or Pacific Islander adults with T2D. Using data from a randomized control trial in which 218 Marshallese adults with T2D participated in a 10-week diabetes self-management education intervention, this study tested our hypothesis that physical activity would predict physical function when controlling for time and other variables. Levels of physical activity were positively associated with levels of physical function, even after controlling for time and other covariates. These findings provide a more robust understanding of the relationship between physical activity and physical function in a sample of minority adults with T2D. Future studies should further explore levels of physical activity needed to maintain and improve physical function so that culturally appropriate physical activity interventions can be developed.

Assessment of diabetes self-care behaviors and knowledge among Marshallese adults with type 2 diabetes in the Republic of the Marshall Islands.

AIMS: The aim of this study is to assess and document engagement in type 2 diabetes mellitus (T2DM) self-care behaviors and self-reported diabetes knowledge among Marshallese adults living in the Republic of the Marshall Islands (RMI). METHODS: The study uses data from a T2DM health screening study completed in the RMI; survey and biometric data were captured as part of the health screenings. Study objectives were examined using descriptive statistics to describe the characteristics of the participants, their diabetes self-care behaviors, and their levels of self-reported diabetes knowledge. RESULTS: Results indicate many Marshallese diagnosed with T2DM did not engage in adequate self-care behaviors, including blood sugar checks and foot examinations. Participants reported having forgone needed medical care and medication due to issues with cost and/or access, and participants reported low levels of diabetes knowledge. CONCLUSIONS: The results demonstrate the need for further work in improving engagement in diabetes self-care by Marshallese living in the RMI. Increased engagement in self-care and diabetes education programs may help Marshallese with T2DM to improve control of their glucose and avoid long-term health complications, as well as reduce costs to the healthcare system.

Determinants of periodic health examination uptake among adults in Al-Jouf Region, Saudi Arabia.

BACKGROUND: Periodic Health Examinations (PHEs) typically occur annually and provide an important opportunity for providers to screen their patients for undiagnosed health conditions and monitor existing conditions, such as diabetes and hypertension. Unfortunately, PHEs are reported to be low in Saudi Arabia. This study's aim was to assess the regular uptake of PHEs by adults residing in Al-Jouf region, Saudi Arabia. MATERIALS AND METHODS: A cross-sectional survey was conducted among adults (aged ≥ 20 years) residing in five communities in the Al-Jouf Region on sociodemographic characteristics, self-reported chronic conditions, knowledge of PHEs, and their regular uptake. Chi-square tests and multivariate logistic regression analysis were performed to determine the factors associated with regular uptake of PHEs. RESULTS: A total of 624 participants completed the survey questionnaire. Of the participants, 27.7% reported a regular uptake of PHEs. The odds of regular uptake of PHEs were higher among older respondents (odds ratio [OR] =1.98; P = 0.002), those who reported that they had diabetes (OR = 3.25; P < 0.001), hypertension (OR = 4.11; P = 0.001), hyperlipidemia (OR = 2.66; P = 0.003), and those with a higher PHEs knowledge score (OR = 1.35; P < 0.001). However, the odds regular uptake of PHEs among respondents residing in the three governorates and Skaka city were significantly lower (OR = 0.27; P = 0.001 and OR = 0.30; P = 0.002, respectively) than their counterparts. CONCLUSION: Low rates of PHEs uptake were observed among the survey participants in the Al-Jouf Region of Saudi Arabia. The characteristics of individuals associated with low uptake of PHEs were identified. Tailored interventions, such as the use of community health workers and clinic communications, could target these individuals to increase the uptake of PHEs.

Health Profiles of Marshallese With and Without a Type 2 Diabetes Diagnosis in the Republic of the Marshall Islands.

Background: The Republic of the Marshall Islands (RMI) faces a high prevalence of type 2 diabetes (T2DM). Objectives: The aim of the study is to document the health of Marshallese with and without a T2DM diagnosis to inform future interventions. Design: Data are from screenings collected in preparation for a diabetes education intervention. Data, including HbA1c, random glucose, cholesterol, weight, and self-rated health, were collected. Methods: Kruskal-Wallis and Fisher's exact tests were used to identify differences in participants with and without T2DM diagnosis. Results: There were significant differences in both HbA1c level (P ⩽ .0001) and glucose level (P ⩽ .0001) between the diagnosed T2DM and non-diagnosed T2DM groups, as well as diastolic blood pressure (P = .0179), systolic blood pressure (P = .0003), and pulse pressure (P = .0023). There were no differences in weight, body mass index (BMI), high density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol, or self-rated health. Marshallese without a T2DM diagnosis have signs of insulin resistance, including elevated glucose and triglyceride levels. Conclusion: The results indicate a need for a socioecological approach to T2DM interventions, and interventions in the RMI should consider inclusion of blood pressure and cholesterol management. There is a need for interventions to prevent prediabetes and its progression to T2DM.

Characteristics of nursing homes with high percentages of falls and falls with injuries among residents with obesity.

BACKGROUND: Obesity among United States nursing home (NH) residents is increasing. These residents have special care needs, which increases their risk for falls and falls with injuries. NH are responsible for ensuring the health of their residents, including minimizing falls. However, given the special care needs of residents with obesity, different factors may be important for developing programs to minimize falls among this group. AIM: We aimed to identify NH characteristics associated with falls and falls with injuries among residents with obesity. METHOD: We used resident assessment data and logistic regression analysis. RESULTS: We found that rates of falls and falls with injuries among residents with obesity varied significantly based on for-profit status, size, acuity index, obesity rate among residents, and registered nurse hours per patient day. CONCLUSION: Recommendations are made as to how NH may be able to lower risk for falls and falls with injuries among their residents with obesity.

Low uptake of seasonal influenza vaccination in Al-Jouf region of Saudi Arabia.

Introduction: Seasonal influenza is a contagious viral respiratory condition typically occurring in the fall to early spring months of the year globally. The risk of infection from seasonal influenza can be greatly reduced with vaccination. Unfortunately, research has indicated that the seasonal influenza vaccination rate in Saudi Arabia is low. This study assessed the uptake of seasonal influenza vaccination among adults residing in Al-Jouf region, Saudi Arabia. Materials and Methods: A cross-sectional survey targeting adults (20-80 years) residing in Al-Jouf region, Saudi Arabia, was conducted to gather information about their sociodemographic characteristics, chronic conditions, knowledge about periodic health examinations (PHE), regular use of PHE, and uptake of seasonal influenza vaccination. Comparative statistics and a multivariate logistic regression analysis were conducted to determine characteristics associated with the uptake of seasonal influenza vaccination. Results: A total of 624 respondents completed the survey and participated in this study. Among the participants, 27.4% indicated they visited their primary healthcare centers or hospitals every year to get a seasonal influenza vaccination. The regression analysis showed that the odds of getting a seasonal influenza vaccination were higher among employed respondents (Odds Ratio [OR] = 1.73; P = 0.039), respondents who were employees of the healthcare sector (OR = 2.31; P = 0.001), and those with a higher PHE Knowledge Score (OR = 1.22; P = 0.008), compared to their counterparts. Conclusions: Seasonal influenza is a serious condition warranting appropriate prevention measures, including vaccination. However, this study confirmed low rates of seasonal influenza vaccination in Al-Jouf Region of Saudi Arabia. Interventions to boost vaccination uptake, in particular among unemployed individuals, those not working in the healthcare sector, and those with lower PHE knowledge Scores, are therefore recommended.

Factors associated with breast cancer screening services use among women in the United States: An application of the Andersen's Behavioral Model of Health Services Use.

This study applied Andersen's Behavioral Model of Health Services Use to examine predisposing, enabling, and need factors associated with adherence to the United States Preventive Services Task Force (USPSTF) guidelines for breast cancer screening (BCS). Multivariable logistic regression was used to determine factors of BCS services utilization among 5484 women aged 50-74 from the 2019 National Health Interview Survey. Predisposing factors significantly associated with use of BCS services were: being a Black (odds-ratios [OR]:1.49; 95% confidence interval [CI]:1.14-1.95) or a Hispanic woman (OR:2.25; CI:1.62-3.12); being married/partnered (OR:1.32, CI:1.12-1.55); having more than a bachelor's degree (OR: 1.62; CI:1.14-2.30); and living in rural areas (OR:0.72; CI:0.59-0.92). Enabling factors were: poverty level [≤138% federal poverty level (FPL) (OR:0.74; CI:0.56-0.97), >138-250% FPL (OR:0.77; CI:0.61-0.97), and > 250-400% FPL (OR:0.77; CI:0.63-0.94)]; being uninsured (OR:0.29; CI:0.21-0.40); having a usual source of care at a physician office (OR:7.27; CI:4.99-10.57) or other healthcare facilities (OR:4.12; CI:2.68-6.33); and previous breast examination by a healthcare professional (OR:2.10; CI:1.68-2.64). Need factors were: having fair/poor health (OR:0.76; CI:0.59-0.97) and being underweight (OR:0.46; CI:0.30-0.71). Disparities in BCS services utilization by Black and Hispanic women have been reduced. Disparities still exist for uninsured and financially restrained women living in rural areas. Addressing disparities in BCS uptake and improving adherence to USPSTF guidelines may require revamping policies that address disparities in enabling resources, such as health insurance, income, and health care access.

An integrated approach to address diabetes in the context of food insecurity: Delivering health study protocol.

Background: Diabetes self-management education and support (DSMES) interventions among food insecure individuals with type 2 diabetes (T2D) have found modest improvements in nutrition and health outcomes but are limited by barriers to attendance and retention. This study applies a community-based participatory research approach, engaging community members at all levels of intervention planning, development, implementation, and dissemination, to deliver a plain-language DSMES curriculum to food insecure community members with T2D. Methods: This is a single-arm, pre-post design assessing the efficacy of a 12-week home-delivered DSMES curriculum and T2D-appropriate food box intervention to improve the nutrition and health outcomes of food insecure individuals with T2D. The intervention consists of a weekly food box delivery and handout with video links on key DSMES topics, developed and refined using community advisor feedback. Up to 100 English-, Spanish-, or Marshallese-speaking adult participants with T2D (HbA1c ≥ 7%) and food insecurity are being recruited from food pantries in northwest Arkansas. Data is collected at pre-intervention and immediately post-intervention. The primary study outcome is change in HbA1c. Secondary measures include diet quality (Healthy Eating Index-2015, calculated from 3 24-h dietary recall interviews via phone), body mass index, blood pressure, skin carotenoids, food security, T2D self-management behaviors, T2D self-efficacy, and T2D-related distress. Results: Recruitment began in August 2021 and enrollment is anticipated to be complete in March 2023. Conclusion: Findings from this study will provide a rich understanding of diabetes-related health outcomes and dietary patterns of individuals with food insecurity and T2D and inform future food-focused DSMES interventions in this setting.

A Cluster Randomized Controlled Trial Comparing Diabetes Prevention Program Interventions for Overweight/Obese Marshallese Adults.

This study compared the effectiveness of two Diabetes Prevention Program (DPP) interventions on weight loss among overweight and obese Marshallese adults. The study was a two-arm cluster randomized controlled trial conducted in 30 churches in Arkansas and Oklahoma. Marshallese adults with a body mass index ≥25 kg/m2 were eligible for the study. The study sample included 380 participants. Participants received either a faith-based adaptation of the DPP or a family-focused adaptation of the DPP, each delivered over 24 weeks. The primary outcome was weight change from baseline. Secondary outcomes included changes in Hemoglobin A1c, blood pressure, dietary intake, family support for healthy behaviors, and physical activity. Outcomes were examined longitudinally using general linear mixed effects regression models, adjusting for baseline outcomes, sociodemographic covariates, and clustering of participants within churches. Reductions in weight were small for both groups. Overall, only 7.1% of all participants lost 5% or more of their baseline body weight. There were no significant differences in weight loss between the 2 arms at 6 months (P = .3599) or at 12 months (P = .3207). Significant differences in systolic and diastolic blood pressure were found between the 2 arms at 6 months (P = .0293; P = .0068, respectively). Significant within-arm changes were found for sugar-sweetened beverage consumption and family support for both arms at both follow-ups. Both interventions achieved a modest weight loss. While even modest weight loss can be clinically significant, future research is needed to identify chronic disease prevention interventions that can successfully reduce weight for this at-risk population.

Characteristics Associated with Knowledge about Periodic Health Examinations among Adults in Al-Jouf Region, KSA.

Objectives: A lack of knowledge is one of the key barriers that hinders the use of Periodic Health Examinations (PHEs). This study aimed to investigate the knowledge of PHE among adults residing in Al-Jouf region, KSA, and determine characteristics associated with such knowledge. Methods: A cross-sectional survey targeting adults (≥18 years) residing in Al-Jouf region, KSA, was conducted to gather information relating to their sociodemographic characteristics, needs for healthcare, and knowledge about and practices toward PHE. Comparative statistics and multivariate linear regression analysis were conducted to determine the key characteristics associated with knowledge about PHE. Results: A total of 624 respondents completed the survey and participated in this study. Among the participants, the mean PHE knowledge score was 5.26 (SD = 0.05) with a range of 0-7. Regression analysis showed that the PHE knowledge score was significantly higher among females, respondents with a college degree, and those worked in the healthcare field when compared to their counterparts. Conclusion: Analysis revealed a relatively high overall knowledge score for PHE among surveyed adults in KSA although knowledge score varied in males, those with lower educational levels and those who did not work in the healthcare field; these cohorts were significantly less knowledgeable about PHE than their peers even after controlling for other characteristics that may affect knowledge levels. Research to address knowledge of other health topics and health behaviors, including the utilization of health services, may provide guidance to those in KSA to improve the knowledge and use of PHE overall and within specific groups.

Characteristics of United States nursing homes with high percentages of stage 2-4 pressure injuries among high-risk nursing home residents with obesity.

Obesity rates in nursing homes (NHs) are increasing. Residents with obesity are at risk for poor outcomes such as pressure injuries (PIs) due to special care needs such as bariatric medical equipment and special protocols for skin care. PIs among resident populations is a sign of poor quality NH care. The purpose of this retrospective observational study was to identify characteristics of NHs with high rates of stage 2-4 PIs among their high-risk residents with obesity. Resident assessment data were aggregated to the NH level. NH structure and process of care and antecedent conditions of the residents and environment measures were used in bivariate comparisons and multivariate logistic regression models to identify associations with NHs having high rates of stage 2-4 PIs among high-risk residents with obesity. We identified three characteristics for which the effect on the odds was at least 10% for clinical significance - for-profit status, large facilities, and the hours of certified nursing assistants (CNAs) per patient day (HRPPD). This study identified several NH characteristics that are associated with higher risk for PIs, which can be targeted with evidence-based interventions to reduce the risk of these adverse safety events occurring.

Characteristics of Nursing Homes with High Rates of Urinary Tract Infections among Their Residents with Obesity.

Nursing home residents with obesity are at high risk for contracting urinary tract infections. In this research study, we found nursing homes in multi-facility chain organizations, for-profit status, nursing home size, obesity rate of resident population, and market competition were significantly associated with rates of urinary tract infections among residents with obesity.

Assessment of Colorectal Cancer Screening Disparities in U.S. Men and Women Using a Demographically Representative Sample.

Timely receipt of colorectal cancer (CRC) screening can reduce morbidity and mortality. This is the first known study to adopt Andersen's model of health services use to identify factors associated with CRC screening among US adults. The data from National Health Interview Survey from 2019 was utilized to conduct the analyses. Multivariable logistic regression was used to separately analyze data from 7,503 age-eligible women and 6,486 age-eligible men. We found similar CRC screening levels among men (57.7%) and women (57.6%). Factors associated with higher screening odds in women were older age, married/cohabitating with a partner, Black race, >bachelor's degree, having a usual source of care, and personal cancer history. Factors associated with lower odds for women were American Indian/Alaska Native race, living in the US for ≤10 years, ≤138% federal poverty level (FPL), uninsured or having Medicare, and in fair/poor health. For men, factors associated with higher screening odds were older age, homosexuality, married/cohabitating with a partner, Black race, >high school/general educational development education, having military insurance, having a usual source of care, and personal cancer history. Factors associated with lower odds for men were being a foreign-born US resident, living in the South or Midwest, ≤138% FPL, and being uninsured or having other insurance. Despite lower screening rates in the past, Black adults show a significantly higher likelihood of CRC screening than White adults; yet, screening disparities remain in certain other groups. CRC screening efforts should continue to target groups with lower screening rates to eliminate screening disparities.

Study protocol for family model diabetes self-management education with Marshallese participants in faith-based organizations.

Background: Culturally-appropriate family models of diabetes self-management education and support (DSMES) using community health workers (CHWs) have been shown to help address barriers to improving type 2 diabetes mellitus (T2DM) self-management for racial/ethnic minority communities; however, there is limited DSMES research among Marshallese and other Pacific Islanders. Using a community-based participatory research approach, we engaged community stakeholders to co-design a study to implement a culturally adapted family model DSMES (F-DSMES) intervention in faith-based organizations (FBOs) (i.e., churches). Methods: Using a cluster-randomized controlled trial design, we will assess the effectiveness of the F-DSMES intervention for Marshallese patients with T2DM in Arkansas and Oklahoma. Twenty-four FBOs (with 12 primary participants per FBO) will be randomized to one of two study arms: the intervention arm or the wait-list control arm. Primary participants must have at least one family member willing to attend education sessions and data collection events. The F-DSMES intervention consists of ten h of diabetes education delivered by CHWs over eight to ten weeks. Data will be collected from the intervention arm at pre-intervention (baseline), immediate post-intervention (12 weeks), and three months post-intervention. The wait-list control arm will complete a second pre-intervention data collection before receiving the intervention. The primary study outcome will be glycemic control, as measured by HbA1c. Secondary measures include glucose, weight, body mass index, blood pressure, diabetes self-management behaviors, and diabetes management self-efficacy. Conclusion: The knowledge gained from this research will inform future DSMES and other health promotion interventions conducted with Marshallese and other Pacific Islander communities.

Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model.

BACKGROUND: Diabetes self-management education and support (DSMES) is an effective approach for improving diabetes self-care behaviors to achieve improved glycemic management and other health outcomes. Engaging family members may improve outcomes, both for the person with diabetes (PWD) and for the family members. However, family models of DSMES have been inconsistently defined and delivered. We operationalize Family-DSMES to be generalizable and replicable, detail our protocol for a comparative effectiveness trial comparing Standard-DSMES with Family-DSMES on outcomes for PWDs and family members, and detail our mixed-methods implementation evaluation plan. METHODS: We will examine Family-DSMES relative to Standard-DSMES using a Hybrid Type 1 effectiveness-implementation design. Participants are ≥18 years old with type 2 diabetes mellitus and hemoglobin A1c ≥7.0%, recruited from rural and urban primary care clinics that are part of an academic medical center. Each participant invites a family member. Dyads are randomly assigned to Family- or Standard-DSMES, delivered in a small-group format via telehealth. Data are collected at baseline, immediately post-intervention, and 6-, 12-, and 18-months post-intervention. Outcomes include PWDs' hemoglobin A1c (primary), other biometric, behavioral, and psychosocial outcomes (secondary), and family members' diabetes-related distress, involvement in the PWD's diabetes management, self-efficacy for providing support, and biometric outcomes (exploratory). Our mixed-methods implementation evaluation will include process data collected during the trial and stakeholder interviews guided by the Consolidated Framework for Implementation Research. CONCLUSION: Results will fill knowledge gaps about which type of DSMES may be most effective and guide Family-DSMES implementation efforts. REGISTRATION: The trial is pre-registered at clinicaltrials.gov (#NCT04334109).