Primary Occurrence of Cardiovascular Events After Adding Sodium-Glucose Cotransporter-2 Inhibitors or Glucagon-like Peptide-1 Receptor Agonists Compared With Dipeptidyl Peptidase-4 Inhibitors: A Cohort Study in Veterans With Diabetes.

BACKGROUND: The effectiveness of glucagon-like peptide-1 receptor agonists (GLP1RA) and sodium-glucose cotransporter-2 inhibitors (SGLT2i) in preventing major adverse cardiac events (MACE) is uncertain for those without preexisting cardiovascular disease. OBJECTIVE: To test the hypothesis that MACE incidence was lower with the addition of GLP1RA or SGLT2i compared with dipeptidyl peptidase-4 inhibitors (DPP4i) for primary cardiovascular prevention. DESIGN: Retrospective cohort study of U.S. veterans from 2001 to 2019. SETTING: Veterans aged 18 years or older receiving care from the Veterans Health Administration, with data linkage to Medicare, Medicaid, and the National Death Index. PATIENTS: Veterans adding GLP1RA, SGLT2i, or DPP4i onto metformin, sulfonylurea, or insulin treatment alone or in combination. Episodes were stratified by history of cardiovascular disease. MEASUREMENTS: Study outcomes were MACE (acute myocardial infarction, stroke, or cardiovascular death) and heart failure (HF) hospitalization. Cox models compared the outcome between medication groups using pairwise comparisons in a weighted cohort adjusted for covariates. RESULTS: The cohort included 28 759 GLP1RA versus 28 628 DPP4i weighted pairs and 21 200 SGLT2i versus 21 170 DPP4i weighted pairs. Median age was 67 years, and diabetes duration was 8.5 years. Glucagon-like peptide-1 receptor agonists were associated with lower MACE and HF versus DPP4i (adjusted hazard ratio [aHR], 0.82 [95% CI, 0.72 to 0.94]), yielding an adjusted risk difference (aRD) of 3.2 events (CI, 1.1 to 5.0) per 1000 person-years. Sodium-glucose cotransporter-2 inhibitors were not associated with MACE and HF (aHR, 0.91 [CI, 0.78 to 1.08]; aRD, 1.28 [-1.12 to 3.32]) compared with DPP4i. LIMITATION: Residual confounding; use of DPP4i, GLP1RA, and SGLT2i as first-line therapies were not examined. CONCLUSION: The addition of GLP1RA was associated with primary reductions of MACE and HF hospitalization compared with DPP4i use; SGLT2i addition was not associated with primary MACE prevention. PRIMARY FUNDING SOURCE: VA Clinical Science Research and Development and supported in part by the Centers for Diabetes Translation Research.

Mixed-Methods Randomized Evaluation of FAMS: A Mobile Phone-Delivered Intervention to Improve Family/Friend Involvement in Adults' Type 2 Diabetes Self-Care.

BACKGROUND: Family and friends have both helpful and harmful effects on adults' diabetes self-management. Family-focused Add-on to Motivate Self-care (FAMS) is a mobile phone-delivered intervention designed to improve family/friend involvement, self-efficacy, and self-care via monthly phone coaching, texts tailored to goals, and the option to invite a support person to receive texts. PURPOSE: We sought to evaluate how FAMS was received by a diverse group of adults with Type 2 diabetes and if FAMS improved diabetes-specific family/friend involvement (increased helpful and reduced harmful), diabetes self-efficacy, and self-care (diet and physical activity). We also assessed if improvements in family/friend involvement mediated improvements in self-efficacy and self-care. METHODS: Participants were prospectively assigned to enhanced treatment as usual (control), an individualized text messaging intervention alone, or the individualized text messaging intervention plus FAMS for 6 months. Participants completed surveys at baseline, 3 and 6 months, and postintervention interviews. Between-group and multiple mediator analyses followed intention-to-treat principles. RESULTS: Retention, engagement, and fidelity were high. FAMS was well received and helped participants realize the value of involving family/friends in their care. Relative to control, FAMS participants had improved family/friend involvement, self-efficacy, and diet (but not physical activity) at 3 and 6 months (all ps < .05). Improvements in family/friend involvement mediated effects on self-efficacy and diet for FAMS participants but not for the individualized intervention group. CONCLUSIONS: The promise of effectively engaging patients' family and friends lies in sustained long-term behavior change. This work represents a first step toward this goal by demonstrating how content targeting helpful and harmful family/friend involvement can drive short-term effects. TRIAL REGISTRATION NUMBER: NCT02481596.

Self-Care Disparities Among Adults with Type 2 Diabetes in the USA.

Suboptimal glycemic control is more common among non-Hispanic Blacks (NHBs) and Hispanics than non-Hispanic Whites (NHWs). Disparities in the performance of self-care behaviors may contribute to this. To synthesize knowledge on current self-care disparities, we reviewed studies from January 2011-March 2016 that included NHWs, NHBs, and Hispanics with type 2 diabetes in the USA. Self-care behaviors included diet, exercise, medications, self-monitoring of blood glucose (SMBG), self-foot exams, and not smoking. Of 1241 articles identified in PubMed, 25 met our inclusion criteria. These studies report consistent disparities in medication adherence. Surprisingly, we found consistent evidence of no disparities in exercise and some evidence of reverse disparities: compared to NHWs, Hispanics had healthier diets and NHBs had more regular SMBG. Consistent use of validated measures could further inform disparities in diet and exercise. Additional research is needed to test for disparities in self-foot exams, not smoking, and diabetes-specific problem solving and coping.

Association between intensification of metformin treatment with insulin vs sulfonylureas and cardiovascular events and all-cause mortality among patients with diabetes.

IMPORTANCE: Preferred second-line medication for diabetes treatment after metformin failure remains uncertain. OBJECTIVE: To compare time to acute myocardial infarction (AMI), stroke, or death in a cohort of metformin initiators who added insulin or a sulfonylurea. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort constructed with national Veterans Health Administration, Medicare, and National Death Index databases. The study population comprised veterans initially treated with metformin from 2001 through 2008 who subsequently added either insulin or sulfonylurea. Propensity score matching on characteristics was performed, matching each participant who added insulin to 5 who added a sulfonylurea. Patients were followed through September 2011 for primary analyses or September 2009 for cause-of-death analyses. MAIN OUTCOMES AND MEASURES: Risk of a composite outcome of AMI, stroke hospitalization, or all-cause death was compared between therapies with marginal structural Cox proportional hazard models adjusting for baseline and time-varying demographics, medications, cholesterol level, hemoglobin A1c level, creatinine level, blood pressure, body mass index, and comorbidities. RESULTS: Among 178,341 metformin monotherapy patients, 2948 added insulin and 39,990 added a sulfonylurea. Propensity score matching yielded 2436 metformin + insulin and 12,180 metformin + sulfonylurea patients. At intensification, patients had received metformin for a median of 14 months (IQR, 5-30), and hemoglobin A1c level was 8.1% (IQR, 7.2%-9.9%). Median follow-up after intensification was 14 months (IQR, 6-29 months). There were 172 vs 634 events for the primary outcome among patients who added insulin vs sulfonylureas, respectively (42.7 vs 32.8 events per 1000 person-years; adjusted hazard ratio [aHR], 1.30; 95% CI, 1.07-1.58; P = .009). Acute myocardial infarction and stroke rates were statistically similar, 41 vs 229 events (10.2 and 11.9 events per 1000 person-years; aHR, 0.88; 95% CI, 0.59-1.30; P = .52), whereas all-cause death rates were 137 vs 444 events, respectively (33.7 and 22.7 events per 1000 person-years; aHR, 1.44; 95% CI, 1.15-1.79; P = .001). There were 54 vs 258 secondary outcomes: AMI, stroke hospitalizations, or cardiovascular deaths (22.8 vs 22.5 events per 1000 person-years; aHR, 0.98; 95% CI, 0.71-1.34; P = .87). CONCLUSIONS AND RELEVANCE: Among patients with diabetes who were receiving metformin, the addition of insulin vs a sulfonylurea was associated with an increased risk of a composite of nonfatal cardiovascular outcomes and all-cause mortality. These findings require further investigation to understand risks associated with insulin use in these patients.

Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: Protocol for a Pragmatic Randomized Controlled Trial.

BACKGROUND: Despite the potential to significantly reduce complications, many patients do not consistently receive diabetes preventive care. Our research team recently applied user-centered design sprint methodology to develop a patient portal intervention empowering patients to address selected diabetes care gaps (eg, no diabetes eye examination in last 12 months). OBJECTIVE: This study aims to evaluate the effect of our novel diabetes care gap intervention on completion of selected evidence-based diabetes preventive care services and secondary outcomes. METHODS: We are conducting a pragmatic randomized controlled trial of the effect of the intervention on diabetes care gaps. Adult patients with diabetes mellitus (DM) are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible if they have type 1 or 2 DM, can read in English, are aged 18-75 years, have a current patient portal account, and have reliable access to a mobile device with internet access. We exclude patients with medical conditions that prevent them from using a mobile device, severe difficulty seeing, pregnant women or women who plan to become pregnant during the study period, and patients on dialysis. Participants will be randomly assigned to the intervention or usual care. The primary outcome measure will be the number of diabetes care gaps among 4 DM preventive care services (diabetes eye examination, pneumococcal vaccination, hemoglobin A1c, and urine microalbumin) at 12 months after randomization. Secondary outcomes will include diabetes self-efficacy, confidence managing diabetes in general, understanding of diabetes preventive care, diabetes distress, patient portal satisfaction, and patient-initiated orders at baseline, 3 months, 6 months, and 12 months after randomization. An ordinal logistic regression model will be used to quantify the effect of the intervention on the number of diabetes care gaps at the 12-month follow-up. For dichotomous secondary outcomes, a logistic regression model will be used with random effects for the clinic and provider variables as needed. For continuous secondary outcomes, a regression model will be used. RESULTS: This study is ongoing. Recruitment was closed in February 2022; a total of 433 patients were randomized. Of those randomized, most (n=288, 66.5%) were non-Hispanic White, 33.5% (n=145) were racial or ethnic minorities, 33.9% (n=147) were aged 65 years or older, and 30.7% (n=133) indicated limited health literacy. CONCLUSIONS: The study directly tests the hypothesis that a patient portal intervention-alerting patients about selected diabetes care gaps, fostering understanding of their significance, and allowing patients to initiate care-will reduce diabetes care gaps compared with usual care. The insights gained from this study may have broad implications for developing future interventions to address various care gaps, such as gaps in cancer screening, and contribute to the development of effective, scalable, and sustainable approaches to engage patients in chronic disease management and prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT04894903; https://classic.clinicaltrials.gov/ct2/show/NCT04894903. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56123.

Comparative effectiveness of sulfonylurea and metformin monotherapy on cardiovascular events in type 2 diabetes mellitus: a cohort study.

BACKGROUND: The effects of sulfonylureas and metformin on outcomes of cardiovascular disease (CVD) in type 2 diabetes are not well-characterized. OBJECTIVE: To compare the effects of sulfonylureas and metformin on CVD outcomes (acute myocardial infarction and stroke) or death. DESIGN: Retrospective cohort study. SETTING: National Veterans Health Administration databases linked to Medicare files. PATIENTS: Veterans who initiated metformin or sulfonylurea therapy for diabetes. Patients with chronic kidney disease or serious medical illness were excluded. MEASUREMENTS: Composite outcome of hospitalization for acute myocardial infarction or stroke, or death, adjusted for baseline demographic characteristics; medications; cholesterol, hemoglobin A1c, and serum creatinine levels; blood pressure; body mass index; health care utilization; and comorbid conditions. RESULTS: Among 253 690 patients initiating treatment (98 665 with sulfonylurea therapy and 155 025 with metformin therapy), crude rates of the composite outcome were 18.2 per 1000 person-years in sulfonylurea users and 10.4 per 1000 person-years in metformin users (adjusted incidence rate difference, 2.2 [95% CI, 1.4 to 3.0] more CVD events with sulfonylureas per 1000 person-years; adjusted hazard ratio [aHR], 1.21 [CI, 1.13 to 1.30]). Results were consistent for both glyburide (aHR, 1.26 [CI, 1.16 to 1.37]) and glipizide (aHR, 1.15 [CI, 1.06 to 1.26]) in subgroups by CVD history, age, body mass index, and albuminuria; in a propensity score-matched cohort analysis; and in sensitivity analyses. LIMITATION: Most of the veterans in the study population were white men; data on women and minority groups were limited but reflective of the Veterans Health Administration population. CONCLUSION: Use of sulfonylureas compared with metformin for initial treatment of diabetes was associated with an increased hazard of CVD events or death. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality and the U.S. Department of Health and Human Services.

Understanding patient portal use: implications for medication management.

BACKGROUND: The Internet can be leveraged to provide disease management support, including medication adherence promotion that, when tailored, can effectively improve adherence to medications. The growing adoption of patient portals represents an opportunity to support medication management and adherence more broadly, but virtually no data exist about the real and potential impact of existing portals on these outcomes. OBJECTIVE: We sought to (1) understand who uses an existing patient portal and reasons for use and nonuse, (2) understand how portal users are using a portal to manage their medications, and (3) explore participants' ideas for improving portal functionality for medication management and adherence support. METHODS: A total of 75 adults with type 2 diabetes participated in a mixed-methods study involving focus groups, a survey, and a medical chart review. We used quantitative data to identify differences between portal users and nonusers, and to test the relationship between the frequency of portal use and glycemic control among users. We used qualitative methods to understand how and why participants use a portal and their ideas for improving its medication management functionality. RESULTS: Of the enrolled participants, 81% (61/75) attended a focus group and/or completed a survey; portal users were more likely than nonusers to participate in that capacity (Fisher exact test; P=.01). Users were also more likely than nonusers to be Caucasian/white (Fisher exact test; P<.001), have higher incomes (Fisher exact test; P=.005), and be privately insured (Fisher exact test; P<.001). Users also tended to have more education than nonusers (Mann-Whitney U; P=.05), although this relationship was not significant at P<.05. Among users, more frequent use of a portal was associated with better A1C (Spearman rho =-0.30; P=.02). Reasons for nonuse included not knowing about the portal (n=3), not having access to a computer (n=3), or having a family member serve as an online delegate (n=1). Users reported using the portal to request prescription refills/reauthorizations and to view their medication list, and they were enthusiastic about the idea of added refill reminder functionality. They were also interested in added functionality that could streamline the refill/reauthorization process, alert providers to fill/refill nonadherence, and provide information about medication side effects and interactions. CONCLUSIONS: Although there are disparities in patient portal use, patients use portals to manage their medications, are enthusiastic about further leveraging portals to support medication management and adherence, and those who use a portal more frequently have better glycemic control. However, more features and functionality within a portal platform is needed to maximize medication management and adherence promotion.

Glycemic outcomes of a family-focused intervention for adults with type 2 diabetes: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

AIMS: Family/friend Activation to Motivate Self-care (FAMS) is a self-care support intervention delivered via mobile phones. We evaluated FAMS' effects on hemoglobin A1c (HbA1c) and intervention targets among adults with type 2 diabetes in a 15-month RCT. METHODS: Persons with diabetes (PWDs) were randomized to FAMS or control with their support person (family/friend, optional). FAMS included monthly phone coaching and text messages for PWDs, and text messages for support persons over a 9-month intervention period. RESULTS: PWDs (N = 329) were 52 % male, 39 % reported minoritized race or ethnicity, with mean HbA1c 8.6 ± 1.7 %. FAMS improved HbA1c among PWDs with a non-cohabitating support person (-0.64 %; 95 % CI [-1.22 %, -0.05 %]), but overall mean effects were not significant. FAMS improved intervention targets including self-efficacy, dietary behavior, and family/friend involvement during the intervention period; these improvements mediated post-intervention HbA1c improvements (total indirect effect -0.27 %; 95 % CI [-0.49 %, -0.09 %]) and sustained HbA1c improvements at 12 months (total indirect effect -0.19 %; 95 % CI [-0.40 %, -0.01 %]). CONCLUSIONS: Despite improvements in most intervention targets, HbA1c improved only among PWDs engaging non-cohabitating support persons suggesting future family interventions should emphasize inclusion of these relationships. Future work should also seek to identify intervention targets that mediate improvements in HbA1c.

Well-being outcomes of a family-focused intervention for persons with type 2 diabetes and support persons: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

AIMS: Type 2 diabetes self-management occurs within social contexts. We sought to test the effects of Family/friend Activation to Motivate Self-care (FAMS), a self-care support intervention delivered via mobile phones, on psychosocial outcomes for persons with diabetes (PWDs) and their support persons. METHODS: PWDs had the option to enroll with a friend/family member as a support person in a 15-month RCT to evaluate FAMS versus enhanced usual care. FAMS included 9 months of monthly phone coaching and text message support for PWDs, and text message support for enrolled support persons. RESULTS: PWDs (N = 329) were 52% male and 39% reported minoritized race or ethnicity ; 50% enrolled with elevated diabetes distress. Support persons (N = 294) were 26% male and 33% reported minoritized race or ethnicity. FAMS improved PWDs' diabetes distress (d = -0.19) and global well-being (d = 0.21) during the intervention, with patterns of larger effects among minoritized groups. Post-intervention (9-month) and sustained (15-month) improvements were driven by changes in PWDs' self-efficacy, self-care behaviors, and autonomy support. Among support persons, FAMS improved helpful involvement without increasing burden or harmful involvement. CONCLUSIONS: FAMS improved PWDs' psychosocial well-being, with post-intervention and sustained improvements driven by improved self-efficacy, self-care, and autonomy support. Support persons increased helpful involvement without adverse effects.

Well-being outcomes of a family-focused intervention for persons with type 2 diabetes and support persons: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

Aims: Type 2 diabetes self-management occurs within social contexts. We sought to test the effects of Family/friends Activation to Motivate Self-care (FAMS), a self-care support intervention delivered via mobile phones, on psychosocial outcomes for persons with diabetes (PWDs) and their support persons. Methods: PWDs had the option to enroll with a friend/family member as a support person in a 15-month RCT to evaluate FAMS versus enhanced usual care. FAMS included 9-months of monthly phone coaching and text message support for PWDs, and text message support for enrolled support persons. Results: PWDs (N=329) were 52% male and 39% from minoritized racial or ethnic groups; 50% enrolled with elevated diabetes distress. Support persons (N=294) were 26% male and 33% minoritized racial or ethnic groups. FAMS improved PWDs' diabetes distress ( d =-0.19) and global well-being ( d =0.21) during the intervention, with patterns of larger effects among minoritized groups. Post-intervention and sustained (15-month) improvements were driven by changes in PWDs' self-efficacy, self-care behaviors, and autonomy support. Among support persons, FAMS improved helpful involvement without increasing burden or harmful involvement. Conclusions: FAMS improved PWDs' psychosocial well-being, with post-intervention and sustained improvements driven by improved self-efficacy, self-care, and autonomy support. Support persons increased helpful involvement without adverse effects.

Glycemic outcomes of a family-focused intervention for adults with type 2 diabetes: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

Aims: Family/friends Activation to Motivate Self-care (FAMS) is a self-care support intervention delivered via mobile phones. We evaluated FAMS effects on hemoglobin A1c (HbA1c) and intervention targets among adults with type 2 diabetes in a 15-month RCT. Methods: Persons with diabetes (PWDs) and their support persons (family/friend, optional) were randomized to FAMS or control. FAMS included monthly phone coaching and text messages for PWDs, and text messages for support persons over a 9-month intervention period. Results: PWDs (N=329) were 52% male, 39% from minoritized racial or ethnic groups, with mean HbA1c 8.6±1.7%. FAMS improved HbA1c among PWDs with a non-cohabitating support person (-0.64%; 95% CI [-1.22%, -0.05%]), but overall effects were not significant. FAMS improved intervention targets including self-efficacy, dietary behavior, and family/friend involvement during the intervention period; these improvements mediated post-intervention HbA1c improvements (total indirect effect -0.27%; 95% CI [-0.49%, -0.09%]) and sustained HbA1c improvements at 12 months (total indirect effect -0.19%; 95% CI [-0.40%, -0.01%]). Conclusions: Despite improvements in most intervention targets, HbA1c improved only among PWDs engaging non-cohabitating support persons suggesting future family interventions should emphasize inclusion of these relationships. Future work should also seek to identify intervention targets that mediate improvements in HbA1c.

Interventions Incorporating Therapeutic Alliance to Improve Medication Adherence in Black Patients with Diabetes, Hypertension and Kidney Disease: A Systematic Review.

Background: Black Americans have a disproportionately increased risk of diabetes, hypertension, and kidney disease, and higher associated morbidity, mortality, and hospitalization rates than their White peers. Structural racism amplifies these disparities, and negatively impacts self-care including medication adherence, critical to chronic disease management. Systematic evidence of successful interventions to improve medication adherence in Black patients with diabetes, hypertension, and kidney disease is lacking. Knowledge of the impact of therapeutic alliance, ie, the unique relationship between patients and providers, which optimizes outcomes especially for minority populations, is unclear. The role and application of behavioral theories in successful development of medication adherence interventions specific to this context also remains unclear. Objective: To evaluate the existing evidence on the salience of a therapeutic alliance in effective interventions to improve medication adherence in Black patients with diabetes, hypertension, or kidney disease. Data Sources: Medline (via PubMed), EMBASE (OvidSP), Cumulative Index of Nursing and Allied Health Literature (CINAHL) (EBSCOhost), and PsycINFO (ProQuest) databases. Review Methods: Only randomized clinical trials and pre/post intervention studies published in English between 2009 and 2022 with a proportion of Black patients greater than 25% were included. Narrative synthesis was done. Results: Eleven intervention studies met the study criteria and eight of those studies had all-Black samples. Medication adherence outcome measures were heterogenous. Five out of six studies which effectively improved medication adherence, incorporated therapeutic alliance. Seven studies informed by behavioral theories led to significant improvement in medication adherence. Discussion/Conclusion: Study findings suggest that therapeutic alliance-based interventions are effective in improving medication adherence in Black patients with diabetes and hypertension. Further research to test the efficacy of therapeutic alliance-based interventions to improve medication adherence in Black patients should ideally incorporate cultural adaptation, theoretical framework, face-to-face delivery mode, and convenient locations.

Development and results of a kidney disease knowledge survey given to patients with CKD.

BACKGROUND: Little is known about disease-specific knowledge in patients with chronic kidney disease (CKD). We developed and examined the results of a survey to characterize kidney disease knowledge. DESIGN: Survey about kidney disease knowledge, with questions developed by experts. SETTING & PARTICIPANTS: 401 adult patients with CKD (stages 1-5) attending a nephrology clinic from April-October 2009. OUTCOMES & MEASUREMENTS: We calculated survey reliability using the Kuder-Richardson-20 coefficient and established construct validity by testing a priori hypotheses of associations between survey results and patient characteristics. We descriptively analyzed survey responses and applied linear regression analyses to evaluate associations with patient characteristics. Health literacy was measured using the Rapid Estimate of Adult Literacy in Medicine. RESULTS: Participants' median age was 58 (25th-75th percentile, 46-68) years, 83% were white, 18% had limited literacy, and 77% had CKD stages 3-5. The 28-question knowledge survey had good reliability (Kuder-Richardson-20 coefficient = 0.72), and mean knowledge score was 66% ± 15% (SD). In support of the construct validity of our knowledge survey, bivariate analysis shows that scores were associated with age (ß = -0.01/10 years; 95% CI, -0.02 to -0.005; P = 0.003), formal education (ß = 0.09; 95% CI, 0.03-0.15; P = 0.004), health literacy (ß = 0.06; 95% CI, 0.03-0.10; P = 0.001), kidney education class participation (ß = 0.05; 95% CI, 0.01-0.09; P = 0.009), knowing someone else with CKD (ß = 0.05; 95% CI, 0.02-0.08; P = 0.001), and awareness of one's own CKD diagnosis (ß = 0.07; 95% CI, 0.04-0.10; P < 0.001). Findings were similar in adjusted analyses. LIMITATIONS: Recruitment from 1 clinic limits generalizability of findings. CONCLUSIONS: For patients with CKD, this Kidney Knowledge Survey (KiKS) is reliable and valid and identifies areas of and risk factors for poor kidney knowledge. Further study is needed to determine the impact of CKD knowledge on self-care behaviors and clinical outcomes.

Patient centered primary care is associated with patient hypertension medication adherence.

There is increasing evidence that patient centered care, including communication skills, is an essential component to chronic illness care. Our aim was to evaluate patient centered primary care as a determinant of medication adherence. We mailed 1,341 veterans with hypertension the Short Form Primary Care Assessment Survey (PCAS) which measures elements of patient centered primary care. We prospectively collected each patient's antihypertensive medication adherence for 6 months. Patients were characterized as adherent if they had medication for >80%. 654 surveys were returned (50.7%); and 499 patients with complete data were analyzed. Antihypertensive adherence increased as scores in patient centered care increased [RR 3.18 (95% CI 1.44, 16.23) bootstrap 5000 resamples] for PCAS score of 4.5 (highest quartile) versus 1.5 (lowest quartile). Future research is needed to determine if improving patient centered care, particularly communication skills, could lead to improvements in health related behaviors such as medication adherence and health outcomes.

Health literacy explains racial disparities in diabetes medication adherence.

Although low health literacy and suboptimal medication adherence are more prevalent in racial/ethnic minority groups than Whites, little is known about the relationship between these factors in adults with diabetes, and whether health literacy or numeracy might explain racial/ethnic disparities in diabetes medication adherence. Previous work in HIV suggests health literacy mediates racial differences in adherence to antiretroviral treatment, but no study to date has explored numeracy as a mediator of the relationship between race/ethnicity and medication adherence. This study tested whether health literacy and/or numeracy were related to diabetes medication adherence, and whether either factor explained racial differences in adherence. Using path analytic models, we explored the predicted pathways between racial status, health literacy, diabetes-related numeracy, general numeracy, and adherence to diabetes medications. After adjustment for covariates, African American race was associated with poor medication adherence (r = -0.10, p < .05). Health literacy was associated with adherence (r = .12, p < .02), but diabetes-related numeracy and general numeracy were not related to adherence. Furthermore, health literacy reduced the effect of race on adherence to nonsignificance, such that African American race was no longer directly associated with lower medication adherence (r = -0.09, p = .14). Diabetes medication adherence promotion interventions should address patient health literacy limitations.

Low health literacy associates with increased mortality in ESRD.

Limited health literacy is common in the United States and associates with poor clinical outcomes. Little is known about the effect of health literacy in patients with advanced kidney disease. In this prospective cohort study we describe the prevalence of limited health literacy and examine its association with the risk for mortality in hemodialysis patients. We enrolled 480 incident chronic hemodialysis patients from 77 dialysis clinics between 2005 and 2007 and followed them until April 2008. Measured using the Rapid Estimate of Adult Literacy in Medicine, 32% of patients had limited (<9th grade reading level) and 68% had adequate health literacy (≥9th grade reading level). Limited health literacy was more likely in patients who were male and non-white and who had fewer years of education. Compared with adequate literacy, limited health literacy associated with a higher risk for death (HR 1.54; 95% CI 1.01 to 2.36) even after adjustment for age, sex, race, and diabetes. In summary, limited health literacy is common and associates with higher mortality in chronic hemodialysis patients. Addressing health literacy may improve survival for these patients.

Evaluation of the My Diabetes Care Patient Portal Intervention: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: My Diabetes Care (MDC) is a multi-faceted intervention embedded within an established patient portal, My Health at Vanderbilt. MDC is designed to help patients better understand their diabetes health data and support self-care. MDC uses infographics to visualize and summarize patients' diabetes health data, incorporates motivational strategies, provides literacy-level appropriate educational resources, and links to a diabetes online patient support community and diabetes news feeds. OBJECTIVE: This study aims to evaluate the effects of MDC on patient activation in adult patients with type 2 diabetes mellitus. Moreover, we plan to assess secondary outcomes, including system use and usability, and the effects of MDC on cognitive and behavioral outcomes (eg, self-care and self-efficacy). METHODS: We are conducting a 6-month, 2-arm, parallel-design, pragmatic pilot randomized controlled trial of the effect of MDC on patient activation. Adult patients with type 2 diabetes mellitus are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible for the study if they are currently being treated with at least one diabetes medication, are able to speak and read in English, are 21 years or older, and have an existing My Health at Vanderbilt account and reliable access to a desktop or laptop computer with internet access. We exclude patients living in long-term care facilities, patients with known cognitive deficits or severe visual impairment, and patients currently participating in any other diabetes-related research study. Participants are randomly assigned to MDC or usual care. We collect self-reported survey data, including the Patient Activation Measure (R) at baseline, 3 months, and 6 months. We will use mixed-effects regression models to estimate potentially time-varying intervention effects while adjusting for the baseline measure of the outcome. The mixed-effects model will use fixed effects for patient-level characteristics and random effects for health care provider variables (eg, primary care physicians). RESULTS: This study is ongoing. Recruitment was closed in May 2020; 270 patients were randomized. Of those randomized, most (214/267, 80.1%) were non-Hispanic White, and 13.1% (35/267) were non-Hispanic Black, 43.7% (118/270) reported being 65 years or older, and 33.6% (90/268) reported limited health literacy. We obtained at least 95.6% (258/270) completion among participants through the 3-month follow-up assessment. CONCLUSIONS: This randomized controlled trial will be one of the first to evaluate a patient-facing diabetes digital health intervention delivered via a patient portal. By embedding MDC into Epic's MyChart platform with more than 127 million patient records, our intervention is directly integrated into routine care, highly scalable, and sustainable. Our findings and evolving patient portal functionality will inform the continued development of MDC to best meet users' needs and a larger trial focused on the impact of MDC on clinical end points. TRIAL REGISTRATION: ClinicalTrials.gov NCT03947333; https://clinicaltrials.gov/ct2/show/NCT03947333. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25955.

The My Diabetes Care Patient Portal Intervention: Usability and Pre-Post Assessment.

BACKGROUND: My Diabetes Care (MDC) is a novel, multifaceted patient portal intervention designed to help patients better understand their diabetes health data and support self-management. MDC uses infographics to visualize and summarize patients' diabetes health data, incorporates motivational strategies, and provides literacy level-appropriate educational resources. OBJECTIVES: We aimed to assess the usability, acceptability, perceptions, and potential impact of MDC. METHODS: We recruited 69 participants from four clinics affiliated with Vanderbilt University Medical Center. Participants were given 1 month of access to MDC and completed pre- and post-questionnaires including validated measures of usability and patient activation, and questions about user experience. RESULTS: Sixty participants completed the study. Participants' mean age was 58, 55% were females, 68% were Caucasians, and 48% had limited health literacy (HL). Most participants (80%) visited MDC three or more times and 50% spent a total of ≥15 minutes on MDC. Participants' median System Usability Scale (SUS) score was 78.8 [Q1, Q3: 72.5, 87.5] and significantly greater than the threshold value of 68 indicative of "above average" usability (p < 0.001). The median SUS score of patients with limited HL was similar to those with adequate HL (77.5 [72.5, 85.0] vs. 82.5 [72.5, 92.5]; p = 0.41). Participants most commonly reported the literacy level-appropriate educational links and health data infographics as features that helped them better understand their diabetes health data (65%). All participants (100%) intended to continue to use MDC. Median Patient Activation Measure® scores increased postintervention (64.3 [55.6, 72.5] vs. 67.8 [60.6, 75.0]; p = 0.01). CONCLUSION: Participants, including those with limited HL, rated the usability of MDC above average, anticipated continued use, and identified key features that improved their understanding of diabetes health data. Patient activation improved over the study period. Our findings suggest MDC may be a beneficial addition to existing patient portals.

Hospitalization for Heart Failure Among Patients With Diabetes Mellitus and Reduced Kidney Function Treated With Metformin Versus Sulfonylureas: A Retrospective Cohort Study.

Background Metformin and sulfonylurea are commonly prescribed oral medications for type 2 diabetes mellitus. The association of metformin and sulfonylureas on heart failure outcomes in patients with reduced estimated glomerular filtration rate remains poorly understood. Methods and Results This retrospective cohort combined data from National Veterans Health Administration, Medicare, Medicaid, and the National Death Index. New users of metformin or sulfonylurea who reached an estimated glomerular filtration rate of 60 mL/min per 1.73 m2 or serum creatinine of 1.5 mg/dL and continued metformin or sulfonylurea were included. The primary outcome was hospitalization for heart failure. Echocardiogram reports were obtained to determine each patient's ejection fraction (EF) (reduced EF <40%; midrange EF 40%-49%; ≥50%). The primary analysis estimated the cause-specific hazard ratios for metformin versus sulfonylurea and estimated the cumulative incidence functions for heart failure hospitalization and competing events. The weighted cohort included 24 685 metformin users and 24 805 sulfonylurea users with reduced kidney function (median age 70 years, estimated glomerular filtration rate 55.8 mL/min per 1.73 m2). The prevalence of underlying heart failure (12.1%) and cardiovascular disease (31.7%) was similar between groups. There were 16.9 (95% CI, 15.8-18.1) versus 20.7 (95% CI, 19.5-22.0) heart failure hospitalizations per 1000 person-years for metformin and sulfonylurea users, respectively, yielding a cause-specific hazard of 0.85 (95% CI, 0.78-0.93). Among heart failure hospitalizations, 44.5% did not have echocardiogram information available; 29.3% were categorized as reduced EF, 8.9% as midrange EF, and 17.2% as preserved EF. Heart failure hospitalization with reduced EF (hazard ratio, 0.79; 95% CI, 0.67-0.93) and unknown EF (hazard ratio, 0.84; 95% CI 0.74-96) were significantly lower in metformin versus sulfonylurea users. Conclusions Among patients with type 2 diabetes mellitus who developed worsening kidney function, persistent metformin compared with sulfonylurea use was associated with reduced heart failure hospitalization.

Effects of a Tailored Text Messaging Intervention Among Diverse Adults With Type 2 Diabetes: Evidence From the 15-Month REACH Randomized Controlled Trial.

OBJECTIVE: Text messaging interventions have high potential for scalability and for reductions in health disparities. However, more rigorous, long-term trials are needed. We examined the long-term efficacy and mechanisms of a tailored text messaging intervention. RESEARCH DESIGN AND METHODS: Adults with type 2 diabetes participated in a parallel-groups, 15-month randomized controlled trial and were assigned to receive Rapid Education/Encouragement and Communications for Health (REACH) for 12 months or control. REACH included interactive texts and tailored texts addressing medication adherence and nontailored texts supporting other self-care behaviors. Outcomes included hemoglobin A1c (HbA1c), diabetes medication adherence, self-care, and self-efficacy. RESULTS: Participants (N = 506) were approximately half racial/ethnic minorities, and half were underinsured, had annual household incomes <$35,000, and had a high school education or less; 11% were homeless. Average baseline HbA1c was 8.6% ± 1.8%; 70.0 ± 19.7 mmol/mol) with n = 219 having HbA1c ≥8.5% (69 mmol/mol). Half were prescribed insulin. Retention was over 90%. Median response rate to interactive texts was 91% (interquartile range 75%, 97%). The treatment effect on HbA1c at 6 months (-0.31%; 95% CI -0.61%, -0.02%) was greater among those with baseline HbA1c ≥8.5% (-0.74%; 95% CI -1.26%, -0.23%), and there was no evidence of effect modification by race/ethnicity or socioeconomic disadvantage. REACH improved medication adherence and diet through 12 months and self-efficacy through 6 months. Treatment effects were not significant for any outcome at 15 months. REACH reduced barriers to adherence, but barrier reduction did not mediate outcome improvements. CONCLUSIONS: REACH engaged at-risk patients in diabetes self-management and improved short-term HbA1c. More than texts alone may be needed to sustain the effects.