Medical assistant health coaching ("MAC") for type 2 diabetes in diverse primary care settings: A pragmatic, cluster-randomized controlled trial protocol.

In the US, nearly 11% of adults were living with diagnosed diabetes in 2017, and significant type 2 diabetes (T2D) disparities are experienced by socioeconomically disadvantaged, racial/ethnic minority populations, including Hispanics. The standard 15-min primary care visit does not allow for the ongoing self-management support that is needed to meet the complex needs of individuals with diabetes. "Team-based" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or "health coaching." While rigorous trials have shown MA health coaching to improve diabetes outcomes, less is known about if and how such a model can be integrated within real world, primary care clinic workflows. Medical Assistant Health Coaching for Type 2 Diabetes in Diverse Primary Care Settings - A Pragmatic, Cluster-Randomized Controlled Trial will address this gap. Specifically, this study compares MA health coaching versus usual care in improving diabetes clinical control among N = 600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California. Electronic medical records are used to identify eligible patients at both health systems, and to examine change in clinical control over one year in the overall sample. Changes in behavioral and psychosocial outcomes are being evaluated by telephone assessment in a subset (n = 300) of participants, and rigorous process and cost evaluations will assess potential for sustainability and scalability.

Does Diabetes Distress Influence Clinical Response to an mHealth Diabetes Self-Management Education and Support Intervention?

PURPOSE: The purpose of this study was to examine whether baseline levels of diabetes distress (DD) impacted clinical benefit from a mobile health (mHealth) diabetes self-management education and support (DSME/S) intervention ("Dulce Digital"). METHODS: This secondary analysis included the full sample of 126 Hispanic adults (mean age = 48.43 years, SD = 9.80) with type 2 diabetes and glycosylated hemoglobin A1C >7.5% enrolled from a Federally Qualified Health Center in a randomized, nonblinded clinical trial that compared Dulce Digital to usual care. Dulce Digital participants received educational/motivational, medication reminders, and blood glucose monitoring prompt text messages over 6 months. RESULTS: Baseline levels of DD prospectively moderated the effect of Dulce Digital (vs usual care) on glycemic control over 6 months, such that Dulce Digital participants with higher DD experienced relatively greater benefit from the intervention. The effect of the intervention on A1C change was 178% larger among individuals experiencing moderate/high versus no/low DD. CONCLUSIONS: Although research has found DD to be associated with poorer self-management and clinical outcomes, individuals already distressed about their diabetes may benefit from a lower-burden mHealth DSME/S approach.

My Bridge (Mi Puente), a care transitions intervention for Hispanics/Latinos with multimorbidity and behavioral health concerns: protocol for a randomized controlled trial.

BACKGROUND: Multimorbidity affects four of ten US adults and eight of ten adults ages 65 years and older, and frequently includes both cardiometabolic conditions and behavioral health concerns. Hispanics/Latinos (hereafter, Latinos) and other ethnic minorities are more vulnerable to these conditions, and face structural, social, and cultural barriers to obtaining quality physical and behavioral healthcare. We report the protocol for a randomized controlled trial that will compare Mi Puente (My Bridge), a cost-efficient care transitions intervention conducted by a specially trained Behavioral Health Nurse and Volunteer Community Mentor team, to usual care or best-practice discharge approaches, in reducing hospital utilization and improving patient reported outcomes in Latino adults with multiple cardiometabolic conditions and behavioral health concerns. The study will examine the degree to which Mi Puente produces superior reductions in hospital utilization at 30 and 180 days (primary aim) and better patient-reported outcomes (quality of life/physical health; barriers to healthcare; engagement with outpatient care; patient activation; resources for chronic disease management), and will examine the cost effectiveness of the Mi Puente intervention relative to usual care. METHODS: Participants are enrolled as inpatients at a South San Diego safety net hospital, using information from electronic medical records and in-person screenings. After providing written informed consent and completing self-report assessments, participants randomized to usual care receive best-practice discharge processes, which include educational materials, assistance with outpatient appointments, referrals to community-based providers, and other assistance (e.g., with billing, insurance) as required. Those randomized to Mi Puente receive usual-care materials and processes, along with inpatient visits and up to 4 weeks of follow-up phone calls from the intervention team to address their integrated physical-behavioral health needs and support the transition to outpatient care. DISCUSSION: The Mi Puente Behavioral Health Nurse and Volunteer Community Mentor team intervention is proposed as a cost-effective and culturally appropriate care transitions intervention for Latinos with multimorbidity and behavioral health concerns. If shown to be effective, close linkages with outpatient healthcare and community organizations will help maximize uptake, dissemination, and scaling of the Mi Puente intervention. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02723019. Registered on 30 March 2016.

Pilot Test of a Culturally Appropriate Diabetes Prevention Intervention for At-Risk Latina Women.

Purpose The purpose of the study was to test the preliminary effectiveness, feasibility, and acceptability of a peer-led, culturally appropriate, Diabetes Prevention Program (DPP)-based lifestyle intervention for Latina women at high-risk for type 2 diabetes (T2DM). Methods Participants (N = 61) were overweight/obese (body mass index [BMI] ≥25) Latina women with no diabetes, at elevated risk either due to midlife age (45-65 years; n = 37) or history of gestational diabetes mellitus (n = 24). The study used a 1-group pretest-posttest design and offered 12 weeks of peer-led education sessions in a community setting. The intervention targeted physical activity and dietary behaviors to facilitate weight reduction and included culturally appropriate content, age-specific health information, and stress/emotion management strategies. Clinical and self-report assessments were conducted at baseline, month 3, and month 6. Results Mean participant age was 47.8 years (SD = 10.8). Most (91.2%) were born in Mexico, and 43.3% had a ninth-grade education or less. At month 6, participants achieved a mean reduction of 4.1% body weight (7 lb [3.2 kg]). Statistically significant improvements were observed for dietary behaviors, stress, and depression symptoms. Attrition was low, 5% (3 women). Focus groups indicated that intervention content increased knowledge, was applicable, highly valued, culturally relevant, and would be recommended to others. Conclusions This culturally tailored DPP adaptation was feasible and acceptable for 2 groups of Latina women at high-risk for T2DM and showed preliminary effectiveness in reducing weight and modifying self-reported dietary behaviors, stress, and depression symptoms. Further research is needed to identify ways to enhance weight loss and diabetes prevention in this at-risk, underserved population.

Dulce Digital: An mHealth SMS-Based Intervention Improves Glycemic Control in Hispanics With Type 2 Diabetes.

OBJECTIVE: Type 2 diabetes is growing in epidemic proportions and disproportionately affects lower-income, diverse communities. Text messaging may provide one of the most rapid methods to overcome the "digital divide" to improve care. RESEARCH DESIGN AND METHODS: A randomized, nonblinded, parallel-groups clinical trial design allocated N = 126 low-income, Hispanic participants with poorly controlled type 2 diabetes to receive the Dulce Digital intervention or usual care (UC). Dulce Digital participants received up to three motivational, educational, and/or call-to-action text messages per day over 6 months. The primary outcome was HbA1c; lipids, blood pressure, and BMI were secondary outcomes. Satisfaction and acceptability were evaluated via focus groups and self-report survey items. RESULTS: The majority of patients were middle-aged (mean age 48.43 years, SD 9.80), female (75%), born in Mexico (91%), and uninsured (75%) and reported less than a ninth-grade education level (73%) and mean baseline HbA1c 9.5% (80 mmol/mol), SD 1.3, and fasting plasma glucose 187.17 mg/dL, SD 64.75. A statistically significant time-by-group interaction effect indicated that the Dulce Digital group achieved a significantly greater reduction in HbA1c over time compared with UC (P = 0.03). No statistically significant effects were observed for secondary clinical indicators. The number of blood glucose values texted in by participants was a statistically significant predictor of month 6 HbA1c (P < 0.05). Satisfaction and acceptability ratings for the Dulce Digital intervention were high. CONCLUSIONS: Use of a simple, low-cost text messaging program was found to be highly acceptable in this sample of high-risk, Hispanic individuals with type 2 diabetes and resulted in greater improvement in glycemic control compared with UC.

Dulce Mothers: an intervention to reduce diabetes and cardiovascular risk in Latinas after gestational diabetes.

Latina women with prior gestational diabetes mellitus (GDM) are at elevated risk for type 2 diabetes mellitus and cardiovascular disease. Few primary prevention programs are designed for low socioeconomic status, Spanish-speaking populations. We examined the effectiveness of a Diabetes Prevention Program (DPP) translation in low-income Latinas with a history of GDM. Eighty-four Latinas, 18-45 years old with GDM in the past 3 years, underwent an 8-week peer-educator-led group intervention, with tailoring for Latino culture and recent motherhood. Lifestyle changes and diabetes and cardiovascular risk factors were assessed at study baseline, month 3 and month 6. Participants showed significant improvements in lipids, blood pressure, physical activity, dietary fat intake, and fatalistic and cultural diabetes beliefs (p < 0.05). Formative evaluation provides preliminary evidence of program acceptability. A peer-led, culturally appropriate DPP translation was effective in improving lifestyle changes and some indicators of cardiovascular and diabetes risk in Latinas with GDM.