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.

Empowering patients to address diabetes care gaps: formative usability testing of a novel patient portal intervention.

Objective: The aim of this study was to design and assess the formative usability of a novel patient portal intervention designed to empower patients with diabetes to initiate orders for diabetes-related monitoring and preventive services. Materials and Methods: We used a user-centered Design Sprint methodology to create our intervention prototype and assess its usability with 3 rounds of iterative testing. Participants (5/round) were presented with the prototype and asked to perform common, standardized tasks using think-aloud procedures. A facilitator rated task performance using a scale: (1) completed with ease, (2) completed with difficulty, and (3) failed. Participants completed the System Usability Scale (SUS) scored 0-worst to 100-best. All testing occurred remotely via Zoom. Results: We identified 3 main categories of usability issues: distrust about the automated system, content concerns, and layout difficulties. Changes included improving clarity about the ordering process and simplifying language; however, design constraints inherent to the electronic health record system limited our ability to respond to all usability issues (eg, could not modify fixed elements in layout). Percent of tasks completed with ease across each round were 67%, 60%, and 80%, respectively. Average SUS scores were 87, 74, and 93, respectively. Across rounds, participants found the intervention valuable and appreciated the concept of patient-initiated ordering. Conclusions: Through iterative user-centered design and testing, we improved the usability of the patient portal intervention. A tool that empowers patients to initiate orders for disease-specific services as part of their existing patient portal account has potential to enhance the completion of recommended health services and improve clinical outcomes.

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.

Text messaging to engage friends/family in diabetes self-management support: acceptability and potential to address disparities.

OBJECTIVE: Explore acceptability of engaging family/friends in patients' type 2 diabetes (T2D) self-management using text messaging. MATERIALS AND METHODS: Participants (N = 123) recruited from primary care clinics for a larger trial evaluating mobile phone support for T2D completed self-report measures and a hemoglobin A1c test and then had the option to invite an adult support person to receive text messages. We examined characteristics and reasons of participants who did/did not invite a support person, responses to the invitation, and feedback from patients and support persons. RESULTS: Participants were 55.9 ± 10.1 years old, 55% female, 53% minority, and 54% disadvantaged (low income, less than high school degree/GED, uninsured, and/or homeless). Participants who invited a support person (48%) were slightly younger, more likely to be partnered, and reported more depressive symptoms and more emergency department visits in the year prior to study enrollment as compared to participants who did not (all p <.05). Participants' reasons for inviting a support person included needing help and seeing benefits of engaging others, while reasons for not inviting a support person included concerns about being a "burden" and support person's ability or desire to text. Support persons reported the texts increased awareness, created dialogue, and improved their own health behaviors. DISCUSSION: Patients inviting a support person had higher need and thus may stand to benefit most. Most support persons were open to engagement via text messages. CONCLUSION: Across race and socioeconomic status, text messaging may engage support persons to increase health-related support-particularly for patients with higher levels of need. TRIAL REGISTRATION: Clinicaltrials.gov NCT02409329.

Patient-perceived family stigma of Type 2 diabetes and its consequences.

INTRODUCTION: Adults with type two diabetes (T2D) report being monitored and judged by family members, contributing to feelings of guilt/shame, and attempts to conceal one's diabetes status or self-care efforts. However, studies have not yet quantitatively examined T2D stigma from family members. Our objective was to assess the frequency of T2D family stigma and its association with helpful and harmful diabetes-specific family behaviors and psychological and behavioral consequences of stigma. METHOD: A sample of predominantly African-American adults with T2D and low income completed items written for this study to assess T2D family stigma and consequences of stigma. We explored frequencies and bivariate correlations between these constructs and diabetes-specific family behaviors (measured with the Diabetes Family Behavior Checklist-II). RESULTS: Participants (N = 53) were 57.3 ± 8.7 years old, 70% African American, 96% had annual incomes <$20K, and average HbA1C was 8.0 ± 2.2%. More than half (57%) reported at least 1 experience of family stigma (1.26 ± 1.8 of 9 queried, α = .84), and 28% reported at least 1 consequence (0.6 ± 1.3 of 5 queried, α = .87). Reporting more family stigma was associated with more consequences (ρ = .52, p < .001) but not with helpful or harmful family behaviors. DISCUSSION: Perceptions/experiences of T2D-related family stigma were common in our sample and associated with consequences of stigma including concealment and resentment of self-care, which may affect clinical outcomes. (PsycINFO Database Record

The Design, Usability, and Feasibility of a Family-Focused Diabetes Self-Care Support mHealth Intervention for Diverse, Low-Income Adults with Type 2 Diabetes.

Family members' helpful and harmful actions affect adherence to self-care and glycemic control among adults with type 2 diabetes (T2D) and low socioeconomic status. Few family interventions for adults with T2D address harmful actions or use text messages to reach family members. Through user-centered design and iterative usability/feasibility testing, we developed a mHealth intervention for disadvantaged adults with T2D called FAMS. FAMS delivers phone coaching to set self-care goals and improve patient participant's (PP) ability to identify and address family actions that support/impede self-care. PPs receive text message support and can choose to invite a support person (SP) to receive text messages. We recruited 19 adults with T2D from three Federally Qualified Health Centers to use FAMS for two weeks and complete a feedback interview. Coach-reported data captured coaching success, technical data captured user engagement, and PP/SP interviews captured the FAMS experience. PPs were predominantly African American, 83% had incomes <$35,000, and 26% were married. Most SPs (n = 7) were spouses/partners or adult children. PPs reported FAMS increased self-care and both PPs and SPs reported FAMS improved support for and communication about diabetes. FAMS is usable and feasible and appears to help patients manage self-care support, although some PPs may not have a SP.

Family behaviors and type 2 diabetes: What to target and how to address in interventions for adults with low socioeconomic status.

OBJECTIVES: Diabetes-specific family behaviors are associated with self-care and glycemic control among adults with type 2 diabetes. Formative research is needed to inform assessment of these behaviors and interventions to address obstructive family behaviors (sabotaging and nagging/arguing), particularly among racial/ethnic minorities and low-income adults who struggle most with self-care adherence. METHODS: We conducted a mixed-methods study with adults with type 2 diabetes at a Federally Qualified Health Center to better understand experiences with diabetes-specific family behaviors and willingness to engage family members in diabetes interventions. Participants completed a phone survey (N = 53) and/or attended a focus group (n = 15). RESULTS: Participants were 70% African American and had low socioeconomic status (96% annual income