Background Patient-reported outcomes (PROs) are increasingly being used in the management of type 2 diabetes (T2D) to integrate data from patients’ perspective into clinical care. To date, the majority of PRO tools have lacked patient and provider involvement in their development, thus failing to meet the unique needs of end users, and lack the technical infrastructure to be integrated into the clinic workflow. Objective This study aims to apply a systematic, user-centered design approach to develop i-Matter (investigating a mobile health [mHealth] texting tool for embedding patient-reported data into diabetes management), a theory-driven, mobile PRO system for patients with T2D and their primary care providers. Methods i-Matter combines text messaging with dynamic data visualizations that can be integrated into electronic health records (EHRs) and personalized patient reports. To build i-Matter, we conducted semistructured group and individual interviews with patients with T2D and providers, a design thinking workshop to refine initial ideas and design the prototype, and user testing sessions of prototypes using a rapid-cycle design (ie, design-test-modify-retest). Results Using an iterative user-centered process resulted in the identification of 6 PRO messages that were relevant to patients and providers: medication adherence, dietary behaviors, physical activity, sleep quality, quality of life, and healthy living goals. In user testing, patients recommended improvements to the wording and timing of the PRO text messages to increase clarity and response rates. Patients also recommended including motivational text messages to help sustain engagement with the program. The personalized report was regarded as a key tool for diabetes self-management by patients and providers because it aided in the identification of longitudinal patterns in the PRO data, which increased patient awareness of their need to adopt healthier behaviors. Patients recommended adding individualized tips to the journal on how they can improve their behaviors. Providers preferred having a separate tab built into the EHR that included the personalized report and highlighted key trends in patients’ PRO data over the past 3 months. Conclusions PRO tools that capture patients’ well-being and the behavioral aspects of T2D management are important to patients and providers. A clinical trial will test the efficacy of i-Matter in 282 patients with uncontrolled T2D. Trial Registration ClinicalTrials.gov NCT03652389; https://clinicaltrials.gov/ct2/show/NCT03652389
Background Poor adherence to antihypertensive medications is a significant contributor to the racial gap in rates of blood pressure (BP) control among Latino adults, as compared to Black and White adults. While multi-level interventions (e.g., those aiming to influence practice, providers, and patients) have been efficacious in improving medication adherence in underserved patients with uncontrolled hypertension, the translation of these interventions into routine practice within “real world” safety-net primary care settings has been inadequate and slow. This study will fill this evidence-to-practice gap by evaluating the effectiveness of practice facilitation (PF) as a practical and tailored strategy for implementing Advancing Medication Adherence for Latinos with Hypertension through a Team-based Care Approach (ALTA), a multi-level approach to improving medication adherence and BP control in 10 safety-net practices in New York that serve Latino patients. Methods and design We will conduct this study in two phases: (1) a pre-implementation phase where we will refine the PF strategy, informed by the Consolidated Framework for Implementation Research, to facilitate the implementation of ALTA into routine care at the practices; and (2) an implementation phase during which we will evaluate, in a stepped-wedge cluster randomized controlled trial, the effect of the PF strategy on ALTA implementation fidelity (primary outcome), as well as on clinical outcomes (secondary outcomes) at 12 months. Implementation fidelity will be assessed using a mixed methods approach based on the five core dimensions outlined by Proctor’s Implementation Outcomes Framework. Clinical outcome measures include BP control (defined as BP< 130/80 mmHg) and medication adherence (assessed using the proportion of days covered via pharmacy records). Discussion The study protocol applies rigorous research methods to identify how implementation strategies such as PF may work to expedite the translation process for implementing evidence-based approaches into routine care at safety-net practices to improve health outcomes in Latino patients with hypertension, who suffer disproportionately from poor BP control. By examining the barriers and facilitators that affect implementation, this study will contribute knowledge that will increase the generalizability of its findings to other safety-net practices and guide effective scale-up across primary care practices nationally. Trial registration ClinicalTrials.gov NCT03713515, date of registration: October 19, 2018.
Depression is associated with adverse outcomes in epilepsy but is undertreated in this population. Project UPLIFT, a telephone-based depression self-management program, was developed for adults with epilepsy and has been shown to reduce depressive symptoms in English-speaking patients. There remains an unmet need for accessible mental health programs for Hispanic adults with epilepsy. The purpose of this study was to evaluate the feasibility, acceptability, and effects on depressive symptoms of a culturally adapted version of UPLIFT for the Hispanic community. Hispanic patients with elevated depressive symptoms (n = 72) were enrolled from epilepsy clinics in New York City and randomized to UPLIFT or usual care. UPLIFT was delivered in English or Spanish to small groups in eight weekly telephone sessions. Feasibility was assessed by recruitment, retention, and adherence rates and acceptability was assessed by self-reported satisfaction with the intervention. Depressive symptoms (PHQ-9 scores) were compared between study arms over 12 months. The mean age was 43.3±11.3, 71% of participants were female and 67% were primary Spanish speakers. Recruitment (76% consent rate) and retention rates (86–93%) were high. UPLIFT participants completed a median of six out of eight sessions and satisfaction ratings were high, but rates of long-term practice were low. Rates of clinically significant depressive symptoms (PHQ-9 ≥5) were lower in UPLIFT versus usual care throughout follow-up (63% vs. 72%, 8 weeks; 40% vs. 70%, 6 months; 47% vs. 70%, 12 months). Multivariable-adjusted regressions demonstrated statistically significant differences at 6 months (OR = 0.24, 95% CI, 0.06–0.93), which were slightly reduced at 12 months (OR = 0.30, 95% CI, 0.08–1.16). Results suggest that UPLIFT is feasible and acceptable among Hispanic adults with epilepsy and demonstrate promising effects on depressive symptoms. Larger trials in geographically diverse samples are warranted.
Data from the 2015 National Health Interview Survey found that the prevalence of active epilepsy has increased to three million adults. Although findings have been mixed, some research indicates that Blacks and Hispanics share a higher burden of epilepsy prevalence compared with non-Hispanic whites. Moreover, depression is a common comorbid condition among people with epilepsy (PWE), affecting up to 55% of the epilepsy population. Widespread use and increased public health impact of evidence-based self-management interventions is critical to reducing disease burden and may require adapting original interventions into more culturally relevant versions for racial and ethnic minority groups. Project UPLIFT provides access to mental health self-management skills training that is distance-delivered, does not interfere with medication management, and has been shown to be effective in reducing depressive symptoms. This paper presents the process of exploring the adaptation of Project UPLIFT for Black and Hispanic PWE and herein suggests that evidence-based interventions can be successfully adapted for new populations or cultural settings through a careful and systematic process. Additional key lessons learned include the importance of community engagement and that language matters. Ultimately, if the adapted Project UPLIFT intervention produces positive outcomes for diverse populations of PWE, it will extend the strategies available to reduce the burden of depression. Implementing evidence-based interventions such as Project UPLIFT is critical to reducing disease burden; however, their delivery may need to be tailored to the needs and culture of the populations of interest.
Introduction: Post-stroke depression (PSD) is estimated to affect one-third of stroke survivors and is associated with long-term disability but scarce data exist in minority populations. This analysis examined the frequency and correlates of PSD in a cohort of Black and Hispanic stroke survivors. Methods: We analyzed baseline data from an ongoing clinical trial comprising 450 Blacks and Hispanics with recent stroke from New York City stroke centers. Participants were interviewed at baseline to assess depressive symptoms using the Patient Reported Outcomes Measurement Information System (PROMIS) Depression Measure. PSD was defined as a PROMIS score ≥55 indicating at least mild depression. Other data collected included demographics, clinical factors, health-related quality of life, functional independence (Barthel Index), stroke-related disability and executive functioning (Frontal Assessment Battery). Results: Data was available for 209 Hispanics and 202 Blacks. The sample was 44% female with average age 61.7±11.1 years. Socioeconomic status was low with 72.6% of participants having annual income <$25,000 and 49.3% having less than high school education. PSD was identified in 32.4% of the sample. In bivariate analyses, participants with vs. without PSD were more likely to be female (54.2% vs. 39.2%, p=.003), on disability (44.0% vs. 25.9%, p<.001) and have annual income <$25,000 (81.6% vs 68.3%, p=.011). Participants with vs. without PSD also had lower baseline systolic BP (146.6±12.0 vs. 150.4±15.9, p=.005), were more likely to have ≥3 comorbid conditions (39.6% vs. 26.3%, p=.014), and had worse scores on all measures of physical disability, functional independence, cognitive function and quality of life (p≤.01). In multivariate analysis, PSD was associated with younger age, lower quality of life and not being married (p<.05). In addition, foreign-born participants were more likely than US-born participants to have PSD (OR=3.34, 95% CI=1.40-7.97, p=.006). Conclusions: PSD was common in this cohort of minority stroke survivors and was associated with cognitive and physical disability. The finding of a higher rate in foreign-born survivors is novel and warrants further research regarding long-term effects of PSD in this population.
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