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New translational strategies are needed to improve diabetes outcomes among low-income African-Americans. Our goal was to develop/pilot test a patient intervention combining culturally tailored diabetes education with shared decision-making training. This was an observational cohort study. Surveys and clinical data were collected at baseline, program completion, and 3 and 6 months. There were 21 participants; the mean age was 61 years. Eighty-six percent of participants attended >70 % of classes. There were improvements in diabetes self-efficacy, self-care behaviors (i.e., following a "healthful eating plan" (mean score at baseline 3.4 vs. 5.2 at program's end; p = 0.002), self glucose monitoring (mean score at baseline 4.3 vs. 6.2 at program's end; p = 0.04), and foot care (mean score at baseline 4.1 vs. 6.0 at program's end; p = 0.001)), hemoglobin A1c (8.24 at baseline vs. 7.33 at 3-month follow-up, p = 0.02), and HDL cholesterol (51.2 at baseline vs. 61.8 at 6-month follow-up, p = 0.01). Combining tailored education with shared decision-making may be a promising strategy for empowering low-income African-Americans and improving health outcomes.

Background Recruiting participants into clinical trials continues to be a challenge, which can result in study delay or termination. Recent studies have used social media to enhance recruitment outcomes. An assessment of the literature on the use of social media for this purpose is required. Objective This study aims to answer the following questions: (1) How is the use of social media, in combination with traditional approaches to enhance clinical trial recruitment and enrollment, represented in the literature? and (2) Do the data on recruitment and enrollment outcomes presented in the literature allow for comparison across studies? Methods We conducted a comprehensive literature search across 7 platforms to identify clinical trials that combined social media and traditional methods to recruit patients. Study and participant characteristics, recruitment methods, and recruitment outcomes were evaluated and compared. Results We identified 2371 titles and abstracts through our systematic search. Of these, we assessed 95 full papers and determined that 33 studies met the inclusion criteria. A total of 17 studies reported enrollment outcomes, of which 9 achieved or exceeded their enrollment target. The proportion of participants enrolled from social media in these studies ranged from 0% to 49%. Across all 33 studies, the proportion of participants recruited and enrolled from social media varied greatly. A total of 9 studies reported higher enrollment rates from social media than any other methods, and 4 studies reported the lowest cost per enrolled participant from social media. Conclusions While the assessment of the use of social media to improve clinical trial participation is hindered by reporting inconsistencies, preliminary data suggest that social media can increase participation and reduce per-participant cost. The adoption of consistent standards for reporting recruitment and enrollment outcomes is required to advance our understanding and use of social media to support clinical trial success.

The Clinical Translation Science Award (CTSA) initiative calls upon academic health centers to engage communities around a clinical research relationship measured ultimately in terms of public health. Among a few initiatives involving university accountability for advancing public interests, a small CTSA workgroup devised a community engagement (CE) logic model that organizes common activities within a university-community infrastructure to facilitate community engagement in research. While the model focuses on the range of institutional CE inputs, it purposefully does not include an approach for assessing how community engagement influences research implementation and outcomes. Rather, with communities and individuals beginning to transition into new research roles, this article emphasizes studying community engagement through specific relationship types and assessing how expanded research teams contribute to the full spectrum of translational science. The authors propose a typology consisting of three relationship types—engagement, collaboration and shared leadership—to provide a foundation for investigating community–academic contributions to the new CTSA research paradigm. The typology shifts attention from specific community–academic activities and, instead, encourages analyses focused on measuring the strength of relationships through variables like synergy and trust. The collaborative study of CE relationships will inform an understanding of CTSA infrastructure development in support of translational research and its goal, which is expressed in the logic model: better science, better answers, better population health.

IMPORTANCE Complex medication regimens pose self-management challenges, particularly among populations with low levels of health literacy. OBJECTIVE To test medication management tools delivered through a commercial electronic health record (EHR) with and without a nurse-led education intervention. DESIGN, SETTING, AND PARTICIPANTS This 3-group cluster randomized clinical trial was performed in community health centers in Chicago, Illinois. Participants included 794 patients with hypertension who self-reported using 3 or more medications concurrently (for any purpose). Data were collected from April 30, 2012, through February 29, 2016, and analyzed by intention to treat. INTERVENTIONS Clinics were randomly assigned to to groups: electronic health record-based medication management tools (medication review sheets at visit check-in, lay medication information sheets printed after visits; EHR-alone group), EHR-based tools plus nurse-led medication management support (EHR plus education group), or usual care. MAIN OUTCOMES AND MEASURES Outcomes at 12 months included systolic blood pressure (primary outcome), medication reconciliation, knowledge of drug indications, understanding of medication instructions and dosing, and self-reported medication adherence. Medication outcomes were assessed for all hypertension prescriptions, all prescriptions to treat chronic disease, and all medications. RESULTS Among the 794 participants (68.6% women; mean [SD] age, 52.7 [9.6] years), systolic blood pressure at 12 months was greater in the EHR-alone group compared with the usual care group by 3.6 mm Hg (95% CI, 0.3 to 6.9 mm Hg). Systolic blood pressure in the EHR plus education group was not significantly lower compared with the usual care group (difference, −2.0 mm Hg; 95% CI, −5.2 to 1.3 mm Hg) but was lower compared with the EHR-alone group (−5.6 mm Hg; 95% CI, −8.8 to −2.4 mm Hg). At 12 months, hypertension medication reconciliation was improved in the EHR-alone group (adjusted odds ratio [OR], 1.8; 95% CI, 1.1 to 2.9) and the EHR plus education group (adjusted odds ratio [OR], 2.0; 95% CI, 1.3 to 3.3) compared with usual care. Understanding of medication instructions and dosing was greater in the EHR plus education group than the usual care group for hypertension medications (OR, 2.3; 95% CI, 1.1 to 4.8) and all medications combined (OR, 1.7; 95% CI, 1.0 to 2.8). Compared with usual care, the EHR tools alone and EHR plus education interventions did not improve hypertension medication adherence (OR, 0.9; 95% CI, 0.6-1.4 for both) or knowledge of chronic drug indications (OR for EHR tools alone, 1.0 [95% CI, 0.6 to 1.5] and OR for EHR plus education, 1.1 [95% CI, 0.7-1.7]). CONCLUSIONS AND RELEVANCE The study found that EHR tools in isolation improved medication reconciliation but worsened blood pressure. Combining these tools with nurse-led support suggested improved understanding of medication instructions and dosing but did not lower blood pressure compared with usual care. TRIAL REGISTRATION ClinicalTrials.gov identifier: N...

BackgroundThe high prevalence of major depressive disorder in adolescents and the low rate of successful treatment highlight a pressing need for accessible, affordable adolescent depression prevention programs. The Internet offers opportunities to provide adolescents with high quality, evidence-based programs without burdening or creating new care delivery systems. Internet-based interventions hold promise, but further research is needed to explore the efficacy of these approaches and ways of integrating emerging technologies for behavioral health into the primary care system.Methods/DesignWe developed a primary care Internet-based depression prevention intervention, Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training (CATCH-IT), to evaluate a self-guided, online approach to depression prevention and are conducting a randomized clinical trial comparing CATCH-IT to a general health education Internet intervention. This article documents the research framework and randomized clinical trial design used to evaluate CATCH-IT for adolescents, in order to inform future work in Internet-based adolescent prevention programs. The rationale for this trial is introduced, the current status of the study is reviewed, and potential implications and future directions are discussed.DiscussionThe current protocol represents the only current, systematic approach to connecting at-risk youth with self-directed depression prevention programs in a medical setting. This trial undertakes the complex public health task of identifying at-risk individuals through mass screening of the general primary care population, rather than solely relying on volunteers recruited over the Internet, and the trial design provides measures of both symptomatic and diagnostic clinical outcomes. At the present time, we have enrolled N = 234 adolescents/expected 400 and N = 186 parents/expected 400 in this trial, from N = 6 major health systems. The protocol described here provides a model for a new generation of interventions that blend substantial computer-based instruction with human contact to intervene to prevent mental disorders such as depression. Because of the potential for broad generalizability of this model, the results of this study are important, as they will help develop the guidelines for preventive interventions with youth at-risk for the development of depressive and other mental disorders.Trial registrationClinical Trial Registry: NCT01893749 date 6 May 2012.

Background: The institutions which comprise the Clinical and Translational Science Award consortium and the National Center for Advancing Translational Sciences continue to explore and develop community engaged research strategies and to study the role of community academic partnerships in advancing the science of community engagement. Objectives: To explore Clinical and Translational Science institutions (CTSA) in relation to an Institute of Medicine recommendation that community engagement occur in all stages of translational research and be defined and evaluated consistently. Methods: A sequential multi-methods study starting with an online pilot survey followed by survey respondents and site informant interviews. A revised survey was sent to the community engagement and evaluation leads at each CTSA institution, requesting a single institutional response about definitions, indicators and metrics of community engagement and community-engaged research. Results: A plurality of CTSA institutions selected the definition of community engagement from the Principles of Community Engagement. While claiming unique institutional priorities create barriers to developing shared metrics, responses indicate an overall lack of attention to the development and deployment of metrics to assess community engagement in and contributions to research. Conclusions: Although definitions of community engagement differ among CTSAs, there appears more similarities than differences in the indicators and measures tracked and reported on across all definitions, perhaps due to commonalities among program infrastructures and goals. Metrics will likely need to be specific to translational research stages. Assessment of community engagement within translational science will require increased institutional commitment.

Community-based participatory research (CBPR) partnerships exist as complex, dynamic relationships that incorporate shared decision that supports trust development between communities and academics. Within CBPR, the interest in understanding the concept of trust has grown with the realization that, without trust, CBPR relationships fracture. A barrier to monitoring the trust health of a partnership is the lack of a shared operationalization of the concept, its antecedents, and measurement tools. To address these barriers, a six-category trust typology was created as a developmental theory of trust progress. To advance the theory, this article reports on the quantitative structural elements of the trust typology, identifies variability in trust correlates, and creates an empirical foundation for the trust types. Using Engage for Equity data, trust covariates included measures of synergy, CBPR principles, participation, and influence. Structural equation models were used to assess associations between trust types and the latent constructs measured by the items in each measure. The findings demonstrate that the six trust types generally operate on a continuum. Specifically, it does appear that trust deficit, role-based trust, functional trust, proxy trust, and reflective trust are on a single continuum from low to high. Scale scores for reflective trust and proxy trust were consistently and statistically significantly higher than those for functional trust, role-based, neutral, and trust deficit. These results support the construct validity of the trust typology as representing “higher levels” of trust phases. Due to the dynamic nature of partnerships, regular monitoring of partnership trust types can serve as a proxy for partnership functioning.