Project ACTIVE: a Randomized Controlled Trial of Personalized and Patient-Centered Preventive Care in an Urban Safety-Net Setting.

BACKGROUND: Evidence-based preventive care in the USA is underutilized, diminishing population health and worsening health disparities. We developed Project ACTIVE, a program to improve adherence with preventive care goals through personalized and patient-centered care. OBJECTIVE: To determine whether Project ACTIVE improved utilization of preventive care and/or estimated life expectancy compared to usual care. DESIGN: Single-site randomized controlled trial. PARTICIPANTS: Cluster-randomized 140 English or Spanish speaking adult patients in primary care with at least one of twelve unfulfilled preventive care goals based on USPSTF grade A and B recommendations. INTERVENTION: Project ACTIVE employs a validated mathematical model to predict and rank individualized estimates of health benefit that would arise from improved adherence to different preventive care guidelines. Clinical staff engaged the participant in a shared medical decision-making (SMD) process to identify highest priority unfulfilled clinical goals, and health coaching staff engaged the participant to develop and monitor action steps to reach those goals. MAIN MEASURES: Change in number of unfulfilled preventive care goals from USPSTF grade A and B recommendations and change in overall gain in estimated life expectancy. KEY RESULTS: In an intent-to-treat analysis, Project ACTIVE increased the average number of fulfilled preventive care goals out of 12 by 0.68 in the intervention arm compared with 0.15 in the control arm (mean difference [95% CI] 0.53 [0.19-0.86]), yielding a gain in estimated life expectancy of 8.8 months (3.8, 14.2). In a per-protocol analysis, Project ACTIVE increased fulfilled preventive care goals by 0.80 in the intervention arm compared with 0.16 in the control arm (mean difference [95% CI], 0.65 [0.25-1.04]), yielding a gain in estimated life expectancy of 13.7 months (6.2, 21.2). Among the 12 preventive care goals, more improvement occurred for alcohol use, hypertension, hyperlipidemia, depression, and smoking. CONCLUSIONS: Project ACTIVE improved unfulfilled preventive care goals and improved estimated life expectancy. CLINICAL TRIAL REGISTRATION NUMBER: NCT04211883.

"Always on the go": A qualitative study of the perceptions of cardiovascular disease risk among Latino cab drivers.

BACKGROUND: The taxicab industry is a burgeoning occupation that predominantly employs immigrant males from low socioeconomic backgrounds. Factors such as sedentary nature, environmental factors, high stress coupled with socioeconomic factors may increase cardiovascular disease risk among taxicab drivers. Latinos, a growing immigrant population make up approximately 20% of this industry. However, few studies focus on their experiences as cab drivers or on the factors that may increase their cardiovascular risks. METHODS: This was an ethnographic qualitative study. Data was collected via individual interviews combined with Go-Alongs. The Go-Along is an observational qualitative method whereby researchers accompany participants during routine activities and make observations. Interviews and observations were transcribed and coded to identify emerging themes. RESULTS: Thirty-two Latino male cab drivers participated; their mean age was 45 + 12 years; 47% did not finish high school; and 63% earned $30 000 or less. Time and stress emerged as dominant themes. Time constraints posed a barrier to healthy eating and physical activity. Drivers reported stress from constantly worrying about their finances and personal safety. Drivers also described stress from the physical toll of driving on the body. Go-Alongs supported these themes and identified social interactions and environmental factors that could be leveraged for health promotion. CONCLUSIONS: This study provided an opportunity for cab drivers to describe their perspectives on reasons why their occupation was associated with a high risk for cardiovascular disease. The Go-Alongs contributed to the understanding of the social and environmental context that characterized cardiovascular risks in this occupation.

Knowledge and use of recruitment support tools among study coordinators at an academic medical center: The Novel Approaches to Recruitment Planning Study.

BACKGROUND: Study coordinators play an essential role on study teams; however, there remains a paucity of research on the supports and services they need to effectively recruit and retain study participants. METHODS: A cross-sectional survey was conducted with 147 study coordinators from a large academic medical center. Survey items assessed barriers and facilitators to recruitment and retention, anxiety about reaching enrollment numbers, confidence for talking to potential study participants about research involvement, awareness and use of CTSA resources, and PI involvement with recruitment planning. RESULTS: Significant associations were found between anxiety about reaching target enrollment numbers and whether the study coordinator was the primary person responsible for developing a recruitment strategy. Three years or more serving as a study coordinator and levels of anxiety for reaching enrollment numbers was also significant. CONCLUSION: More institutional level supports and formal training opportunities are needed to enhance study coordinators' effectiveness to recruit participants.

Mobile Phone Ownership, Health Apps, and Tablet Use in US Adults With a Self-Reported History of Hypertension: Cross-Sectional Study.

BACKGROUND: Mobile phone and tablet ownership have increased in the United States over the last decade, contributing to the growing use of mobile health (mHealth) interventions to help patients manage chronic health conditions like diabetes. However, few studies have characterized mobile device ownership and the presence of health-related apps on mobile devices in people with a self-reported history of hypertension. OBJECTIVE: This study aimed to describe the prevalence of smartphone, tablet, and basic mobile phone ownership and the presence of health apps by sociodemographic factors and self-reported hypertension status (ie, history) in a nationally representative sample of US adults, and to describe whether mobile devices are associated with health goal achievement, medical decision making, and patient-provider communication. METHODS: Data from 3285 respondents from the 2017 Health Information National Trends Survey were analyzed. Participants were asked if they owned a smartphone, tablet, or basic mobile phone and if they had health apps on a smartphone or tablet. Participants were also asked if their smartphones or tablets helped them achieve a health-related goal like losing weight, make a decision about how to treat an illness, or talk with their health care providers. Chi-square analyses were conducted to test for differences in mobile device ownership, health app presence, and app helpfulness by patient characteristics. RESULTS: Approximately 1460 (37.6% weighted prevalence) participants reported a history of hypertension. Tablet and smartphone ownership were lower in participants with a history of hypertension than in those without a history of hypertension (55% vs 66%, P=.001, and 86% vs 68%, P<.001, respectively). Participants with a history of hypertension were more likely to own a basic mobile phone only as compared to those without a history of hypertension (16% vs 9%, P<.001). Among those with a history of hypertension exclusively, basic mobile phone, smartphone, and tablet ownership were associated with age and education, but not race or sex. Older adults were more likely to report having a basic mobile phone only, whereas those with higher education were more likely to report owning a tablet or smartphone. Compared to those without a history of hypertension, participants with a history of hypertension were less likely to have health-related apps on their smartphones or tablets (45% vs 30%, P<.001) and report that mobile devices helped them achieve a health-related goal (72% vs 63%, P=.01). CONCLUSIONS: Despite the increasing use of smartphones, tablets, and health-related apps, these tools are used less among people with a self-reported history of hypertension. To reach the widest cross-section of patients, a mix of novel mHealth interventions and traditional health communication strategies (eg, print, web based, and in person) are needed to support the diverse needs of people with a history of hypertension.

Results from the Trial Using Motivational Interviewing, Positive Affect, and Self-Affirmation in African Americans with Hypertension (TRIUMPH).

OBJECTIVE: Our objective was to determine the effectiveness of combining positive affect and self-affirmation strategies with motivational interviewing in achieving blood pressure control among hypertensive African Americans (AA) compared with AA hypertensives in an education-only control group. DESIGN: Randomized trial. SETTING: Ambulatory practices in the South Bronx and Harlem, New York City. PARTICIPANTS: African American adults with uncontrolled hypertension. INTERVENTIONS: Participants were randomized to a positive affect and self-affirmation intervention or an education control group. The positive affect and self-affirmation intervention involved having participants think about things that made them happy and that reminded them of their core values on a daily basis. These strategies were reinforced every two months through motivational interviewing. The control arm received a workbook of strategies on blood pressure control. All participants were called every two months for one year. MAIN OUTCOMES: Blood pressure control rate. RESULTS: A total of 238 participants were randomized. The average age was 56 ± 11 years, approximately 70% were female, 80% were not married, and up to 70% had completed high school. There was no difference in control rates between the intervention and the control group. However, at one year, female participants were more likely to be controlled. Participants with high depressive symptoms or high perceived stress at baseline were less likely to be controlled. CONCLUSIONS: While this study did not demonstrate an intervention effect, it does provide important insight into the psychosocial factors that may underlie blood pressure control in African Americans. Implications for future behavioral intervention trials are discussed.

Ethical considerations for conducting health disparities research in community health centers: a social-ecological perspective.

Community health centers (CHCs) provide optimal research settings. They serve a high-risk, medically underserved population in the greatest need of intervention. Low socioeconomic status renders this population particularly vulnerable to research misconduct. Traditional principles of research ethics are often applied to participants only. The social-ecological model offers a comprehensive framework for applying these principles across multiple levels (participants, providers, organizations, communities, and policy). Our experience with the Trial Using Motivational Interviewing, Positive Affect and Self-Affirmation in African-Americans with Hypertension, a randomized trial conducted in CHCs, led us to propose a new platform for discussing research ethics; examine the social, community, and political factors surrounding research conducted in CHCs; and recommend how future research should be conducted in such settings.

The Trial Using Motivational Interviewing and Positive Affect and Self-Affirmation in African-Americans with Hypertension (TRIUMPH): from theory to clinical trial implementation.

This paper describes the application of a translational research model in developing The Trial Using Motivational Interviewing and Positive Affect and Self-Affirmation in African-Americans with Hypertension (TRIUMPH), a theoretically-based, randomized controlled trial. TRIUMPH targets blood pressure control among African-Americans with hypertension in a community health center and public hospital setting. TRIUMPH applies positive affect, self-affirmation, and motivational interviewing as strategies to increase medication adherence and blood pressure control. A total of 220 participants were recruited in TRIUMPH and are currently being followed. This paper provides a detailed description of the theoretical framework and study design of TRIUMPH and concludes with a critical reflection of the lessons learned in the process of implementing a health behavior intervention in a community-based setting. TRIUMPH provides a model for incorporating the translational science research paradigm to conducting pragmatic behavioral trials in a real-world setting in a vulnerable population. Lessons learned through interactions with our community partners reinforce the value of community engagement in research.