Health Disparities, Clinical Trials, and the Digital Divide Thematic Reviews on Forward Thinking on Clinical Trials in Clinical Practice

In the last few years, there have been rapid advances in technology and the use of digital tools in healthcare and clinical research. While these innovations have immense potential to improve healthcare delivery and outcomes, there are genuine concerns related to inadvertent widening of the digital gap consequentially exacerbating health disparities. As such, it is important that we critically evaluate the impact of expansive digital transformation in medicine and clinical research on health equity. For digital solutions to truly improve the landscape of healthcare and clinical trial participation for all persons in an equitable way, targeted interventions to address historical injustices, structural racism, as well as social and digital determinants of health are essential. The urgent need to focus on interventions to promote health equity was made abundantly clear with the COVID-19 pandemic which magnified long-standing social and racial health disparities.

Facebook Intervention to Connect Alaska Native People with Resources and Support to Quit Smoking: CAN Quit Pilot Randomized Controlled Trial.

INTRODUCTION: There is some evidence that social media interventions can promote smoking cessation. This randomized controlled pilot study is the first to evaluate the feasibility and potential efficacy of a Facebook smoking cessation intervention among Alaska Native adults. METHODS: Recruitment and data collection occurred December 2019-March 2021. Participants were recruited statewide in Alaska using Facebook advertisements with a targeted sample of 60 enrolled. Participants were stratified by gender, age, and rural/urban residence and randomly assigned to receive referral resources on evidence-based cessation treatments (EBCTs) (control, n=30) or these resources plus a three-month, closed/private, culturally tailored, Facebook group (intervention, n=31) that connected participants to EBCT resources and was moderated by two Alaska Native Trained Tobacco Specialists. Assessments were conducted online post-randomization at one, three, and six months. Outcomes were feasibility (recruitment, retention, intervention engagement), self-reported use of EBCTs, and biochemically confirmed seven-day point-prevalence smoking abstinence. RESULTS: Of intervention participants, 90% engaged (e.g., posted, commented) more than once. Study retention was 57% at six months (no group differences). The proportion utilizing EBCTs was about double for intervention compared with the control group participants at three and six months. Smoking abstinence was higher for intervention than control participants at three months (6.5% vs. 0%, p=0.16) but comparable at six months (6.4% vs. 6.7%, p=0.97). CONCLUSIONS: While additional research is needed to promote long-term cessation, this pilot trial supports recruitment feasibility during the COVID-19 pandemic, consumer uptake, and a signal for intervention efficacy on the uptake of cessation treatment and short-term smoking abstinence. IMPLICATIONS: This study is the first evaluation of a social media intervention for smoking cessation among Indigenous people. We learned that statewide Facebook recruitment of Alaska Native adults who smoke was feasible and there was a signal for the efficacy of a Facebook intervention on the uptake of evidence-based cessation treatment and short-term (three months) biochemically verified smoking abstinence. Clinically, social media platforms may complement current care models by connecting Alaska Native individuals and others living in hard-to-reach communities to cessation treatment resources.

Exploring the perceived effectiveness and cultural acceptability of COVID-19 relevant social media intervention content among Alaska Native people who Smoke: The CAN Quit study.

Social media platforms have potential for reach and effectiveness to motivate smoking cessation and use of evidence-based cessation treatment, even during the worldwide COVID-19 pandemic. This study builds on our prior community participatory approach to developing content postings for the CAN Quit Facebook intervention among Alaska Native (AN) people who smoke. With input from a community advisory committee, we selected new content on COVID-19 preventive practices (e.g., masking) and evaluated them using a validated, six-item perceived effectiveness scale and a single item assessing cultural relevance. We obtained feedback on six content postings (two videos and four text/pictures) from an online survey administered to 41 AN people (14 men, 27 women; age range 22-61 years) who smoke in Alaska statewide with 49 % residing in rural Alaska. Perceived effectiveness scale scores were high across postings, ranging from 3.9 to 4.4 out of a maximum score of 5.0. Cultural relevance item scores ranged from 3.9 to 4.3. We found no appreciable differences by sex, age, or rural/urban location for either score. This study adds new information on the adaptation, acceptability, and perceived effectiveness of content on COVID-19 preventive practices for future inclusion in a social media-based intervention for smoking cessation specifically tailored for AN people.

Factors Facilitating Academic-Community Research Partnerships With African American Churches: Recruitment Process for a Community-Based, Cluster Randomized Controlled Trial During the COVID-19 Pandemic.

African American (AA) churches are valuable partners in implementing health promotion programming (HPP) to combat health disparities. The study purpose was to evaluate AA church characteristics associated with enrollment into the FAITH! (Fostering African American Improvement in Total Health) Trial, a community-based, cluster randomized controlled trial (RCT) of a mobile health intervention for cardiovascular health promotion among AA churches. Churches located in Minneapolis-St. Paul and Rochester, Minnesota were invited to complete an electronic screening survey and follow-up telephone interview including the PREACH (Predicting Readiness to Engage African American Churches in Health) tool to assess church characteristics and infrastructure for HPP. The primary outcome was church enrollment in the FAITH! Trial. Key predictors included overall PREACH scores and its subscales (Personnel, Physical Structure, Faith-based Approach, Funding), congregation size, and mean congregation member age. Of the 26 churches screened, 16 (61.5%) enrolled in the trial. The enrolled churches had higher overall mean PREACH scores (36.1 vs. 30.2) and subscales for Personnel (8.8 vs. 5.6), Faith-based Approach (11.0 vs. 9.6), and Funding (7.3 vs. 4.8) compared with non-enrolled churches; all differences were not statistically significant due to small sample size. Twelve (75.0%) of the enrolled churches had >75 members versus six (60.0%) of the non-enrolled churches. Twelve (80.0%) of the enrolled churches had an average congregation member age ≤54 years versus six (67.0%) of the non-enrolled churches. AA churches enrolling into a community-based RCT reported greater infrastructure for HPP, larger congregations, and members of younger age. These characteristics may be helpful to consider among researchers partnering with AA churches for HPP studies.

Midwest rural-urban disparities in use of patient online services for COVID-19.

PURPOSE: Rural populations are disproportionately affected by the COVID-19 pandemic. We characterized urban-rural disparities in patient portal messaging utilization for COVID-19, and, of those who used the portal during its early stage in the Midwest. METHODS: We collected over 1 million portal messages generated by midwestern Mayo Clinic patients from February to August 2020. We analyzed patient-generated messages (PGMs) on COVID-19 by urban-rural locality and incorporated patients' sociodemographic factors into the analysis. FINDINGS: The urban-rural ratio of portal users, message senders, and COVID-19 message senders was 1.18, 1.31, and 1.79, indicating greater use among urban patients. The urban-rural ratio (1.69) of PGMs on COVID-19 was higher than that (1.43) of general PGMs. The urban-rural ratios of messaging were 1.72-1.85 for COVID-19-related care and 1.43-1.66 for other health care issues on COVID-19. Compared with urban patients, rural patients sent fewer messages for COVID-19 diagnosis and treatment but more messages for other reasons related to COVID-19-related health care (eg, isolation and anxiety). The frequent senders of COVID-19-related messages among rural patients were 40+ years old, women, married, and White. CONCLUSIONS: In this Midwest health system, rural patients were less likely to use patient online services during a pandemic and their reasons for its use differ from urban patients. Results suggest opportunities for increasing equity in rural patient engagement in patient portals (in particular, minority populations) for COVID-19. Public health intervention strategies could target reasons why rural patients might seek health care in a pandemic, such as social isolation and anxiety.

Development and initial cognitive testing of the Digital Equity Screening Tool (DEST): Community participatory approach to assessing digital inequality.

COVID-19 has widened the existing digital divide, especially for people from socially and economically deprived communities. We describe a program evaluation using a community participatory approach to develop self-reported items of patient experience with technology inclusive of digital access and literacy. The feedback received from Community Advisory Boards and Community Engagement Studio members led to the evaluation and refinement of the individual items. The community-based participatory approach highlighted in our paper to develop these items could serve as a model for other screening tool development for enhancing equity and inclusiveness in clinical care and research.

A Need for Digitally Inclusive Health Care Service in the United States: Recommendations for Clinicians and Health Care Systems.

The COVID-19 pandemic led to digital health service expansion that widened the existing digital divide. Residing in areas of limited broadband internet connectivity, lacking access to smart devices, and/or having low digital health literacy (ease, comfort, and skills to use technology) pose barriers to receiving health care remotely. This unequal access to health care is further exacerbated for older adults, those with lower income and less education, racial and ethnic minorities, and those who do not speak English. Because an individual's digital access (broadband internet connectivity and access to smart devices) and literacy can affect health care quality and outcomes, it is proposed that those 2 factors should be categorized as a key domain of social determinants of health. In this commentary, the authors highlight digital access and literacy barriers in the context of the United States health care service delivery. They underscore the importance of screening every patient during regular clinical visits for digital access and literacy as social determinants of health, using the electronic health record. The authors believe this will enhance digital health care by creating a more person-centered, inclusive method for clinicians and health care systems to digitally connect to patients of all backgrounds.

Rural Patient Experiences of Accessing Care for Chronic Conditions: A Systematic Review and Thematic Synthesis of Qualitative Studies.

PURPOSE: Access to health care is a long-standing concern for rural patients; however, administrative measures fail to capture the subjective patient experience of accessing health care. The purpose of this review was to synthesize the qualitative literature on patient and caregiver experiences of accessing health care services for chronic disease management among US residents of rural areas. METHODS: We searched Embase, MEDLINE, PsycInfo, CINAHL, and Scopus to identify qualitative studies published during 2010-2019. A thematic synthesis approach was used to analyze findings from included studies. RESULTS: A total of 62 studies involving 1,354 unique participants were included. The largest share of studies (24.2%) was focused on the experience of patients with cancer, followed by behavioral health (16.1%), HIV and AIDS (14.5%), and diabetes (12.9%). We identified 4 primary analytic themes of barriers and facilitators associated with the experience of accessing health care services for chronic disease management in rural areas: (1) navigating the rural environment, (2) navigating the health care system, (3) financing chronic disease management, and (4) rural life (ie, common elements of a distinct "rural" way of thinking and behaving). CONCLUSIONS: In this comprehensive review, we found that important cultural, structural, and individual factors influenced the rural patient's experience of health care access and use, including barriers and facilitators posed by geographic and built environments, and distinct rural mores. Our findings can inform policies and programs that both facilitate structural aspects of access and include culturally appropriate interventions.VISUAL ABSTRACT.

Patient Telemedicine Perceptions During the COVID-19 Pandemic Within a Multi-State Medical Institution: Qualitative Study

Background: During the COVID-19 pandemic, to prevent the spread of the virus, federal regulatory barriers around telemedicine were lifted, and health care institutions encouraged patients to use telemedicine, including video appointments. Many patients, however, still chose face-2-face (f2f) appointments for nonemergent clinical care. Objective: We explored patients’ personal and environmental barriers to the use of video appointments from April 2020 to December 2020. Methods: We conducted qualitative telephone interviews of Mayo Clinic patients who attended f2f appointments at the Mayo Clinic from April 2020 to December 2020 but did not utilize Mayo Clinic video appointment services during that time frame. Results: We found that, although most patients were concerned about preventing COVID-19 transmission, they trusted Mayo Clinic to keep them safe when attending f2f appointments. Many expressed that a video appointment made it difficult to establish rapport with their providers. Other common barriers to video appointments were perceived therapeutic benefits of f2f appointments, low digital literacy, and concerns about privacy and security. Conclusions: Our study provides an in-depth investigation into barriers to engaging in video appointments for nonemergent clinical care in the context of the COVID-19 pandemic. Our findings corroborate many barriers prevalent in the prepandemic literature and suggest that rapport barriers need to be analyzed and problem-solved at a granular level.

Role of geographic risk factors and social determinants of health in COVID-19 epidemiology: Longitudinal geospatial analysis in a midwest rural region

Background:Studies examining the role of geographic factors in coronavirus disease-2019 (COVID-19) epidemiology among rural populations are lacking.Methods:Our study is a population-based longitudinal study based on rural residents in four southeast Minnesota counties from March through October 2020. We used a kernel density estimation approach to identify hotspots for COVID-19 cases. Temporal trends of cases and testing were examined by generating a series of hotspot maps during the study period. Household/individual-level socioeconomic status (SES) was measured using the HOUSES index and examined for association between identified hotspots and SES.Results:During the study period, 24,243 of 90,975 residents (26.6%) were tested for COVID-19 at least once;1498 (6.2%) of these tested positive. Compared to other rural residents, hotspot residents were overall younger (median age: 40.5 vs 43.2), more likely to be minorities (10.7% vs 9.7%), and of higher SES (lowest HOUSES [SES] quadrant: 14.6% vs 18.7%). Hotspots accounted for 30.1% of cases (14.5% of population) for rural cities and 60.8% of cases (27.1% of population) for townships. Lower SES and minority households were primarily affected early in the pandemic and higher SES and non-minority households affected later.Conclusion:In rural areas of these four counties in Minnesota, geographic factors (hotspots) play a significant role in the overall burden of COVID-19 with associated racial/ethnic and SES disparities, of which pattern differed by the timing of the pandemic (earlier in pandemic vs later). The study results could more precisely guide community outreach efforts (e.g., public health education, testing/tracing, and vaccine roll out) to those residing in hotspots.

Use of Live Community Events on Facebook to Share Health and Clinical Research Information With a Minnesota Statewide Community: Exploratory Study.

BACKGROUND: Community engagement can make a substantial difference in health outcomes and strengthen the capacity to deal with disruptive public health events such as the COVID-19 pandemic. Social media platforms such as Facebook are a promising avenue to reach the broader public and enhance access to clinical and translational science, and require further evaluation from the scientific community. OBJECTIVE: This study aims to describe the use of live community events to enhance communication about clinical and health research through a Facebook platform case study (Minnesota [MN] Research Link) with a Minnesota statewide community. We examined variables associated with video engagement including video length and type of posting. METHODS: From June 2019 to February 2021, MN Research Link streamed 38 live community events on its public Facebook page, MN Research Link. Live community events highlighted different investigators' clinical and health research in the areas of mental health, health and wellness, chronic diseases, and immunology/infectious diseases. Facebook analytics were used to determine the number of views, total minutes viewed, engagement metrics, and audience retention. An engagement rate was calculated by the total number of interactions (likes, shares, and comments) divided by the total length of the live event by the type of live community event. RESULTS: The 38 live community events averaged 23 minutes and 1 second in duration. The total time viewed for all 38 videos was 10 hours, 44 minutes, and 40 seconds. Viewers' watch time averaged 23 seconds of content per video. After adjusting for video length, promotional videos and research presentations had the highest engagement and retention rates. Events that included audience participation did not have higher retention rates compared to events without audience participation. CONCLUSIONS: The use of live community events showed adequate levels of engagement from participants. A view time of 23 seconds on average per video suggests that short informational videos engage viewers of clinical and translational science content. Live community events on Facebook can be an effective method of advancing health promotion and clinical and translational science content; however, certain types of events have more impact on engagement than others.

Pilot Social Network Weight Loss Intervention With Two Immigrant Populations During the COVID-19 Pandemic.

PURPOSE: To examine the feasibility and acceptability of a social network weight loss intervention delivered by lay health promoters (HPs) to immigrant populations. DESIGN: Single-arm, non-randomized, pilot study of a social network weight loss intervention developed by a community-based participatory research partnership and delivered by HPs. SETTING: Community-based setting in Southeastern Minnesota, United States. SAMPLE: Somali and Hispanic immigrants to the United States: 4 social networks of adults (2 Hispanic and 2 Somali) with 39 network participants. INTERVENTION: Twelve-week behavioral weight loss intervention delivered by HPs (4 weeks in-person and then 8 weeks virtual). MEASURES: Feasibility was assessed by recruitment and retention rates. Acceptability was assessed by surveys and focus groups with HPs and participants. Behavioral measures included servings of fruits and vegetables, drinking soda, and physical activity. Physiologic measures included weight, blood pressure, glucose, cholesterol, and triglycerides. ANALYSIS: Paired t-tests of pre- to post-intervention changes at the end of 12 weeks of treatment. RESULTS: Recruitment was feasible and post-intervention was 100%. Participants highly rated the intervention on satisfaction, motivation, and confidence to eat a healthy diet, be physically active, and lose weight. Participants were motivated by group social support and cohesion of their social networks. On average, participants lost weight (91.6 ± 15.9 to 89.7 ± 16.6 kg, P < .0001), lowered their systolic blood pressure (133.9±16.9 to 127.2 ± 15.8 mm Hg; P < .001), lowered their diastolic blood pressure (81 ± 9.5 to 75.8 ± 9.6 mm Hg; P < .0001), had more servings of vegetables per day (1.9 ± 1.2 to 2.6 ± 1.4; P < .001), and increased their physical activity (2690 ± 3231 to 6595 ± 7322 MET-minutes per week; P = .02). CONCLUSION: This pilot study of 2 immigrant communities who participated in a peer-led weight loss social network intervention delivered during the COVID-19 pandemic demonstrated high feasibility and acceptability. Participants lost weight, improved their health status, and improved their health behaviors.

Community-based, cluster-randomized pilot trial of a cardiovascular mHealth intervention: Rationale, design, and baseline findings of the FAITH! Trial.

BACKGROUND: Compared to whites, African-Americans have lower prevalence of ideal cardiovascular health (CVH) based on the American Heart Association Life's Simple 7 (LS7). These CVH inequities have worsened during the COVID-19 pandemic. Ideal LS7 health-promoting behaviors and biological risk factors (eg, diet, blood pressure) are associated with improved CVH outcomes. The FAITH! (Fostering African-American Improvement in Total Health) App, a community-informed, mobile health (mHealth) intervention, previously demonstrated significant improvements in LS7 components among African-Americans, suggesting that mHealth interventions may be effective in improving CVH. This paper presents the FAITH! Trial design, baseline findings, and pandemic-related lessons learned. METHODS: Utilizing a community-based participatory research approach, this study assessed the feasibility/preliminary efficacy of a refined FAITH! App for promoting LS7 among African-Americans in faith communities using a cluster, randomized controlled trial. Participants received the FAITH! App (immediate intervention) or were assigned to a delayed intervention comparator group. Baseline data were collected via electronic surveys and health assessments. Primary outcomes are change in LS7 score from baseline to 6-months post-intervention and app engagement/usability. RESULTS: Of 85 enrolled individuals, 76 completed baseline surveys/health assessments, for a participation rate of 89% (N = 34 randomized to the immediate intervention, N = 42 to delayed intervention). At baseline, participants were predominantly female (54/76, 71%), employed (56/76, 78%) and of high cardiometabolic risk (72/76, 95% with hypertension and/or overweight/obesity) with mean LS7 scores in the poor range (6.8, SD = 1.9). CONCLUSIONS: The FAITH! Trial recruitment was feasible, and its results may inform the use of mHealth tools to increase ideal CVH among African-Americans.

Factors associated with willingness to wear a mask to prevent the spread of COVID-19 in a Midwestern Community.

OBJECTIVE: To identify motivators and barriers to wearing a mask to prevent COVID-19. PARTICIPANTS AND METHODS: An anonymous, online survey of adults from Southeastern Minnesota conducted August 2020. We assessed willingness to wear a mask and its associations with socio-demographics, COVID-19-related factors and prevention behaviors using multivariable ordinal logistic regression. RESULTS: Of 7,786 respondents (78% women, 51% rural), 9% reported 'not at all willing', 27% 'willing', and 64% 'very willing' to wear a mask. Factors independently associated with willingness to wear a mask were: urban residence (OR = 1.23, 95% CI 1.05-1.44, p = 0.009); college degree or greater (OR 1.42, CI 1.05-1.93, p = 0.025); age (18-29 years OR 1.29, CI 01.02-1.64, p = 0.038; 30-39 OR = 1.37, CI 1.12-1.69, p = 0.003; 60-69 OR = 1.44, CI 1.09-1.91, p = 0.011; 70-89 OR 2.09, CI 1.32-3.37, p = 0.002; 40-49 reference group); and (all p < 0.001) democratic party affiliation (OR 1.79, CI 1.40-2.29), correct COVID-19 knowledge (OR 1.50, CI 1.28-1.75), 5 + COVID-19 prevention behaviors (OR 2.74, CI 1.98-3.81), positive perceived impacts for wearing a mask (OR 1.55, 1.52-1.59), perceived COVID-19 severity (OR 2.1, CI 1.44-3.1), and greater stress (OR 1.03, CI 1.02-1.04), and trust in the Centers for Disease Control (CDC) (OR 1.78, CI 1.45 -2.19). CONCLUSION: Results from this sample of SEMN residents suggest interventions to enhance COVID-19 knowledge, positive expectations for mask wearing, and trust in the CDC are warranted. Research is needed to understand cultural and other barriers and facilitators among sub-populations, e.g., rural residents less willing to wear a mask.

Views and experiences of youth participants in a pediatric advisory board for human subjects research

Introduction:Community Advisory Boards (CABs) are typically comprised of adult community members who provide feedback on health-related, adult-focused research. Few, if any, CABs comprised of youth participants exist. In 2019, a Midwest medical center recruited a diverse group of 18 11–17-year-old community members to a Pediatric Advisory Board (PAB) to provide feedback on the recruitment and involvement of minors in research.Methods:Semi-structured interviews with n = 12 PAB members were conducted to understand their experiences and views on participating in the PAB. Parents (n = 7) were interviewed separately to assess the congruence of views on PAB membership between parents and their children. Interview transcripts were qualitatively analyzed to identify iterative themes.Results:PAB members thought the PAB addressed an unmet need of soliciting feedback from youth to develop age-appropriate study materials and to understand potential concerns of young participants. While PAB members expressed interest in the research topics presented by researchers, a few members indicated barriers to full participation, including lack of self-confidence, anxiety, and discomfort sharing opinions in a group setting. Parents supported their child’s PAB participation and hoped it would help them build confidence in developing and sharing their opinions in ways that were meaningful for them, which PAB members largely reported occurring over their period of involvement.Conclusion:Findings from a novel Midwest PAB indicated benefits to PAB members. While contributing to pediatric research planning by providing feedback on recruiting youth and improving study protocols, they gained confidence in providing opinions on biomedical research and developed their scientific literacy.

Feasibility of a virtual Facebook community platform for engagement on health research.

INTRODUCTION: Community engagement is important for advancing Clinical and Translational Science (CTS), but face-to-face engagement has limited reach and scale. We examined the feasibility of a novel virtual Facebook community platform for public engagement on health research statewide in Minnesota. METHODS: The Facebook platform, MN Research Link, was evaluated from June 19, 2019 to June 30, 2020. Facebook advertisements and boosts were used to recruit followers. Content, based on prior formative work, included health research information and interactive postings (e.g., live interviews with researchers). Standard metrics obtained from Facebook analytics included participation (followers), content reach (views), and engagement (likes, shares, comments, clicks). RESULTS: During the 12-month period, we acquired 1406 followers (31% rural residents), with a retention of followers of 99.7%. Mean number of views per month was 9379.83 (Mdn = 2791, range 724-41,510). Engagement metrics indicated a mean of 535.2 likes, shares, comments, and/or clicks per month (Mdn = 296.5, range 55-1535). The page continued to acquire new followers, but a slight decrease in engagement was observed in the final months after state COVID-19 mitigation strategies were implemented. CONCLUSION: As the complexity of CTS continues to grow, along with social distancing measures resulting from the COVID-19 pandemic, the availability of virtual digital platforms to reach and engage community stakeholders in conversations about health and research has increasing importance. Preliminary findings from this program evaluation indicate that a Facebook community platform is feasible to engage Minnesota residents in conversations around health and research topics. Future work will evaluate its potential for reach, scale, and sustainability.