Fecal Immunochemical Test Screening and Risk of Colorectal Cancer Death.

Importance: The fecal immunochemical test (FIT) is widely used for colorectal cancer (CRC) screening, but evidence of its effectiveness is limited. Objective: To evaluate whether FIT screening is associated with a lower risk of dying from CRC overall, according to cancer location, and within demographic groups. Design, Setting, and Participants: This nested case-control study in a cohort of screening-eligible people was conducted in 2 large, integrated health systems of racially, ethnically, and socioeconomically diverse members with long-term programs of mailed FIT screening outreach. Eligible participants included people aged 52 to 85 years who died from colorectal adenocarcinoma between 2011 and 2017 (cases); cases were matched in a 1:8 ratio based on age, sex, health-plan membership duration, and geographic area to randomly selected persons who were alive and CRC-free on case's diagnosis date (controls). Data analysis was conducted from January 2002 to December 2017. Exposures: Completing 1 or more FIT screenings in the 5-year period prior to the CRC diagnosis date among cases or the corresponding date among controls; in secondary analyses, 2- to 10-year intervals were evaluated. Main Outcomes and Measures: The primary study outcome was CRC death overall and by tumor location. Secondary analyses were performed to assess CRC death by race and ethnicity. Results: From a cohort of 2 127 128 people, a total of 10 711 participants (3529 aged 60-69 years [32.9%]; 5587 male [52.1%] and 5124 female [47.8%]; 1254 non-Hispanic Asian [11.7%]; 973 non-Hispanic Black [9.1%]; 1929 Hispanic or Latino [18.0%]; 6345 non-Hispanic White [59.2%]) was identified, including 1103 cases and 9608 controls. Among controls during the 10-year period prior to the reference date, 6101 (63.5%) completed 1 or more FITs with a cumulative 12.6% positivity rate (768 controls), of whom 610 (79.4%) had a colonoscopy within 1 year. During the 5-year period, 494 cases (44.8%) and 5345 controls (55.6%) completed 1 or more FITs. In regression analysis, completing 1 or more FIT screening was associated with a 33% lower risk of death from CRC (adjusted odds ratio [aOR], 0.67; 95% CI, 0.59-0.76) and 42% lower risk in the left colon and rectum (aOR, 0.58; 95% CI, 0.48-0.71). There was no association with right colon cancers (aOR, 0.83; 95% CI, 0.69-1.01) but the difference in the estimates between the right colon and left colon or rectum was statistically significant (P = .01). FIT screening was associated with lower CRC mortality risk among non-Hispanic Asian (aOR, 0.37; 95% CI, 0.23-0.59), non-Hispanic Black (aOR, 0.58; 95% CI, 0.39-0.85) and non-Hispanic White individuals (aOR, 0.70; 95% CI, 0.57-0.86) (P for homogeneity = .04 for homogeneity). Conclusions and Relevance: In this nested case-control study, completing FIT was associated with a lower risk of overall death from CRC, particularly in the left colon, and the associations were observed across racial and ethnic groups. These findings support the use of FIT in population-based screening strategies.

The effect of adding physician recommendation in digitally-enabled outreach for COVID-19 vaccination in socially/economically disadvantaged populations.

INTRODUCTION: People from backgrounds that are economically/socially disadvantaged experienced disproportionately high COVID-19 death rates and had lower vaccination rates. Effective outreach strategies for increasing vaccine uptake during the pandemic are not fully known. Among patients receiving care at a Federally Qualified Health Center, we tested whether community engaged digitally-enabled outreach from a trusted clinician messenger increased COVID vaccine uptake. STUDY DESIGN, SETTING, AND PARTICIPANTS: A 3-parallel-arm randomized controlled trial with a hybrid effectiveness-implementation design was conducted among patients ≥ 18 years old on study enrollment during 2021 with 1,650 assigned in 3:10:20 ratio; 2,328 were later selected for two subsequent implementation rounds. INTERVENTIONS: From April 13 to June 10, 2021, patients were proactively sent a text-messaging invitation to make an appointment for vaccination as part of the routine practice with a link to frequently asked questions (Arm 1, n = 150) with added personalized clinician recommendation alone (Arm 2, n = 500) or with enabled 2-way SMS messaging feature (Arm 3, n = 1,000). Further implementation used messaging addressing vaccine hesitancy (n = 1,323) or adverse reactions to vaccines (n = 1,005). MAIN OUTCOMES AND MEASURES: The primary outcome was the completion of the first SARS-Cov-2 vaccine dose determined at 14, 30 and 90 days after outreach. RESULTS: Of 1,650 patients in effectiveness Arms, 61% was female. Vaccination rates for Arms 1, 2, and 3, were 6% (n = 9), 5.4% (n = 27) and 3.3% (n = 33) at 14 days, and 11.5% (n = 17), 11.6% (n = 58), and 8.5% (n = 85) at 90 days, respectively, which were similar in pairwise comparisons. At 90 days, vaccination rates were similar across the two implementation rounds (3.9% vs. 3.6%) and were similar to the rate (3.3%) among patients who were not selected for intervention arms or implementation rounds (n = 8,671). CONCLUSIONS: Digitally-enabled outreach that included SMS messaging outreach augmented with clinician recommendations did not improve COVID-19 vaccination rates. TRIAL REGISTRATION: This study is registered at ClinicalTrails.gov Identifier: NC-T04952376.

Bias due to coarsening of time intervals in the inference for the effectiveness of colorectal cancer screening.

BACKGROUND: Observational studies are frequently used to estimate the comparative effectiveness of different colorectal cancer (CRC) screening methods due to the practical limitations and time needed to conduct large clinical trials. However, time-varying confounders, e.g. polyp detection in the last screening, can bias statistical results. Recently, generalized methods, or G-methods, have been used for the analysis of observational studies of CRC screening, given their ability to account for such time-varying confounders. Discretization, or the process of converting continuous functions into discrete counterparts, is required for G-methods when the treatment and outcomes are assessed at a continuous scale. DEVELOPMENT: This paper evaluates the interplay between time-varying confounding and discretization, which can induce bias in assessing screening effectiveness. We investigate this bias in evaluating the effect of different CRC screening methods that differ from each other in typical screening frequency. APPLICATION: First, using theory, we establish the direction of the bias. Then, we use simulations of hypothetical settings to study the bias magnitude for varying levels of discretization, frequency of screening and length of the study period. We develop a method to assess possible bias due to coarsening in simulated situations. CONCLUSIONS: The proposed method can inform future studies of screening effectiveness, especially for CRC, by determining the choice of interval lengths where data are discretized to minimize bias due to coarsening while balancing computational costs.

Colorectal Cancer Screening After Sequential Outreach Components in a Demographically Diverse Cohort.

Importance: Organized screening outreach can reduce differences in colorectal cancer (CRC) incidence and mortality between demographic subgroups. Outcomes associated with additional outreach, beyond universal outreach, are not well known. Objective: To compare CRC screening completion by race and ethnicity, age, and sex after universal automated outreach and additional personalized outreach. Design, Setting, and Participants: This observational cohort study included screening-eligible individuals aged 50 to 75 years assessed during 2019 in a community-based organized CRC screening program within the Kaiser Permanente Northern California (KPNC) integrated health care delivery setting. For KPNC members who are not up to date with screening by colonoscopy, each year the program first uses automated outreach (mailed prescreening notification postcards and fecal immunochemical test [FIT] kits, automated telephone calls, and postcard reminders), followed by personalized components for nonresponders (telephone calls, electronic messaging, and screening offers during office visits). Data analyses were performed between November 2021 and February 2023 and completed on February 5, 2023. Exposures: Completed CRC screening via colonoscopy, sigmoidoscopy, or FIT. Main Outcomes and Measures: The primary outcome was the proportion of participants completing an FIT or colonoscopy after each component of the screening process. Differences across subgroups were assessed using the χ2 test. Results: This study included 1 046 745 KPNC members. Their mean (SD) age was 61.1 (6.9) years, and more than half (53.2%) were women. A total of 0.4% of members were American Indian or Alaska Native, 18.5% were Asian, 7.2% were Black, 16.2% were Hispanic, 0.8% were Native Hawaiian or Other Pacific Islander, and 56.5% were White. Automated outreach significantly increased screening participation by 31.1%, 38.1%, 29.5%, 31.9%, 31.8%, and 34.5% among these groups, respectively; follow-up personalized outreach further significantly increased participation by absolute additional increases of 12.5%, 12.4%, 13.3%, 14.4%, 14.7%, and 11.2%, respectively (all differences P < .05 compared with White members). Overall screening coverage at the end of the yearly program differed significantly among members who were American Indian or Alaska Native (74.1%), Asian (83.5%), Black (77.7%), Hispanic (76.4%), or Native Hawaiian or Other Pacific Islander (74.4%) compared with White members (82.2%) (all differences P < .05 compared with White members). Screening completion was similar by sex; older members were substantially more likely to be up to date with CRC screening both before and at the end of the screening process. Conclusions and Relevance: In this cohort study of a CRC screening program, sequential automated and personalized strategies each contributed to substantial increases in screening completion in all demographic groups. These findings suggest that such programs may potentially reduce differences in CRC screening completion across demographic groups.

Projected Colorectal Cancer Incidence and Mortality Based on Observed Adherence to Colonoscopy and Sequential Stool-Based Screening.

INTRODUCTION: Modeling supporting recommendations for colonoscopy and stool-based colorectal cancer (CRC) screening tests assumes 100% sequential participant adherence. The impact of observed adherence on the long-term effectiveness of screening is unknown. We evaluated the effectiveness of a program of screening colonoscopy every 10 years vs annual high-sensitivity guaiac-based fecal occult blood testing (HSgFOBT) using observed sequential adherence data. METHODS: The MIcrosimulation SCreening ANalysis (MISCAN) model used observed sequential screening adherence, HSgFOBT positivity, and diagnostic colonoscopy adherence in HSgFOBT-positive individuals from the National Colonoscopy Study (single-screening colonoscopy vs ≥4 HSgFOBT sequential rounds). We compared CRC incidence and mortality over 15 years with no screening or 10 yearly screening colonoscopy vs annual HSgFOBT with 100% and differential observed adherence from the trial. RESULTS: Without screening, simulated incidence and mortality over 15 years were 20.9 (95% probability interval 15.8-26.9) and 6.9 (5.0-9.2) per 1,000 participants, respectively. In the case of 100% adherence, only screening colonoscopy was predicted to result in lower incidence; however, both tests lowered simulated mortality to a similar level (2.1 [1.6-2.9] for screening colonoscopy and 2.5 [1.8-3.4] for HSgFOBT). Observed adherence for screening colonoscopy (83.6%) was higher than observed sequential HSgFOBT adherence (73.1% first round; 49.1% by round 4), resulting in lower simulated incidence and mortality for screening colonoscopy (14.4 [10.8-18.5] and 2.9 [2.1-3.9], respectively) than HSgFOBT (20.8 [15.8-28.1] and 3.9 [2.9-5.4], respectively), despite a 91% adherence to diagnostic colonoscopy with FOBT positivity. The relative risk of CRC mortality for screening colonoscopy vs HSgFOBT was 0.75 (95% probability interval 0.68-0.80). Findings were similar in sensitivity analyses with alternative assumptions for repeat colonoscopy, test performance, risk, age, and projection horizon. DISCUSSION: Where sequential adherence to stool-based screening is suboptimal and colonoscopy is accessible and acceptable-as observed in the national colonoscopy study, microsimulation, comparative effectiveness, screening recommendations.

Time to Endoscopy or Colonoscopy Among Adults Younger Than 50 Years With Iron-Deficiency Anemia and/or Hematochezia in the VHA.

Importance: To date, the diagnostic test completion rate and the time to diagnostic endoscopy or colonoscopy among adults with iron-deficiency anemia (IDA) and/or hematochezia have not been well characterized. Objective: To evaluate the diagnostic test completion rate and the time to diagnostic testing among veterans younger than 50 years with IDA and/or hematochezia. Design, Setting, and Participants: This cohort study was conducted within the Veterans Health Administration between October 1, 1999, and December 31, 2019, among US veterans aged 18 to 49 years from 2 separate cohorts: those with a diagnosis of IDA (n = 59 169) and those with a diagnosis of hematochezia (n = 189 185). Statistical analysis was conducted from August 2021 to August 2023. Exposures: Diagnostic testing factors included age, sex, race and ethnicity, Veterans Health Administration geographic region, and hemoglobin test value (IDA cohort only). Main Outcomes and Measures: Primary outcomes of diagnostic testing were (1) bidirectional endoscopy after diagnosis of IDA and (2) colonoscopy or sigmoidoscopy after diagnosis of hematochezia. The association between diagnostic testing factors and diagnostic test completion was examined using Poisson models. Results: There were 59 169 veterans with a diagnosis of IDA (mean [SD] age, 40.7 [7.1] years; 30 502 men [51.6%]), 189 185 veterans with a diagnosis of hematochezia (mean [SD] age, 39.4 [7.6] years; 163 690 men [86.5%]), and 2287 veterans with IDA and hematochezia (mean [SD] age, 41.6 [6.9] years; 1856 men [81.2%]). The cumulative 2-year diagnostic workup completion rate was 22% (95% CI, 22%-22%) among veterans with IDA and 40% (95% CI, 40%-40%) among veterans with hematochezia. Veterans with IDA were mostly aged 40 to 49 years (37 719 [63.7%]) and disproportionately Black (24 480 [41.4%]). Women with IDA (rate ratio [RR], 0.42; 95% CI, 0.40-0.43) had a lower likelihood of diagnostic test completion compared with men with IDA. Black (RR, 0.65; 95% CI, 0.62-0.68) and Hispanic (RR, 0.88; 95% CI, 0.82-0.94) veterans with IDA were less likely to receive diagnostic testing compared with White veterans with IDA. Veterans with hematochezia were mostly White (105 341 [55.7%]). Among veterans with hematochezia, those aged 30 to 49 years were more likely to receive diagnostic testing than adults younger than 30 years of age (age 30-39 years: RR, 1.15; 95% CI, 1.12-1.18; age 40-49 years: RR, 1.36; 95% CI, 1.33-1.40). Hispanic veterans with hematochezia were less likely to receive diagnostic testing compared with White veterans with hematochezia (RR, 0.96; 95% CI, 0.93-0.98). Conclusions and Relevance: In the cohorts of veterans younger than 50 years with IDA and/or hematochezia, the diagnostic test completion rate was low. Follow-up was less likely among female, Black, and Hispanic veterans with IDA and Hispanic veterans with hematochezia. Optimizing timely follow-up across social and demographic groups may contribute to improving colorectal cancer outcomes and mitigate disparities.

Advancing health equity through social care interventions.

OBJECTIVE: To use evidence on addressing racism in social care intervention research to create a framework for advancing health equity for all populations with marginalized social identities (e.g., race, gender, and sexual orientation). Such groups have disproportionate social needs (e.g., food insecurity) and negative social determinants of health (SDOH; e.g., poverty). We recommend how the Agency for Healthcare Research and Quality (AHRQ) could advance health equity for marginalized populations through social care research and care delivery. DATA SOURCES AND STUDY SETTING: This commentary is informed by a literature review of social care interventions that were affiliated with healthcare systems; input from health equity researchers, policymakers, and community leaders attending the AHRQ Health Equity Summit; and consensus of the authors. PRINCIPAL FINDINGS: We recommend that AHRQ: (1) create an ecosystem that values research on SDOH and the effectiveness and implementation of social care interventions in the healthcare sector; (2) work with other federal agencies to (a) develop position statements with actionable recommendations about racism and other systems that perpetuate marginalization based on social identity and (b) develop aligned, complementary approaches to research and care delivery that address social marginalization; (3) advance both inclusive care delivery and inclusive research teams; (4) advance understanding of racism as a social determinant of health and effective strategies to mitigate its adverse impact on health; (5) advance the creation and scaling of effective strategies for addressing SDOH in healthcare systems, particularly in co-creation with community partners; and (6) require social care intervention researchers to use methods that advance our understanding of social health equity. CONCLUSIONS: AHRQ, as a federal agency, could help advance health equity using a range of strategies, including using the agency's levers to ensure AHRQ stakeholders examine and address the unique experiences of socially marginalized populations in SDOH and social care intervention research.

Factors Associated With COVID-19 Vaccine Acceptance Among Patients Receiving Care at a Federally Qualified Health Center.

BACKGROUND: COVID-19 vaccine hesitancy in the United States is high, with at least 63 million unvaccinated individuals to date. Socioeconomically disadvantaged populations experience lower COVID-19 vaccination rates despite facing a disproportionate COVID-19 burden. OBJECTIVE: To assess the factors associated with COVID-19 vaccine acceptance among under-resourced, adult patients. METHODS: Participants were patients receiving care at a Federally Qualified Health Center (FQHC) in St. Paul, Minnesota. Data were collected via multiple modes over 2 phases in 2020 (self-administered electronic survey) and 2021 (study team-administered survey by telephone, self-administered written survey) to promote diversity and inclusion for study participation. The primary outcome was COVID-19 vaccine acceptance. Using logistic regression analysis, associations between vaccine acceptance and factors including risk perception, concerns about the COVID-19 vaccine, social determinants of health (SDOH), co-morbidities, pandemic-induced hardships, and stress were assessed by adjusted odds ratios (AORs) and 95% confidence intervals (CI). RESULTS: One hundred sixty-eight patients (62.5% female; mean age [SD]: 49.9 [17.4] years; 32% <$20 000 annual household income; 69%

Impact of a scalable training program on the quality of colonoscopy performance and risk of postcolonoscopy colorectal cancer.

BACKGROUND AND AIMS: Endoscopist adenoma detection rates (ADRs) vary widely and are associated with patients' risk of postcolonoscopy colorectal cancers (PCCRCs). However, few scalable physician-directed interventions demonstrably both improve ADR and reduce PCCRC risk. METHODS: Among patients undergoing colonoscopy, we evaluated the influence of a scalable online training on individual-level ADRs and PCCRC risk. The intervention was a 30-minute, interactive, online training, developed using behavior change theory, to address factors that potentially impede detection of adenomas. Analyses included interrupted time series analyses for pretraining versus posttraining individual-physician ADR changes (adjusted for temporal trends) and Cox regression for associations between ADR changes and patients' PCCRC risk. RESULTS: Across 21 endoscopy centers and all 86 eligible endoscopists, ADRs increased immediately by an absolute 3.13% (95% confidence interval [CI], 1.31-4.94) in the 3-month quarter after training compared with .58% per quarter (95% CI, .40-.77) and 0.33% per quarter (95% CI, .16-.49) in the 3-year pretraining and posttraining periods, respectively. Posttraining ADR increases were higher among endoscopists with pretraining ADRs below the median. Among 146,786 posttraining colonoscopies (all indications), each 1% absolute increase in screening ADR posttraining was associated with a 4% decrease in their patients' PCCRC risk (hazard ratio, .96; 95% CI, .93-.99). An ADR increase of ≥10% versus <1% was associated with a 55% reduced risk of PCCRC (hazard ratio, .45; 95% CI, .24-.82). CONCLUSIONS: A scalable, online behavior change training intervention focused on modifiable factors was associated with significant and sustained improvements in ADR, particularly among endoscopists with lower ADRs. These ADR changes were associated with substantial reductions in their patients' risk of PCCRC.

Supporting Mental Health and Psychological Resilience Among the Health Care Workforce: Gaps in the Evidence and Urgency for Action.

Since the COVID-19 pandemic started, health care workers have faced various challenges to their mental health due to extreme working conditions. Yet these workers have continued to deliver care in the face of stressors and death among their patients, family, and social networks. The pandemic highlighted weaknesses within our health care work environment, especially pertaining to a need to provide increased psychological resilience to clinicians. There has been little research to determine the best practices for psychological health in workplaces and interventions to improve psychological resilience. Although some studies have attempted to provide solutions, there are noteworthy gaps in the literature on effective interventions to use in the time of crisis. The most common include an absence of preintervention data concerning the overall mental well-being of health care workers, inconsistent application of interventions, and a lack of standard assessment tools across studies. There is an urgent need for system-level strategies that not only transform the way workplaces are organized, but also destigmatize, recognize, support, and treat mental health conditions among health care workers. There is also need for more evidence-based resources to improve resilience on the job, and thereby increase clinicians' capacity to address new medical crises. Doing so may mitigate rates of burnout and other psychological conditions in times of crisis among health care workers.

Patient and Health Care Professional Perspectives on Stigma in Integrated Behavioral Health: Barriers and Recommendations.

PURPOSE: Stigma related to mental health is well documented and a major barrier to using mental and physical health care. Integrated behavioral health (IBH) in primary care, in which behavioral/mental health care services are located within a primary care setting, may reduce the experience of stigma. The purpose of this study was to assess the opinions of patients and health care professionals about mental illness stigma as a barrier to engagement with IBH and to gain insight into strategies to reduce stigma, encourage discussion of mental health, and increase uptake of IBH care. METHODS: We conducted semistructured interviews with 16 patients referred to IBH in a prior year and 15 health care professionals (12 primary care physicians and 3 psychologists). Interviews were transcribed and inductively coded separately by 2 coders for common themes and subthemes under the topic headings of barriers, facilitators, and recommendations. RESULTS: We identified 10 converging themes from interviews with patients and the health care professionals, representing important complementary perspectives, with respect to barriers, facilitators, and recommendations. Barriers included professionals, families, and the public as sources of stigma, as well as self-stigma or avoidance, or internalizing negative stereotypes. Facilitators and recommendations included normalizing discussion of mental health and mental health care-seeking action, using patient-centered and empathetic communication strategies, sharing by health care professionals of their own experiences, and tailoring the discussion of mental health to patients' preferred understanding. CONCLUSIONS: Health care professionals can help reduce perceptions of stigma by having conversations with patients that normalize mental health discussion, use patient-centered communication, promote professional self-disclosure, and are tailored to patients' preferred understanding.

Impact of Stigma on Clinician Training for Opioid Use Disorder Care: A Qualitative Study in a Primary Care Learning Collaborative.

PURPOSE: We undertook a study to examine how stigma influences the uptake of training on medication for opioid use disorder (MOUD) in primary care academic programs. METHODS: We conducted a qualitative study of 23 key stakeholders responsible for implementing MOUD training in their academic primary care training programs that were participants in a learning collaborative in 2018. We assessed barriers to and facilitators of successful program implementation and used an integrated approach to develop a codebook and analyze the data. RESULTS: Participants represented the family medicine, internal medicine, and physician assistant fields, and they included trainees. Most participants described clinician and institutional attitudes, misperceptions, and biases that enabled or hindered MOUD training. Perceptions included concerns that patients with OUD are "manipulative" or "drug seeking." Elements of stigma in the origin domain (ie, beliefs by primary care clinicians or the community that OUD is a choice and not a disease), the enacted domain (eg, hospital bylaws banning MOUD and clinicians declining to obtain an X-Waiver to prescribe MOUD), and the intersectional domain (eg, inadequate attention to patient needs) were perceived as major barriers to MOUD training by most respondents. Participants described strategies that improved the uptake of training, including giving attention to clinician concerns, clarifying the biology of OUD, and ameliorating clinician fears of being ill equipped to provide care for patients. CONCLUSIONS: OUD-related stigma was commonly reported in training programs and impeded the uptake of MOUD training. Potential strategies to address stigma in the training context, beyond providing content on effective evidence-based treatments, include addressing the concerns of primary care clinicians and incorporating the chronic care framework into OUD treatment.

The Current State of Antiracism Curricula in Undergraduate and Graduate Medical Education: A Qualitative Study of US Academic Health Centers.

PURPOSE: We undertook a study to evaluate the current state of pedagogy on antiracism, including barriers to implementation and strengths of existing curricula, in undergraduate medical education (UME) and graduate medical education (GME) programs in US academic health centers. METHODS: We conducted a cross-sectional study with an exploratory qualitative approach using semistructured interviews. Participants were leaders of UME and GME programs at 5 institutions participating in the Academic Units for Primary Care Training and Enhancement program and 6 affiliated sites from November 2021 to April 2022. RESULTS: A total of 29 program leaders from the 11 academic health centers participated in this study. Three participants from 2 institutions reported the implementation of robust, intentional, and longitudinal antiracism curricula. Nine participants from 7 institutions described race and antiracism-related topics integrated into health equity curricula. Only 9 participants reported having "adequately trained" faculty. Participants mentioned individual, systemic, and structural barriers to implementing antiracism-related training in medical education such as institutional inertia and insufficient resources. Fear related to introducing an antiracism curriculum and undervaluing of this curriculum relative to other content were identified. Through learners and faculty feedback, antiracism content was evaluated and included in UME and GME curricula. Most participants identified learners as a stronger voice for transformation than faculty; antiracism content was mainly included in health equity curricula. CONCLUSIONS: Inclusion of antiracism in medical education requires intentional training, focused institutional policies, enhanced foundational awareness of the impact of racism on patients and communities, and changes at the level of institutions and accreditation bodies.

The Effect of Adding Physician Recommendation in Digitally-Enabled Outreach for COVID-19 Vaccination in Socially/Economically Disadvantaged Populations Subtitle: A Randomized Controlled Trial.

Introduction: People from backgrounds that are economically/socially disadvantaged experienced disproportionately high COVID-19 death rates and had lower vaccination rates. Effective outreach strategies for increasing vaccine uptake during the pandemic are not fully known. Among patients receiving care at a Federally Qualified Health Center, we tested whether community engaged digitally-enabled outreach increased COVID vaccine uptake. Study Design Setting and Participants: A 3-parallel-arm randomized controlled trial with a hybrid effectiveness-implementation design was conducted among patients ≥18 years old on study enrollment during 2021 with 1,650 assigned in 3:10:20 ratio; 2,328 were later selected for two subsequent implementation rounds. Interventions: From April 13 to June 10, 2021, patients were proactively sent a text-messaging invitation to make an appointment for vaccination as part of the routine practice (Arm 1, n=150) with added personalized clinician recommendation alone (Arm 2, n=500) or with an explicit nudge for answers to frequently asked questions (Arm 3, n=1,000). Further implementation used messaging addressing vaccine hesitancy (n=1,323) or adverse reactions to vaccines (n=1,005). Main Outcomes and Measures: The primary outcome was the completion of the first SARS-Cov-2 vaccine dose determined at 14, 30 and 90 days after outreach. Results: Of 1,650 patients in effectiveness Arms, 61% was female. Vaccination rates for Arms 1, 2, and 3, were 6% (n=9), 5.4% (n=27) and 3.3% (n=33) at 14 days, and 11.5% (n=17), 11.6% (n=58), and 8.5% (n=85) at 90 days, respectively, which were similar in pairwise comparisons. At 90 days, vaccination rates were similar across the two implementation rounds (3.9% vs. 3.6%) and were similar to the rate (3.3%) among patients who were not selected for intervention arms or implementation rounds (n=8,671). Conclusions: Digitally-enabled outreach that included SMS messaging outreach augmented with clinician recommendations did not improve COVID-19 vaccination rates. Trial Registration: This study is registered at ClinicalTrails.gov Identifier: NC-T04952376.

Community engagement education in academic health centers, colleges, and universities.

Community engagement (CE) is critical for advancing health equity and a key approach for promoting inclusive clinical and translational science. However, it requires a workforce trained to effectively design, implement, and evaluate health promotion and improvement strategies through meaningful collaboration with community members. This paper presents an approach for designing CE curricula for research, education, clinical care, and public health learners. A general pedagogical framework is presented to support curriculum development with the inclusion of community members as facilitators or faculty. The overall goal of the curriculum is envisioned as enabling learners to effectively demonstrate the principles of CE in working with community members on issues of concern to communities to promote health and well-being. We highlight transformations needed for the commonly used critical service-learning model and the importance of faculty well-versed in CE. Courses may include didactics and practicums with well-defined objectives and evaluation components. Because of the importance of building and maintaining relationships in CE, a preparatory phase is recommended prior to experiential learning, which should be guided and designed to include debriefing and reflective learning. Depending on the scope of the course, evaluation should include community perspectives on the experience.

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.

Inclusionary Trials: A Review of Lessons Not Learned.

The COVID-19 pandemic revealed weaknesses in the public health infrastructure of the United States, including persistent barriers to engaging marginalized communities toward inclusion in clinical research, including trials. Inclusive participation in clinical trials is crucial for promoting vaccine confidence, public trust, and addressing disparate health outcomes. A long-standing body of literature describes the value of community-based participatory research in increasing marginalized community participation in research. Community-based participatory research emphasizes shared leadership with community members in all phases of the research process, including in the planning and implementation, interpretation, and dissemination. Shared leadership between academic and industry with marginalized communities can assist with inclusive participation in vaccine trials and increase public trust in the development of the vaccines and other therapies used during public emergencies. Nevertheless, epidemiologic and clinical research do not yet have a strong culture of community partnership in the scientific process, which takes time to build and therefore may be difficult to develop and rapidly scale to respond to the pandemic. We outline practices that contribute to a lack of inclusive participation and suggest steps that trialists and other researchers can take to increase marginalized communities' participation in research. Practices include planning for community engagement during the planning and recruitment phases, having regular dialogues with communities about their priorities, supporting them throughout a study, and navigating complex structural determinants of health. Additionally, we discuss how research institutions can support inclusive practices by reexamining their policies to increase participation in clinical trials and instilling institutional trustworthiness.