SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres.

INTRODUCTION: SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs). METHODS AND ANALYSIS: The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2×2×2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2×2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors. ETHICS AND DISSEMINATION: The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT05533918 and NCT05533359.

Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial.

INTRODUCTION: Over 40% of US adults meet criteria for obesity, a major risk factor for chronic disease. Obesity disproportionately impacts populations that have been historically marginalised (eg, low socioeconomic status, rural, some racial/ethnic minority groups). Evidence-based interventions (EBIs) for weight management exist but reach less than 3% of eligible individuals. The aims of this pilot randomised controlled trial are to evaluate feasibility and acceptability of dissemination strategies designed to increase reach of EBIs for weight management. METHODS AND ANALYSIS: This study is a two-phase, Sequential Multiple Assignment Randomized Trial, conducted with 200 Medicaid patients. In phase 1, patients will be individually randomised to single text message (TM1) or multiple text messages (TM+). Phase 2 is based on treatment response. Patients who enrol in the EBI within 12 weeks of exposure to phase 1 (ie, responders) receive no further interventions. Patients in TM1 who do not enrol in the EBI within 12 weeks of exposure (ie, TM1 non-responders) will be randomised to either TM1-Continued (ie, no further TM) or TM1 & MAPS (ie, no further TM, up to 2 Motivation And Problem Solving (MAPS) navigation calls) over the next 12 weeks. Patients in TM+ who do not enrol in the EBI (ie, TM+ non-responders) will be randomised to either TM+Continued (ie, monthly text messages) or TM+ & MAPS (ie, monthly text messages, plus up to 2 MAPS calls) over the next 12 weeks. Descriptive statistics will be used to characterise feasibility (eg, proportion of patients eligible, contacted and enrolled in the trial) and acceptability (eg, participant opt-out, participant engagement with dissemination strategies, EBI reach (ie, the proportion of participants who enrol in EBI), adherence, effectiveness). ETHICS AND DISSEMINATION: Study protocol was approved by the University of Utah Institutional Review Board (#00139694). Results will be disseminated through study partners and peer-reviewed publications. TRIAL REGISTRATION NUMBER: clinicaltrials.gov; NCT05666323.

Preliminary Reach of an Information Technology Approach to Support COVID-19 Testing in Schools.

OBJECTIVES: SCALE-UP Counts tests population health management interventions to promote coronavirus disease 2019 (COVID-19) testing in kindergarten through 12th-grade schools that serve populations that have been historically marginalized. METHODS: Within 6 participating schools, we identified 3506 unique parents/guardians who served as the primary contact for at least 1 student. Participants were randomized to text messaging (TM), text messaging + health navigation (HN) (TM + HN), or usual care. Bidirectional texts provided COVID-19 symptom screening, along with guidance on obtaining and using tests as appropriate. If parents/guardians in the TM + HN group were advised to test their child but either did not test or did not respond to texts, they were called by a trained health navigator to address barriers. RESULTS: Participating schools served a student population that was 32.9% non-white and 15.4% Hispanic, with 49.6% of students eligible to receive free lunches. Overall, 98.8% of parents/guardians had a valid cell phone, of which 3.8% opted out. Among the 2323 parents/guardians included in the intervention, 79.6% (n = 1849) were randomized to receive TM, and 19.1% (n = 354) engaged with TM (ie, responded to at least 1 message). Within the TM + HN group (40.1%, n = 932), 1.3% (n = 12) qualified for HN at least once, of which 41.7% (n = 5) talked to a health navigator. CONCLUSIONS: TM and HN are feasible ways to reach parents/guardians of kindergarten through 12th-grade students to provide COVID-19 screening messages. Strategies to improve engagement may strengthen the impact of the intervention.

Inpatient Mortality Among Patients With Acute Respiratory Distress Syndrome at ECMO and Non-ECMO Centers in the United States.

BACKGROUND: A 2009 randomized control trial found patients with severe acute respiratory distress syndrome (ARDS) who transferred to an extra-corporeal membrane oxygenation therapy (ECMO) center had better survival, even if they did not receive ECMO. This study aimed to use a national US database to determine if care at ECMO centers offer a survival advantage in patients with ARDS with mechanical ventilation only. METHODS: Hospitalizations of patients 18-64 years old who had ARDS and mechanical ventilation in the 2010-2016 Health care Cost and Utilization Project National Readmission Database were included. ECMO centers performed at least 1 veno-venous ECMO hospitalization annually; or >5, >20, and >50 on sensitivity analysis. Multivariable logistic regression compared inpatient mortality, after adjusting for timing of hospitalization, patient demographics, comorbidities, and hospital characteristics. RESULTS: Of the 1 224 447 ARDS hospitalizations and mechanical ventilation, 41% were at ECMO centers. ECMO centers were more likely to be larger, private, non-profit, teaching hospitals. ARDS at admission was more common at non-ECMO centers (31% vs 23%, P < .0001); however, other patient demographics and comorbidities did not differ. After adjustment, no difference in inpatient mortality was seen between ECMO and non-ECMO centers (OR 0.99, 95% CI: 0.97, 1.02). This relationship did not change in sensitivity analyses. DISCUSSION: Adult patients with ARDS requiring mechanical ventilation may not have improved outcomes if treated at an ECMO center and suggest that early transfer of all ARDS patients to ECMO centers may not be warranted. Further evaluation of ECMO center volume and illness severity is needed.

Cancer survivors' financial hardship and their caregivers' employment: results from a statewide survey.

PURPOSE: Many caregivers take paid and/or unpaid time off work, change from full-time to part-time, or leave the workforce. We hypothesized that cancer survivor-reported material hardship (e.g., loans, bankruptcy), behavioral hardship (e.g., skipping care/medication due to cost), and job lock (i.e., staying at a job for fear of losing insurance) would be associated with caregiver employment changes. METHODS: Adult cancer survivors (N = 627) were surveyed through the Utah Cancer Registry in 2018-2019, and reported whether their caregiver had changed employment because of their cancer (yes, no). Material hardship was measured by 9 items which we categorized by the number of instances reported (0, 1-2, and ≥ 3). Two items represented both behavioral hardship (not seeing doctor/did not take medication because of cost) and survivor/spouse job lock. Odds ratios (OR) were estimated using survey-weighted logistic regression to examine the association of caregiver employment changes with material and behavioral hardship and job lock, adjusting for cancer and sociodemographic factors. RESULTS: There were 183 (29.2%) survivors reporting their caregiver had an employment change. Survivors with ≥ 3 material hardships (OR = 3.13, 95%CI 1.68-5.83), who skipped doctor appointments (OR = 2.88, 95%CI 1.42-5.83), and reported job lock (OR = 2.05, 95%CI 1.24-3.39) and spousal job lock (OR = 2.19, 95%CI 1.17-4.11) had higher odds of caregiver employment changes than those without these hardships. CONCLUSIONS: Caregiver employment changes that occur because of a cancer diagnosis are indicative of financial hardship. IMPLICATIONS FOR CANCER SURVIVORS: Engaging community and hospital support for maintenance of stable caregiver employment and insurance coverage during cancer may lessen survivors' financial hardship.

Adherence to Guideline-Recommended cancer screening among Utah cancer survivors.

BACKGROUND: Adherence to cancer screening is important for cancer survivors because they are at high risk of subsequent cancer diagnoses or recurrence. We assessed adherence to breast, cervical, and colorectal cancer-(CRC)-screening guidelines and evaluated demographic disparities among a population-based sample of survivors. METHODS: A representative sample of Utah survivors diagnosed from 2012-2018 with any reportable invasive cancer was selected from central cancer registry records for a survey about survivorship needs. We estimated the proportion of eligible survivors adhering to U.S. Preventive Services Task Force screening guidelines and calculated risk ratios and 95% confidence intervals. Analyses were age-adjusted and weighted to account for sample design and nonresponse. RESULTS: And 1421 survivors completed the survey (57.2% response rate). Screening adherence was 74.4% for breast, 69.4% for cervical, and 79.7% for CRC. Rural residents were more likely to adhere to breast cancer screening than urban residents (86.1% vs. 72.7%; adjusted RR = 1.19, CI = 1.05, 1.36). Higher educational attainment was associated with increased adherence to cervical and colorectal cancer screening. Younger age was associated with greater adherence to cervical cancer screening (p = 0.006) but lower adherence to CRC screening (p = 0.003). CRC screening adherence was lower among the uninsured and those without a primary care provider (45.6%) compared to those with a regular provider (83.0%; adjusted RR = 0.57, CI = 0.42, 0.79). CONCLUSIONS: Surveys based on samples from central cancer registries can provide population estimates to inform cancer control. Findings demonstrate work is needed to ensure all Utah cancer survivors obtain recommended cancer screenings. Efforts should focus particularly on increasing uptake of breast and cervical cancer screening and reducing demographic disparities in CRC screening. PRECIS: Despite high risk for subsequent cancer diagnosis, Utah cancer survivors are not all obtaining recommended breast, cervical, and colorectal cancer screenings. This presents a significant healthcare gap.

High variability in transmission of SARS-CoV-2 within households and implications for control.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) poses a high risk of transmission in close-contact indoor settings, which may include households. Prior studies have found a wide range of household secondary attack rates and may contain biases due to simplifying assumptions about transmission variability and test accuracy. METHODS: We compiled serological SARS-CoV-2 antibody test data and prior SARS-CoV-2 test reporting from members of 9,224 Utah households. We paired these data with a probabilistic model of household importation and transmission. We calculated a maximum likelihood estimate of the importation probability, mean and variability of household transmission probability, and sensitivity and specificity of test data. Given our household transmission estimates, we estimated the threshold of non-household transmission required for epidemic growth in the population. RESULTS: We estimated that individuals in our study households had a 0.41% (95% CI 0.32%- 0.51%) chance of acquiring SARS-CoV-2 infection outside their household. Our household secondary attack rate estimate was 36% (27%- 48%), substantially higher than the crude estimate of 16% unadjusted for imperfect serological test specificity and other factors. We found evidence for high variability in individual transmissibility, with higher probability of no transmissions or many transmissions compared to standard models. With household transmission at our estimates, the average number of non-household transmissions per case must be kept below 0.41 (0.33-0.52) to avoid continued growth of the pandemic in Utah. CONCLUSIONS: Our findings suggest that crude estimates of household secondary attack rate based on serology data without accounting for false positive tests may underestimate the true average transmissibility, even when test specificity is high. Our finding of potential high variability (overdispersion) in transmissibility of infected individuals is consistent with characterizing SARS-CoV-2 transmission being largely driven by superspreading from a minority of infected individuals. Mitigation efforts targeting large households and other locations where many people congregate indoors might curb continued spread of the virus.

Probability-Based Estimates of Severe Acute Respiratory Syndrome Coronavirus 2 Seroprevalence and Detection Fraction, Utah, USA.

We aimed to generate an unbiased estimate of the incidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in 4 urban counties in Utah, USA. We used a multistage sampling design to randomly select community-representative participants >12 years of age. During May 4-June 30, 2020, we collected serum samples and survey responses from 8,108 persons belonging to 5,125 households. We used a qualitative chemiluminescent microparticle immunoassay to detect SARS-CoV-2 IgG in serum samples. We estimated the overall seroprevalence to be 0.8%. The estimated seroprevalence-to-case count ratio was 2.5, corresponding to a detection fraction of 40%. Only 0.2% of participants from whom we collected nasopharyngeal swab samples had SARS-CoV-2-positive reverse transcription PCR results. SARS-CoV-2 antibody prevalence during the study was low, and prevalence of PCR-positive cases was even lower. The comparatively high SARS-CoV-2 detection rate (40%) demonstrates the effectiveness of Utah's testing strategy and public health response.

Comparison of direct surgical cost for humeral shaft fracture fixation: open reduction internal fixation versus intramedullary nailing.

BACKGROUND AND/OR HYPOTHESIS: Prior literature has supported similar complication rates and outcomes for humeral shaft fractures treated with open reduction internal fixation (ORIF) with a plate/screw construct versus intramedullary nailing (IMN). The purpose of this study is to determine whether surgical encounter total direct costs (SETDCs) differ between ORIF and IMN for these fractures. METHODS: Adult patients (≥ 18 years) treated for isolated humeral shaft fractures by ORIF or IMN between June 18, 2014 and June 17, 2019 at a single tertiary academic center were available for inclusion. SETDCs for ORIF and IMN groups, obtained through our institution's information technology value tool, were adjusted to 2019 US dollars and converted to relative costs per institutional policy. SETDCs for ORIF and IMN were compared using the Wilcoxon rank-sum test. RESULTS: Demographic factors did not differ between ORIF and IMN cohorts with the exception of age (mean of 18.6 years older for IMN; P < .001) and American Society of Anesthesiologist class (higher for IMN; P = .029). Substantial cost variation was observed among the 39 included ORIF and 21 IMN cases. Costs pertaining to operating room utilization (P = .77), implants (P = .64), and the recovery room (P = .27) were similar for ORIF and IMN, whereas supply costs were significantly greater for IMN with a median (interquartile range) of 0.21 (0.17 ∼ 0.28), more than twice the supply costs of ORIF (0.09 [0.05 ∼ 0.13], P < .001). The SETDC of IMN was significantly greater than that of ORIF (median [interquartile range]:1.00 [0.9 to 1.13] vs. 0.83 [0.71∼1.05], respectively; P = .047). DISCUSSION AND/OR CONCLUSION: Our study found that the SETDC for humeral shaft fracture fixation was greater for IMN than for ORIF, although patient cohorts differed significantly with respect to age and the American Society of Anesthesiologist class. Surgeons should take these findings into consideration when consenting patients with humeral shaft fractures for the appropriate fixation type.

Low SARS-CoV-2 Transmission in Elementary Schools - Salt Lake County, Utah, December 3, 2020-January 31, 2021.

School closures affected more than 55 million students across the United States when implemented as a strategy to prevent the transmission of SARS-CoV-2, the virus that causes COVID-19 (1). Reopening schools requires balancing the risks for SARS-CoV-2 infection to students and staff members against the benefits of in-person learning (2). During December 3, 2020-January 31, 2021, CDC investigated SARS-CoV-2 transmission in 20 elementary schools (kindergarten through grade 6) that had reopened in Salt Lake County, Utah. The 7-day cumulative number of new COVID-19 cases in Salt Lake County during this time ranged from 290 to 670 cases per 100,000 persons.† Susceptible§ school contacts¶ (students and staff members exposed to SARS-CoV-2 in school) of 51 index patients** (40 students and 11 staff members) were offered SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) testing. Among 1,041 susceptible school contacts, 735 (70.6%) were tested, and five of 12 cases identified were classified as school-associated; the secondary attack rate among tested susceptible school contacts was 0.7%. Mask use among students was high (86%), and the median distance between students' seats in classrooms was 3 ft. Despite high community incidence and an inability to maintain ≥6 ft of distance between students at all times, SARS-CoV-2 transmission was low in these elementary schools. The results from this investigation add to the increasing evidence that in-person learning can be achieved with minimal SARS-CoV-2 transmission risk when multiple measures to prevent transmission are implemented (3,4).

A Comparison of Open Carpal Tunnel Release Outcomes Between Procedure Room and Operating Room Settings.

PURPOSE: Carpal tunnel release (CTR) surgical costs are minimized when performed in the procedure room (PR) setting, compared with the operating room. However, it remains unclear whether outcomes differ between surgical settings. Our purpose was to compare outcomes at 1 year or greater follow-up after open CTR between patients treated in PR versus operating room settings using the Boston Carpal Tunnel Questionnaire (BCTQ). METHODS: A change in clinical care protocols at our institution occurred in 2014. Before this, all CTRs were performed in the operating room; thereafter, these were transitioned to the PR. Adult patients who underwent isolated unilateral or bilateral open CTR in either surgical setting were considered for inclusion, in which procedures were conducted between January 2014 and October 2018 for the PR group and January 2009 and March 2014 for the operating room group. The Functional Status Scale (FSS) and the Symptom Severity Scale (SSS) components of the BCTQ were collected for all eligible patients at a minimum of 1 year after surgery. We used univariate and multivariable linear regression to determine whether postoperative BCTQ scores were equivalent between PR and operating room groups within a threshold of one-fourth of the lowest estimates of the minimal clinically important difference. RESULTS: No differences in demographics, comorbidities, or insurance type were observed between the 104 PR and 112 operating room patients. Survey response rate was 25% and 25% for the PR and operating room patients, respectively. At a mean follow-up of 3 ± 1 years, FSS and SSS scores were equivalent between PR and operating room groups on bivariate analysis. The multivariable equivalence test also demonstrated equivalent FSS and SSS scores between PR and operating room groups within a one-fourth minimal clinically important difference threshold while controlling for age, sex, presence of diabetes or thyroid disease, unilateral versus bilateral CTR, and surgeon. CONCLUSIONS: Clinical outcomes did not differ between PR and operating room settings after open CTR. Type of study/level of evidence: Therapeutic III.

Factors Associated With Decision Regret Among Patients With Diverticulitis in the Elective Setting.

BACKGROUND: We aimed to identify decision process measures associated with patient decisional regret regarding the decision to pursue elective colectomy or observation for diverticulitis. MATERIALS AND METHODS: This was a single-center cross-sectional survey study. We included adult patients treated for diverticulitis between 2014 and 2019 and excluded patients who required urgent or emergent colectomy. The primary outcome was regret regarding the decision to pursue elective surgery or observation for diverticulitis, measured using the Decision Regret Scale. We used multivariable linear regression to examine hypothesized predictors of decision regret, including decisional conflict (Decision Conflict Scale and its subscales), shared decision-making, and decision role concordance. RESULTS: Of 923 eligible patients, 133 were included in the analysis. Patients had a median of five episodes of diverticulitis (interquartile range 3-8), occurring a median of 2 y (interquartile range 1-3) before survey administration. Thirty-eight patients (29%) underwent elective surgery for diverticulitis. Decision regret (Decision Regret Scale score ≥25) was present in 42 patients (32%). After controlling for surgery, gender, health status, and years since treatment, decision regret was associated with decisional conflict and inversely associated with values clarity, decision role concordance, shared decision-making, and feeling informed, supported, and effective in decision-making (all P < 0.001). CONCLUSIONS: Nearly one-third of survey respondents experienced regret regarding the decision between elective surgery and observation for diverticulitis. Decision regret may be reduced through efforts to improve patient knowledge, values clarity, role concordance, and shared decision-making.

Hypertension in the Young Adult Trauma Population: Rethinking the Traditional "Incidentaloma".

BACKGROUND: Hypertension (HTN) is a treatable and preventable risk factor for cardiovascular disease that is often overlooked in young adults. As a result, young patients with HTN may enter the health care system as a trauma without a preexisting diagnosis. The potential impact of HTN (diagnosed and undiagnosed) on trauma outcomes is not known. MATERIALS AND METHODS: Patients aged 18-39 y from the 2013-2017 North Carolina Trauma Registry were included. Patients were stratified as having no HTN, previously diagnosed HTN (PD-HTN), or newly diagnosed HTN (ND-HTN) during a trauma admission. Multivariable logistic and linear regression compared inpatient outcomes between patients with and without HTN, as well as ND-HTN and PD-HTN. RESULTS: Six percent of trauma patients were diagnosed with HTN (n = 1906; 14% ND-HTN). Those with HTN were more likely to have an inpatient complication (odds ratio [OR]: 1.65, 95% confidence interval [CI]: 1.32-2.07) and intensive care unit stay (OR: 1.28, 95% CI: 1.12-1.46) compared with patients without HTN. Compared with PD-HTN, those with ND-HTN were more likely to present with extreme injury. In addition, patients with ND-HTN had higher odds of inpatient complications (OR: 1.95, 95% CI: 1.18-3.22) and 30-d readmission (OR: 2.00, 95% CI: 0.95-4.20) after accounting for demographics and injury severity. CONCLUSIONS: More than 10% of young adult trauma patients with HTN are not diagnosed before admission. HTN appears to have a detrimental impact on patient outcomes, with newly diagnosed patients having the worst outcomes. Trauma may serve as an opportunity for the diagnosis and treatment of HTN in young adults. Future studies should assess the impact of intervention on trauma outcomes.

Factors Associated With Becoming Edentulous in the US Health and Retirement Study.

BACKGROUND/OBJECTIVE: To determine factors associated with older adults becoming edentulous (complete tooth loss). DESIGN: Longitudinal study over a 6-year period. SETTING: United States, 2006, 2012. PARTICIPANTS: Nationally representative US sample of adults, aged 50 years and older (n = 9982), participating in the Health and Retirement Study in 2006 and 2012. At the outset, they were dentate and not institutionalized. INTERVENTION: None. MEASUREMENTS: Self-report of being dentate or edentulous, demographic variables, dental utilization and other health behaviors, self-rated general health, and incidence between 2006 and 2012 of comorbid medical conditions, functional limitations, and disabilities. RESULTS: From 2006 to 2012, 563 individuals (5%) became edentulous and 9419 (95%) remained dentate. Adults who became edentulous by 2012 were more likely than those who remained dentate to be black/African American compared to white, to be less educated, were current smokers, had diabetes, and reported poorer self-rated general health, more functional limitations and disabilities, and fewer dental visits (all P < .0001), among other factors. Of those with regular dental visits (at least once every 2 years during the 6-year period), 2.3% became edentulous compared to 9.9% among those without regular dental visits. After adjusting for age and other potential confounders, there was a strong association with poor dental attendance and smoking. Nonregular dental attenders were more likely than regular attenders to become edentulous (odds ratio [OR] = 2.74; 95% confidence interval [CI] = 2.12-3.53), and current smokers were more likely than never smokers to become edentulous (OR = 2.46; 95% CI = 1.74-3.46). CONCLUSION: Although more contemporaneous data are needed to determine causality, regular dental utilization and smoking are modifiable factors that could prevent edentulism, even when many other comorbid conditions are present. J Am Geriatr Soc, 1-7, 2019. J Am Geriatr Soc 67:2318-2324, 2019.