Outcomes of Shared Decision-Making for Low-Dose Screening for Lung Cancer in an Academic Medical Center.

Shared decision-making (SDM) helps patients weigh risks and benefits of screening approaches. Little is known about SDM visits between patients and healthcare providers in the context of lung cancer screening. This study explored the extent that patients were informed by their provider of the benefits and harms of lung cancer screening and expressed certainty about their screening choice. We conducted a survey with 75 patients from an academic medical center in the Southeastern U.S. Survey items included knowledge of benefits and harms of screening, patients' value elicitation during SDM visits, and decisional certainty. Patient and provider characteristics were collected through electronic medical records or self-report. Descriptive statistics, Kruskal-Wallis tests, and Pearson correlations between screening knowledge, value elicitation, and decisional conflict were calculated. The sample was predominately non-Hispanic White (73.3%) with no more than high school education (53.4%) and referred by their primary care provider for screening (78.7%). Patients reported that providers almost always discussed benefits of screening (81.3%), but infrequently discussed potential harms (44.0%). On average, patients had low knowledge about screening (score = 3.71 out of 8) and benefits/harms. Decisional conflict was low (score = - 3.12) and weakly related to knowledge (R= - 0.25) or value elicitation (R= - 0.27). Black patients experienced higher decisional conflict than White patients (score = - 2.21 vs - 3.44). Despite knowledge scores being generally low, study patients experienced low decisional conflict regarding their decision to undergo lung cancer screening. Additional work is needed to optimize the quality and consistency of information presented to patients considering screening.

Synthetic Negative Controls: Using Simulation to Screen Large-scale Propensity Score Analyses.

The propensity score has become a standard tool to control for large numbers of variables in healthcare database studies. However, little has been written on the challenge of comparing large-scale propensity score analyses that use different methods for confounder selection and adjustment. In these settings, balance diagnostics are useful but do not inform researchers on which variables balance should be assessed or quantify the impact of residual covariate imbalance on bias. Here, we propose a framework to supplement balance diagnostics when comparing large-scale propensity score analyses. Instead of focusing on results from any single analysis, we suggest conducting and reporting results for many analytic choices and using both balance diagnostics and synthetically generated control studies to screen analyses that show signals of bias caused by measured confounding. To generate synthetic datasets, the framework does not require simulating the outcome-generating process. In healthcare database studies, outcome events are often rare, making it difficult to identify and model all predictors of the outcome to simulate a confounding structure closely resembling the given study. Therefore, the framework uses a model for treatment assignment to divide the comparator population into pseudo-treatment groups where covariate differences resemble those in the study cohort. The partially simulated datasets have a confounding structure approximating the study population under the null (synthetic negative control studies). The framework is used to screen analyses that likely violate partial exchangeability due to lack of control for measured confounding. We illustrate the framework using simulations and an empirical example.

Importance of Social Determinants in Screening for Depression.

IMPORTANCE: The most common screening tool for depression is the Patient Health Questionnaire-9 (PHQ-9). Despite extensive research on the clinical and behavioral implications of the PHQ-9, data are limited on the relationship between PHQ-9 scores and social determinants of health and disease. OBJECTIVE: To assess the relationship between the PHQ-9 at intake and other measurements intended to assess social determinants of health. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional analyses of 2502 participants from the Baseline Health Study (BHS), a prospective cohort of adults selected to represent major demographic groups in the US; participants underwent deep phenotyping on demographic, socioeconomic, clinical, laboratory, functional, and imaging findings. INTERVENTIONS: None. MAIN OUTCOMES AND MEASURES: Cross-sectional measures of clinical and socioeconomic status (SES). RESULTS: In addition to a host of clinical and biological factors, higher PHQ-9 scores were associated with female sex, younger participants, people of color, and Hispanic ethnicity. Multiple measures of low SES, including less education, being unmarried, not currently working, and lack of insurance, were also associated with higher PHQ-9 scores across the entire spectrum of PHQ-9 scores. A summative score of SES, which was the 6th most predictive factor, was associated with higher PHQ-9 score after adjusting for 150 clinical, lab testing, and symptomatic characteristics. CONCLUSIONS AND RELEVANCE: Our findings underscore that depression should be considered a comorbidity when social determinants of health are addressed, and both elements should be considered when designing appropriate interventions.

The experiences of community organizations partnering with a medical school to improve students' understanding of the social determinants of health: A qualitative study.

PURPOSE: There has been increasing interest among national organizations for medical schools to provide students experiential training in the social determinants of health (SDH) through community partnerships. Despite this interest, there is limited data about how these experiential activities can be designed most effectively, and community organizations' views of partnering with medical schools on these curricula is unknown. The authors' objective was to determine community organizations' and clinical clerkship directors' perceptions of the benefits and challenges of utilizing academic-community partnerships to improve medical students' understanding of the SDH. METHODS: The authors conducted a qualitative study consisting of open-ended, semi-structured interviews (between 2018 and 2021). All community organizations and clinical clerkship directors who partnered with a health equity curriculum were eligible to participate. Semi-structured interviews elicited participants' perceptions of the academic-community partnership; experience with the curriculum and the students; and recommendations for improving the curriculum. All interviews were audio recorded and transcribed. The authors used a directed content analysis approach to code the interviews inductively and identified emerging themes through an iterative process. RESULTS: Of the fifteen participants interviewed, ten were from community organizations and five from clinical clerkships. Three primary themes emerged: (1) community organizations felt educating students about the SDH aligned with the organization's mission and they benefited from consistent access to volunteers; (2) students benefited through greater exposure to the SDH; (3) participants suggested standardizing students' experiences, ensuring the students and organizations are clear about the goals and expectations, and working with organizations that have experience with or the capacity for a large volume of volunteers as ways to improve the experiential activity. CONCLUSION: This study found that community organizations were very willing to partner with a medical school to provide students experiential learning about the SDH, and this partnership was beneficial for both the students and the organizations.

Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor-Driven Virtual Diabetes Clinic: Prospective Trial.

BACKGROUND: The Onduo virtual diabetes clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote personalized lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists for medication management and prescription of real-time continuous glucose monitoring (RT-CGM) devices for intermittent use. OBJECTIVE: This prospective single-arm study evaluated glycemic outcomes associated with participation in the Onduo VDC for 4 months. METHODS: Adults aged ≥18 years with T2D and a baseline glycated hemoglobin (HbA1c) of ≥8% to ≤12% were enrolled from 2 primary care centers from February 2019 to October 2019. Participants were asked to engage at ≥1 time per week with their care team and to participate in a telemedicine consultation with a clinic endocrinologist for diabetes medication review. Participants were asked to use a RT-CGM device and wear six 10-day sensors (total 60 days of sensor wear) intermittently over the course of 4 months. The primary outcome was change in HbA1c at 4 months from baseline. Other endpoints included change in weight and in RT-CGM glycemic metrics, including percent time <70, 70-180, 181-250, and >250 mg/dL. Changes in blood pressure and serum lipids at 4 months were also evaluated. RESULTS: Participants (n=55) were 57.3 (SD 11.6) years of age, body mass index 33.7 (SD 7.2), and 40% (22/55) female. HbA1c decreased significantly by 1.6% (SD 1%; P<.001). When stratified by baseline HbA1c of 8.0% to 9.0% (n=36) and >9.0% (n=19), HbA1c decreased by 1.2% (SD 0.6%; P<.001) and 2.4% (SD 1.3%; P<.001), respectively. Continuous glucose monitoring-measured (n=43) percent time in range (TIR) 70-180 mg/dL increased by 10.2% (SD 20.5%; P=.002), from 65.4% (SD 23.2%) to 75.5% (SD 22.7%), which was equivalent to a mean increase of 2.4 hours TIR per day. Percent time 181-250 mg/dL and >250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively. There was no change in percent time <70 mg/dL. Mean weight decreased by 9.0 lb (SD 10.4; P<.001). Significant improvements were also observed in systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and triglycerides (P=.04 to P=<.001). CONCLUSIONS: Participants in the Onduo VDC experienced significant improvement in HbA1c, increased TIR, decreased time in hyperglycemia, and no increase in hypoglycemia at 4 months. Improvements in other metabolic health parameters including weight and blood pressure were also observed. In conclusion, the Onduo VDC has potential to support people with T2D and their clinicians between office visits by increasing access to specialty care and advanced diabetes technology including RT-CGM. TRIAL REGISTRATION: ClinicalTrials.gov NCT03865381; https://clinicaltrials.gov/ct2/show/NCT03865381.

Impact of Participation in a Virtual Diabetes Clinic on Diabetes-Related Distress in Individuals With Type 2 Diabetes.

The Onduo Virtual Diabetes Clinic is a telehealth program for people with type 2 diabetes that combines mobile app technology, remote personalized lifestyle coaching, connected blood glucose meters, real-time continuous glucose monitoring (rtCGM) devices, and clinical support from board-certified endocrinologists. This analysis evaluated change in diabetes distress among 228 program participants who reported moderate distress (score 2.0-2.9) or high distress (score ≥3.0) on the 17-item Diabetes Distress Scale (DDS17) at enrollment. Participants reported significant reductions in overall distress from 3.0 ± 0.8 at baseline to 2.5 ± 0.9 (P <0.001) at an average of 6 months of follow-up. Significant reductions in all DDS17 subscale scores were observed; most notable were reductions in the regimen-related and emotional distress subscales (-0.9 and -0.4, respectively; both P <0.001). Significantly greater reductions in overall distress (P = 0.012) and regimen-related distress (P <0.001) were reported by participants who were prescribed and used intermittent rtCGM (n = 77) versus nonusers (n = 151). Although the generalizability of these findings may be limited by the study's small sample size and potential for self-selection bias, these results do suggest that telemedicine programs such as the Onduo VDC could be a valuable tool for addressing the problem of diabetes-related distress.

Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients: A Randomized Controlled Trial.

Background: Screening for colorectal cancer (CRC) reduces mortality, yet more than one third of age-eligible Americans are unscreened. Objective: To examine the effect of a digital health intervention, Mobile Patient Technology for Health-CRC (mPATH-CRC), on rates of CRC screening. Design: Randomized clinical trial. (ClinicalTrials.gov: NCT02088333). Setting: 6 community-based primary care practices. Participants: 450 patients (223 in the mPATH-CRC group and 227 in usual care) scheduled for a primary care visit and due for routine CRC screening. Intervention: An iPad application that displays a CRC screening decision aid, lets patients order their own screening tests, and sends automated follow-up electronic messages to support patients. Measurements: The primary outcome was chart-verified completion of CRC screening within 24 weeks. Secondary outcomes were ability to state a screening preference, intention to receive screening, screening discussions, and orders for screening tests. All outcome assessors were blinded to randomization. Results: Baseline characteristics were similar between groups; 37% of participants had limited health literacy, and 53% had annual incomes less than $20 000. Screening was completed by 30% of mPATH-CRC participants and 15% of those receiving usual care (logistic regression odds ratio, 2.5 [95% CI, 1.6 to 4.0]). Compared with usual care, more mPATH-CRC participants could state a screening preference, planned to be screened within 6 months, discussed screening with their provider, and had a screening test ordered. Half of mPATH-CRC participants (53%; 118 of 223) "self-ordered" a test via the program. Limitation: Participants were English speakers in a single health care system. Conclusion: A digital health intervention that allows patients to self-order tests can increase CRC screening. Future research should identify methods for implementing similar interventions in clinical care. Primary Funding Source: National Cancer Institute.

Insights Into Older Adult Patient Concerns Around the Caregiver Proxy Portal Use: Qualitative Interview Study.

BACKGROUND: Electronic patient portals have become common and offer many potential benefits for patients' self-management of health care. These benefits could be especially important for older adult patients dealing with significant chronic illness, many of whom have caregivers, such as a spouse, adult child, or other family member or friend, who help with health care management. Patient portals commonly contain large amounts of personal information, including diagnoses, health histories, medications, specialist appointments, lab results, and billing and insurance information. Some health care systems provide proxy accounts for caregivers to access a portal on behalf of a patient. It is not well known how much and in what way caregivers are using patient portals on behalf of patients and whether patients see any information disclosure risks associated with such access. OBJECTIVE: The objective of this study was to examine how older adult patients perceive the benefits and risks of proxy patient portal access by their caregivers. METHODS: We conducted semistructured interviews with 10 older adult patients with chronic illness. We asked them about their relationship with their caregivers, their use of their patient portal, their caregiver's use of the portal, and their perceptions about the benefits and risks of their caregiver's use of the portals. We also asked them about their comfort level with caregivers having access to information about a hypothetical diagnosis of a stigmatized condition. Two investigators conducted a thematic analysis of the qualitative data. RESULTS: All patients identified caregivers. Some had given caregivers access to their portals, in all cases by sharing log-in credentials, rather than by setting up an official proxy account. Patients generally saw benefits in their caregivers having access to the information and functions provided by the portal. Patients generally reported that they would be uncomfortable with caregivers learning of stigmatized conditions and also with caregivers (except spouses) accessing financial billing information. CONCLUSIONS: Patients share their electronic patient portal credentials with caregivers to receive the benefits of those caregivers having access to important medical information but are unaware of all the information those caregivers can access. Better portal design could alleviate these unwanted information disclosures.

Characterization of infant mu rhythm immediately before crawling: A high-resolution EEG study.

Crawling is an important milestone in infant motor development. However, infants with developmental motor disorders can exhibit delays, or even miss, in the acquisition of crawling skill. And little information is available from the neurodevelopmental domain about the changes in brain function with intervention. The mu rhythm can potentially play a substantial role in understanding human motor development at early ages in infants, as it has in adults. Studies about the mu rhythm in infants were in coarse temporal resolution with longitudinal samples taken months or years apart. Details about the infant mu rhythm at a fine age resolution has not been fully revealed, which leads to contradictory evidence about its formulation and developmental changes of its spectral origins and, therefore, impedes the full understanding of motor brain development before crawling skill acquisition. The present study aims to expand knowledge about the infant mu rhythm and its spatio-spectral pattern shifts along maturation immediately before crawling. With high-density EEG data recorded on a weekly basis and simultaneous characterization of spatio-spectral patterns of the mu rhythm, subtle developmental changes in its spectral peak, frequency range, and scalp topography are revealed. This mu rhythm further indicates a significant correlation to the crawling onset while powers from other frequency bands do not show such correlations. These details of developmental changes about the mu rhythm provide an insight of rapid changes in the human motor cortex in the first year of life. Our results are consistent with previous findings about the peak frequency shifting of the mu rhythm and further depict detailed developmental curves of its frequency ranges and spatial topographies. The infant mu rhythm could potentially be used to assess motor brain deficiencies at early ages and to evaluate intervention effectiveness in children with neuromotor disorders.

The prevalence of binge drinking among primary care residents.

BACKGROUND: Over one quarter of American adults binge drink, resulting in significant alcohol-related morbidity and mortality. Although brief interventions can decrease patients' alcohol use, many physicians in training do not provide this service. This study examines the prevalence of binge drinking among primary care residents, and the association of resident drinking behaviors with addressing patients' hazardous alcohol use. METHODS: Between July 2013 and August 2014, the authors surveyed all trainees in 6 primary care residency programs. The survey assessed self-reported frequency of binge drinking, confidence working with hazardous drinkers, and the performance of brief interventions when hazardous drinking was detected in patients. RESULTS: 221 of 246 residents completed the survey (response rate 89.8%). Half of residents (109/221) reported at least one episode of binge drinking in the prior year, and 18% (39/221) reported binge drinking at least once a month. In multivariable analysis, monthly binge drinking was associated with male gender (OR 2.5, 95% CI 1.1-5.4) and year of training (OR 0.25 for Year 3 vs. Year 1, 95% CI 0.07-0.90). Few residents felt confident they could help patients cut down or quit alcohol, regardless of personal binge drinking history (19% for those who binged monthly, 24% for those who binged 1-11 times a year, and 27% for those who never binged, p for trend = 0.31). Performance of brief interventions did not vary by personal binge drinking history. CONCLUSIONS: Binge drinking is common among primary care residents. In addition to training residents to effectively intervene with hazardous drinkers, residency programs should address the high prevalence of binge drinking by their physicians in training.

Primary Care Providers' Views of Patient Portals: Interview Study of Perceived Benefits and Consequences.

BACKGROUND: The United States government is encouraging physicians to adopt patient portals-secure websites that allow patients to access their health information. For patient portals to recognize their full potential and improve patient care, health care providers' acceptance and encouragement of their use will be essential. However, little is known about provider concerns or views of patient portals. OBJECTIVE: We conducted this qualitative study to determine how administrators, clinic staff, and health care providers at practices serving a lower income adult population viewed patient portals in terms of their potential benefit, areas of concern, and hopes for the future. METHODS: We performed in-depth interviews between October 2013 and June 2014 with 20 clinic personnel recruited from health centers in four North Carolina counties. Trained study personnel conducted individual interviews following an interviewer guide to elicit perceptions of the benefits and disadvantages of patient portals. Interviews were recorded and transcribed. Research team members reviewed transcribed interviews for major themes to construct a coding dictionary. Two researchers then coded each transcript with any coding discrepancies resolved through discussion. RESULTS: The interviews revealed that clinic personnel viewed patient portals as a mandated product that had potential to improve communication and enhance information sharing. However, they expressed many concerns including portals' potential to generate more work, confuse patients, alienate non-users, and increase health disparities. Clinic personnel expected few older and disadvantaged patients to use a portal. CONCLUSIONS: Given that clinic personnel have significant concerns about portals' unintended consequences, their uptake and impact on care may be limited. Future studies should examine ways portals can be implemented in practices to address providers' concerns and meet the needs of vulnerable populations.

House Officer-Driven Reduction in Laboratory Utilization.

OBJECTIVES: To determine whether sharing laboratory charge and personal utilization information with physicians can reduce laboratory test orders and expenditures, thereby decreasing the overutilization of laboratory testing. METHODS: This was a prospective study. By querying our electronic medical records, we calculated the median laboratory charges per patient/per day (PP/PD) and median laboratory tests ordered PP/PD for the resident general internal medicine and hospitalist services. For 10 weeks, we shared this team-based information with physicians with weekly updates. We calculated total laboratory charges for the 10 most common discharge diagnoses to capture laboratory charges for entire episodes of care. RESULTS: During the intervention, the mean number of laboratory tests ordered PP/PD by resident service decreased from 5.56 to 5.17 (-0.389, P <0.001); the mean charge PP/PD decreased from $488 to $461 (-$27, P < 0.001). The hospitalist service decreased the number of laboratory tests ordered PP/PD from 3.54 to 3.36 (-0.18, P = 0.77) and the mean charge PP/PD decreased from $331 to $301 (-$30, P = 0.96). The statistically significant decline in laboratory charges persisted after controlling for the 10 most common discharge diagnoses. Compared with the 3-month period before the study began, physicians in the 10-week intervention period ordered 1464 fewer laboratory tests, resulting in a $188,000 reduction in charges and a 3% to 4% reduction in utilization. CONCLUSIONS: Informing physicians of the charges for laboratory tests and their personal utilization patterns can reduce the number of laboratory tests ordered and laboratory expenditures, especially for physicians in training.

Primary care residents lack comfort and experience with alcohol screening and brief intervention: a multi-site survey.

BACKGROUND: Approximately one in six adults in the United States (U.S.) binge drinks. The U.S. Preventive Services Task Force recommends that primary care physicians screen patients for such hazardous alcohol use, and when warranted, deliver a brief intervention. OBJECTIVE: We aimed to determine primary care residents' current practices, perceived barriers and confidence with conducting alcohol screening and brief interventions (SBI). DESIGN: This was a multi-site, cross-sectional survey conducted from March 2010 through December 2012. PARTICIPANTS: We invited all residents in six primary care residency programs (three internal medicine programs and three family medicine programs) to participate. Of 244 residents, 210 completed the survey (response rate 86 %). MAIN MEASURES: Our survey assessed residents' alcohol screening practices (instruments used and frequency of screening), perceived barriers to discussing alcohol, brief intervention content, and self-rated ability to help hazardous drinkers. To determine the quality of brief interventions delivered, we examined how often residents reported including the three key recommended elements of feedback, advice, and goal-setting. KEY RESULTS: Most residents (60 %, 125/208) reported "usually" or "always" screening patients for alcohol misuse at the initial clinic visit, but few residents routinely screened patients at subsequent acute-care (17 %, 35/208) or chronic-care visits (33 %, 68/208). Only 19 % (39/210) of residents used screening instruments capable of detecting binge drinking. The most frequently reported barrier to SBI was lack of adequate training (54 %, 108/202), and only 21 % (43/208) of residents felt confident they could help at -risk drinkers. When residents did perform a brief intervention, only 24 % (49/208) "usually" or "always" included the three recommended elements. CONCLUSIONS: A minority of residents in this multi-site study appropriately screen or intervene with at-risk alcohol users. To equip residents to effectively address hazardous alcohol use, there is a critical need for educational and clinic interventions to support alcohol-related SBI.

Controversies in cancer screening.

New studies raise concerns about whether screening for some cancers may cause more harm than good. This commentary reviews evidence relevant to current controversies in cancer screening, highlights why it is so difficult to formulate universal screening recommendations, and emphasizes the importance of informed and shared decision making.

Optimizing empiric antibiotic therapy in patients with severe ß-lactam allergy.

Antibiotic selection is challenging in patients with severe ß-lactam allergy due to declining reliability of alternate antibiotics. Organisms isolated from these patients may exhibit unique resistance phenotypes. The objective of this study was to determine which alternate antibiotics or combinations provide adequate empirical therapy for patients with ß-lactam allergy who develop Gram-negative infections at our institution. We further sought to determine the effects of risk factors for drug resistance on empirical adequacy. A retrospective analysis was conducted for adult patients hospitalized from September 2009 to May 2010 who had a severe ß-lactam allergy and a urine, blood, or respiratory culture positive for a Gram-negative organism and who met predefined criteria for infection. Patient characteristics, culture and susceptibility data, and predefined risk factors for antibiotic resistance were collected. Adequacies of ß-lactam and alternate antibiotics were compared for all infections and selected subsets. The primary outcome was adequacy of each alternate antibiotic or combination for all infections. One hundred sixteen infections (40 pneumonias, 67 urinary tract infections, and 9 bacteremias) were identified. Single alternate agents were adequate less frequently than ß-lactams and combination regimens. Only in cases without risk factors for resistance did single-agent regimens demonstrate acceptable adequacy rates; each factor conferred a doubling of risk for resistance. Resistance risk factors should be considered in selecting empirical antibiotics for Gram-negative pathogens in patients unable to take ß-lactams due to severe allergy.

Patient Perspectives on a Targeted Text Messaging Campaign to Encourage Screening for Diabetes: Qualitative Study.

BACKGROUND: A sizeable proportion of prediabetes and diabetes cases among adults in the United States remain undiagnosed. Patient-facing clinical decision support (CDS) tools that leverage electronic health records (EHRs) have the potential to increase diabetes screening. Given the widespread mobile phone ownership across diverse groups, text messages present a viable mode for delivering alerts directly to patients. The use of unsolicited text messages to offer hemoglobin A1c (HbA1c) screening has not yet been studied. It is imperative to gauge perceptions of "cold texts" to ensure that information and language are optimized to promote engagement with text messages that affect follow-through with health behaviors. OBJECTIVE: This study aims to gauge the perceptions of and receptiveness to text messages to inform content that would facilitate engagement with text messages intended to initiate a mobile health (mHealth) intervention for targeted screening. Messages were designed to invite those not already diagnosed with diabetes to make a decision to take part in HbA1c screening and walk them through the steps required to perform the behavior based solely on an automated text exchange. METHODS: In total, 6 focus groups were conducted at Wake Forest Baptist Health (WFBH) between September 2019 and February 2020. The participants were adult patients without diabetes who had completed an in-person visit at the Family and Community Medicine Clinic within the previous year. We displayed a series of text messages and asked the participants to react to the message content and suggest improvements. Content was deductively coded with respect to the Health Belief Model (HBM) and inductively coded to identify other emergent themes that could potentially impact engagement with text messages. RESULTS: Participants (N=36) were generally receptive to the idea of receiving a text-based alert for HbA1c screening. Plain language, personalization, and content, which highlighted perceived benefits over perceived susceptibility and perceived severity, were important to participants' understanding of and receptiveness to messages. The patient-physician relationship emerged as a recurring theme in which patients either had a desire or held an assumption that their provider would be working behind the scenes throughout each step of the process. Participants needed further clarification to understand the steps involved in following through with HbA1c screening and receiving results. CONCLUSIONS: Our findings suggest that patients may be receptive to text messages that alert them to a risk of having an elevated HbA1c in direct-to-patient alerts that use cold texting. Using plain and positive language, integrating elements of personalization, and defining new processes clearly were identified by participants as modifiable content elements that could act as facilitators that would help overcome barriers to engagement with these messages. A patient's relationship with their provider and the financial costs associated with texts and screening may affect receptiveness and engagement in this process.

Effectiveness and implementation of mPATH™-CRC: a mobile health system for colorectal cancer screening.

BACKGROUND: Screening for colorectal cancer (CRC) is widely recommended but underused, even though CRC is the third most diagnosed cancer and the second leading cause of cancer death in the USA. The mPATH™ program is an iPad-based application designed to identify patients due for CRC screening, educate them on the commonly used screening tests, and help them select their best option, with the goal of increasing CRC screening rates. METHODS: The mPATH™ program consists of questions asked of all adult patients at check-in (mPATH™-CheckIn), as well as a module specific for patients due for CRC screening (mPATH™-CRC). In this study, the mPATH™ program is evaluated through a Type III hybrid implementation-effectiveness design. Specifically, the study consists of three parts: (1) a cluster-randomized controlled trial of primary care clinics comparing a "high touch" evidence-based implementation strategy with a "low touch" implementation strategy; (2) a nested pragmatic study evaluating the effectiveness of mPATH-CRC™ on completion of CRC screening; and (3) a mixed-methods study evaluating factors that facilitate or impede the maintenance of interventions like mPATH-CRC™. The primary objective is to compare the proportion of patients aged 50-74 who are eligible for CRC screening who complete mPATH™-CRC in the 6th month following implementation between the "high touch" and "low touch" implementation strategies. Effectiveness of mPATH™-CRC is evaluated by comparing the proportion who complete CRC screening within 16 weeks of their visit to the clinic between a pre-implementation cohort (8 months before implementation) and a post-implementation cohort (8 months after implementation). DISCUSSION: This study will provide data on both the implementation of the mPATH™ program and its effectiveness in improving screening rates for CRC. In addition, this work has the potential to have an even broader impact by identifying strategies to support the sustained use of other similar technology-based primary care interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03843957. Registered on 18 February 2019.

Adaptation of a Personalized Electronic Care Planning Tool for Cancer Follow-up Care: Formative Study.

BACKGROUND: Most patients diagnosed with colorectal cancer will survive for at least 5 years; thus, engaging patients to optimize their health will likely improve outcomes. Clinical guidelines recommend patients receive a comprehensive care plan (CP) when transitioning from active treatment to survivorship, which includes support for ongoing symptoms and recommended healthy behaviors. Yet, cancer care providers find this guideline difficult to implement. Future directions for survivorship care planning include enhancing information technology support for developing personalized CPs, using CPs to facilitate self-management, and assessing CPs in clinical settings. OBJECTIVE: We aimed to develop an electronic tool for colorectal cancer follow-up care (CFC) planning. METHODS: Incorporating inputs from health care professionals and patient stakeholders is fundamental to the successful integration of any tool into the clinical workflow. Thus, we followed the Integrate, Design, Assess, and Share (IDEAS) framework to adapt an existing application for stroke care planning (COMPASS-CP) to meet the needs of colorectal cancer survivors (COMPASS-CP CFC). Constructs from the Consolidated Framework for Implementation Research (CFIR) guided our approach. We completed this work in 3 phases: (1) gathering qualitative feedback from stakeholders about the follow-up CP generation design and workflow; (2) adapting algorithms and resource data sources needed to generate a follow-up CP; and (3) optimizing the usability of the adapted prototype of COMPASS-CP CFC. We also quantitatively measured usability (target average score ≥70; range 0-100), acceptability, appropriateness, and feasibility. RESULTS: In the first phase, health care professionals (n=7), and patients and caregivers (n=7) provided qualitative feedback on COMPASS-CP CFC that informed design elements such as selection, interpretation, and clinical usefulness of patient-reported measures. In phase 2, we built a minimal viable product of COMPASS-CP CFC. This tool generated CPs based on the needs identified by patient-completed measures (including validated patient-reported outcomes) and electronic health record data, which were then matched with resources by zip code and preference to support patients' self-management. Elements of the CFIR assessed revealed that most health care professionals believed the tool would serve patients' needs and had advantages. In phase 3, the average System Usability Scale score was above our target score for health care professionals (n=5; mean 71.0, SD 15.2) and patients (n=5; mean 95.5, SD 2.1). Participants also reported high levels of acceptability, appropriateness, and feasibility. Additional CFIR-informed feedback, such as desired format for training, will inform future studies. CONCLUSIONS: The data collected in this study support the initial usability of COMPASS-CP CFC and will inform the next steps for implementation in clinical care. COMPASS-CP CFC has the potential to streamline the implementation of personalized CFC planning to enable systematic access to resources that will support self-management. Future research is needed to test the impact of COMPASS-CP CFC on patient health outcomes.

The Optimizing Lung Screening Trial (WF-20817CD): Multicenter Randomized Effectiveness Implementation Trial to Increase Tobacco Use Cessation for Individuals Undergoing Lung Screening.

BACKGROUND: One-half of all people who undergo lung cancer screening (LCS) currently use tobacco. However, few published studies have explored how to implement effective tobacco use treatment optimally during the LCS encounter. RESEARCH QUESTION: Was the Optimizing Lung Screening intervention (OaSiS) effective at reducing tobacco use among patients undergoing LCS in community-based radiology facilities? STUDY DESIGN AND METHODS: The OaSiS study (National Cancer Institute [NCI] Protocol No.: WF-20817CD) is an effectiveness-implementation hybrid type II cluster randomized trial of radiology facilities conducted in partnership with the Wake Forest National Cancer Institute Community Oncology Research Program research base. We randomly assigned 26 radiology facilities in 20 states to the intervention or usual care group. Staff at intervention facilities implemented a variety of strategies targeting the clinic and care team. Eligible patient participants were aged 55 to 77 years undergoing LCS and currently using tobacco. Of 1,094 who completed a baseline survey (523 intervention group, 471 control group) immediately before the LCS appointment, 956 completed the 6-month follow-up (86% retention rate). Fifty-four percent of those who reported not using tobacco at 6 months completed biochemical verification via mailed cotinine assay. Generalized estimating equation marginal models were used in an intention-to-treat analysis to predict 7-day tobacco use abstinence. RESULTS: The average self-reported abstinence among participants varied considerably across facilities (0%-27%). Despite a significant increase in average cessation rate over time (0% at baseline to approximately 13% at 6 months; P < .0001), tobacco use did not differ by trial group at 14 days (OR, 0.96; 95% CI, 0.46-1.99; P = .90), 3 months (OR, 1.17; 95% CI, 0.69-1.99; P = .56), or 6 months (OR, 0.97; 95% CI, 0.65-1.43; P = .87). INTERPRETATION: The OaSiS trial participants showed a significant reduction in tobacco use over time, but no difference by trial arm was found. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03291587; URL: www. CLINICALTRIALS: gov.

Characterization of asthma exacerbations in primary care using cluster analysis.

RATIONALE: Patients with a history of asthma exacerbations are at a higher risk for future episodes of severe asthma exacerbations. Characterization of asthma phenotypes could help improve asthma management, including reducing exacerbations. AIM: The aim of this study is to identify distinctive patient characteristics associated with a history of asthma exacerbations using cluster analysis. METHODS: We used data assessing asthma control from two cross-sectional surveys of adult and pediatric patients in the primary care setting. A supervised cluster analysis with recursive partitioning approach was applied to identify characteristics that maximized the differences across subgroups. RESULTS: The sample comprised 2205 adults and 2435 children and adolescents with asthma. Key predictors were identified in seven adult clusters including visiting an asthma specialist, number of hours worked, and excessive use of rescue medication. The rate ratio (RR) for having an exacerbation was significantly higher (2.88; 95% confidence interval (CI), 2.46-3.36) in Cluster 7, with more female patients reporting severe disease, high body mass index, sinus infections, gastroesophageal reflux disease, skin allergies, and lower asthma control score. Features identified in the six pediatric clusters included visiting an asthma specialist, missed school days, race/ethnicity, and age. The RR for having an exacerbation was higher in Cluster 6 (2.36; 95% CI, 2.11-2.64), with patients reporting more severe disease, sinus and skin allergies, and lower asthma control score. CONCLUSIONS: Identification of specific risk factors can be enhanced by using supervised cluster analysis. This approach allows grouping of patients with unique characteristics to help identify patients at higher risk of exacerbations.