Virtual Care: Perspectives From Family Physicians.

BACKGROUND: During the COVID-19 pandemic, virtual care expanded rapidly at Michigan Medicine and other health systems. From family physicians' perspectives, this shift to virtual care has the potential to affect workflow, job satisfaction, and patient communication. As clinics reopened and care delivery models shifted to a combination of in-person and virtual care, the need to understand physician experiences with virtual care arose in order to improve both patient and provider experiences. This study investigated Michigan Medicine family medicine physicians' perceptions of virtual care through qualitative interviews to better understand how to improve the quality and effectiveness of virtual care for both patients and physicians. METHODS: We employed a qualitative descriptive design to examine physician perspectives through semistructured interviews. We coded and analyzed transcripts using thematic analysis, facilitated by MAXQDA (VERBI) software. RESULTS: The results of the analysis identified four major themes: (a) chief concerns that are appropriate for virtual evaluation, (b) physician perceptions of patient benefits, (c) focused but contextually enriched patient-physician communication, and (d) structural support needed for high-quality virtual care. CONCLUSIONS: These findings can help further direct the discussion of how to make use of resources to improve the quality and effectiveness of virtual care.

Human technology intermediation to reduce cognitive load: understanding healthcare staff members' practices to facilitate telehealth access in a Federally Qualified Health Center patient population.

OBJECTIVES: The aim of this study was to investigate how healthcare staff intermediaries support Federally Qualified Health Center (FQHC) patients' access to telehealth, how their approaches reflect cognitive load theory (CLT) and determine which approaches FQHC patients find helpful and whether their perceptions suggest cognitive load (CL) reduction. MATERIALS AND METHODS: Semistructured interviews with staff (n = 9) and patients (n = 22) at an FQHC in a Midwestern state. First-cycle coding of interview transcripts was performed inductively to identify helping processes and participants' evaluations of them. Next, these inductive codes were mapped onto deductive codes from CLT. RESULTS: Staff intermediaries used 4 approaches to support access to, and usage of, video visits and patient portals for FQHC patients: (1) shielding patients from cognitive overload; (2) drawing from long-term memory; (3) supporting the development of schemas; and (4) reducing the extraneous load of negative emotions. These approaches could contribute to CL reduction and each was viewed as helpful to at least some patients. For patients, there were beneficial impacts on learning, emotions, and perceptions about the self and technology. Intermediation also resulted in successful visits despite challenges. DISCUSSION: Staff intermediaries made telehealth work for FQHC patients, and emotional support was crucial. Without prior training, staff discovered approaches that aligned with CLT and helped patients access technologies. Future healthcare intermediary interventions may benefit from the application of CLT in their design. Staff providing brief explanations about technical problems and solutions might help patients learn about technologies informally over time. CONCLUSION: CLT can help with developing intermediary approaches for facilitating telehealth access.

Identifying Inequities in Video and Audio Telehealth Services for Primary Care Encounters During COVID-19: Repeated Cross-Sectional, Observational Study.

BACKGROUND: The COVID-19 pandemic resulted in rapid changes in how patient care was provided, particularly through the expansion of telehealth and audio-only phone-based care. OBJECTIVE: The goal of this study was to evaluate inequities in video and audio-only care during various time points including the initial wave of the COVID-19 pandemic, later stages of the pandemic, and a historical control. We sought to understand the characteristics of care during this time for a variety of different groups of patients that may experience health care inequities. METHODS: We conducted a retrospective analysis of electronic health record (EHR) data from encounters from 34 family medicine and internal medicine primary care clinics in a large, Midwestern health system, using a repeated cross-sectional, observational study design. These data included patient demographic data, as well as encounter, diagnosis, and procedure records. Data were obtained for all in-person and telehealth encounters (including audio-only phone-based care) that occurred during 3 separate time periods: an initial COVID-19 period (T2: March 16, 2020, to May 3, 2020), a later COVID-19 period (T3: May 4, 2020, to September 30, 2020), and a historical control period from the previous year (T1: March 16, 2019, to September 30, 2019). Primary analysis focused on the status of each encounter in terms of whether it was completed as scheduled, it was canceled, or the patient missed the appointment. A secondary analysis was performed to evaluate the likelihood of an encounter being completed based on visit modality (phone, video, in-person). RESULTS: In total, there were 938,040 scheduled encounters during the 3 time periods, with 178,747 unique patients, that were included for analysis. Patients with completed encounters were more likely to be younger than 65 years old (71.8%-74.1%), be female (58.8%-61.8%), be White (75.6%-76.7%), and have no significant comorbidities (63.2%-66.8%) or disabilities (53.2%-61.1%) in all time periods than those who had only canceled or missed encounters. Effects on different subpopulations are discussed herein. CONCLUSIONS: Findings from this study demonstrate that primary care utilization across delivery modalities (in person, video, and phone) was not equivalent across all groups before and during the COVID-19 pandemic and different groups were differentially impacted at different points. Understanding how different groups of patients responded to these rapid changes and how health care inequities may have been affected is an important step in better understanding implementation strategies for digital solutions in the future.

Facilitators and barriers to blood pressure telemonitoring: A mixed-methods study.

Background: Telemonitoring of blood pressure (BP) may improve BP control. However, many patients are not using BP telemonitoring due to personal, technological, and health system barriers. Individuals are required to have electronic health literacy (e-HL), defined as knowledge and skills to use technology services effectively, such as BP telemonitoring. Objective: The objective was to determine the facilitators and barriers experienced by patients with hypertension in telemonitoring of BP using the e-HL framework (e-HLF). Methods: This study was a prospective mixed-methods study using a convergent design. We recruited a convenience sample of 21 patients with hypertension. The qualitative section was online or phone individual in-depth interviews based on the e-HLF, which has seven domains. The quantitative section was an online survey consisting of demographics, an e-HL questionnaire, and patient-provider communication preferences. A joint display was used in the mixed-methods analysis. Results: Five themes including knowledge, motivation, skills, systems, and behaviors along with 28 subthemes comprising facilitators or barriers of BP telemonitoring were identified. The mixed-methods results showed concordance between the participants' e-HL status and their experiences in the ability to actively engage with BP monitoring and managing digital services (domain 3) of the e-HLF. Other e-HL domains showed discordance. Conclusion: Patients may engage with BP telemonitoring when they feel the usefulness of concurrent access to telemonitoring services that suit their needs.

Equity in virtual care: A mixed methods study of perspectives from physicians.

BACKGROUND: Virtual care expanded rapidly during the COVID-19 pandemic, and how this shift affected healthcare disparities among subgroups of patients is of concern. Racial and ethnic minorities, older adults, individuals with less education, and lower-income households have lower rates of home broadband, smartphone ownership, and patient portal adoption, which may directly affect access to virtual care. Because primary care is a major access point to healthcare, perspectives of primary care providers are critical to inform the implementation of equitable virtual care. OBJECTIVE: The aim of this mixed methods study was to explore primary care physician experiences and perceptions of barriers and facilitators to equitable virtual care. DESIGN: We used an explanatory sequential mixed methods design, which consists of first collecting and analyzing quantitative survey data, then using those results to inform a qualitative follow-up phase to explain and expand on results. PARTICIPANTS: Primary care physicians in a family medicine department at an academic medical center responded to surveys (n = 38) and participated in interviews (n = 16). APPROACH: Participants completed a survey concerning frequency and preferences about video visits, pros and cons of video visits, communication aspects, and sufficiency of the technology. A purposeful sample of participants completed semi-structured interviews about their virtual care experiences with a focus on equity for subpopulations. KEY RESULTS: The results indicated that physicians have observed equity issues for unique patient populations. The results add to the understanding of nuanced ways in which virtual care can increase and decrease healthcare access for unique populations. Patients with limited English proficiency were particularly affected by inequity in virtual care access. CONCLUSION: Additional research and interventions are needed to improve portal access for those with limited English proficiency. Improvements should focus on health system interventions that expand access without requiring increased patient burden.

Reach Out Emergency Department: A Randomized Factorial Trial to Determine the Optimal Mobile Health Components to Reduce Blood Pressure.

BACKGROUND: Mobile health (mHealth) strategies initiated in safety-net Emergency Departments may be one approach to address the US hypertension epidemic, but the optimal mHealth components or dose are unknown. METHODS: Reach Out is an mHealth, health theory-based, 2×2×2 factorial trial among hypertensive patients evaluated in a safety-net Emergency Department in Flint, Michigan. Reach Out consisted of 3 mHealth components, each with 2 doses: (1) healthy behavior text messaging (yes versus no), (2) prompted self-measured blood pressure (BP) monitoring and feedback (weekly versus daily), and (3) facilitated primary care provider appointment scheduling and transportation (yes versus no). The primary outcome was a change in systolic BP from baseline to 12 months. In a complete case analysis, we fit a linear regression model and accounted for age, sex, race, and prior BP medications to explore the association between systolic BP and each mHealth component. RESULTS: Among 488 randomized participants, 211 (43%) completed follow-up. Mean age was 45.5 years, 61% were women, 54% were Black people, 22% did not have a primary care doctor, 21% lacked transportation, and 51% were not taking antihypertensive medications. Overall, systolic BP declined after 6 months (-9.2 mm Hg [95% CI, -12.2 to -6.3]) and 12 months (-6.6 mm Hg, -9.3 to -3.8), without a difference across the 8 treatment arms. The higher dose of mHealth components were not associated with a greater change in systolic BP; healthy behavior text messages (point estimate, mmHG=-0.5 [95% CI, -6.0 to 5]; P=0.86), daily self-measured BP monitoring (point estimate, mmHG=1.9 [95% CI, -3.7 to 7.5]; P=0.50), and facilitated primary care provider scheduling and transportation (point estimate, mmHG=0 [95% CI, -5.5 to 5.6]; P=0.99). CONCLUSIONS: Among participants with elevated BP recruited from an urban safety-net Emergency Department, BP declined over the 12-month intervention period. There was no difference in change in systolic BP among the 3 mHealth components. Reach Out demonstrated the feasibility of reaching medically underserved people with high BP cared for at a safety-net Emergency Departments, yet the efficacy of the Reach Out mHealth intervention components requires further study. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03422718.

Perceptions of telehealth among older U.S. adults during the COVID-19 pandemic: A national survey.

INTRODUCTION: COVID-19 necessitated a shift from in-person to virtual care for all patients, particularly older adults. It is unknown how older individuals' views of telehealth changed during this time and how this may affect their future use of telehealth services. METHODS: We used data from a cross-sectional online survey of a nationally representative sample of 2074 U.S. adults ages 50-80 who were participants in the National Poll on Healthy Aging. We performed a descriptive and multivariable analysis of individuals' perspectives on past and future telehealth visits, sociodemographics, and health status. RESULTS: Before March 2020, 5.8% of respondents had used telehealth, compared to 32.0% by June 2020. Of telehealth users, 36.1% indicated their most recent telehealth visit used audio-only (i.e., without video) technology. In multivariable analysis, those who never used video technology compared to those who were "very comfortable" (average marginal effect (AME) 49%, 95% CI: 36-63), identified as Hispanic (AME 19% vs White, non-Hispanic, 95% CI: 5-32), or were female (AME 9%, 95% CI: 1-17) were more likely to report audio-only use. Concerns remained about the inability to conduct physical exams (75%) and telehealth quality of care (67%), though most (64%) older adults indicated an interest in future telehealth visits. DISCUSSION: Telehealth use increased substantially among older U.S. adults during the early months of the COVID-19 pandemic; however, many reported using audio-only telehealth, an important consideration for policymakers and providers. Addressing older adults' concerns about and barriers to telehealth visits is needed to ensure telehealth does not exacerbate disparities in their care.

Equitable Research PRAXIS: A Framework for Health Informatics Methods.

OBJECTIVES: There is growing attention to health equity in health informatics research. However, the literature lacks a comprehensive framework outlining critical considerations for health informatics research with marginalized groups. METHODS: Literature review and experiences from nine equity-focused health informatics conducted in the United States and Canada. Studies focus on disparities related to age, disability or chronic illness, gender/sex, place of residence (rural/urban), race/ethnicity, sexual orientation, and socioeconomic status. RESULTS: We found four key equity-related methodological considerations. To assist informaticists in addressing equity, we contribute a novel framework to synthesize these four considerations: PRAXIS (Participation and Representation, Appropriate methods and interventions, conteXtualization and structural competence, Investigation of Systematic differences). Participation and representation refers to the necessity for meaningful participation of marginalized groups in research, to elevate the voices of marginalized people, and to represent marginalized people as they are comfortable (e.g., asset-based versus deficit-based). Appropriate methods and interventions mean targeting methods, instruments, and interventions to reach and engage marginalized people. Contextualization and structural competence mean avoiding individualization of systematic disparities and targeting social conditions that (re-)produce inequities. Investigation of systematic differences highlights that experiences of people marginalized according to specific traits differ from those not so marginalized, and thus encourages studying the specificity of these differences and investigating and preventing intervention-generated inequality. We outline guidance for operationalizing these considerations at four research stages. CONCLUSIONS: This framework can assist informaticists in systematically addressing these considerations in their research in four research stages: project initiation; sampling and recruitment; data collection; and data analysis. We encourage others to use these insights from multiple studies to advance health equity in informatics.

Barriers and Considerations in the Design and Implementation of Digital Behavioral Interventions: Qualitative Analysis.

BACKGROUND: Digital behavioral interventions have become increasingly popular for their ability to support patient diagnosis and treatment, chronic disease self-management, behavior change, and adherence to recommended care. However, digital intervention development is impeded by challenges such as limited technical skills, limited access to developers, and cost. The purpose of this study is to elicit in-depth qualitative feedback from intervention developers who have interest in digital behavioral interventions but lack programming skills regarding the barriers they experience and key considerations in the design and implementation of digital interventions. OBJECTIVE: This study aims to understand barriers in the design and implementation of digital behavioral interventions, as well as to identify key considerations for researchers who are developing these interventions. METHODS: We conducted semistructured qualitative interviews with 18 researchers who had experience either designing (but not coding) digital behavioral interventions or running research studies with them. Participants were a convenience sample of users of the Computerized Intervention Authoring System platform, an existing no-code development platform for building digital intervention content, and were recruited through either direct email solicitation or snowball sampling. All interviews were conducted and recorded over videoconference between February and April 2020. Recordings from interviews were transcribed and thematically analyzed by multiple coders. RESULTS: Interviews were completed with 18 participants and lasted between 24 and 65 (mean 46.9, SD 11.3) minutes. Interviewees were predominantly female (17/18, 94%) and represented different job roles, ranging from researcher to project/study staff. Three key barriers in the development of digital behavior interventions were identified during interviews: lack of cross-disciplinary understanding; variability in recipients' technology access, infrastructure, and literacy; and the idea that evidence-based in-person interactions do not translate directly to digital interactions. Interviewees identified several key considerations that interventionists learned to prioritize, which have the potential to overcome these barriers and lead to successful interventions. CONCLUSIONS: Barriers in the development of digital behavioral interventions are often created by a lack of cross-disciplinary understanding, which can lead to difficulties conceptualizing interventions, unrealistic expectations in terms of cost, and confusion about the development process. Moreover, concerns about research study participant characteristics and access to technology, as well as the translation of in-person interventions to digital, are apparent. Appropriate training in how to work with software development teams may help future digital behavior intervention creators overcome these barriers and may lead to new, exciting innovations in this space.

The Perceived Benefits of Digital Interventions for Behavioral Health: Qualitative Interview Study.

BACKGROUND: Digital interventions have gained momentum in terms of behavioral health. However, owing to lacking standard approaches or tools for creating digital behavioral interventions, clinical researchers follow widely varying conceptions of how best to go about digital intervention development. Researchers also face significant cost-, time-, and expertise-related challenges in digital intervention development. Improving the availability of tools and guidance for researchers will require a thorough understanding of the motivations and needs of researchers seeking to create digital interventions. OBJECTIVE: This study aims to understand the perceptions of behavioral researchers toward digital interventions, and inform the use of these interventions, by documenting the reasons why researchers are increasingly focusing their efforts on digital interventions and their perspectives on the perceived benefits that digital approaches can provide for researchers and intervention recipients. METHODS: We conducted semistructured qualitative interviews with 18 researchers who had experience designing digital behavioral interventions or running studies with them. A convenience sample of interviewees was recruited from among users of the Computerized Intervention Authoring System platform, a web-based tool that facilitates the process of creating and deploying digital interventions in behavioral research. Interviews were conducted over teleconference between February and April 2020. Recordings from the interviews were transcribed and thematically analyzed by multiple coders. RESULTS: Interviews were completed with 18 individuals and lasted between 24 and 65 (mean 46.9, SD 11.3) minutes. Interviewees were predominantly female (17/18, 94%) and represented different job roles, ranging from researcher to project or study staff. Four major themes came out of the interviews concerning the benefits of digital interventions for behavioral health: convenience and flexibility for interventionists and recipients, support for implementing evidence-based interventions with fidelity, scaling and improving access to interventions, and getting a foot in the door despite stigma and disenfranchisement. CONCLUSIONS: Interviewees described a number of important potential benefits of digital interventions, particularly with respect to scientific rigor, scalability, and overcoming barriers to reaching more people. There are complex considerations with regard to translating behavior change strategies into digital forms of delivery, and interventionists make individual, sometimes unexpected, choices with minimal evidence of their relative effectiveness. Future research should investigate how behavioral researchers can be supported in making these choices toward usability, ease of access, and approachability of digital interventions. Our study underscores the need for authoring platforms that can facilitate the process of creating and deploying digital interventions to reach their full potential for interventionists and recipients alike.

Predictors of Smartphone and Tablet Use Among Patients With Hypertension: Secondary Analysis of Health Information National Trends Survey Data.

BACKGROUND: Uncontrolled hypertension leads to significant morbidity and mortality. The use of mobile health technology, such as smartphones, for remote blood pressure (BP) monitoring has improved BP control. An increase in BP control is more significant when patients can remotely communicate with their health care providers through technologies and receive feedback. Little is known about the predictors of remote BP monitoring among hypertensive populations. OBJECTIVE: The objective of this study is to quantify the predictors of smartphone and tablet use in achieving health goals and communicating with health care providers via SMS text messaging among hypertensive patients in the United States. METHODS: This study was a cross-sectional, secondary analysis of the 2017 and 2018 Health Information National Trends Survey 5, cycles 1 and 2 data. A total of 3045 respondents answered "Yes" to the question "Has a doctor or other healthcare provider ever told you that you had high blood pressure or hypertension?", which defined the subpopulation used in this study. We applied the Health Information National Trends Survey full sample weight to calculate the population estimates and 50 replicate weights to calculate the SEs of the estimates. We used design-adjusted descriptive statistics to describe the characteristics of respondents who are hypertensive based on relevant survey items. Design-adjusted multivariable logistic regression models were fitted to estimate predictors of achieving health goals with the help of smartphone or tablet and sending or receiving an SMS text message to or from a health care provider in the last 12 months. RESULTS: An estimated 36.9%, SE 0.9% (183,285,150/497,278,883) of the weighted adult population in the United States had hypertension. The mean age of the hypertensive population was 58.3 (SE 0.48) years. Electronic communication with the doctor or doctor's office through email or internet (odds ratio 2.93, 95% CI 1.85-4.63; P<.001) and having a wellness app (odds ratio 1.82, 95% CI 1.16-2.86; P=.02) were significant predictors of using SMS text message communication with a health care professional, adjusting for other demographic and technology-related variables. The odds of achieving health-related goals with the help of a tablet or smartphone declined significantly with older age (P<.001) and ownership of basic cellphones (P=.04). However, they increased significantly with being a woman (P=.045) or with being married (P=.03), having a wellness app (P<.001), using devices other than smartphones or tablets to monitor health (P=.008), making health treatment decisions (P=.048), and discussing with a provider (P=.02) with the help of a tablet or smartphone. CONCLUSIONS: Intervention measures accounting for age, gender, marital status, and the patient's technology-related health behaviors are required to increase smartphone and tablet use in self-care and SMS text message communication with health care providers.

Pharmacogenomic testing for mental health (Part I): documenting early adopter perceptions of use for eight scenarios.

Aim: We sought to understand how early adopters used pharmacogenomic (PGx) testing for treating depression and attention deficient hyperactivity disorder (ADHD). Patients & methods: We conducted a phone survey with prescribers who had previously ordered an Informed PGx (Progenity, Inc., MI, USA) test. Results: We identified 1037 prescribers in our sampling period. Respondents (n = 64) were predominantly female (61.5%) and in pediatrics (n = 42; 64.6%). PGx testing was used for multiple scenarios (mean 3.3 ± 1.6); the most common was after no response to medication was observed (80%; 51/64). Most respondents state that test results typically reveal an altered metabolizer status. Conclusion: PGx test results ordered by early adopters often reveal altered metabolizers which leads them to change the depression/ADHD medication regimen. Future work should evaluate the clinical utility of PGx testing for depression/ADHD treatment.

Pharmacogenomic testing for mental health (Part II): qualitative analysis of early adopter prescriber perceptions.

Aim: We sought to explore how early adopters use pharmacogenomic (PGx) testing for treating depression and attention-deficit/hyperactivity disorder. Patients & methods: Prescribers of the Informed PGx (Progenity, Inc., Ann Arbor, MI 48108, USA) test completed a phone survey assessing use of PGx testing for different scenarios. We conducted a qualitative thematic text analysis of transcribed audio recordings of open-ended responses (n = 62). Results: PGx testing was used when treating multiple comorbidities or resistant disease, and to ease patients' concerns with future therapy. Use of PGx testing is influenced by insurance coverage, interpretability of results and results turnaround time. Conclusion: Prescribers used PGx tests to modify medications for complex patients with depression, attention-deficit/hyperactivity disorder and other disorders to alleviate concerns related to adverse effects and lack of effectiveness.

Understanding the Feasibility, Acceptability, and Efficacy of a Clinical Pharmacist-led Mobile Approach (BPTrack) to Hypertension Management: Mixed Methods Pilot Study.

BACKGROUND: Hypertension is a prevalent and costly burden in the United States. Clinical pharmacists within care teams provide effective management of hypertension, as does home blood pressure monitoring; however, concerns about data quality and latency are widespread. One approach to close the gap between clinical pharmacist intervention and home blood pressure monitoring is the use of mobile health (mHealth) technology. OBJECTIVE: We sought to investigate the feasibility, acceptability, and preliminary effectiveness of BPTrack, a clinical pharmacist-led intervention that incorporates patient- and clinician-facing apps to make electronically collected, patient-generated data available to providers in real time for hypertension management. The patient app also included customizable daily medication reminders and educational messages. Additionally, this study sought to understand barriers to adoption and areas for improvement identified by key stakeholders, so more widespread use of such interventions may be achieved. METHODS: We conducted a mixed methods pilot study of BPTrack, to improve blood pressure control in patients with uncontrolled hypertension through a 12-week pre-post intervention. All patients were recruited from a primary care setting where they worked with a clinical pharmacist for hypertension management. Participants completed a baseline visit, then spent 12 weeks utilizing BPTrack before returning to the clinic for follow-up. Collected data from patient participants included surveys pre- and postintervention, clinical measures (for establishing effectiveness, with the primary outcome being a change in blood pressure and the secondary outcome being a change in medication adherence), utilization of the BPTrack app, interviews at follow-up, and chart review. We also conducted interviews with key stakeholders. RESULTS: A total of 15 patient participants were included (13 remained through follow-up for an 86.7% retention rate) in a single group, pre-post assessment pilot study. Data supported the hypothesis that BPTrack was feasible and acceptable for use by patient and provider participants and was effective at reducing patient blood pressure. At the 12-week follow-up, patients exhibited significant reductions in both systolic blood pressure (baseline mean 137.3 mm Hg, SD 11.1 mm Hg; follow-up mean 131.0 mm Hg, SD 9.9 mm Hg; P=.02) and diastolic blood pressure (baseline mean 89.4 mm Hg, SD 7.7 mm Hg; follow-up mean 82.5 mm Hg, SD 8.2 mm Hg; P<.001). On average, patients uploaded at least one blood pressure measurement on 75% (SD 25%) of study days. No improvements in medication adherence were noted. Interview data revealed areas of improvement and refinement for the patient experience. Furthermore, stakeholders require integration into the electronic health record and a modified clinical workflow for BPTrack to be truly useful; however, both patients and stakeholders perceived benefits of BPTrack when used within the context of a clinical relationship. CONCLUSIONS: Results demonstrate that a pharmacist-led mHealth intervention promoting home blood pressure monitoring and clinical pharmacist management of hypertension can be effective at reducing blood pressure in primary care patients with uncontrolled hypertension. Our data also support the feasibility and acceptability of these types of interventions for patients and providers. TRIAL REGISTRATION: ClinicalTrials.gov NCT02898584; https://clinicaltrials.gov/ct2/show/NCT02898584. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.8059.

Effect of Adding Telephone-Based Brief Coaching to an mHealth App (Stay Strong) for Promoting Physical Activity Among Veterans: Randomized Controlled Trial.

BACKGROUND: Though maintaining physical conditioning and a healthy weight are requirements of active military duty, many US veterans lose conditioning and rapidly gain weight after discharge from active duty service. Mobile health (mHealth) interventions using wearable devices are appealing to users and can be effective especially with personalized coaching support. We developed Stay Strong, a mobile app tailored to US veterans, to promote physical activity using a wrist-worn physical activity tracker, a Bluetooth-enabled scale, and an app-based dashboard. We tested whether adding personalized coaching components (Stay Strong+Coaching) would improve physical activity compared to Stay Strong alone. OBJECTIVE: The goal of this study is to compare 12-month outcomes from Stay Strong alone versus Stay Strong+Coaching. METHODS: Participants (n=357) were recruited from a national random sample of US veterans of recent wars and randomly assigned to the Stay Strong app alone (n=179) or Stay Strong+Coaching (n=178); both programs lasted 12 months. Personalized coaching components for Stay Strong+Coaching comprised of automated in-app motivational messages (3 per week), telephone-based human health coaching (up to 3 calls), and personalized weekly goal setting. All aspects of the enrollment process and program delivery were accomplished virtually for both groups, except for the telephone-based coaching. The primary outcome was change in physical activity at 12 months postbaseline, measured by average weekly Active Minutes, captured by the Fitbit Charge 2 device. Secondary outcomes included changes in step counts, weight, and patient activation. RESULTS: The average age of participants was 39.8 (SD 8.7) years, and 25.2% (90/357) were female. Active Minutes decreased from baseline to 12 months for both groups (P<.001) with no between-group differences at 6 months (P=.82) or 12 months (P=.98). However, at 12 months, many participants in both groups did not record Active Minutes, leading to missing data in 67.0% (120/179) for Stay Strong and 61.8% (110/178) for Stay Strong+Coaching. Average baseline weight for participants in Stay Strong and Stay Strong+Coaching was 214 lbs and 198 lbs, respectively, with no difference at baseline (P=.54) or at 6 months (P=.28) or 12 months (P=.18) postbaseline based on administrative weights, which had lower rates of missing data. Changes in the number of steps recorded and patient activation also did not differ by arm. CONCLUSIONS: Adding personalized health coaching comprised of in-app automated messages, up to 3 coaching calls, plus automated weekly personalized goals, did not improve levels of physical activity compared to using a smartphone app alone. Physical activity in both groups decreased over time. Sustaining long-term adherence and engagement in this mHealth intervention proved difficult; approximately two-thirds of the trial's 357 participants failed to sync their Fitbit device at 12 months and, thus, were lost to follow-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/12526.

Reach out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial.

BACKGROUND: Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States. The Emergency Department represents an underutilized opportunity to impact difficult-to-reach populations. There are 136 million visits to the Emergency Department each year and nearly all have at least one blood pressure measured and recorded. Additionally, an increasing number of African Americans and socioeconomically disadvantaged patients are overrepresented in the Emergency Department patient population. In the age of electronic health records and mobile health, the Emergency Department has the potential to become an integral partner in chronic disease management. The electronic health records in conjunction with mobile health behavior interventions can be leveraged to identify hypertensive patients to impact otherwise unreached populations. METHODS: Reach Out is a factorial trial studying multicomponent, behavioral interventions to reduce blood pressure in the Emergency Department patient population. Potential participants are identified by automated alerts from the electronic health record and, following consent, receive a blood pressure cuff to take home. During the initial screening phase, they are prompted to submit weekly blood pressure readings. Responders with persistent hypertension are then randomized into one of three component arms, consisting of varying intensity levels: (1) healthy behavior text messaging (daily vs. none), (2) blood pressure self-monitoring (daily vs. weekly), and (3) facilitated primary care provider appointment scheduling and transportation (yes vs. no). If participants are randomized to receive facilitated primary care provider appointment scheduling and are not established with a primary care provider, care will be established at a local Federally Qualified Health Center. Participants are followed for 12 months. DISCUSSION: The Reach Out study is designed to determine which behavioral intervention components or 'dose' of components contributes to a reduction in systolic blood pressure after 1 year (Aim 1). The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2). Ideally, the Reach Out system will contribute to hypertension management, serving as a model for safety net hospitals and Federally Qualified Health Centers to improve chronic disease management in underserved communities. TRIAL REGISTRATION: This study was registered at clinicaltrials.gov, identifier NCT03422718. The record was first available to the public on January 30, 2018 prior to the enrollment of patients on March 25, 2019.

Deaf Adults' Health Literacy and Access to Health Information: Protocol for a Multicenter Mixed Methods Study.

BACKGROUND: Deaf American Sign Language (ASL) users often struggle with limited health literacy compared with their hearing peers. However, the mechanisms driving limited health literacy and how this may impact access to and understanding of health information for Deaf individuals have not been determined. Deaf individuals are more likely than hearing individuals to use the internet, yet they continue to report significant barriers to health information. This study presents an opportunity to identify key targets that impact information access for a largely marginalized population. OBJECTIVE: This study aims to elucidate the role of information marginalization on health literacy in Deaf ASL users and to better understand the mechanisms of health literacy in this population for the purpose of identifying viable targets for future health literacy interventions. METHODS: This is an exploratory mixed methods study to identify predictors and moderators of health literacy in the Deaf population. These predictors of health literacy will be used to inform the second step that qualitatively explains the findings, including how Deaf individuals access and understand Web-based health information. Multiple interviewer- and computer-based instruments underwent translation and adaptation, from English to ASL, to make them accessible for the Deaf participants in our study. A planned sample of 450 Deaf ASL users and 450 hearing native English speakers, aged 18 to 70 years, will be recruited from 3 partnering sites: Rochester, NY; Flint, MI; and Chicago, IL. These individuals will participate in a single data collection visit. A subset of participants (approximately 30) with key characteristics of interest will be invited for a second data collection visit to observe and inquire more about their ability to directly access, navigate, and comprehend Web-based health information. The study will help assess how the ways health literacy and information are visualized may differ between Deaf individuals and hearing individuals. The study will also survey participants' ownership and use of computer and mobile devices and their level of Web-based information use, including health information. RESULTS: Adaptation and translation of protocols and instruments have been completed and are now in use for the study. Recruitment is underway and will continue until late 2020. Results from this study will be used to provide a guide on how to structure Web-based health information in a way that maximizes accessibility and improves health literacy for Deaf individuals. CONCLUSIONS: The results from this mixed methods proposal will advance what is known about health literacy and health information accessibility for Deaf individuals. This innovative study will generate rich data on how to formulate health information and health literacy interventions more accurately to take advantage of visual learning skills. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/14889.

Using Pharmacogenomic Testing in Primary Care: Protocol for a Pilot Randomized Controlled Study.

BACKGROUND: Antidepressants are used by primary care providers to treat a variety of conditions, including (but not limited to) depression and anxiety. A trial-and-error approach is typically used to identify effective therapy, as treatment efficacy and safety can vary based on the response, which is affected by certain gene types. Pharmacokinetic pharmacogenomic (PGx) testing provides phenotypic classification of individuals as poor, intermediate, extensive, and ultrarapid CYP450 metabolizers, providing information for optimal drug selection. OBJECTIVE: The objective of this pilot study is to examine the feasibility, acceptability, and preliminary effectiveness of PGx testing when used after starting a new antidepressant medication. METHODS: We are conducting a pilot study with physicians from 6 Department of Family Medicine clinics at the University of Michigan who are willing to use PGx test results to manage antidepressant medication use. From enrolled physicians, patients were recruited to participate in a 6-month randomized, wait-list controlled trial in which patient participants newly prescribed an antidepressant had PGx testing and were randomized equally to have the results released to their primary care physician as soon as results were available or after 3 months. Patients were excluded if they had been taking the antidepressant for more than 4 weeks or if they had undergone PGx testing in the past. Physician participants completed a baseline survey to assess demographics, as well as knowledge, feasibility, and acceptability of PGx testing for this population. At the conclusion of the study, physician participants will complete a survey to assess knowledge, satisfaction, feasibility, acceptability, perceived effectiveness, and barriers to widespread adoption of PGx testing. Patient participants will complete a baseline, 3-month, and 6-month assessment, and control patient participants will have an additional 9-month assessment. Data collected will include the reason for antidepressant use, self-reported medication adherence, side effects, patient health questionnaire 8-item depression scale, generalized anxiety disorder 7-item scale, 12-Item Short-Form Health Survey, work status or changes, and physician and emergency department visits. PGx knowledge and perceptions (including acceptability and feasibility) as well as demographic information will also be obtained. RESULTS: We recruited 23 physician participants between November 2017 and January 2019, and 52 patient participants between January 2018 and April 2019. Currently, all physician and patient participants have been recruited, and we expect data collection to conclude in January 2020. CONCLUSIONS: This study will examine the preliminary effectiveness of PGx testing after treatment initiation and determine the feasibility and acceptability of PGx testing for use in primary care. Through this study, we expect to demonstrate the benefit of PGx testing and lay the foundation for translating this approach into use within primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03270891; https://clinicaltrials.gov/ct2/show/NCT03270891. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/13848.

Influence of Scribes on Patient-Physician Communication in Primary Care Encounters: Mixed Methods Study.

BACKGROUND: With the increasing adoption of electronic health record (EHR) systems, documentation-related burdens have been increasing for health care providers. Recent estimates indicate that primary care providers spend about one-half of their workdays interacting with the EHR, of which about half is focused on clerical tasks. To reduce documentation burdens associated with the EHR, health care systems and physician practices are increasingly implementing medical scribes to assist providers with real-time documentation. Scribes are typically unlicensed paraprofessionals who assist health care providers by documenting notes electronically under the direction of a licensed practitioner or physician in real time. Despite the promise of scribes, few studies have investigated their effect on clinical encounters, particularly with regard to patient-provider communication. OBJECTIVE: The purpose of this quasi-experimental pilot study was to understand how scribes affect patient-physician communication in primary care clinical encounters. METHODS: We employed a convergent mixed methods design and included a sample of three physician-scribe pairs and 34 patients. Patients' clinical encounters were randomly assigned to a scribe or nonscribe group. We conducted patient surveys focused on perceptions of patient-provider communication and satisfaction with encounters, video recorded clinical encounters, and conducted physician interviews about their experiences with scribes. RESULTS: Overall, the survey results revealed that patients across both arms reported very high satisfaction of communication with their physician, their physician's use of the EHR, and their care, with very little variability. Video recording analysis supported patient survey data by demonstrating high measures of communication among physicians in both scribed and nonscribed encounters. Furthermore, video recordings revealed that the presence of scribes had very little effect on the clinical encounter. CONCLUSIONS: From the patient's perspective, scribes are an acceptable addition to clinical encounters. Although they do not have much impact on patients' perceptions of satisfaction and their impact on the clinical encounter itself was minimal, their potential to reduce documentation-related burden on physicians is valuable. Physicians noted important issues related to scribes, including important considerations for implementing scribe programs, the role of scribes in patient interactions, how physicians work with scribes, characteristics of good scribes, and the role of scribes in physician workflow.