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.

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.

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.

Physical activity in COPD: Minimal clinically important difference for medical events.

Estimates of the minimal clinically important difference (MCID) for physical activity (PA) in chronic obstructive pulmonary disease (COPD) are needed. The objective is to provide an anchor-based estimate of the MCID for daily step count. PA was promoted in persons with COPD using a pedometer (Omron HJ-720ITC) alone or a pedometer plus interactive website for 3 months. Participants wore the pedometer daily and received phone calls monthly to ascertain medical events. Medical events were counted when a participant self-reported that he/she had (1) worsening of breathing, (2) change to breathing medications, (3) medical care from an emergency room for any reason, or (4) hospitalization for any reason. Generalized linear regression models assessed daily step count as change at the end of study and averaged over the 15, 31, or 61 days centered on the event, in those with an event compared to those without one. All categories of events carried equal weight in the analyses. We studied 93 persons, 46 of whom had an event. Participants who experienced an event had a decrease of 1086 (95% confidence interval (CI): -2124 to -48) or 887 (95% CI: -2030 to 257) steps/day in the pedometer plus website or pedometer alone groups, respectively, compared to those without one. In the days centered on an event, participants who had an event experienced a decrease of 882-983 steps/day (pedometer plus website) or a decrease of 351-495 steps/day (pedometer alone), compared to those without one. The MCID for PA in COPD ranges from 350 steps/day to 1100 steps/day.

Long-Term Effects of an Internet-Mediated Pedometer-Based Walking Program for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial.

BACKGROUND: Regular physical activity (PA) is recommended for persons with chronic obstructive pulmonary disease (COPD). Interventions that promote PA and sustain long-term adherence to PA are needed. OBJECTIVE: We examined the effects of an Internet-mediated, pedometer-based walking intervention, called Taking Healthy Steps, at 12 months. METHODS: Veterans with COPD (N=239) were randomized in a 2:1 ratio to the intervention or wait-list control. During the first 4 months, participants in the intervention group were instructed to wear the pedometer every day, upload daily step counts at least once a week, and were provided access to a website with four key components: individualized goal setting, iterative feedback, educational and motivational content, and an online community forum. The subsequent 8-month maintenance phase was the same except that participants no longer received new educational content. Participants randomized to the wait-list control group were instructed to wear the pedometer, but they did not receive step-count goals or instructions to increase PA. The primary outcome was health-related quality of life (HRQL) assessed by the St George's Respiratory Questionnaire Total Score (SGRQ-TS); the secondary outcome was daily step count. Linear mixed-effect models assessed the effect of intervention over time. One participant was excluded from the analysis because he was an outlier. Within the intervention group, we assessed pedometer adherence and website engagement by examining percent of days with valid step-count data, number of log-ins to the website each month, use of the online community forum, and responses to a structured survey. RESULTS: Participants were 93.7% male (223/238) with a mean age of 67 (SD 9) years. At 12 months, there were no significant between-group differences in SGRQ-TS or daily step count. Between-group difference in daily step count was maximal and statistically significant at month 4 (P<.001), but approached zero in months 8-12. Within the intervention group, mean 76.7% (SD 29.5) of 366 days had valid step-count data, which decreased over the months of study (P<.001). Mean number of log-ins to the website each month also significantly decreased over the months of study (P<.001). The online community forum was used at least once during the study by 83.8% (129/154) of participants. Responses to questions assessing participants' goal commitment and intervention engagement were not significantly different at 12 months compared to 4 months. CONCLUSIONS: An Internet-mediated, pedometer-based PA intervention, although efficacious at 4 months, does not maintain improvements in HRQL and daily step counts at 12 months. Waning pedometer adherence and website engagement by the intervention group were observed. Future efforts should focus on improving features of PA interventions to promote long-term behavior change and sustain engagement in PA. CLINICALTRIAL: Clinicaltrials.gov NCT01102777; https://clinicaltrials.gov/ct2/show/NCT01102777 (Archived by WebCite at http://www.webcitation.org/6iyNP9KUC).

Taking Healthy Steps: rationale, design and baseline characteristics of a randomized trial of a pedometer-based Internet-mediated walking program in veterans with chronic obstructive pulmonary disease.

BACKGROUND: Low levels of physical activity are common in patients with chronic obstructive pulmonary disease (COPD), and a sedentary lifestyle is associated with poor outcomes including increased mortality, frequent hospitalizations, and poor health-related quality of life. Internet-mediated physical activity interventions may increase physical activity and improve health outcomes in persons with COPD. METHODS/DESIGN: This manuscript describes the design and rationale of a randomized controlled trial that tests the effectiveness of Taking Healthy Steps, an Internet-mediated walking program for Veterans with COPD. Taking Healthy Steps includes an uploading pedometer, a website, and an online community. Eligible and consented patients wear a pedometer to obtain one week of baseline data and then are randomized on a 2:1 ratio to Taking Healthy Steps or to a wait list control. The intervention arm receives iterative step-count feedback; individualized step-count goals, motivational and informational messages, and access to an online community. Wait list controls are notified that they are enrolled, but that their intervention will start in one year; however, they keep the pedometer and have access to a static webpage. DISCUSSION: Participants include 239 Veterans (mean age 66.7 years, 93.7% male) with 155 randomized to Taking Healthy Steps and 84 to the wait list control arm; rural-living (45.2%); ever-smokers (93.3%); and current smokers (25.1%). Baseline mean St. George's Respiratory Questionnaire Total Score was 46.0; 30.5% reported severe dyspnea; and the average number of comorbid conditions was 4.9. Mean baseline daily step counts was 3497 (+/- 2220).Veterans with COPD can be recruited to participate in an online walking program. We successfully recruited a cohort of older Veterans with a significant level of disability including Veterans who live in rural areas using a remote national recruitment strategy. TRIAL REGISTRATION: Clinical Trials.gov NCT01102777.

Rural disparities impact response to a web-based physical activity self-management intervention in COPD: A secondary analysis.

PURPOSE: This secondary exploratory analysis examined rural-urban differences in response to a web-based physical activity self-management intervention for chronic obstructive pulmonary disease (COPD). METHODS: Participants with COPD (N = 239 US Veterans) were randomized to either a multicomponent web-based intervention (goal setting, iterative feedback of daily step counts, motivational and educational information, and an online community forum) or waitlist-control for 4 months with a 12-month follow-up. General linear modeling estimated the impact of rural/urban status (using Rural-Urban Commuting Area [RUCA] codes) on (1) 4- and 12-month daily step-count change compared to waitlist-control, and (2) intervention engagement (weekly logons and participant feedback). FINDINGS: Rural (n = 108) and urban (n = 131) participants' mean age was 66.7±8.8 years. Rural/urban status significantly moderated 4-month change in daily step counts between randomization groups (p = 0.041). Specifically, among urban participants, intervention participants improved by 1500 daily steps more than waitlist-control participants (p = 0.001). There was no difference among rural participants. In the intervention group, rural participants engaged less with the step-count graphs on the website than urban participants at 4 months (p = 0.019); this difference dissipated at 12 months. More frequent logons were associated with greater change in daily step counts (p = 0.004); this association was not moderated by rural/urban status. CONCLUSIONS: The web-based intervention was effective for urban, but not rural, participants at 4 months. Rural participants were also less engaged at 4 months, which may explain differences in effectiveness. Technology-based interventions can help address urban-rural disparities in patients with COPD, but may also contribute to them unless resources are available to support engagement with the technology.

The Effect of an mHealth Self-Monitoring Intervention (MI-BP) on Blood Pressure Among Black Individuals With Uncontrolled Hypertension: Randomized Controlled Trial.

BACKGROUND: Hypertension is one of the most important cardiovascular disease risk factors and affects >100 million American adults. Hypertension-related health inequities are abundant in Black communities as Black individuals are more likely to use the emergency department (ED) for chronic disease-related ambulatory care, which is strongly linked to lower blood pressure (BP) control, diminished awareness of hypertension, and adverse cardiovascular events. To reduce hypertension-related health disparities, we developed MI-BP, a culturally tailored multibehavior mobile health intervention that targeted behaviors of BP self-monitoring, physical activity, sodium intake, and medication adherence in Black individuals with uncontrolled hypertension recruited from ED and community-based settings. OBJECTIVE: We sought to determine the effect of MI-BP on BP as well as secondary outcomes of physical activity, sodium intake, medication adherence, and BP control compared to enhanced usual care control at 1-year follow-up. METHODS: We conducted a 1-year, 2-group randomized controlled trial of the MI-BP intervention compared to an enhanced usual care control group where participants aged 25 to 70 years received a BP cuff and hypertension-related educational materials. Participants were recruited from EDs and other community-based settings in Detroit, Michigan, where they were screened for initial eligibility and enrolled. Baseline data collection and randomization occurred approximately 2 and 4 weeks after enrollment to ensure that participants had uncontrolled hypertension and were willing to take part. Data collection visits occurred at 13, 26, 39, and 52 weeks. Outcomes of interest included BP (primary outcome) and physical activity, sodium intake, medication adherence, and BP control (secondary outcomes). RESULTS: We obtained consent from and enrolled 869 participants in this study yet ultimately randomized 162 (18.6%) participants. At 1 year, compared to the baseline, both groups showed significant decreases in systolic BP (MI-BP group: 22.5 mm Hg decrease in average systolic BP and P<.001; control group: 24.1 mm Hg decrease and P<.001) adjusted for age and sex, with no significant differences between the groups (time-by-arm interaction: P=.99). Similar patterns where improvements were noted in both groups yet no differences were found between the groups were observed for diastolic BP, physical activity, sodium intake, medication adherence, and BP control. Large dropout rates were observed in both groups (approximately 60%). CONCLUSIONS: Overall, participants randomized to both the enhanced usual care control and MI-BP conditions experienced significant improvements in BP and other outcomes; however, differences between groups were not detected, speaking to the general benefit of proactive outreach and engagement focused on cardiometabolic risk reduction in urban-dwelling, low-socioeconomic-status Black populations. High dropout rates were found and are likely to be expected when working with similar populations. Future work is needed to better understand engagement with mobile health interventions, particularly in this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT02955537; https://clinicaltrials.gov/study/NCT02955537. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/12601.

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.

Pedometer-based internet-mediated intervention for adults with chronic low back pain: randomized controlled trial.

BACKGROUND: Chronic pain, especially back pain, is a prevalent condition that is associated with disability, poor health status, anxiety and depression, decreased quality of life, and increased health services use and costs. Current evidence suggests that exercise is an effective strategy for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low-cost approach to help patients with chronic back pain initiate and maintain an exercise program. OBJECTIVE: The objective of the study was to determine whether a pedometer-based, Internet-mediated intervention can reduce chronic back pain-related disability. METHODS: A parallel group randomized controlled trial was conducted with 1:1 allocation to the intervention or usual care group. 229 veterans with nonspecific chronic back pain were recruited from one Department of Veterans Affairs (VA) health care system. Participants randomized to the intervention received an uploading pedometer and had access to a website that provided automated walking goals, feedback, motivational messages, and social support through an e-community (n=111). Usual care participants (n=118) also received the uploading pedometer but did not receive the automated feedback or have access to the website. The primary outcome was measured using the Roland Morris Disability Questionnaire (RDQ) at 6 months (secondary) and 12 months (primary) with a difference in mean scores of at least 2 considered clinically meaningful. Both a complete case and all case analysis, using linear mixed effects models, were conducted to assess differences between study groups at both time points. RESULTS: Baseline mean RDQ scores were greater than 9 in both groups. Primary outcome data were provided by approximately 90% of intervention and usual care participants at both 6 and 12 months. At 6 months, average RDQ scores were 7.2 for intervention participants compared to 9.2 for usual care, an adjusted difference of 1.6 (95% CI 0.3-2.8, P=.02) for the complete case analysis and 1.2 (95% CI -0.09 to 2.5, P=.07) for the all case analysis. A post hoc analysis of patients with baseline RDQ scores ≥4 revealed even larger adjusted differences between groups at 6 months but at 12 months the differences were no longer statistically significant. CONCLUSIONS: Intervention participants, compared with those receiving usual care, reported a greater decrease in back pain-related disability in the 6 months following study enrollment. Between-group differences were especially prominent for patients reporting greater baseline levels of disability but did not persist over 12 months. Primarily, automated interventions may be an efficient way to assist patients with managing chronic back pain; additional support may be needed to ensure continuing improvements. TRIAL REGISTRATION: ClinicalTrials.gov NCT00694018; http://clinicaltrials.gov/ct2/show/NCT00694018 (Archived by WebCite at http://www.webcitation.org/6IsG4Y90E).

Chronic Obstructive Pulmonary Disease Access and Adherence to Pulmonary Rehabilitation Intervention (CAPRI): Protocol for a randomized controlled trial and adaptations during the COVID-19 pandemic.

BACKGROUND: Pulmonary rehabilitation (PR) is the standard of care for chronic obstructive pulmonary disease (COPD) management. However, significant barriers limit access and adherence to PR and alternatives are needed. The purpose of this randomized controlled trial is to test the efficacy of a web-based, pedometer-mediated intervention to increase physical activity (PA) for persons with COPD who decline PR or meet U.S. guidelines for referral to PR but have not participated (CAPRI-1). In addition, we will test whether the intervention maintains PA following PR in an exploratory aim (CAPRI-2). METHODS: Participants with COPD (N = 120) will be recruited and randomized 1:1 to a 12-week web-based, pedometer-mediated intervention or usual care (UC) (CAPRI-1). The intervention provides: 1) objective monitoring of walking and iterative feedback, 2) individualized step-count goals, 3) motivational messages and educational content, and 4) an online community. The primary outcome is change in daily step count from baseline to 12 weeks. Secondary outcomes include: (a) exercise capacity; (b) self-reported PA; (c) PA intensity; (d) exercise self-regulatory efficacy, (e) health-related quality of life, (f) dyspnea, (g) depression symptoms, and (h) healthcare utilization. CAPRI-2 will test whether participants (N = 96) assigned to the intervention following PR completion show greater maintenance of daily step count compared to UC at 3, 6, 9, and 12 months. DISCUSSION: If the intervention is efficacious, it may be an alternative for those who cannot attend PR or a maintenance program following completion of conventional PR. We also present adaptations made to the protocol in response to the COVID-19 pandemic.

Implementing a mentoring program for clinical research professionals: A novel professional development initiative for university health research staff.

Clinical and translational research relies on a well-trained workforce, but mentorship programs designed expressly for this workforce are lacking. This paper presents the development of a mentoring program for research staff and identifies key programmatic outcomes. Research staff participating in this program were matched with a senior mentor. Focus groups were conducted to identify key program outcomes. Surveys were administered throughout the program period to assess participants' experience, gains in skill, and subsequent careers. Analysis of the resultant qualitative and quantitative data are used to characterize the implementation and impact of the program. A total of 47 mentees and 30 mentors participated in program between 2018 and 2023. A comprehensive logic model of short-, intermediate- and long-term outcomes was developed. Participants reported positive valuations of every programmatic outcome assessed including their program experience, learning and research careers. The pool of available mentors also grew as new mentors were successfully recruited for each cohort. This mentorship program developed and implemented by senior research staff successfully provided junior research staff with professional development support, mentorship, and professional development opportunities. Junior and senior health research staff built mentoring relationships that advanced their clinical and translational research careers.

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.

Development of a Novel Intervention (Mindful Steps) to Promote Long-Term Walking Behavior in Chronic Cardiopulmonary Disease: Protocol for a Randomized Controlled Trial.

BACKGROUND: Despite current rehabilitation programs, long-term engagement in physical activity remains a significant challenge for patients with chronic obstructive pulmonary disease (COPD) and heart failure (HF). Novel strategies to promote physical activity in these populations are greatly needed. Emerging literature on the benefits of both mind-body interventions and web-based interventions provide the rationale for the development of the Mindful Steps intervention for increasing walking behavior. OBJECTIVE: This study aims to develop a novel multimodal mind-body exercise intervention through adaptation of an existing web-based physical activity intervention and incorporation of mind-body exercise, and to pilot test the delivery of the new intervention, Mindful Steps, in a randomized controlled feasibility trial in older adults with COPD and/or HF. METHODS: In phase 1, guided by a theoretical conceptual model and review of the literature on facilitators and barriers of physical activity in COPD and HF, we convened an expert panel of researchers, mind-body practitioners, and clinicians to inform development of the novel, multimodal intervention. In phase 2, we are conducting a pilot randomized controlled feasibility trial of the Mindful Steps intervention that includes in-person mind-body exercise classes, an educational website, online mind-body videos, and a pedometer with step-count feedback and goals to increase walking behavior in patients with COPD and/or HF. Outcomes include feasibility measures as well as patient-centered measures. RESULTS: The study is currently ongoing. Phase 1 intervention development was completed in March 2019, and phase 2 data collection began in April 2019. CONCLUSIONS: Through the integration of components from a web-based physical activity intervention and mind-body exercise, we created a novel, multimodal program to impact long-term physical activity engagement for individuals with COPD and HF. This developmental work and pilot study will provide valuable information needed to design a future clinical trial assessing efficacy of this multimodal approach. TRIAL REGISTRATION: ClinicalTrials.gov NCT03003780; https://clinicaltrials.gov/ct2/show/NCT03003780. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27826.

A randomised trial of a web-based physical activity self-management intervention in COPD.

Improving exercise capacity is a primary objective in COPD. Declines in exercise capacity result in reduced physical activity and health-related quality of life (HRQoL). Self-management interventions can teach patients skills and behaviours to manage their disease. Technology-mediated interventions have the potential to provide easily accessible support for disease self-management. We evaluated the effectiveness of a web-based self-management intervention, focused on physical activity promotion, on exercise capacity in COPD. This 6-month randomised controlled trial (NCT02099799) enrolled 153 persons with COPD at two US sites (VABoston, n=108; VABirmingham, n=45). Participants were allocated (1:1) to the web-based self-management intervention (physical activity promotion through personalised, progressive step-count goals, feedback, online COPD-related education and social support via an online community) or usual care. The primary outcome was exercise capacity (6-min walk distance (6 MWD)). Secondary outcomes included physical activity (daily steps per day), HRQoL (St. George's Respiratory Questionnaire Total Score), dyspnoea, COPD-related knowledge and social support. Change in step-count goals reflected intervention engagement. Participants' mean age was 69 (sd=7), and mean forced expiratory volume in 1 s % predicted was 61% (sd=21%). Change in 6MWD did not differ between groups. Intervention participants improved their mean daily step counts by 1312 more than those in the usual care group (p<0.001). Groups did not differ on other secondary outcomes. VABirmingham participants were significantly more engaged with the intervention, although site did not modify the effect of the intervention on 6MWD or secondary outcomes. The intervention did not improve exercise capacity but improved physical activity at 6 months. Additional intervention modifications are needed to optimise its COPD self-management capabilities.

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.

Veterans walk to beat back pain: study rationale, design and protocol of a randomized trial of a pedometer-based internet mediated intervention for patients with chronic low back pain.

BACKGROUND: Chronic back pain is a significant problem worldwide and may be especially prevalent among patients receiving care in the U.S. Department of Veterans Affairs healthcare system. Back pain affects adults at all ages and is associated with disability, lost workplace productivity, functional limitations and social isolation. Exercise is one of the most effective strategies for managing chronic back pain. Yet, there are few clinical programs that use low cost approaches to help patients with chronic back pain initiate and maintain an exercise program. METHODS/DESIGN: We describe the design and rationale of a randomized controlled trial to assess the efficacy of a pedometer-based Internet mediated intervention for patients with chronic back pain. The intervention uses an enhanced pedometer, website and e-community to assist these patients with initiating and maintaining a regular walking program with the primary aim of reducing pain-related disability and functional interference. The study specific aims are: 1) To determine whether a pedometer-based Internet-mediated intervention reduces pain-related functional interference among patients with chronic back pain in the short term and over a 12-month timeframe. 2) To assess the effect of the intervention on walking (measured by step counts), quality of life, pain intensity, pain related fear and self-efficacy for exercise. 3) To identify factors associated with a sustained increase in walking over a 12-month timeframe among patients randomized to the intervention. DISCUSSION: Exercise is an integral part of managing chronic back pain but to be effective requires that patients actively participate in the management process. This intervention is designed to increase activity levels, improve functional status and make exercise programs more accessible for a broad range of patients with chronic back pain. TRIAL REGISTRATION NUMBER: NCT00694018.