Incorporating TechQuity in Virtual Care Within the Veterans Health Administration: Identifying Future Research and Operations Priorities.

BACKGROUND: The Covid-19 pandemic dramatically changed healthcare delivery, driving rapid expansion of synchronous (i.e., real-time) audio-only and video telehealth, otherwise known as virtual care. Yet evidence describes significant inequities in virtual care utilization, with certain populations more dependent on audio-only virtual care than video-based care. Research is needed to inform virtual care policies and processes to counteract current inequities in access and health outcomes. OBJECTIVE: Given the importance of incorporating equity into virtual care within the Veterans Health Administration (VHA), we convened a Think Tank to identify priorities for future research and virtual care operations focused on achieving equitable implementation of virtual care within the VHA. METHODS: We used participatory activities to engage clinicians, researchers, and operational partners from across the VHA to develop priorities for equitable implementation of virtual care. We refined priorities through group discussion and force-ranked prioritization and outlined next steps for selected priorities. KEY RESULTS: Think Tank participants included 43 individuals from the VHA who represented diverse geographical regions, offices, and backgrounds. Attendees self-identified their associations primarily as operations (n = 9), research (n = 28), or both (n = 6). We identified an initial list of 63 potential priorities for future research and virtual care operations. Following discussion, we narrowed the list to four priority areas: (1) measure inequities in virtual care, (2) address emerging inequities in virtual care, (3) deploy virtual care equitably to accommodate differently abled veterans, and (4) measure and address potential adverse consequences of expanded virtual care. We discuss related information, data, key partners, and outline potential next steps. CONCLUSIONS: This Think Tank of research and operational partners from across the VHA identified promising opportunities to incorporate equity into the design and implementation of virtual care. Although much work remains, the priorities identified represent important steps toward achieving this vital goal.

Implementing evidence-based telephone coaching for health behavior program enrollment: A quality improvement project.

INTRODUCTION: This program evaluation describes the use of implementation facilitation to support uptake of a telephone-based engagement coaching intervention, ACTIVATE, using paraprofessional staff, to support health behavior program enrollment. METHOD: The RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework guided the formative evaluation. A mixed-methods approach was used to integrate qualitative (i.e., rapid analysis approach) and quantitative (i.e., descriptive statistics, chi-square test of independence, logistic regression) analyses for each outcome. RESULTS: Most patients (95%; 319 of 335) were offered ACTIVATE, and 82 patients completed ACTIVATE. Delivery with paraprofessional staff was feasible with adaptations for translation from research to a clinical setting, which are described. External facilitation (a form of implementation facilitation) was associated with higher reach. DISCUSSION: Delivery of telephone-based coaching by paraprofessional staff to support health behavior program enrollment was feasible. External facilitation was important to the translation of ACTIVATE from research to clinical practice. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Secondary Prevention Risk Interventions via Telemedicine and Tailored Patient Education (SPRITE): A randomized trial to improve post myocardial infarction management.

OBJECTIVE: We evaluated the impact of a low intensity web-based and intensive nurse-administered intervention to reduce systolic blood pressure (SBP) among patients with prior MI. METHODS: Secondary Prevention Risk Interventions via Telemedicine and Tailored Patient Education (SPRITE) was a three-arm trial. Patients were randomized to 1) post-MI education-only; 2) nurse-administered telephone program; or 3) web-based interactive tool. The study was conducted 2009-2013. RESULTS: Participants (n = 415) had a mean age of 61 years (standard deviation [SD], 11). Relative to the education-only group, the 12-month differential improvement in SBP was - 3.97 and - 3.27 mmHg for nurse-administered telephone and web-based groups, respectively. Neither were statistically significant. Post hoc exploratory subgroup analyses found participants who received a higher dose (>12 encounters) in the nurse-administered telephone intervention (n = 60; 46%) had an 8.8 mmHg (95% CI, 0.69, 16.89; p = 0.03) differential SBP improvement versus low dose (<11 encounters; n = 71; 54%). For the web-based intervention, those who had higher dose (n = 73; 53%; >1 web encounter) experienced a 2.3 mmHg (95% CI, -10.74, 6.14; p = 0.59) differential SBP improvement versus low dose (n = 65; 47%). CONCLUSIONS: The main effects were not statistically significant. PRACTICAL IMPLICATIONS: Completing the full dose of the intervention may be essential to experience the intervention effect. CLINICAL TRIAL REGISTRATION: The unique identifier is NCT00901277 (http://www. CLINICALTRIALS: gov/ct2/show/NCT00901277?term=NCT00901277&rank=1).

Addressing Hypertension Outcomes Using Telehealth and Population Health Managers: Adaptations and Implementation Considerations.

PURPOSE OF REVIEW: There is a growing evidence base describing population health approaches to improve blood pressure control. We reviewed emerging trends in hypertension population health management and present implementation considerations from an intervention called Team-supported, Electronic health record-leveraged, Active Management (TEAM). By doing so, we highlight the role of population health managers, practitioners who use population level data and to proactively engage at-risk patients, in improving blood pressure control. RECENT FINDINGS: Within a population health paradigm, we discuss telehealth-delivered approaches to equitably improve hypertension care delivery. Additionally, we explore implementation considerations and complementary features of team-based, telehealth-delivered, population health management. By leveraging the unique role and expertise of a population health manager as core member of team-based telehealth, health systems can implement a cost-effective and scalable intervention that addresses multi-level barriers to hypertension care delivery. We describe the literature of telehealth-based population health management for patients with hypertension. Using the TEAM intervention as a case study, we then present implementation considerations and intervention adaptations to integrate a population health manager within the health care team and effectively manage hypertension for a defined patient population. We emphasize practical considerations to inform implementation, scaling, and sustainability. We highlight future research directions to advance the field and support translational efforts in diverse clinical and community contexts.

Veterans' Interpretation of Diabetes Distress in Diabetes Self-Management: Findings From Cognitive Interviews.

PURPOSE: The purpose of this project was to identify additional facets of diabetes distress (DD) in veterans that may be present due to the veteran's military-related experience. METHODS: The study team completed cognitive interviews with veterans with type 2 diabetes mellitus (T2DM) to examine how they answered the Diabetes Distress Scale (DD Scale), a tool that assesses DD. The DD Scale was used because of its strong associations with self-management challenges, physician-related distress, and clinical outcomes. RESULTS: The veterans sample (n= 15) was 73% male, mean age of 61 (SD = 8.6), 53% Black, 53% with glycosylated hemoglobin level <9%, and 67% with prescribed insulin. The DD Scale is readily understood by veterans and interpreted. Thematic analysis indicated additional domains affecting DD and T2DM self-management, including access to care, comorbidities, disruptions in routine, fluctuations in emotions and behaviors, interactions with providers, lifelong nature of diabetes, mental health concerns, military as culture, personal characteristics, physical limitations, physical pain, sources of information and support, spirituality, and stigma. CONCLUSIONS: This study describes how a veteran's military experience may contribute to DD in the context of T2DM self-management. Findings indicate clinicians and researchers should account for additional domains when developing self-management interventions and discussing self-management behaviors with individuals with T2DM.

Applied Rapid Qualitative Analysis to Develop a Contextually Appropriate Intervention and Increase the Likelihood of Uptake.

BACKGROUND: Rapid approaches to collecting and analyzing qualitative interview data can accelerate discovery timelines and intervention development while maintaining scientific rigor. We describe the application of these methods to a program designed to improve care coordination between the Veterans Health Administration (VHA) and community providers. METHODS: Care coordination between VHA and community providers can be challenging in rural areas. The Telehealth-based Coordination of Non-VHA Care (TECNO Care) intervention was designed to improve care coordination among VHA and community providers. To ensure contextually appropriate implementation of TECNO Care, we conducted preimplementation interviews with veterans, VHA administrators, and VHA and community providers involved in community care. Using both a rapid approach and qualitative analysis, an interviewer and 1-2 note-taker(s) conducted interviews. RESULTS: Over 5 months, 18 stakeholders were interviewed and we analyzed these data to identify how best to deliver TECNO Care. Responses relevant to improving care coordination include health system characteristics; target population; metrics and outcomes; challenges with the current system; and core components. Veterans who frequently visit VHA or community providers and are referred for additional services are at risk for poor outcomes and may benefit from additional care coordination. Using these data, we designed TECNO Care to include information on VHA services and processes, assist in the timely completion of referrals, and facilitate record sharing. CONCLUSION: Rapid qualitative analysis can inform near real-time intervention development and ensure relevant content creation while setting the stage for stakeholder buy-in. Rigorous and timely analyses support the delivery of contextually appropriate, efficient, high-value patient care.

Improving cardiovascular outcomes by using team-supported, EHR-leveraged, active management: Disseminating a successful quality improvement project.

BACKGROUND: Uncontrolled blood pressure (BP) is common among Veterans. Rural Veterans are at risk for suboptimal care coordination as successful programs may be implemented at lower rates due to individual- and system-level factors. There is strong evidence to support the use of remotely delivered support and patient-generated data from home BP monitors and virtual BP visits to manage BP. OBJECTIVE: The purpose of this project is to augment the current approach to addressing uncontrolled BP so that existing clinical staff can reach a larger patient population. METHODS: Our project will address uncontrolled BP by leveraging team-based care, the Veteran's Health Administration Electronic Health Record, and patient-centered medical home data to address patient, provider, and system barriers to cardiovascular disease (CVD) preventive care. We will implement this project in cardiovascular disease practices in three rural Veterans Health Administration clinics. We will evaluate implementation processes as well as patient-level (e.g., clinical outcomes, referrals to specialty services) outcomes in a one-arm, pre-post design. DISCUSSION: This manuscript describes our process in expanding the implementation of a successful project to improve BP control in high-risk, rural Veterans. Findings from our study will inform an understanding of both implementation and clinical effectiveness outcomes of a potentially scalable BP intervention in rural, community-based clinics. Appropriate management of Veterans with uncontrolled BP can reduce morbidity and mortality related to CVD. In turn, improvements in BP, can lead to improved quality metrics and potentially decrease costs for a healthcare system.

Prevalence of insomnia disorder and sleep apnea in a sample of veterans at risk for cardiovascular disease.

STUDY OBJECTIVES: The objectives of this study were to examine the proportion of study participants screening positive for insomnia disorder and/or sleep apnea in veterans engaged in routine health care and known to be at risk for cardiovascular disease and to compare these proportions with those previously documented in medical records. METHODS: This was a cross-sectional analysis of baseline data from a randomized clinical intervention trial for patients at risk of cardiovascular disease and a review of study participants' medical records. Participants were veterans ≥ 40 years of age, enrolled in Veterans Affairs primary care, and diagnosed with hypertension and/or hypercholesterolemia. Self-report outcomes were the proportion of patients screening positive for an insomnia disorder and sleep apnea, self-reporting a sleep apnea diagnosis, and endorsing undertreated sleep apnea. Medical record outcomes were the proportion of patients diagnosed with insomnia and sleep apnea. RESULTS: Participants (n = 420) were veterans (84.8% male) with a mean age of 61.1 years. More than half of the sample (52.1%) screened positive for sleep apnea without prior self-reported diagnosis. More than one-third of the sample (39%) screened positive for an insomnia disorder. Medical records revealed considerably lower rates, with 3.8% diagnosed with insomnia, 20.5% diagnosed with sleep apnea, and about 1% diagnosed with both conditions. CONCLUSIONS: Undiagnosed and undertreated sleep disorders are common among veterans at risk for cardiovascular disease. Most of the sample (82%) screened positive for, or met, study criteria for sleep apnea or an insomnia disorder. Limitations include the use of self-reported sleep apnea treatment adherence, an insomnia disorder diagnosis based on questionnaire score, and a sample comprised primarily of male veterans. Routine sleep disorders screening in veterans at risk for cardiovascular disease could help to identify those at even greater risk because of the adverse effects of undiagnosed or undertreated sleep disorders. CLINICAL TRIAL REGISTRATION: Registry; ClinicalTrials.gov; Name: Cardiovascular Intervention Improvement Telemedicine Study; URL: https://clinicaltrials.gov/ct2/show/NCT01142908; Identifier: NCT01142908.

Accelerating Implementation of Virtual Care in an Integrated Health Care System: Future Research and Operations Priorities.

BACKGROUND: Virtual care is critical to Veterans Health Administration (VHA) efforts to expand veterans' access to care. Health care policies such as the Veterans Access, Choice, and Accountability (CHOICE) Act and the Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act impact how the VHA provides care. Research on ways to refine virtual care delivery models to meet the needs of veterans, clinicians, and VHA stakeholders is needed. OBJECTIVE: Given the importance of virtual approaches for increasing access to high-quality VHA care, in December 2019, we convened a Think Tank, Accelerating Implementation of Virtual Care in VHA Practice, to consider challenges to virtual care research and practice across the VHA, discuss novel approaches to using and evaluating virtual care, assess perspectives on virtual care, and develop priorities to enhance virtual care in the VHA. METHODS: We used a participatory approach to develop potential priorities for virtual care research and activities at the VHA. We refined these priorities through force-ranked prioritization and group discussion, and developed solutions for selected priorities. RESULTS: Think Tank attendees (n = 18) consisted of VHA stakeholders, including operations partners (e.g., Office of Rural Health, Office of Nursing Services, Health Services Research and Development), clinicians (e.g., physicians, nurses, psychologists, physician assistants), and health services researchers. We identified an initial list of fifteen potential priorities and narrowed these down to four. The four priorities were (1) scaling evidence-based practices, (2) centralizing virtual care, (3) creating high-value care within the VHA with virtual care, and (4) identifying appropriate patients for virtual care. CONCLUSION: Our Think Tank took an important step in setting a partnered research agenda to optimize the use of virtual care within the VHA. We brought together research and operations stakeholders and identified possibilities, partnerships, and potential solutions for virtual care.

Lessons learned from two randomized controlled trials: CITIES and STOP-DKD.

BACKGROUND: Even well-designed, theoretically driven clinical trials can fall short of achieving the desired clinical outcomes. Our research team had an opportunity to conduct two randomized controlled trials that were enrolling patients in parallel. While both studies were targeting chronic disease management among patients with multiple comorbid conditions, the patient population and settings varied. The studies were the Cardiovascular Intervention Improvement Telemedicine Study (CITIES) and Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) studies. Both studies had null findings. OBJECTIVES: Our goal is to discuss common design considerations across CITIES and STOP-DKD and potential implications for the design of future randomized controlled trials. METHODS: These were two 1:1 randomized controlled trials with attention control groups that recruited patients from various clinical practices in the Research Triangle area of North Carolina. CONCLUSIONS: We make three recommendations for future studies. First, we assert that it is important to allow for piloting the enrollment process to ensure that it is possible to identify and recruit a patient population that is well aligned with the clinical outcomes of the intervention. Second, analysis plans should be more targeted in their approach and should consider heterogeneity of treatment effects. Third, in order to support the transition of evidence generated from randomized controlled trials into clinical practice, it is important to consider even early stage randomized controlled trials through an implementation science lens. TRIAL REGISTRATION: Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) NCT01829256; Cardiovascular Intervention Improvement Telemedicine Study NCT01142908.

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.

Health Coaching Has Differential Effects on Veterans with Limited Health Literacy and Numeracy: a Secondary Analysis of ACTIVATE.

BACKGROUND: Health coaching is an effective behavior change strategy. Understanding if there is a differential impact of health coaching on patients with low health literacy has not been well investigated. OBJECTIVE: To determine whether a telephone coaching intervention would result in similar improvements in enrollment in prevention programs and patient activation among Veterans with low versus high health literacy (specifically, reading literacy and numeracy). DESIGN: Secondary analysis of a randomized controlled trial. PARTICIPANTS: Four hundred seventeen Veterans with at least one modifiable risk factor: current smoker, BMI ≥ 30, or < 150 min of moderate physical activity weekly. METHODS: A single-item assessment of health literacy and a subjective numeracy scale were assessed at baseline. A logistic regression and general linear longitudinal models were used to examine the differential impact of the intervention compared to control on enrollment in prevention programs and changes in patient activation measures (PAM) scores among patients with low versus high health literacy. RESULTS: The coaching intervention resulted in higher enrollment in prevention programs and improvements in PAM scores compared to usual care regardless of baseline health literacy. The coaching intervention had a greater effect on the probability of enrollment in prevention programs for patients with low numeracy (intervention vs control difference of 0.31, 95% CI 0.18, 0.45) as compared to those with high numeracy (0.13, 95% CI - 0.01, 0.27); the low compared to high differential effect was clinically, but not statistically significant (0.18, 95% CI - 0.01, 0.38; p = 0.07). Among patients with high numeracy, the intervention group had greater increases in PAM as compared to the control group at 6 months (mean difference in improvement 4.8; 95% CI 1.7, 7.9; p = 0.003). This led to a clinically and statistically significant differential intervention effect for low vs high numeracy (- 4.6; 95% CI - 9.1, - 0.15; p = 0.04). CONCLUSIONS: We suggest that health coaching may be particularly beneficial in behavior change strategies in populations with low numeracy when interpretation of health risk information is part of the intervention. CLINICALTRIALS. GOV IDENTIFIER: NCT01828567.

Understanding the Effect of Adding Automated and Human Coaching to a Mobile Health Physical Activity App for Afghanistan and Iraq Veterans: Protocol for a Randomized Controlled Trial of the Stay Strong Intervention.

BACKGROUND: Although maintaining a healthy weight and physical conditioning are requirements of active military duty, many US veterans rapidly gain weight and lose conditioning when they separate from active-duty service. Mobile health (mHealth) interventions that incorporate wearables for activity monitoring have become common, but it is unclear how to optimize engagement over time. Personalized health coaching, either through tailored automated messaging or by individual health coaches, has the potential to increase the efficacy of mHealth programs. In an attempt to preserve conditioning and ward off weight gain, we developed Stay Strong, a mobile app that is tailored to veterans of recent conflicts and tracks physical activity monitored by Fitbit Charge 2 devices and weight measured on a Bluetooth-enabled scale. OBJECTIVE: The goal of this study is to determine the effect of activity monitoring plus health coaching compared with activity monitoring alone. METHODS: In this randomized controlled trial, with Stay Strong, a mobile app designed specifically for veterans, we plan to enroll 350 veterans to engage in an mHealth lifestyle intervention that combines the use of a wearable physical activity tracker and a Bluetooth-enabled weight scale. The Stay Strong app displays physical activity and weight data trends over time. Enrolled participants are randomized to receive the Stay Strong app (active comparator arm) or Stay Strong + Coaching, an enhanced version of the program that adds coaching features (automated tailored messaging with weekly physical activity goals and up to 3 telephone calls with a health coach-intervention arm) for 1 year. Our primary outcome is change in physical activity at 12 months, with weight, pain, patient activation, and depression serving as secondary outcome measures. All processes related to recruitment, eligibility screening, informed consent, Health Insurance Portability and Accountability Act authorization, baseline assessment, randomization, the bulk of intervention delivery, and outcome assessment will be accomplished via the internet or smartphone app. RESULTS: The study recruitment began in September 2017, and data collection is expected to conclude in 2019. A total of 465 participants consented to participate and 357 (357/465, 77%) provided baseline levels of physical activity and were randomized to 1 of the 2 interventions. CONCLUSIONS: This novel randomized controlled trial will provide much-needed findings about whether the addition of telephone-based human coaching and other automated supportive-coaching features will improve physical activity compared with using a smartphone app linked to a wearable device alone. TRIAL REGISTRATION: ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293 (Archived by WebCite at http://www.webcitation.org/75KQeIFwh). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12526.

A Coaching by Telephone Intervention on Engaging Patients to Address Modifiable Cardiovascular Risk Factors: a Randomized Controlled Trial.

BACKGROUND: A large proportion of deaths and chronic illnesses can be attributed to three modifiable risk factors: tobacco use, overweight/obesity, and physical inactivity. OBJECTIVE: To test whether telephone-based health coaching after completion of a comprehensive health risk assessment (HRA) increases patient activation and enrollment in a prevention program compared to HRA completion alone. DESIGN: Two-arm randomized trial at three sites. SETTING: Primary care clinics at Veterans Affairs facilities. PARTICIPANTS: Four hundred seventeen veterans with at least one modifiable risk factor (BMI ≥ 30, < 150 min of at least moderate physically activity per week, or current smoker). INTERVENTION: Participants completed an online HRA. Intervention participants received two telephone-delivered health coaching calls at 1 and 4 weeks to collaboratively set goals to enroll in, and attend structured prevention programs designed to reduce modifiable risk factors. MEASUREMENTS: Primary outcome was enrollment in a structured prevention program by 6 months. Secondary outcomes were Patient Activation Measure (PAM) and Framingham Risk Score (FRS). RESULTS: Most participants were male (85%), white (50%), with a mean age of 56. Participants were eligible, because their BMI was ≥ 30 (80%), they were physically inactive (50%), and/or they were current smokers (39%). When compared to HLA only at 6 months, health coaching intervention participants reported higher rates of enrollment in a prevention program, 51 vs 29% (OR = 2.5; 95% CI: 1.7, 3.9; p < 0.0001), higher rates of program participation, 40 vs 23% (OR = 2.3; 95% CI: 1.5, 3.6; p = 0.0004), and greater improvement in PAM scores, mean difference 2.5 (95% CI: 0.2, 4.7; p = 0.03), but no change in FRS scores, mean difference 0.7 (95% CI - 0.7, 2.2; p = 0.33). CONCLUSIONS: Brief telephone health coaching after completing an online HRA increased patient activation and increased enrollment in structured prevention programs to improve health behaviors. CLINICALTRIALS. GOV IDENTIFIER: NCT01828567.

Telemedicine cardiovascular risk reduction in veterans: The CITIES trial.

BACKGROUND: Comprehensive programs addressing tailored patient self-management and pharmacotherapy may reduce barriers to cardiovascular disease (CVD) risk reduction. METHODS: This is a 2-arm (clinical pharmacist specialist-delivered, telehealth intervention and education control) randomized controlled trial including Veterans with poorly controlled hypertension and/or hypercholesterolemia. Primary outcome was Framingham CVD risk score at 6 and 12 months, with systolic blood pressure; diastolic blood pressure; total cholesterol; low-density lipoprotein; high-density lipoprotein; body mass index; and, for those with diabetes, HbA1c as secondary outcomes. RESULTS: Among 428 Veterans, 50% were African American, 85% were men, and 33% had limited health literacy. Relative to the education control group, the clinical pharmacist specialist-delivered intervention did not show a reduction in CVD risk score at 6 months (-1.8, 95% CI -3.9 to 0.3; P = .10) or 12 months (-0.3, 95% CI -2.4 to 1.7; P = .74). No differences were seen in systolic blood pressure, diastolic blood pressure, or low-density lipoprotein at 6 or 12 months. We did observe a significant decline in total cholesterol at 6 months (-7.0, 95% CI -13.4 to -0.6; P = .03) in the intervention relative to education control group. Among patients in the intervention group, 34% received at least 5 of the 12 planned intervention calls and were considered "compliers." A sensitivity analysis of the "complier average causal effect" of intervention compared to control showed a mean difference in CVD risk score reduction of 5.7 (95% CI -12.0 to 0.7) at 6 months and -1.7 (95% CI -7.6 to 4.8) at 12 months. CONCLUSIONS: Despite increased access to pharmacist resources, we did not observe significant improvements in CVD risk for patients randomized to the intervention compared to education control over 12 months. However, the intervention may have positive impact among those who actively participate, particularly in the short term.

Changing CHANGE: adaptations of an evidence-based telehealth cardiovascular disease risk reduction intervention.

Relatively few successful medication adherence interventions are translated into real-world clinical settings. The Prevention of Cardiovascular Outcomes in African Americans with Diabetes (CHANGE) intervention was originally conceived as a randomized controlled trial to improve cardiovascular disease-related medication adherence and health outcomes. The purpose of the study was to describe the translation of the CHANGE trial into two community-based clinical programs. CHANGE 2 was available to Medicaid patients with diabetes and hypertension whose primary care homes were part of a care management network in the Northern Piedmont region of North Carolina. CHANGE 3 was available to low-income patients receiving care in three geographical areas with multiple chronic conditions at low or moderate risk for developing cardiovascular disease. Adaptations were made to ensure fit with available organizational resources and the patient population's health needs. Data available for evaluation are presented. For CHANGE 2, we evaluated improvement in A1c control using paired t test. For both studies, we describe feasibility measured by percentage of patients who completed the curriculum. CHANGE 2 involved 125 participants. CHANGE 3 had 127 participants. In CHANGE 2, 69 participants had A1c measurements at baseline and 12-month follow-up; A1c improved from 8.4 to 7.8 (p = .008). In CHANGE 3, interventionists completed 47% (n = 45) of calls to enroll participants at the 4-month encounter, and among those eligible for a 12-month call (n = 52), 21% of 12-month calls were completed with participants. In CHANGE 2, 40% of participants (n = 50) completed all 12 encounters. Thoughtful adaptation is critical to translate clinical trials into community-based clinic settings. Successful implementation of adapted evidence-based interventions may be feasible and can positively affect patients' disease control.

Evaluation of a packaging approach to improve cholesterol medication adherence.

OBJECTIVES: Elevated low-density lipoprotein cholesterol (LDL-C) is a major modifiable risk factor for cardiovascular disease, a leading cause of death in the United States. Our goal was to evaluate a simple, scalable, and affordable medication packaging method for improving cholesterol medication adherence and subsequently lowering LDL-C levels. STUDY DESIGN: Mixed-method study. METHODS: This mixed-method study involved US military veterans with LDL-C levels greater than 130 mg/dL and/or less than 80% refill adherence of cholesterol-lowering medication in the last 12 months; they were randomized to an education-only (control) group or an adherence packaging intervention group. Adherence packaging group participants' statin medication was provided in special blister packaging labeled for daily use that included written reminder prompts. Outcomes included 12-month cholesterol medication possession ratio (MPR) for medication refills; baseline, 6-, and 12-month self-reported cholesterol medication use; LDL-C and high-density lipoprotein cholesterol (HDL-C) levels; and total cholesterol changes over 12 months. Qualitative evaluation of the intervention is presented as well. RESULTS: We enrolled 240 individuals (120 intervention, 120 control). Overall, 54.2% of the adherence packaging intervention group was adherent per MPR over 12 months compared with 46.6% of the education-only group (difference = 7.6%; 95% confidence interval, -5% to 20%; P ≤.24). Both arms reported improvements in self-reported cholesterol adherence at 12 months, and decreases in LDL-C, HDL-C, and total cholesterol were observed, but differences in change between arms were not statistically significant. Qualitatively, patients reported high levels of satisfaction with the blister package. CONCLUSIONS: In a sample of US veterans, prefilled calendared blister packaging provided an inexpensive method for improving cholesterol medication adherence.

Impact of Gender on Satisfaction and Confidence in Cholesterol Control Among Veterans at Risk for Cardiovascular Disease.

BACKGROUND: Compared with men, women have poorer lipid control. Although potential causes of this disparity have been explored, it is unknown whether patient-centered factors such as satisfaction and confidence contribute. We evaluated (1) whether satisfaction with lipid control and confidence in ability to improve it vary by gender and (2) whether sociodemographic characteristics modify the association. MATERIALS AND METHODS: We evaluated baseline survey responses from the Cardiovascular Intervention Improvement Telemedicine Study, including self-rated satisfaction with cholesterol levels and confidence in controlling cholesterol. Participants had poorly controlled hypertension and/or hypercholesterolemia. RESULTS: A total of 428 veterans (15% women) participated. Compared with men, women had higher low-density lipoprotein values at 141.2 versus 121.7 mg/dL, respectively (p < 0.05), higher health literacy, and were less likely to have someone to help track their medications (all p < 0.05). In an adjusted model, women were less satisfied with their cholesterol levels than men with estimated mean scores of 4.3 versus 5.6 on a 1-10 Likert scale (p < 0.05). There was no significant difference in confidence by gender. Participants with support for tracking medications reported higher confidence levels than those without, estimated mean 7.8 versus 7.2 (p < 0.05). CONCLUSIONS: Women veterans at high risk for cardiovascular disease were less satisfied with their lipid control than men; however, confidence in ability to improve lipid levels was similar. Veterans without someone to help to track medications were less confident, and women were less likely to have this type of social support. Lack of social support for medication tracking may be a factor in lingering gender-based disparities in hyperlipidemia.

A Coaching by Telephone Intervention for Veterans and Care Team Engagement (ACTIVATE): A study protocol for a Hybrid Type I effectiveness-implementation randomized controlled trial.

INTRODUCTION: A large proportion of deaths and many illnesses can be attributed to three modifiable risk factors: tobacco use, overweight/obesity, and physical inactivity. Health risk assessments (HRAs) are widely available online but have not been consistently used in healthcare systems to activate patients to participate in prevention programs aimed at improving lifestyle behaviors. OBJECTIVES: The goal of this study is to test whether adding telephone-based coaching to use of a comprehensive HRA increases at-risk patients' activation and enrollment into a prevention program compared to HRA use alone. METHODS: Participants were randomized to either complete an HRA alone or in conjunction with a telephone coaching intervention. To be eligible Veterans had to have at least one modifiable risk factor (current smoker, overweight/obese, or physically inactive). The primary outcome is enrollment and participation in a prevention program by 6months. Secondary outcomes include change in a Patient Activation Measure and Framingham Risk Score. DISCUSSION: This study is the first to test a web-based health risk assessment coupled with a health coaching intervention within a large healthcare system. Results from this study will help the Veterans Health Administration (VHA) implement its national plan to include comprehensive health risk assessments as a tool to engage Veterans in prevention. The results will also inform health systems outside VHA who seek to implement Medicare's advisement that health risk assessment become a mandatory component of care under the Affordable Care Act.