Browsing by Author "McCant, Felicia"
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Item Open Access A health literacy pilot intervention to improve medication adherence using Meducation® technology.(Patient education and counseling, 2014-05) Zullig, Leah L; McCant, Felicia; Melnyk, S Dee; Danus, Susanne; Bosworth, Hayden BObjective
To determine whether antihypertensive medication adherence could improve using a Meducation® technology health literacy intervention.Methods
We conducted a six-month feasibility study among patients with cardiovascular disease (CVD) risk factors receiving care from hospital-based primary care clinics. All patients received a personalized Meducation® calendar listing CVD-related medications. We evaluated changes in medication adherence and clinical outcomes at six months.Results
There was a 42% enrollment rate (n=23). Forty percent had low health literacy, defined as less than 9th grade reading level. At three months, self-reported medication adherence improved. At six months, medication possession ratio improved 3.2%. Also, at six months there were decreases in patients' average systolic blood pressure (0.5 mmHg), diastolic blood pressure (1.5 mmHg), and body weight (3.6 pounds) (p>0.05).Conclusions
A health literacy intervention may be a feasible mechanism to improve cardiovascular-related medication adherence and outcomes.Practice implications
Health literacy interventions may improve adherence while requiring relatively few resources to implement.Item Open Access A protocol to evaluate the efficacy, perceptions, and cost of a cholesterol packaging approach to improve medication adherence.(Contemporary clinical trials, 2014-09) Zullig, Leah L; Pathman, Joshua; Melnyk, S Dee; Brown, Jamie N; Sanders, Linda L; Koropchak, Celine; Howard, Teresa; Danus, Susanne; McCant, Felicia; Bosworth, Hayden BPurpose
Elevated low-density lipoprotein cholesterol (LDL-C) is a major modifiable risk factor for cardiovascular disease (CVD), a leading cause of death in the United States. Despite clinical practice guidelines aimed at facilitating LDL-C control, many Veterans do not achieve guideline-recommended LDL-C levels.Methods
We describe a study focused on VA healthcare system users at risk for CVD (i.e., LDL-C level >130 mg/dl and/or <80% cholesterol pill refill adherence in the last 12 months). We are conducting a two and a half year randomized controlled trial (i.e., intervention administered over 12 months) among Veterans with uncontrolled cholesterol receiving care at select VA-affiliated primary care clinics in North Carolina. We anticipate enrolling 250 diverse patients (10% women; 40% African American). Patients are randomized to an educational control group or intervention group. Intervention group participants' medication is provided in special blister packaging labeled for daily use that includes reminders; MeadWestvaco Corporation's pre-filled DosePak® contains standard doses of statins in accordance with the existing prescriptions.Conclusions
Pre-filled blister packaging may provide an inexpensive solution to improve medication adherence. Our study enrolls a diverse sample and provides information about whether an adherence packaging intervention can: 1) improve medication adherence; 2) improve patients' LDL-C levels; 3) be well received by patients and providers; and 4) provide a cost effective solution to improve medication adherence.Item Open Access Accelerating Implementation of Virtual Care in an Integrated Health Care System: Future Research and Operations Priorities.(Journal of general internal medicine, 2021-08) Lewinski, Allison A; Sullivan, Caitlin; Allen, Kelli D; Crowley, Matthew J; Gierisch, Jennifer M; Goldstein, Karen M; Gray, Kaileigh; Hastings, Susan N; Jackson, George L; McCant, Felicia; Shapiro, Abigail; Tucker, Matthew; Turvey, Carolyn; Zullig, Leah L; Bosworth, Hayden BBackground
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.Item Open Access Addressing Hypertension Outcomes Using Telehealth and Population Health Managers: Adaptations and Implementation Considerations.(Current hypertension reports, 2022-08) Drake, Connor; Lewinski, Allison A; Rader, Abigail; Schexnayder, Julie; Bosworth, Hayden B; Goldstein, Karen M; Gierisch, Jennifer; White-Clark, Courtney; McCant, Felicia; Zullig, Leah LPurpose 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.Item Open Access Applied Rapid Qualitative Analysis to Develop a Contextually Appropriate Intervention and Increase the Likelihood of Uptake.(Medical care, 2021-06) Lewinski, Allison A; Crowley, Matthew J; Miller, Christopher; Bosworth, Hayden B; Jackson, George L; Steinhauser, Karen; White-Clark, Courtney; McCant, Felicia; Zullig, Leah LBackground
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.Item Open Access Changing CHANGE: adaptations of an evidence-based telehealth cardiovascular disease risk reduction intervention.(Translational behavioral medicine, 2018-03) Zullig, Leah L; McCant, Felicia; Silberberg, Mina; Johnson, Fred; Granger, Bradi B; Bosworth, Hayden BRelatively 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.Item Open Access Economic analysis of a tailored behavioral intervention to improve blood pressure control for primary care patients.(American heart journal, 2010-08) Datta, Santanu K; Oddone, Eugene Z; Olsen, Maren K; Orr, Melinda; McCant, Felicia; Gentry, Pam; Bosworth, Hayden BBackground
Few telemedicine programs have undergone cost analyses, impeding their implementation into practice. We report on the economic analysis of a nurse-administered intervention designed to improve blood pressure control among hypertensive veterans.Methods
We randomized hypertensive patients at the Durham Veterans Affairs Medical Center primary care clinic to behavioral (n = 294) or nonbehavioral (n = 294) interventions. Behavioral intervention patients received tailored information bimonthly for 2 years via telephone. To calculate intervention cost, we microcosted the nurse's labor cost and computer hardware and software costs, applied a direct-to-indirect cost ratio, and distributed the costs over an estimated cohort of patients. We analyzed data from the Veterans Affairs Decision Support System to assess whether the intervention impacted overall health care utilization and costs. We used life expectancy estimates from the literature to develop decision models to calculate cost per life-year saved.Results
The mean annual intervention cost was $112 (range $61-$259). During 2 years of follow-up, patients in the intervention group incurred $7,800 in inpatient costs and $9,741 in outpatient costs; the nonintervention group incurred $6,866 in inpatient costs and $9,599 in outpatient costs. The total cost difference was not statistically significant (P = .56). Cost-effectiveness of the behavioral intervention ranged from $42,457 per life-year saved for normal-weight women to $87,300 per life-year saved for normal-weight men.Conclusions
The study results suggest that a nurse-administered, tailored behavioral intervention can be implemented at nominal cost and be cost-effective; however, there was no apparent lowering of health care utilization and costs during the 2 years of follow-up.Item Open Access Economic evaluation of telephone self-management interventions for blood pressure control.(American heart journal, 2012-06) Wang, Virginia; Smith, Valerie A; Bosworth, Hayden B; Oddone, Eugene Z; Olsen, Maren K; McCant, Felicia; Powers, Benjamin J; Van Houtven, Courtney HaroldBackground
Half of patients with hypertension have poor blood pressure (BP) control. Recent models for treating hypertension have integrated disease monitoring and telephone-based interventions delivered in patients' homes. This study evaluated the costs of the Hypertension Intervention Nurse Telemedicine Study (HINTS), aimed to improve BP control in veterans.Methods
Eligible veterans were randomized to either usual care or 1 of 3 telephone-based intervention groups using home BP telemonitoring: (1) behavioral management, (2) medication management, or (3) combined. Intervention costs were derived from information collected during the trial. Direct medical costs (inpatient, outpatient, and outpatient pharmacy, including hypertension-specific pharmacy) at 18 months by group were calculated using Veterans Affairs (VA) Decision Support System data. Bootstrapped CIs were computed to compare intervention and medical costs between intervention groups and usual care.Results
Patients receiving behavior or medication management showed significant gains in BP control at 12 months; there were no differences in BP control at 18 months. In subgroup analysis, patients with poor baseline BP control receiving combined intervention significantly improved BP at 12 and 18 months. In overall and subgroup samples, average intervention costs were similar in the 3 study arms, and at 18 months, there were no statistically significant differences in direct VA medical costs or total VA costs between treatment arms and usual care.Conclusions
To optimize investment in telephone-based home interventions such as the HINTS, it is important to identify groups of patients who are most likely to benefit from more intensive home BP management.Item Open Access Evaluation of a packaging approach to improve cholesterol medication adherence.(The American journal of managed care, 2017-09) Bosworth, Hayden B; Brown, Jamie N; Danus, Susanne; Sanders, Linda L; McCant, Felicia; Zullig, Leah L; Olsen, Maren KElevated 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.Mixed-method study.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.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.In a sample of US veterans, prefilled calendared blister packaging provided an inexpensive method for improving cholesterol medication adherence.Item Open Access Health beliefs and desire to improve cholesterol levels among patients with hyperlipidemia.(Patient education and counseling, 2016-05) Zullig, Leah L; Sanders, Linda L; Thomas, Steven; Brown, Jamie N; Danus, Susanne; McCant, Felicia; Bosworth, Hayden BObjective
Because hyperlipidemia is asymptomatic, many veterans affairs (VA) patients may not perceive it seriously. We assessed key Health Belief model concepts to describe patients' cholesterol-related health beliefs and examine associations between patient-level factors and desire to improve cholesterol control.Methods
We used baseline data from an ongoing randomized clinical trial. Eligible patients were receiving care at the Durham VA and had CVD risk-total cholesterol levels >130 mg/dL and/or <80% medication adherence in the previous 12 months. A survey assessed patients' health beliefs about high cholesterol and self-reported medication adherence. Multivariable logistic regression examined whether there was an association between desire to control cholesterol and cholesterol status.Results
Approximately 64% (n=155) of patients perceived high cholesterol as 'very serious'. In multivariable logistic regression analysis, patients who perceived high cholesterol as 'very serious' (OR 2. 26, p=0.032) and/or with high self-efficacy (OR 4.70, p<0.001) had increased odds of desiring cholesterol control.Conclusion
The factors most significantly associated with desire to improve cholesterol control were perceiving hyperlipidemia as 'very serious and self-efficacy for cholesterol control.Practice implication
Educating patients, with the goal of appropriately increasing their perceived risk of disease, is likely necessary to impact cholesterol control.Item Open Access Home blood pressure management and improved blood pressure control: results from a randomized controlled trial.(Archives of internal medicine, 2011-07) Bosworth, Hayden B; Powers, Benjamin J; Olsen, Maren K; McCant, Felicia; Grubber, Janet; Smith, Valerie; Gentry, Pamela W; Rose, Cynthia; Van Houtven, Courtney; Wang, Virginia; Goldstein, Mary K; Oddone, Eugene ZBackground
To determine which of 3 interventions was most effective in improving blood pressure (BP) control, we performed a 4-arm randomized trial with 18-month follow-up at the primary care clinics at a Veterans Affairs Medical Center.Methods
Eligible patients were randomized to either usual care or 1 of 3 telephone-based intervention groups: (1) nurse-administered behavioral management, (2) nurse- and physician-administered medication management, or (3) a combination of both. Of the 1551 eligible patients, 593 individuals were randomized; 48% were African American. The intervention telephone calls were triggered based on home BP values transmitted via telemonitoring devices. Behavioral management involved promotion of health behaviors. Medication management involved adjustment of medications by a study physician and nurse based on hypertension treatment guidelines.Results
The primary outcome was change in BP control measured at 6-month intervals over 18 months. Both the behavioral management and medication management alone showed significant improvements at 12 months-12.8% (95% confidence interval [CI], 1.6%-24.1%) and 12.5% (95% CI, 1.3%-23.6%), respectively-but not at 18 months. In subgroup analyses, among those with poor baseline BP control, systolic BP decreased in the combined intervention group by 14.8 mm Hg (95% CI, -21.8 to -7.8 mm Hg) at 12 months and 8.0 mm Hg (95% CI, -15.5 to -0.5 mm Hg) at 18 months, relative to usual care.Conclusions
Overall intervention effects were moderate, but among individuals with poor BP control at baseline, the effects were larger. This study indicates the importance of identifying individuals most likely to benefit from potentially resource intensive programs.Trial registration
clinicaltrials.gov Identifier: NCT00237692.Item Open Access Implementing a Population Health Management Intervention to Control Cardiovascular Disease Risk Factors.(Journal of general internal medicine, 2020-06) Jazowski, Shelley A; Bosworth, Hayden B; Goldstein, Karen M; White-Clark, Courtney; McCant, Felicia; Gierisch, Jennifer M; Zullig, Leah LItem Open Access Improving cardiovascular outcomes by using team-supported, EHR-leveraged, active management: Disseminating a successful quality improvement project.(Contemporary clinical trials communications, 2021-03) Lewinski, Allison A; Bosworth, Hayden B; Goldstein, Karen M; Gierisch, Jennifer M; Jazowski, Shelley; McCant, Felicia; White-Clark, Courtney; Smith, Valerie A; Zullig, Leah LBackground
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.Item Open Access Lessons learned from two randomized controlled trials: CITIES and STOP-DKD.(Contemporary clinical trials communications, 2020-09) Zullig, Leah L; Oakes, Megan M; McCant, Felicia; Bosworth, Hayden BBackground
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.Item Open Access Prevalence of insomnia disorder and sleep apnea in a sample of veterans at risk for cardiovascular disease.(Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2021-07) Ulmer, Christi S; McCant, Felicia; Stechuchak, Karen M; Olsen, Maren; Bosworth, Hayden BStudy 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.Item Open Access Secondary Prevention Risk Interventions via Telemedicine and Tailored Patient Education (SPRITE): A randomized trial to improve post myocardial infarction management.(Patient education and counseling, 2022-09) Zullig, Leah L; Peterson, Eric D; Shah, Bimal R; Grambow, Steven C; Oddone, Eugene Z; McCant, Felicia; Lindquist, Jennifer Hoff; Bosworth, Hayden BObjective
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).Item Open Access Secondary prevention risk interventions via telemedicine and tailored patient education (SPRITE): a randomized trial to improve postmyocardial infarction management.(Circulation. Cardiovascular quality and outcomes, 2011-03) Shah, Bimal R; Adams, Martha; Peterson, Eric D; Powers, Benjamin; Oddone, Eugene Z; Royal, Kira; McCant, Felicia; Grambow, Steven C; Lindquist, Jennifer; Bosworth, Hayden BBackground
Secondary prevention by risk factor modification improves patient outcomes, yet it is often not achieved in clinical practice. Reasons for failure stem from challenges of prioritizing risk factor reduction and engaging patients in changing their behaviors. We hypothesize that a novel telemedicine intervention with tailored patient education could improve cardiovascular risk factors.Methods
To evaluate this intervention, we propose enrolling 450 patients with a recent myocardial infarction and hypertension into a 3-arm randomized, controlled trial. The first arm (n=150) will receive home blood pressure (BP) monitors plus a nurse-delivered, telephone-based tailored patient education intervention and will be enrolled into HealthVault, a Microsoft electronic health record platform. The second arm (n=150) will also receive BP monitors plus a tailored patient education intervention and be enrolled in HeartVault. However, the patient education intervention will be delivered by a Web-based program and will cover topics identical to those in the nurse-delivered intervention. Both arms will be compared with a control group receiving standard care (n=150). All participants will have an in-person assessment at baseline and at completion of the study, including standardized measurements of BP, LDL cholesterol, and glycosylated hemoglobin (in diabetic subjects). The study design will allow assessment of a telephone-based, nurse-administered disease management program versus standard care. The main outcome of interest is the reduction in systolic BP in each intervention group compared with the control group at 12 months. Secondary outcomes assessed will include reductions in LDL cholesterol, body weight, and glycosylated hemoglobin, as well as adherence to evidence-based therapies and improvement in health behaviors.Conclusion
If successful in optimizing BP control, managing other coronary heart disease risk factors, and demonstrating a lower cost, the Web-based disease management tool has the potential to enhance coronary artery disease management, quality of care, and ultimately, patient outcomes. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00901277.Item Open Access Telemedicine cardiovascular risk reduction in veterans.(American heart journal, 2013-04) Melnyk, S Dee; Zullig, Leah L; McCant, Felicia; Danus, Susanne; Oddone, Eugene; Bastian, Lori; Olsen, Maren; Stechuchak, Karen M; Edelman, David; Rakley, Susan; Morey, Miriam; Bosworth, Hayden BBackground
Patients with co-occurrence of hypertension, hyperlipidemia, and diabetes have an increased risk of cardiovascular disease (CVD) events. Comprehensive programs addressing both tailored patient self-management and pharmacotherapy are needed to address barriers to optimal cardiovascular risk reduction. We are examining a Clinical pharmacy specialist-, telephone-administered intervention, relying on home monitoring, with a goal of providing tailored medication and behavioral intervention to Veterans with CVD risk.Methods
Randomized controlled trial including patients with hypertension (blood pressure >150/100 mm Hg) or elevated low density liporotein (>130 mg/dL). Longitudinal changes in CVD risk profile and improvement in health behaviors over time will be examined.Conclusion
Given the national prevalence of CVD and the dismal rates of risk factor control, intensive but easily disseminated interventions are required to treat this epidemic. This study will be an important step in testing the effectiveness of a behavioral and medication intervention to improve CVD control among Veterans.Item Open Access Telemedicine cardiovascular risk reduction in veterans: The CITIES trial.(American heart journal, 2018-05) Bosworth, Hayden B; Olsen, Maren K; McCant, Felicia; Stechuchak, Karen M; Danus, Susanne; Crowley, Matthew J; Goldstein, Karen M; Zullig, Leah L; Oddone, Eugene ZBACKGROUND: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.Item Open Access Veterans' Interpretation of Diabetes Distress in Diabetes Self-Management: Findings From Cognitive Interviews.(The science of diabetes self-management and care, 2021-10) Lewinski, Allison A; Shapiro, Abigail; Bosworth, Hayden B; Crowley, Matthew J; McCant, Felicia; Howard, Teresa; Jeffreys, Amy S; McConnell, Eleanor; Tanabe, Paula; Barcinas, Susan; Coffman, Cynthia J; King, Heather APurpose
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.