Browsing by Author "Olsen, Maren K"
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Item Open Access Baseline Antihypertensive Drug Count and Patient Response to Hypertension Medication Management.(Journal of clinical hypertension (Greenwich, Conn.), 2016-04) Crowley, Matthew J; Olsen, Maren K; Woolson, Sandra L; King, Heather A; Oddone, Eugene Z; Bosworth, Hayden BTelemedicine-based medication management improves hypertension control, but has been evaluated primarily in patients with low antihypertensive drug counts. Its impact on patients taking three or more antihypertensive agents is not well-established. To address this evidence gap, the authors conducted an exploratory analysis of an 18-month, 591-patient trial of telemedicine-based hypertension medication management. Using general linear models, the effect of medication management on blood pressure for patients taking two or fewer antihypertensive agents at study baseline vs those taking three or more was compared. While patients taking two or fewer antihypertensive agents had a significant reduction in systolic blood pressure with medication management, those taking three or more had no such response. The between-subgroup effect difference was statistically significant at 6 months (-6.4 mm Hg [95% confidence interval, -12.2 to -0.6]) and near significant at 18 months (-6.0 mm Hg [95% confidence interval, -12.2 to 0.2]). These findings suggest that baseline antihypertensive drug count may impact how patients respond to hypertension medication management and emphasize the need to study management strategies specifically in patients taking three or more antihypertensive medications.Item Open Access Comprehensive Support for Family Caregivers of Post-9/11 Veterans Increases Veteran Utilization of Long-term Services and Supports: A Propensity Score Analysis.(Inquiry : a journal of medical care organization, provision and financing, 2018-01) Shepherd-Banigan, Megan; Smith, Valerie A; Stechuchak, Karen M; Miller, Katherine EM; Hastings, Susan Nicole; Wieland, Gilbert Darryl; Olsen, Maren K; Kabat, Margaret; Henius, Jennifer; Campbell-Kotler, Margaret; Van Houtven, Courtney HaroldFamily caregivers are an important component of the long-term services and supports (LTSS) system. However, caregiving may have negative consequences for caregiver physical and emotional health. Connecting caregivers to formal short-term home- and community-based services (HCBS), through information resources and referrals, might alleviate family caregiver burden and delay nursing home entry for the patient. The aim of this study was to evaluate the early impact of the Program of Comprehensive Assistance for Family Caregivers (PCAFC) (established by P.L. 111-163 for family caregivers of seriously injured post-9/11 Veterans) on Veteran use of LTSS. A two-cohort pre-post design with a nonequivalent comparison group (treated n = 15 650; comparison n = 8339) was used to (1) examine the association between caregiver enrollment in PCAFC and any VA-purchased or VA-provided LTSS use among Veterans and (2) describe program-related trends in HCBS and institutional LTSS use. The comparison group was an inverse-propensity-score weighted sample of Veterans whose caregivers applied for, but were not accepted into, the program. From baseline through 24 months post application, use of any LTSS ranged from 13.1% to 17.8% for Veterans whose caregivers were enrolled in PCAFC versus from 3.8% to 5.3% for Veterans in the comparison group. Participation in PCAFC was associated with a statistically significant increased use of any LTSS from 1 to 24 months post application (over time odds ratios ranged from 2.71 [95% confidence interval: 2.31-3.17] to 4.86 [3.93-6.02]). Support for family caregivers may enhance utilization of LTSS for Veterans with physical, emotional, and/or cognitive conditions.Item Open Access Do the benefits of participation in a hypertension self-management trial persist after patients resume usual care?(Circulation. Cardiovascular quality and outcomes, 2014-03) Maciejewski, Matthew L; Bosworth, Hayden B; Olsen, Maren K; Smith, Valerie A; Edelman, David; Powers, Benjamin J; Kaufman, Miriam A; Oddone, Eugene Z; Jackson, George LBackground
Hypertension self-management has been shown to improve systolic blood pressure (BP) control, but longer-term economic and clinical impacts are unknown. The purpose of this article is to examine clinical and economic outcomes 18 months after completion of a hypertension self-management trial.Methods and results
This study is a follow-up analysis of an 18-month, 4-arm, hypertension self-management trial of 591 veterans with hypertension who were randomized to usual care or 1 of 3 interventions. Clinic-derived systolic blood pressure obtained before, during, and after the trial were estimated using linear mixed models. Inpatient admissions, outpatient expenditures, and total expenditures were estimated using generalized estimating equations. The 3 telephone-based interventions were nurse-administered health behavior promotion, provider-administered medication adjustments based on hypertension treatment guidelines, or a combination of both. Intervention calls were triggered by home BP values transmitted via telemonitoring devices. Clinical and economic outcomes were examined 12 months before, 18 months during, and 18 months after trial completion. Compared with usual care, patients randomized to the combined arm had greater improvement in proportion of BP control during and after the 18-month trial and estimated proportion of BP control improved 18 months after trial completion for patients in the behavioral and medication management arms. Among the patients with inadequate baseline BP control, estimated mean systolic BP was significantly lower in the combined arm as compared with usual care during and after the 18-month trial. Utilization and expenditure trends were similar for patients in all 4 arms.Conclusions
Behavioral and medication management can generate systolic BP improvements that are sustained 18 months after trial completion.Clinical trial registration
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00237692.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 Effect of a Coaching Intervention to Improve Cardiologist Communication: A Randomized Clinical Trial.(JAMA internal medicine, 2023-04) Pollak, Kathryn I; Olsen, Maren K; Yang, Hongqiu; Prose, Neil; Jackson, Larry R; Pinheiro, Sandro O; Dunbar, T Kayla; Johnson, Kimberly SImportance
Communication between cardiologists and patients can significantly affect patient comprehension, adherence, and satisfaction. To our knowledge, a coaching intervention to improve cardiologist communication has not been tested.Objective
To evaluate the effect of a communication coaching intervention to teach evidence-based communication skills to cardiologists.Design, setting, and participants
This 2-arm randomized clinical trial was performed at outpatient cardiology clinics at an academic medical center and affiliated community clinics, and from February 2019 through March 2020 recruited 40 cardiologists and audio recorded 161 patients in the preintervention phase and 240 in the postintervention phase. Data analysis was performed from March 2022 to January 2023.Interventions
Half of the cardiologists were randomized to receive a coaching intervention that involved three 1:1 sessions, 2 of which included feedback on their audio-recorded encounters. Communication coaches taught 5 skills derived from motivational interviewing: (1) sitting down and making eye contact with all in the room, (2) open-ended questions, (3) reflective statements, (4) empathic statements, and (5) "What questions do you have?"Main outcomes and measures
Coders unaware of study arm coded these behaviors in the preintervention and postintervention audio-recorded encounters (objective communication). Patients completed a survey after the visit to report perceptions of communication quality (subjective communication).Results
Analysis included 40 cardiologists (mean [SD] age, 47 [9] years; 7 female and 33 male) and 240 patients in the postintervention phase (mean [SD] age, 58 [15] years; 122 female, 118 male). When controlling for preintervention behaviors, cardiologists in the intervention vs control arm were more likely to make empathic statements (intervention: 52 of 117 [44%] vs control: 31 of 113 [27%]; P = .05); to ask, "What questions do you have?" (26 of 117 [22%] vs 6 of 113 [5%]; P = .002); and to respond with empathy when patients expressed negative emotions (mean ratio of empathic responses to empathic opportunities, 0.50 vs 0.20; P = .004). These effects did not vary based on patient or cardiologist race or sex. We found no arm differences for open-ended questions or reflective statements and were unable to assess differences in patient ratings due to ceiling effects.Conclusions and relevance
In this randomized clinical trial, a communication coaching intervention improved 2 key communication behaviors: expressing empathy and eliciting questions. Empathic communication is a harder-level skill that may improve the patient experience and information comprehension. Future work should explore how best to assess the effect of communication coaching on patient perceptions of care and clinical outcomes and determine its effectiveness in larger, more diverse samples of cardiologists.Trial registration
ClinicalTrials.gov Identifier: NCT03464110.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 Factors associated with non-adherence to three hypertension self-management behaviors: preliminary data for a new instrument.(Journal of general internal medicine, 2013-01) Crowley, Matthew J; Grubber, Janet M; Olsen, Maren K; Bosworth, Hayden BBackground
Clinicians have difficulty in identifying patients that are unlikely to adhere to hypertension self-management. Identifying non-adherence is essential to addressing suboptimal blood pressure control and high costs.Objectives
1) To identify risk factors associated with non-adherence to three key self-management behaviors in patients with hypertension: proper medication use, diet, and exercise; 2) To evaluate the extent to which an instrument designed to identify the number of risk factors present for non-adherence to each of the three hypertension self-management behaviors would be associated with self-management non-adherence and blood pressure.Design
Cross-sectional analysis of randomized trial data.Patients
Six hundred and thirty-six primary care patients with hypertension.Measurements
1) Demographic, socioeconomic, psychosocial, and health belief-related factors; 2) measures of self-reported adherence to recommended medication use, diet recommendations, and exercise recommendations, all collected at baseline assessment; 3) systolic blood pressure (SBP) and diastolic blood pressure (DBP).Results
We identified patient factors associated with measures of non-adherence to medications, diet, and exercise in hypertension. We then combined risk factors associated with ≥1 adherence measure into an instrument that generated three composite variables (medication, diet, and exercise composites), reflecting the number of risk factors present for non-adherence to the corresponding self-management behavior. These composite variables identified subgroups with higher likelihood of medication non-adherence, difficulty following diet recommendations, and difficulty following exercise recommendations. Composite variable levels representing the highest number of self-management non-adherence risk factors were associated with higher SBP and DBP.Conclusions
We identified factors associated with measures of non-adherence to recommended medication use, diet, and exercise in hypertension. We then developed an instrument that was associated with non-adherence to these self-management behaviors, as well as with blood pressure. With further study, this instrument has potential to improve identification of non-adherent patients with hypertension.Item Open Access Heart matters: Gender and racial differences cardiovascular disease risk factor control among veterans.(Women's health issues : official publication of the Jacobs Institute of Women's Health, 2014-09) Goldstein, Karen M; Melnyk, S Dee; Zullig, Leah L; Stechuchak, Karen M; Oddone, Eugene; Bastian, Lori A; Rakley, Susan; Olsen, Maren K; Bosworth, Hayden BBackground
Cardiovascular disease (CVD) is the leading cause of mortality for U.S. women. Racial minorities are a particularly vulnerable population. The increasing female veteran population has an higher prevalence of certain cardiovascular risk factors compared with non-veteran women; however, little is known about gender and racial differences in cardiovascular risk factor control among veterans.Methods
We used analysis of variance, adjusting for age, to compare gender and racial differences in three risk factors that predispose to CVD (diabetes, hypertension, and hyperlipidemia) in a cohort of high-risk veterans eligible for enrollment in a clinical trial, including 23,955 men and 1,010 women.Findings
Low-density lipoprotein (LDL) values were higher in women veterans than men with age-adjusted estimated mean values of 111.7 versus 97.6 mg/dL (p < .01). Blood pressures (BPs) were higher among African-American than White female veterans with age-adjusted estimated mean systolic BPs of 136.3 versus 133.5 mmHg, respectively (p < .01), and diastolic BPs of 82.4 versus 78.9 mmHg (p < .01). African-American veterans with diabetes had worse BP, LDL values, and hemoglobin A1c levels, although the differences were only significant among men.Conclusions
Female veterans have higher LDL cholesterol levels than male veterans and African-American veterans have higher BP, LDL cholesterol, and A1c levels than Whites after adjusting for age. Further examination of CVD gender and racial disparities in this population may help to develop targeted treatments and strategies applicable to the general population.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 Impact of Gender on Satisfaction and Confidence in Cholesterol Control Among Veterans at Risk for Cardiovascular Disease.(Journal of women's health (2002), 2017-07) Goldstein, Karen M; Stechuchak, Karen M; Zullig, Leah L; Oddone, Eugene Z; Olsen, Maren K; McCant, Felicia A; Bastian, Lori A; Batch, Bryan C; Bosworth, Hayden BBackground
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.Item Open Access Improved Glaucoma Medication Adherence in a Randomized Controlled Trial.(Ophthalmology. Glaucoma, 2022-01) Muir, Kelly W; Rosdahl, Jullia A; Hein, Aaron M; Woolson, Sandra; Olsen, Maren K; Kirshner, Miriam; Sexton, Malina; Bosworth, Hayden BPurpose
To test the effectiveness of an intervention designed to improve glaucoma medication adherence.Design
Randomized, controlled trial at a Veterans Affairs (VA) eye clinic.Participants
Veterans with medically treated glaucoma who reported poor adherence and their companions if applicable.Methods
Participants, and their companions if applicable, were randomized to receive an intervention to improve medication adherence that included glaucoma education, personalized disease management suggestions, and a reminder aid, or the control arm that received education regarding general eye health.Main outcome measures
The average proportion of prescribed glaucoma medication doses taken on schedule over the 6 months after randomization according to an electronic monitor between participants in the 2 arms.Results
The mean proportion of prescribed doses taken on schedule was higher in the intervention group compared with controls (0.85 vs. 0.62, P < 0.0001). The difference in proportions between the 2 groups did not vary in regressions models adjusted for companion status, frequency of dosing, and race. The longitudinal model indicated that the intervention group had significantly higher adherence during the first month after randomization and continued to stay higher through 6 months (month by treatment interaction, P = 0.003).Conclusions
A multifaceted intervention can help improve glaucoma medication adherence.Item Open Access Invisible partners in care: Snapshot of well-being among caregivers receiving comprehensive support from Veterans Affairs.(Health science reports, 2019-03) Miller, Katherine EM; Lindquist, Jennifer H; Olsen, Maren K; Smith, Valerie; Voils, Corrine I; Oddone, Eugene Z; Sperber, Nina R; Shepherd-Banigan, Megan; Wieland, G Darryl; Henius, Jennifer; Kabat, Margaret; Van Houtven, Courtney HaroldBackground and aims
Since May 2011, over 23 000 caregivers of Veterans seriously injured on or after September 11, 2001 have enrolled in the Program of Comprehensive Assistance for Family Caregivers (PCAFC). PCAFC provides caregivers training, a stipend, and access to health care. The aim of this study is to describe the characteristics of caregivers in PCAFC and examine associations between caregiver characteristics and caregiver well-being outcomes.Methods
We sent a web survey invitation to 10 000 PCAFC caregivers enrolled as of September 2015. Using linear and logistic regressions, we examine associations between PCAFC caregiver characteristics and caregiver outcomes: perceived financial strain, depressive symptoms (Center for Epidemiologic Studies Depression Scale [CESD-10]), perceived quality of Veteran's Veterans Health Administration (VHA) care, and self-reported caregiver health.Results
We had complete survey data for 899 respondents. Since becoming a caregiver, approximately 50% of respondents reported reducing or stopping work. Mean time spent providing care was 3.8 years (median 3, IQR 1-5) with an average of 4.9 weekdays (median 5, IQR 5-5) and 1.9 weekend days (median 2, IQR 2-2). The mean CESD-10 score was 8.2 (median 7, 4-12), at the cutoff for screening positive for depressive symptoms. A longer duration of caregiving was associated with having 0.08 increase in rating of financial strain (95% CI, 0.02-0.14). Caregiver rating of the Veteran's health status as "fair" or better was a strong predictor of better caregiver outcomes, ie, self-reported caregiver health. However, higher levels of education were associated with worse caregiver outcomes, ie, lower global satisfaction with VHA care, higher CESD-10 score, and higher rating of financial strain.Conclusions
Higher depressive symptoms among longer duration caregivers, coupled with high rates of reductions in hours worked, suggest interventions are needed to address the long-term emotional and financial needs of these caregivers of post-9/11 Veterans and identify subpopulations at risk for worse outcomes.Item Open Access Measuring blood pressure for decision making and quality reporting: where and how many measures?(Annals of internal medicine, 2011-06) Powers, Benjamin J; Olsen, Maren K; Smith, Valerie A; Woolson, Robert F; Bosworth, Hayden B; Oddone, Eugene ZBackground
The optimal setting and number of blood pressure (BP) measurements that should be used for clinical decision making and quality reporting are uncertain.Objective
To compare strategies for home or clinic BP measurement and their effect on classifying patients as having BP that was in or out of control.Design
Secondary analysis of a randomized, controlled trial of strategies to improve hypertension management. (ClinicalTrials.gov registration number: NCT00237692)Setting
Primary care clinics affiliated with the Durham Veterans Affairs Medical Center.Patients
444 veterans with hypertension followed for 18 months.Measurements
Blood pressure was measured repeatedly by using 3 methods: standardized research BP measurements at 6-month intervals; clinic BP measurements obtained during outpatient visits; and home BP measurements using a monitor that transmitted measurements electronically.Results
Patients provided 111,181 systolic BP (SBP) measurements (3218 research, 7121 clinic, and 100,842 home measurements) over 18 months. Systolic BP control rates at baseline (mean SBP<140 mm Hg for clinic or research measurement; <135 mm Hg for home measurement) varied substantially, with 28% classified as in control by clinic measurement, 47% by home measurement, and 68% by research measurement. Short-term variability was large and similar across all 3 methods of measurement, with a mean within-patient coefficient of variation of 10% (range, 1% to 24%). Patients could not be classified as having BP that was in or out of control with 80% certainty on the basis of a single clinic SBP measurement from 120 mm Hg to 157 mm Hg. The effect of within-patient variability could be greatly reduced by averaging several measurements, with most benefit accrued at 5 to 6 measurements.Limitation
The sample was mostly men with a long-standing history of hypertension and was selected on the basis of previous poor BP control.Conclusion
Physicians who want to have 80% or more certainty that they are correctly classifying patients' BP control should use the average of several measurements. Hypertension quality metrics based on a single clinic measurement potentially misclassify a large proportion of patients.Primary funding source
U.S. Department of Veterans Affairs Health Services Research and Development Service.Item Open Access Patient-reported medication adherence barriers among patients with cardiovascular risk factors.(Journal of managed care & specialty pharmacy, 2015-06) Zullig, Leah L; Stechuchak, Karen M; Goldstein, Karen M; Olsen, Maren K; McCant, Felicia M; Danus, Susanne; Crowley, Matthew J; Oddone, Eugene Z; Bosworth, Hayden BBackground
Many patients experience barriers that make it difficult to take cardiovascular disease (CVD)-related medications as prescribed. The Cardiovascular Intervention Improvement Telemedicine Study (CITIES) was a tailored behavioral pharmacist-administered and telephone-based intervention for reducing CVD risk.Objectives
To (a) describe patient-reported barriers to taking their medication as prescribed and (b) evaluate patient-level characteristics associated with reporting medication barriers.Methods
We recruited patients receiving care at primary care clinics affiliated with Durham Veterans Affairs Medical Center. Eligible patients were diagnosed with hypertension and/or hyperlipidemia that were poorly controlled (blood pressure of > 150/100 mmHg and/or low-density lipoprotein value > 130 mg/dL). At the time of enrollment, patients completed an interview with 7 questions derived from a validated medication barriers measure. Patient characteristics and individual medication treatment barriers are described. Multivariable linear regression was used to examine the association between a medication barrier score and patient characteristics.Results
Most patients (n = 428) were married or living with their partners (57%) and were men (85%) who were diagnosed with hypertension and hyperlipidemia (64%). The most commonly reported barriers were having too much medication to take (31%) and forgetting whether medication was taken at a particular time (24%). In adjusted analysis, those who were not employed (1.32, 95% CI = 0.50-2.14) or did not have someone to help with tasks, if needed (1.66, 95% CI = 0.42-2.89), reported higher medication barrier scores. Compared with those diagnosed with hypertension and hyperlipidemia, those with only hypertension (0.91, 95% CI = 0.04-1.79) reported higher medication barrier scores.Conclusions
Barriers to medication adherence are common. Evaluating and addressing barriers may increase medication adherence.Item Open Access Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial.(Contemporary clinical trials, 2023-02) Ulmer, Christi S; Bosworth, Hayden B; Zervakis, Jennifer; Goodwin, Kaitlyn; Gentry, Pamela; Rose, Cynthia; Jeffreys, Amy S; Olsen, Maren K; Weidenbacher, Hollis J; Beckham, Jean C; Voils, Corrine IBackground
Cognitive Behavioral Therapy for Insomnia (CBTi) is recommended as first-line treatment for insomnia, yet patient access to CBTi is limited. Self-help CBTi could increase patient access. Self-help CBTI with provider sup]port is more effective and is preferred by patients. Self-help CBTi has not been evaluated in veterans; a population with greater medical and mental health morbidity and more severe sleep difficulties than non-veterans. Moreover, those with mental health conditions have been largely excluded from prior CBTi self-help trials. Stablishing the efficacy of provider-supported Self-help CBTi is an important first step for expanding veteran access to CBTi.Methods
In a 2-armed randomized controlled trial, a provider-supported self-help CBTi (Tele-Self CBTi) is compared to Health Education for improving insomnia severity (primary outcome) among treatment-seeking veterans with insomnia disorder. Tele-Self CBTi is comprised of two treatment components: self-help CBTi via a professionally designed manual developed using an iterative process of expert review and patient input; and 6 telephone-based support sessions lasting >20 min. Outcomes are assessed at baseline, 8 weeks, and 6 months after baseline. The primary outcome, insomnia severity, is measured using the Insomnia Severity Index. Secondary outcomes include self-reported and actigraphy-assessed sleep, fatigue, depression symptoms, and sleep-related quality of life.Conclusion
Innovative approaches are essential to improving overall health among veterans; a population with highly prevalent insomnia disorder. If effective, Tele-Self CBTi may bridge the gap between unavailable resources and high demand for CBTi and serve as the entry level intervention in a stepped model of care.Clinical trials
Gov identifier
NCT03727438.Item Open Access Racial differences in two self-management hypertension interventions.(The American journal of medicine, 2011-05) Bosworth, Hayden B; Olsen, Maren K; Grubber, Janet M; Powers, Benjamin J; Oddone, Eugene ZBackground
Only one half of Americans have their blood pressure controlled, and there are significant racial differences in blood pressure control. The goal of this study was to examine the effectiveness of 2 patient-directed interventions designed to improve blood pressure control within white and non-white subgroups (African Americans, 49%).Methods
Post hoc analysis of a 2 by 2 randomized trial with 2-year follow-up in 2 university-affiliated primary care clinics was performed. Within white and non-white patients (n=634), 4 groups were examined: 1) usual care; 2) home blood pressure monitoring (3 times per week); 3) tailored behavioral self-management intervention administered via telephone by a nurse every other month; and 4) a combination of the 2 interventions.Results
The overall race by time by treatment group effect suggested differential intervention effects on blood pressure over time for whites and non-whites (systolic blood pressure, P=. 08; diastolic blood pressure, P=.01). Estimated trajectories indicated that among the 308 whites, there was no significant effect on blood pressure at 12 or 24 months for any intervention compared with the control group. At 12 months, the non-whites (n=328) in all 3 intervention groups had systolic blood pressure decreases of 5.3 to 5.7 mm Hg compared with usual care (P <.05). At 24 months, in the combined intervention, non-whites had sustained lower systolic blood pressure compared with usual care (7.5 mm Hg; P <.02). A similar pattern was observed for diastolic blood pressure.Conclusion
Combined home blood pressure monitoring and a tailored behavioral phone intervention seem to be particularly effective for improving blood pressure in non-white patients.Item Open Access Relationship between electronically measured medication adherence and vision-related quality of life in a cohort of patients with open-angle glaucoma.(BMJ open ophthalmology, 2018-01) Thompson, Atalie C; Woolson, Sandra; Olsen, Maren K; Danus, Susanne; Bosworth, Hayden B; Muir, Kelly WObjective
To investigate whether electronically measured medication adherence is associated with vision-related quality of life (VRQoL) in patients with open-angle glaucoma.Methods and analysis
This is a 3-year prospective cohort study of 79 subjects with open-angle glaucoma at a Veterans Affairs medical centre. Participants returned a medication event monitoring system (MEMS) for their glaucoma eye-drops and had at least two visits with glaucoma during the study period. Those taking less than 80% of prescribed glaucoma medication doses were considered to be non-adherent. Subjects were interviewed using the National Eye Institute's Visual Function Questionnaire-25 (VFQ-25) at baseline and after 3 years.Results
Thirty per cent (n=24/79) of participants took less than 80% of prescribed doses of their glaucoma medications at baseline. Patients who did not adhere to their medications at baseline had lower mean composite VFQ-25 scores at baseline (70.66±20.50 vs 75.91±19.12, standardised mean difference=0.27) and after 3 years (71.68±21.93 vs 76.25±21.67, standardised mean difference=0.21). Visual acuity (P=0.03), but not visual field severity (P=0.13) or medication adherence (P=0.30), was significantly associated with composite VFQ-25 score in an adjusted model.Conclusions
Subjects who were non-adherent to their glaucoma medications at baseline as assessed by a MEMS device reported lower VRQoL than adherent subjects at baseline and after 3 years. However, visual acuity was significantly associated with VRQoL. Future studies should assess whether improved adherence to eye-drops impacts VRQoL in patients with glaucoma.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 The Cholesterol, Hypertension, And Glucose Education (CHANGE) study: results from a randomized controlled trial in African Americans with diabetes.(American heart journal, 2013-07) Crowley, Matthew J; Powers, Benjamin J; Olsen, Maren K; Grubber, Janet M; Koropchak, Celine; Rose, Cynthia M; Gentry, Pamela; Bowlby, Lynn; Trujillo, Gloria; Maciejewski, Matthew L; Bosworth, Hayden BBackground
Cardiovascular disease (CVD) and diabetes account for one-third of the mortality difference between African American and white patients. We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes.Methods
We randomized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention. The 12-month intervention provided monthly self-management support and quarterly medication management facilitation. Coprimary outcomes were changes in systolic blood pressure (SBP), hemoglobin A1c (HbA1c), and low-density lipoprotein cholesterol (LDL-C) over 12 months. We estimated between-intervention group differences over time using linear mixed-effects models. The secondary outcome was self-reported medication adherence.Results
The sample was 72% female; 49% had low health literacy, and 37% had annual income <$10,000. Model-based estimates for mean baseline SBP, HbA1c, and LDL-C were 136.8 mm Hg (95% CI 135.0-138.6), 8.0% (95% CI 7.8-8.2), and 99.1 mg/dL (95% CI 94.7-103.5), respectively. Intervention patients received 9.9 (SD 3.0) intervention calls on average. Primary providers replied to 76% of nurse medication management facilitation contacts, 18% of these resulted in medication changes. There were no between-group differences over time for SBP (P = .11), HbA1c (P = .66), or LDL-C (P = .79). Intervention patients were more likely than those receiving usual care to report improved medication adherence (odds ratio 4.4, 95% CI 1.8-10.6, P = .0008), but adherent patients did not exhibit relative improvement in primary outcomes.Conclusions
This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes. Further research is needed to determine how to maximally impact CVD risk factors in African American patients.