Browsing by Author "Smith, Valerie A"
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Item Open Access Assessing a Digital Medicine System in Veterans with Severe Mental Illness: A provider-randomized clinical trial (Preprint)(2021-12-09) Gonzales, Sarah; Okusaga, Olaoluwa O; Reuteman-Fowler, J Corey; Oakes, Megan M; Brown, Jamie N; Moore, Scott; Lewinski, Allison A; Rodriguez, Cristin; Moncayo, Norma; Smith, Valerie A; Malone, Shauna; List, Justine; Cho, Raymond Y; Jeffreys, Amy S; Bosworth, Hayden BBACKGROUNDSuboptimal medication adherence is a significant problem for patients with serious mental illness (SMI). Measuring medication adherence through subjective and objective measures can be challenging, time consuming and inaccurate.
OBJECTIVEWe evaluated a digital medicine system (DMS) compared to treatment as usual (TAU) on adherence to oral aripiprazole and patient and provider perspectives on the feasibility and acceptability of a DMS.
METHODSThis open-label, 2-site, provider-randomized trial assessed aripiprazole refill adherence in Veterans with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. We randomized 26 providers such that their patients either received TAU or DMS for a period of 90 days. Semi-structured interviews with patients and providers were used to examine feasibility and acceptability of using the DMS.
RESULTSWe enrolled 46 patients across 2 Veterans Affairs (VA) sites: (21 in DMS and 25 in TAU). There was no difference in medication refill over 3 and 6 months, respectively (82% and 75% DMS vs. 86% and 82% TAU). The DMS arm had 85% days covered during the period they were engaged with the DMS (144 days on average). Interviews with patients (n=14) and providers (n=5) elicited themes salient to using the DMS. Patient themes included: pre-enrollment adherence strategies and interest in the DMS, positive impact on medication adherence, system usability challenges, support needs, and suggested design/functionality improvements. Provider themes included: concerns for patient medication adherence and interest in the DMS, concerns with the DMS, DMS dashboard usability, challenges of the DMS, and suggestions to increase provider use.
CONCLUSIONSThere was no observed difference in refill rates. Among those who engaged in the DMS arm, refill rates were relatively high (85%). The qualitative analyses highlighted areas for further refinement of the DMS.
CLINICALTRIALNCT03881449
Item Open Access Cardiovascular disease-related chronic conditions among Veterans Affairs nonmetastatic colorectal cancer survivors: a matched case-control analysis.(Cancer management and research, 2019-01) Zullig, Leah L; Smith, Valerie A; Lindquist, Jennifer H; Williams, Christina D; Weinberger, Morris; Provenzale, Dawn; Jackson, George L; Kelley, Michael J; Danus, Susanne; Bosworth, Hayden BPurpose
The growing number of colorectal cancer (CRC) survivors often have multiple chronic conditions. Comparing nonmetastatic CRC survivors and matched noncancer controls, our objectives were to determine the odds of CRC survivors being diagnosed with cardiovascular disease (CVD)-related chronic conditions and their likelihood of control during the year after CRC diagnosis.Patients and methods
We retrospectively identified patients diagnosed with nonmetastatic CRC in the Veterans Affairs health care system from fiscal years 2009 to 2012 and matched each with up to 3 noncancer control patients. We used logistic regression to assess differences in the likelihood of being diagnosed with CVD-related chronic conditions and control between nonmetastatic CRC survivors and noncancer controls.Results
We identified 9,758 nonmetastatic CRC patients and matched them to 29,066 noncancer controls. At baseline, 69.4% of CRC survivors and their matched controls were diagnosed with hypertension, 52.4% with hyperlipidemia, and 36.7% with diabetes. Compared to matched noncancer controls, CRC survivors had 57% higher odds of being diagnosed with hypertension (OR=1.57, 95% CI=1.49-1.64) and 7% higher odds of controlled blood pressure (OR=1.07, 95% CI 1.02, 1.13) in the subsequent year. Compared to matched noncancer control patients, CRC survivors had half the odds of being diagnosed with hyperlipidemia (OR=0.50, 95% CI=0.48-0.52) and lower odds of low-density lipoprotein (LDL) control (OR 0.88, 95% CI 0.81-0.94). There were no significant differences between groups for diabetes diagnoses or control.Conclusion
Compared to noncancer controls, nonmetastatic CRC survivors have 1) greater likelihood of being diagnosed with hypertension and worse blood pressure control in the year following diagnosis; 2) lower likelihood of being diagnosed with hyperlipidemia or LDL control; and 3) comparable diabetes diagnoses and control. There may be a need for hypertension control interventions targeting cancer survivors.Item Open Access Clinical factors associated with persistently poor diabetes control in the Veterans Health Administration: A nationwide cohort study.(PloS one, 2019-01) Alexopoulos, Anastasia-Stefania; Jackson, George L; Edelman, David; Smith, Valerie A; Berkowitz, Theodore SZ; Woolson, Sandra L; Bosworth, Hayden B; Crowley, Matthew JObjective
Patients with persistent poorly-controlled diabetes mellitus (PPDM) despite engagement in clinic-based care are at particularly high risk for diabetes complications and costs. Understanding this population's demographics, comorbidities and care utilization could guide strategies to address PPDM. We characterized factors associated with PPDM in a large sample of Veterans with type 2 diabetes.Methods
We identified a cohort of Veterans with medically treated type 2 diabetes, who received Veterans Health Administration primary care during fiscal years 2012 and 2013. PPDM was defined by hemoglobin A1c levels uniformly >8.5% during fiscal year (FY) 2012, despite engagement with care during this period. We used FY 2012 demographic, comorbidity and medication data to describe PPDM in relation to better-controlled diabetes patients and created multivariable models to examine associations between clinical factors and PPDM. We also constructed multivariable models to explore the association between PPDM and FY 2013 care utilization.Results
In our cohort of diabetes patients (n = 435,820), 12% met criteria for PPDM. Patients with PPDM were younger than better-controlled patients, less often married, and more often Black/African-American and Hispanic or Latino/Latina. Of included comorbidities, only retinopathy (OR 1.68, 95% confidence interval (CI): 1.63,1.73) and nephropathy (OR 1.26, 95% CI: 1.19,1.34) demonstrated clinically significant associations with PPDM. Complex insulin regimens such as premixed (OR 10.80, 95% CI: 10.11,11.54) and prandial-containing regimens (OR 18.74, 95% CI: 17.73,19.81) were strongly associated with PPDM. Patients with PPDM had higher care utilization, particularly endocrinology care (RR 3.56, 95% CI: 3.47,3.66); although only 26.4% of patients saw endocrinology overall.Conclusion
PPDM is strongly associated with complex diabetes regimens, although heterogeneity in care utilization exists. While there is evidence of underutilization, inadequacy of available care may also contribute to PPDM. Our findings should inform tailored approaches to meet the needs of PPDM, who are among the highest-risk, highest-cost patients with diabetes.Item Open Access Colorectal Cancer Statistics From the Veterans Affairs Central Cancer Registry.(Clinical colorectal cancer, 2016-12) Zullig, Leah L; Smith, Valerie A; Jackson, George L; Danus, Susanne; Schnell, Merritt; Lindquist, Jennifer; Provenzale, Dawn; Weinberger, Morris; Kelley, Michael J; Bosworth, Hayden BBackground
Colorectal cancer (CRC) is a common and potentially deadly disease. Although the United States has robust cancer data reporting, information from the Department of Veterans Affairs (VA) healthcare system has often been underrepresented in national cancer data sources. We describe veterans with incident CRC in terms of their patient and tumor characteristics and mortality.Patients and methods
Patients diagnosed or treated with CRC at any VA institution in the fiscal years 2009 to 2012 were identified using 3 data sources: (1) VA Central Cancer Registry (VACCR); (2) VA Corporate Data Warehouse; and (3) VA Reports and Measures Portal. The CRC frequencies within the VA population and survival curves were examined descriptively and compared with the national projections using Surveillance, Epidemiology, and End Results program data.Results
A total of 12,551 veterans with CRC were included in the present analysis. The median age at diagnosis was 65.5 years. Approximately 97% (n = 12,229) of the CRC cases were diagnosed among men. Approximately 44% (n = 5517) of the patients were diagnosed with localized disease. The 3-year survival rate was associated with age (P < .01) and stage (P < .01) at diagnosis. We identified a possible decrease in VA CRC incidence over time.Conclusion
Although the VA CRC patient population was heavily skewed toward the male gender, the patient and tumor characteristics were similar between the incident CRC cases reported by the VACCR and those reported to the Surveillance, Epidemiology, and End Results program. This suggests that research findings resulting from the VACCR might have applicability beyond the VA healthcare system setting.Item Open Access Comprehensive Family Caregiver Support and Caregiver Well-Being: Preliminary Evidence From a Pre-post-survey Study With a Non-equivalent Control Group.(Frontiers in public health, 2019-01) Smith, Valerie A; Lindquist, Jennifer; Miller, Katherine EM; Shepherd-Banigan, Megan; Olsen, Maren; Campbell-Kotler, Margaret; Henius, Jennifer; Kabat, Margaret; Van Houtven, Courtney HaroldIntroduction: In May 2010, the Caregivers and Veterans Omnibus Health Services Act of 2010, was signed into law in the United States, establishing the Program of Comprehensive Assistance for Family Caregivers (PCAFC) provided through the VA Caregiver Support Program (CSP). Prior to this program, over half of family caregivers reported being untrained for the tasks they needed to provide. The training through PCAFC represents the largest effort to train family caregivers in the U.S., and the features of the program, specifically a monthly stipend to caregivers and access to a Caregiver Support Coordinator at each VA medical center nationally, make it the most comprehensive caregiver support program ever enacted in the U.S. Methods: The purpose of this study is to examine the association between PCAFC participation and caregiver well-being following enrollment, comparing participating PCAFC caregivers to caregivers who applied to but were not approved for PCAFC participation (non-participants). Well-being is defined using three diverse but related outcomes: depressive symptoms, perceived financial strain, and perceived quality of the Veteran's health care. Additional well-being measures also examined include the Zarit Burden Inventory and positive aspects of caregiving. Results: The survey sample comprised of 92 caregivers approved for PCAFC and 66 caregivers not approved. The mean age of responding caregivers was 45; over 90% of caregivers were female; and over 80% of caregivers were married in both groups. We find promising trends in well-being associated with PCAFC participation. First, the perception of financial strain declined among participants compared to non-participants. Second, while depressive symptoms did not improve for the PCAFC caregivers, depressive symptoms increased among non-participants. Third, perceived quality of the Veteran's VA healthcare was no different between participants and non-participants. However, the 158 returned surveys reflect only a 5% response rate; hence this evidence is preliminary. Conclusion: Despite cautioning that results be interpreted as preliminary, this study provides unique descriptive information about young caregivers of U.S. post-9/11 Veterans, and offers a first step in filling the evidence gap about how comprehensive caregiver support in the U.S. may affect caregiver well-being. These preliminary findings should be explored and validated in a larger sample.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 Digital Medicine System in Veterans With Severe Mental Illness: Feasibility and Acceptability Study.(JMIR formative research, 2022-12) Gonzales, Sarah; Okusaga, Olaoluwa O; Reuteman-Fowler, J Corey; Oakes, Megan M; Brown, Jamie N; Moore, Scott; Lewinski, Allison A; Rodriguez, Cristin; Moncayo, Norma; Smith, Valerie A; Malone, Shauna; List, Justine; Cho, Raymond Y; Jeffreys, Amy S; Bosworth, Hayden BBackground
Suboptimal medication adherence is a significant problem for patients with serious mental illness. Measuring medication adherence through subjective and objective measures can be challenging, time-consuming, and inaccurate.Objective
The primary purpose of this feasibility and acceptability study was to evaluate the impact of a digital medicine system (DMS) among Veterans (patients) with serious mental illness as compared with treatment as usual (TAU) on medication adherence.Methods
This open-label, 2-site, provider-randomized trial assessed aripiprazole refill adherence in Veterans with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. We randomized 26 providers such that their patients either received TAU or DMS for a period of 90 days. Semistructured interviews with patients and providers were used to examine the feasibility and acceptability of using the DMS.Results
We enrolled 46 patients across 2 Veterans Health Administration sites: 21 (46%) in DMS and 25 (54%) in TAU. There was no difference in the proportion of days covered by medication refill over 3 and 6 months (0.82, SD 0.24 and 0.75, SD 0.26 in DMS vs 0.86, SD 0.19 and 0.82, SD 0.21 in TAU, respectively). The DMS arm had 0.85 (SD 0.20) proportion of days covered during the period they were engaged with the DMS (mean 144, SD 100 days). Interviews with patients (n=14) and providers (n=5) elicited themes salient to using the DMS. Patient findings described the positive impact of the DMS on medication adherence, challenges with the DMS patch connectivity and skin irritation, and challenges with the DMS app that affected overall use. Providers described an overall interest in using a DMS as an objective measure to support medication adherence in their patients. However, providers described challenges with the DMS dashboard and integrating DMS data into their workflow, which decreased the usability of the DMS for providers.Conclusions
There was no observed difference in refill rates. Among those who engaged in the DMS arm, the proportion of days covered by refills were relatively high (mean 0.85, SD 0.20). The qualitative analyses highlighted areas for further refinement of the DMS.Trial registration
ClinicalTrials.gov NCT03881449; https://clinicaltrials.gov/ct2/show/NCT03881449.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 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 Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial.(JAMA internal medicine, 2022-07-25) Crowley, Matthew J; Tarkington, Phillip E; Bosworth, Hayden B; Jeffreys, Amy S; Coffman, Cynthia J; Maciejewski, Matthew L; Steinhauser, Karen; Smith, Valerie A; Dar, Moahad S; Fredrickson, Sonja K; Mundy, Amy C; Strawbridge, Elizabeth M; Marcano, Teresa J; Overby, Donna L; Majette Elliott, Nadya T; Danus, Susanne; Edelman, DavidImportance
Persistently poorly controlled type 2 diabetes (PPDM) is common and causes poor outcomes. Comprehensive telehealth interventions could help address PPDM, but effectiveness is uncertain, and barriers impede use in clinical practice.Objective
To address evidence gaps preventing use of comprehensive telehealth for PPDM by comparing a practical, comprehensive telehealth intervention to a simpler telehealth approach.Design, setting, and participants
This active-comparator, parallel-arm, randomized clinical trial was conducted in 2 Veterans Affairs health care systems. From December 2018 to January 2020, 1128 outpatients with PPDM were assessed for eligibility and 200 were randomized; PPDM was defined as maintenance of hemoglobin A1c (HbA1c) level of 8.5% or higher for 1 year or longer despite engagement with clinic-based primary care and/or diabetes specialty care. Data analyses were preformed between March 2021 and May 2022.Interventions
Each 12-month intervention was nurse-delivered and used only clinical staffing/resources. The comprehensive telehealth group (n = 101) received telemonitoring, self-management support, diet/activity support, medication management, and depression support. Patients assigned to the simpler intervention (n = 99) received telemonitoring and care coordination.Main outcomes and measures
Primary (HbA1c) and secondary outcomes (diabetes distress, diabetes self-care, self-efficacy, body mass index, depression symptoms) were analyzed over 12 months using intent-to-treat linear mixed longitudinal models. Sensitivity analyses with multiple imputation and inclusion of clinical data examined the impact of missing HbA1c measurements. Adverse events and intervention costs were examined.Results
The population (n = 200) had a mean (SD) age of 57.8 (8.2) years; 45 (22.5%) were women, 144 (72.0%) were of Black race, and 11 (5.5%) were of Hispanic/Latinx ethnicity. From baseline to 12 months, HbA1c change was -1.59% (10.17% to 8.58%) in the comprehensive telehealth group and -0.98% (10.17% to 9.19%) in the telemonitoring/care coordination group, for an estimated mean difference of -0.61% (95% CI, -1.12% to -0.11%; P = .02). Sensitivity analyses showed similar results. At 12 months, patients receiving comprehensive telehealth had significantly greater improvements in diabetes distress, diabetes self-care, and self-efficacy; no differences in body mass index or depression were seen. Adverse events were similar between groups. Comprehensive telehealth cost an additional $1519 per patient per year to deliver.Conclusions and relevance
This randomized clinical trial found that compared with telemonitoring/care coordination, comprehensive telehealth improved multiple outcomes in patients with PPDM at a reasonable additional cost. This study supports consideration of comprehensive telehealth implementation for PPDM in systems with appropriate infrastructure and may enhance the value of telehealth during the COVID-19 pandemic and beyond.Trial registration
ClinicalTrials.gov Identifier: NCT03520413.Item Open Access Evaluation of a geriatrics primary care model using prospective matching to guide enrollment.(BMC medical research methodology, 2021-08) Smith, Valerie A; Van Houtven, Courtney Harold; Lindquist, Jennifer H; Hastings, Susan NBackground
Few definitive guidelines exist for rigorous large-scale prospective evaluation of nonrandomized programs and policies that require longitudinal primary data collection. In Veterans Affairs (VA) we identified a need to understand the impact of a geriatrics primary care model (referred to as GeriPACT); however, randomization of patients to GeriPACT vs. a traditional PACT was not feasible because GeriPACT has been rolled out nationally, and the decision to transition from PACT to GeriPACT is made jointly by a patient and provider. We describe our study design used to evaluate the comparative effectiveness of GeriPACT compared to a traditional primary care model (referred to as PACT) on patient experience and quality of care metrics.Methods
We used prospective matching to guide enrollment of GeriPACT-PACT patient dyads across 57 VA Medical Centers. First, we identified matches based an array of administratively derived characteristics using a combination of coarsened exact and distance function matching on 11 identified key variables that may function as confounders. Once a GeriPACT patient was enrolled, matched PACT patients were then contacted for recruitment using pre-assigned priority categories based on the distance function; if eligible and consented, patients were enrolled and followed with telephone surveys for 18 months.Results
We successfully enrolled 275 matched dyads in near real-time, with a median time of 7 days between enrolling a GeriPACT patient and a closely matched PACT patient. Standardized mean differences of < 0.2 among nearly all baseline variables indicates excellent baseline covariate balance. Exceptional balance on survey-collected baseline covariates not available at the time of matching suggests our procedure successfully controlled many known, but administratively unobserved, drivers of entrance to GeriPACT.Conclusions
We present an important process to prospectively evaluate the effects of different treatments when randomization is infeasible and provide guidance to researchers who may be interested in implementing a similar approach. Rich matching variables from the pre-treatment period that reflect treatment assignment mechanisms create a high quality comparison group from which to recruit. This design harnesses the power of national administrative data coupled with collection of patient reported outcomes, enabling rigorous evaluation of non-randomized programs or policies.Item Open Access Food preferences and weight change during low-fat and low-carbohydrate diets.(Appetite, 2016-08-01) McVay, Megan A; Voils, Corrine I; Geiselman, Paula J; Smith, Valerie A; Coffman, Cynthia J; Mayer, Stephanie; Yancy, William SUNLABELLED: Understanding associations between food preferences and weight loss during various effective diets could inform efforts to personalize dietary recommendations and provide insight into weight loss mechanisms. We conducted a secondary analysis of data from a clinical trial in which participants were randomized to either a 'choice' arm, in which they were allowed to select between a low-fat diet (n = 44) or low-carbohydrate diet (n = 61), or to a 'no choice' arm, in which they were randomly assigned to a low-fat diet (n = 49) or low-carbohydrate diet (n = 53). All participants were provided 48 weeks of lifestyle counseling. Food preferences were measured at baseline and every 12 weeks thereafter with the Geiselman Food Preference Questionnaire. Participants were 73% male and 51% African American, with a mean age of 55. Baseline food preferences, including congruency of food preferences with diet, were not associated with weight outcomes. In the low-fat diet group, no associations were found between changes in food preferences and weight over time. In the low-carbohydrate diet group, increased preference for low-carbohydrate diet congruent foods from baseline to 12 weeks was associated with weight loss from 12 to 24 weeks. Additionally, weight loss from baseline to 12 weeks was associated with increased preference for low-carbohydrate diet congruent foods from 12 to 24 weeks. Results suggest that basing selection of low-carbohydrate diet or low-fat diet on food preferences is unlikely to influence weight loss. Congruency of food preferences and weight loss may influence each other early during a low-carbohydrate diet but not low-fat diet, possibly due to different features of these diets. CLINICAL TRIAL REGISTRY: NCT01152359.Item Open Access Identifying treatment effects of an informal caregiver education intervention to increase days in the community and decrease caregiver distress: a machine-learning secondary analysis of subgroup effects in the HI-FIVES randomized clinical trial.(Trials, 2020-02) Shepherd-Banigan, Megan; Smith, Valerie A; Lindquist, Jennifer H; Cary, Michael Paul; Miller, Katherine EM; Chapman, Jennifer G; Van Houtven, Courtney HBackground
Informal caregivers report substantial burden and depressive symptoms which predict higher rates of patient institutionalization. While caregiver education interventions may reduce caregiver distress and decrease the use of long-term institutional care, evidence is mixed. Inconsistent findings across studies may be the result of reporting average treatment effects which do not account for how effects differ by participant characteristics. We apply a machine-learning approach to randomized clinical trial (RCT) data of the Helping Invested Family Members Improve Veteran's Experiences Study (HI-FIVES) intervention to explore how intervention effects vary by caregiver and patient characteristics.Methods
We used model-based recursive partitioning models. Caregivers of community-residing older adult US veterans with functional or cognitive impairment at a single VA Medical Center site were randomized to receive HI-FIVES (n = 118) vs. usual care (n = 123). The outcomes included cumulative days not in the community and caregiver depressive symptoms assessed at 12 months post intervention. Potential moderating characteristics were: veteran age, caregiver age, caregiver ethnicity and race, relationship satisfaction, caregiver burden, perceived financial strain, caregiver depressive symptoms, and patient risk score.Results
The effect of HI-FIVES on days not at home was moderated by caregiver burden (p < 0.001); treatment effects were higher for caregivers with a Zarit Burden Scale score ≤ 28. Caregivers with lower baseline Center for Epidemiologic Studies Depression Scale (CESD-10) scores (≤ 8) had slightly lower CESD-10 scores at follow-up (p < 0.001).Conclusions
Family caregiver education interventions may be less beneficial for highly burdened and distressed caregivers; these caregivers may require a more tailored approach that involves assessing caregiver needs and developing personalized approaches.Trial registration
ClinicalTrials.gov, ID:NCT01777490. Registered on 28 January 2013.Item Open Access Implementation of an Intensive Telehealth Intervention for Rural Patients with Clinic-Refractory Diabetes.(Journal of general internal medicine, 2022-09) Kobe, Elizabeth A; Lewinski, Allison A; Jeffreys, Amy S; Smith, Valerie A; Coffman, Cynthia J; Danus, Susanne M; Sidoli, Elisabeth; Greck, Beth D; Horne, Leanne; Saxon, David R; Shook, Susan; Aguirre, Lina E; Esquibel, Mary G; Evenson, Clarene; Elizagaray, Christopher; Nelson, Vivian; Zeek, Amanda; Weppner, William G; Scodellaro, Stephanie; Perdew, Cassie J; Jackson, George L; Steinhauser, Karen; Bosworth, Hayden B; Edelman, David; Crowley, Matthew JBackground
Rural patients with type 2 diabetes (T2D) may experience poor glycemic control due to limited access to T2D specialty care and self-management support. Telehealth can facilitate delivery of comprehensive T2D care to rural patients, but implementation in clinical practice is challenging.Objective
To examine the implementation of Advanced Comprehensive Diabetes Care (ACDC), an evidence-based, comprehensive telehealth intervention for clinic-refractory, uncontrolled T2D. ACDC leverages existing Veterans Health Administration (VHA) Home Telehealth (HT) infrastructure, making delivery practical in rural areas.Design
Mixed-methods implementation study.Participants
230 patients with clinic-refractory, uncontrolled T2D.Intervention
ACDC bundles telemonitoring, self-management support, and specialist-guided medication management, and is delivered over 6 months using existing VHA HT clinical staffing/equipment. Patients may continue in a maintenance protocol after the initial 6-month intervention period.Main measures
Implementation was evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The primary effectiveness outcome was hemoglobin A1c (HbA1c).Key results
From 2017 to 2020, ACDC was delivered to 230 patients across seven geographically diverse VHA sites; on average, patients were 59 years of age, 95% male, 80% white, and 14% Hispanic/Latinx. Patients completed an average of 10.1 of 12 scheduled encounters during the 6-month intervention period. Model-estimated mean baseline HbA1c was 9.56% and improved to 8.14% at 6 months (- 1.43%, 95% CI: - 1.64, - 1.21; P < .001). Benefits persisted at 12 (- 1.26%, 95% CI: - 1.48, - 1.05; P < .001) and 18 months (- 1.08%, 95% CI - 1.35, - 0.81; P < .001). Patients reported increased engagement in self-management and awareness of glycemic control, while clinicians and HT nurses reported a moderate workload increase. As of this submission, some sites have maintained delivery of ACDC for up to 4 years.Conclusions
When strategically designed to leverage existing infrastructure, comprehensive telehealth interventions can be implemented successfully, even in rural areas. ACDC produced sustained improvements in glycemic control in a previously refractory population.Item Unknown 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 Unknown 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 Unknown Nurse-Led Strategy to Improve Blood Pressure and Cholesterol Level Among People With HIV: A Randomized Clinical Trial.(JAMA network open, 2024-03) Longenecker, Christopher T; Jones, Kelley A; Hileman, Corrilynn O; Okeke, Nwora Lance; Gripshover, Barbara M; Aifah, Angela; Bloomfield, Gerald S; Muiruri, Charles; Smith, Valerie A; Vedanthan, Rajesh; Webel, Allison R; Bosworth, Hayden BImportance
Despite higher atherosclerotic cardiovascular disease (ASCVD) risk, people with HIV (PWH) experience unique barriers to ASCVD prevention, such as changing models of HIV primary care.Objective
To test whether a multicomponent nurse-led strategy would improve systolic blood pressure (SBP) and non-high-density lipoprotein (HDL) cholesterol level in a diverse population of PWH receiving antiretroviral therapy (ART).Design, setting, and participants
This randomized clinical trial enrolled PWH at 3 academic HIV clinics in the US from September 2019 to January 2022 and conducted follow-up for 12 months until January 2023. Included patients were 18 years or older and had a confirmed HIV diagnosis, an HIV-1 viral load less than 200 copies/mL, and both hypertension and hypercholesterolemia. Participants were stratified by trial site and randomized 1:1 to either the multicomponent EXTRA-CVD (A Nurse-Led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention) intervention group or the control group. Primary analyses were conducted according to the intention-to-treat principle.Intervention
The EXTRA-CVD group received home BP monitoring guidance and BP and cholesterol management from a dedicated prevention nurse at 4 in-person visits (baseline and 4, 8, and 12 months) and frequent telephone check-ins up to every 2 weeks as needed. The control group received general prevention education sessions from the prevention nurse at each of the 4 in-person visits.Main outcomes and measures
Study-measured SBP was the primary outcome, and non-HDL cholesterol level was the secondary outcome. Measurements were taken over 12 months and assessed by linear mixed models. Prespecified moderators tested were sex at birth, baseline ASCVD risk, and trial site.Results
A total of 297 PWH were randomized to the EXTRA-CVD arm (n = 149) or control arm (n = 148). Participants had a median (IQR) age of 59.0 (53.0-65.0) years and included 234 males (78.8%). Baseline mean (SD) SBP was 135.0 (18.8) mm Hg and non-HDL cholesterol level was 139.9 (44.6) mg/dL. At 12 months, participants in the EXTRA-CVD arm had a clinically significant 4.2-mm Hg (95% CI, 0.3-8.2 mm Hg; P = .04) lower SBP and 16.9-mg/dL (95% CI, 8.6-25.2 mg/dL; P < .001) lower non-HDL cholesterol level compared with participants in the control arm. There was a clinically meaningful but not statistically significant difference in SBP effect in females compared with males (11.8-mm Hg greater difference at 4 months, 9.6 mm Hg at 8 months, and 5.9 mm Hg at 12 months; overall joint test P = .06).Conclusions and relevance
Results of this trial indicate that the EXTRA-CVD strategy effectively reduced BP and cholesterol level over 12 months and should inform future implementation of multifaceted ASCVD prevention programs for PWH.Trial registration
ClinicalTrials.gov Identifier: NCT03643705.Item Open Access Potential Targets for Deprescribing in Medically Complex Older Adults with Suspected Cognitive Impairment.(Geriatrics (Basel, Switzerland), 2022-05) Pavon, Juliessa M; Berkowitz, Theodore SZ; Smith, Valerie A; Hughes, Jaime M; Hung, Anna; Hastings, Susan NDeprescribing may be particularly beneficial in patients with medical complexity and suspected cognitive impairment (CI). We describe central nervous system (CNS) medication use and side effects in this population and explore the relationship between anticholinergic burden and sleep. We conducted a cross-sectional analysis of baseline data from a pilot randomized-controlled trial in older adult veterans with medical complexity (Care Assessment Need score > 90), and suspected CI (Telephone Interview for Cognitive Status score 20−31). CNS medication classes included antipsychotics, benzodiazepines, H2-receptor antagonists, hypnotics, opioids, and skeletal muscle relaxants. We also coded anticholinergic-active medications according to their Anticholinergic Cognitive Burden (ACB) score. Other measures included self-reported medication side effects and the Pittsburgh Sleep Quality Index (PSQI). ACB association with sleep (PSQI) was examined using adjusted linear regression. In this sample (N = 40), the mean number of prescribed CNS medications was 2.2 (SD 1.5), 65% experienced ≥ 1 side effect, and 50% had an ACB score ≥ 3 (high anticholinergic exposure). The ACB score ≥ 3 compared to ACB < 3 was not significantly associated with PSQI scores (avg diff in score = −0.1, 95% CI −2.1, 1.8). Although results did not demonstrate a clear relationship with worsened sleep, significant side effects and anticholinergic burden support the deprescribing need in this population.Item Open Access Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial.(Contemporary clinical trials, 2020-11) Kobe, Elizabeth A; Edelman, David; Tarkington, Phillip E; Bosworth, Hayden B; Maciejewski, Matthew L; Steinhauser, Karen; Jeffreys, Amy S; Coffman, Cynthia J; Smith, Valerie A; Strawbridge, Elizabeth M; Szabo, Steven T; Desai, Shivan; Garrett, Mary P; Wilmot, Theresa C; Marcano, Teresa J; Overby, Donna L; Tisdale, Glenda A; Durkee, Melissa; Bullard, Susan; Dar, Moahad S; Mundy, Amy C; Hiner, Janette; Fredrickson, Sonja K; Majette Elliott, Nadya T; Howard, Teresa; Jeter, Deborah H; Danus, Susanne; Crowley, Matthew JBackground
Persistent poorly-controlled type 2 diabetes mellitus (PPDM), or maintenance of a hemoglobin A1c (HbA1c) ≥8.5% despite receiving clinic-based diabetes care, contributes disproportionately to the national diabetes burden. Comprehensive telehealth interventions may help ameliorate PPDM, but existing approaches have rarely been designed with clinical implementation in mind, limiting use in routine practice. We describe a study testing a novel telehealth intervention that comprehensively targets clinic-refractory PPDM, and was explicitly developed for practical delivery using existing Veterans Health Administration (VHA) clinical infrastructure.Methods
Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management. The primary outcome is HbA1c. Secondary outcomes include diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs. We hypothesize that the PRACTICE-DM intervention will reduce HbA1c by >0.6% versus standard HT over 12 months.Results
Enrollment for this ongoing trial concluded in January 2020; 200 patients were randomized (99 to standard HT and 101 to the PRACTICE-DM intervention). The cohort has a mean age of 58 and is 23% female and 72% African American. Mean baseline HbA1c and BMI were 10.2% and 34.8 kg/m2.Conclusions
Because it comprehensively targets factors underlying PPDM using existing clinical infrastructure, the PRACTICE-DM intervention may be well suited to lower the complications and costs of PPDM in routine practice.Item Open Access Real-world use of a medication out-of-pocket cost estimator in primary care one year after Medicare regulation.(Journal of the American Geriatrics Society, 2024-01) Sloan, Caroline E; Morton-Oswald, Sarah; Smith, Valerie A; Sinaiko, Anna D; Bowling, C Barrett; An, Jaejin; Maciejewski, Matthew L