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1.  Two Self-management Interventions to Improve Hypertension Control: A Randomized Trial 
Annals of internal medicine  2009;151(10):687-695.
Background
Less than 40% of Americans with hypertension have adequate blood pressure (BP) control.
Objectives
To compare two self-management interventions for improving BP control among hypertensive patients.
Design
A 2 by 2 randomized trial stratified by enrollment site and patient literacy status with two-year follow-up (5/2004-1/2008).
Setting
Two university-affiliated primary care clinics.
Patients
636 patients were randomized (31% recruitment rate) among the 2060 eligible hypertensive patients.
Interventions
Research assistants randomized eligible patients via a centralized blinded and stratified randomization algorithm to receive either: 1) usual care; 2) bi-monthly tailored nurse-administered telephone intervention targeting hypertension-related behaviors; 3) BP monitoring consisting of measuring BP three times per week, or; 4) a combination of the two interventions.
Measurements
The primary outcome was BP control evaluated at six-month intervals over 24 months. 475 (75%) completed the 24-month BP follow-up.
Results
Improvements in proportion of BP control for the intervention groups relative to the usual care group at 24 months were: behavioral group, 4.3% (95% CI: −4.5%, 12.9); home BP monitoring group, 7.6% (95% CI: −1.9%, 17.0%); and, combined interventions, 11.0% (95% CI: 1.9%, 19.8%). For systolic BP, relative to usual care, the 24 month difference was, +0.6 mmHg (95% CI: −2.2, 3.4) for the behavioral intervention group, −0.6 mmHg (95% CI: −3.6, 2.3) for the home monitoring group, and −3.9 mmHg (95% CI: −6.9, −0.9) for the combined interventions. Similar patterns were observed for diastolic BP at 24 months.
Limitations
Changes in medication use and diet were only monitored in intervention participants; 25% lacked 24 month outcome data; 73% had adequate BP control at baseline; the study setting was an academic health center, all factors that potentially limit generalizability.
Conclusion
Combined home BP monitoring and tailored behavioral telephone intervention improved BP control, systolic BP, and diastolic BP at 24 months relative to usual care.
doi:10.1059/0003-4819-151-10-200911170-00148
PMCID: PMC2892337  PMID: 19920269
Hypertension; Lifestyle; Clinical Trial; Self-management; Adherence
2.  The Composition of Intern Work While on Call 
doi:10.1007/s11606-012-2317-9
PMCID: PMC3599036  PMID: 23319412
3.  Racial Differences in the Effect of a Telephone-Delivered Hypertension Disease Management Program 
Journal of General Internal Medicine  2012;27(12):1682-1689.
ABSTRACT
BACKGROUND
African Americans are significantly more likely than whites to have uncontrolled hypertension, contributing to significant disparities in cardiovascular disease and events.
OBJECTIVE
The goal of this study was to examine whether there were differences in change in blood pressure (BP) for African American and non-Hispanic white patients in response to a medication management and tailored nurse-delivered telephone behavioral program.
PARTICIPANTS
Five hundred and seventy-three patients (284 African American and 289 non-Hispanic white) primary care patients who participated in the Hypertension Intervention Nurse Telemedicine Study (HINTS) clinical trial.
INTERVENTIONS
Study arms included: 1) nurse-administered, physician-directed medication management intervention, utilizing a validated clinical decision support system; 2) nurse-administered, behavioral management intervention; 3) combined behavioral management and medication management intervention; and 4) usual care. All interventions were activated based on poorly controlled home BP values.
MAIN MEASURES
Post-hoc analysis of change in systolic and diastolic blood pressure. General linear models (PROC MIXED in SAS, version 9.2) were used to estimate predicted means at 6-month, 12-month, and 18-month time points, by intervention arm and race subgroups (separate models for systolic and diastolic blood pressure).
KEY RESULTS
Improvement in mean systolic blood pressure post-baseline was greater for African American patients in the combined intervention, compared to African American patients in usual care, at 12 months (6.6 mmHg; 95 % CI: -12.5, -0.7; p = 0.03) and at 18 months (9.7 mmHg; -16.0, -3.4; p = 0.003). At 18 months, mean diastolic BP was 4.8 mmHg lower (95 % CI: -8.5, -1.0; p = 0.01) among African American patients in the combined intervention arm, compared to African American patients in usual care. There were no analogous differences for non-Hispanic white patients.
CONCLUSIONS
The combination of home BP monitoring, remote medication management, and telephone tailored behavioral self-management appears to be particularly effective for improving BP among African Americans. The effect was not seen among non-Hispanic white patients.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-012-2138-x) contains supplementary material, which is available to authorized users.
doi:10.1007/s11606-012-2138-x
PMCID: PMC3509293  PMID: 22865016
hypertension; telemedicine; self-management; adherence; veterans
4.  The Effect of a Hypertension Self-Management Intervention on the Unintended Targets of Diabetes and Cholesterol Control 
The American journal of medicine  2009;122(7):639-646.
Background
Most patient chronic disease self-management interventions target single disease outcomes. We evaluated the effect of a tailored hypertension self-management intervention on the unintended targets of glycosylated hemoglobin (Hb A1c) and LDL cholesterol (LDL-C).
Methods
We examined 588 patients from the Veterans Study to Improve the Control of Hypertension (V-STITCH), a two year randomized controlled trial. Patients received either a hypertension self-management intervention delivered by a nurse over the telephone or usual care. Although the study focused on hypertension self-management, we compared changes in Hb A1c among a subgroup of 216 patients with diabetes and LDL-C among 528 patients with measurements during the study period. Changes in these lab values over time were compared between the two treatment groups using linear mixed-effects models.
Results
For the patients with diabetes, the hypertension self-management intervention resulted in a 0.46% reduction in Hb A1c over two years compared to usual care (95% CI: 0.04% to 0.89%; p=0.03). For LDL-C, the self-management intervention arm resulted in a reduction of 0.9mg/dl over two years compared to usual care (95% CI: -7.3mg/dl to 5.6mg/dl; p=0.79).
Conclusions
There was no evidence of a hypertension self-management intervention effect on LDL-C, but there was a modest effect of the intervention on the unintended target of Hb A1c. This effect was similar to that seen in self-management interventions specifically targeting diabetes management. Chronic disease self-management interventions may spill over into patients’ co-morbid diagnoses.
doi:10.1016/j.amjmed.2008.12.022
PMCID: PMC3766525  PMID: 19559166
Self-management; telemedicine; chronic disease; randomized controlled trial
5.  Organizational factors associated with readiness to implement and translate a primary care based telemedicine behavioral program to improve blood pressure control: the HTN-IMPROVE study 
Background
Hypertension is prevalent and often sub-optimally controlled; however, interventions to improve blood pressure control have had limited success.
Objectives
Through implementation of an evidence-based nurse-delivered self-management phone intervention to facilitate hypertension management within large complex health systems, we sought to answer the following questions: What is the level of organizational readiness to implement the intervention? What are the specific facilitators, barriers, and contextual factors that may affect organizational readiness to change?
Study design
Each intervention site from three separate Veterans Integrated Service Networks (VISNs), which represent 21 geographic regions across the US, agreed to enroll 500 participants over a year with at least 0.5 full time equivalent employees of nursing time. Our mixed methods approach used a priori semi-structured interviews conducted with stakeholders (n = 27) including nurses, physicians, administrators, and information technology (IT) professionals between 2010 and 2011. Researchers iteratively identified facilitators and barriers of organizational readiness to change (ORC) and implementation. Additionally, an ORC survey was conducted with the stakeholders who were (n = 102) preparing for program implementation.
Results
Key ORC facilitators included stakeholder buy-in and improving hypertension. Positive organizational characteristics likely to impact ORC included: other similar programs that support buy-in, adequate staff, and alignment with the existing site environment; improved patient outcomes; is positive for the professional nurse role, and is evidence-based; understanding of the intervention; IT infrastructure and support, and utilization of existing equipment and space.
The primary ORC barrier was unclear long-term commitment of nursing. Negative organizational characteristics likely to impact ORC included: added workload, competition with existing programs, implementation length, and limited available nurse staff time; buy-in is temporary until evidence shows improved outcomes; contacting patients and the logistics of integration into existing workflow is a challenge; and inadequate staffing is problematic. Findings were complementary across quantitative and qualitative analyses.
Conclusions
The model of organizational change identified key facilitators and barriers of organizational readiness to change and successful implementation. This study allows us to understand the needs and challenges of intervention implementation. Furthermore, examination of organizational facilitators and barriers to implementation of evidence-based interventions may inform dissemination in other chronic diseases.
doi:10.1186/1748-5908-8-106
PMCID: PMC3847033  PMID: 24010683
Implementation; Hypertension; Blood pressure control; Organization
6.  Patient Self-Management Support: Novel Strategies in Hypertension and Heart Disease 
Cardiology clinics  2010;28(4):655-663.
Cardiovascular diseases (CVD), has become the leading cause of death and disability in most countries in the world. In this paper, we address patient self-management of hypertension and CVD as a crucial component of effective, high quality health care for hypertension and cardiovascular disease care. The patient must be a collaborator in this process and methods of improving patients’ ability and confidence for self-management are needed. Successful self-management programs have often supplemented the traditional patient-physician encounter by using non-physician providers, remote patient encounters (telephone or internet), group settings, and peer support for promoting self-management. Factors to consider in self-management include ensuring the programs are patient-centered, staffing and training, content of the program, patient population served, supporting material, protocols for how staff members are to provide support, communication with patients, communication between health care providers and self-management support. Given our healthcare systems’ inability to achieve a number of quality indicators using traditional office-based physician visits, further consideration is needed to determine the degree to which these interventions and programs can be integrated into primary care, their effectiveness in different groups, and their sustainability for improving chronic disease care.
doi:10.1016/j.ccl.2010.07.003
PMCID: PMC3763915  PMID: 20937448
7.  Informal and Formal Care Infrastructure and Perceived Need for Caregiver Training for Frail U.S. Veterans referred to Home and Community-Based Services 
Chronic illness  2010;6(1):57-66.
Objectives
To describe the informal care network of U.S. veterans referred to home and community-based services (Homemaker Home Health services, H/HHA, or Home-Based Primary Care, HBPC) at the Durham Veterans Affairs Medical Center (VAMC), including: quantity and types of tasks provided and desired content for caregiver training programs.
Methods
All primary care patients referred to H/HHA or HBPC during the preceding 3 months were sent questionnaires in May 2007. Additionally, caregivers were sent questionnaires if a patient gave permission. Descriptive statistics and chi-squared tests were performed.
Results
On average, patients received 5.6 hours of VA care and 47 hours of informal care per week. 26% of patients (38% of patients with caregiver proxy respondents) and 59% of caregivers indicated the caregiver would be interested in participating in a training program by phone or on-site. Significant barriers to participation existed. The most common barriers were: transportation; no time due to caregiving or work demands; caregiver's own health limitations; and no need.
Conclusions
Caregiver training needs to be tailored to overcome barriers to participate. Overcoming these barriers may be possible through in-home phone or internet training outside traditional business hours, and by tailoring training to accommodate limiting health problems among caregivers.
doi:10.1177/1742395309352694
PMCID: PMC3728281  PMID: 20308351
Informal care; caregiver training programs; VA patients; frail elderly
8.  Racial Differences in Two Self Management Hypertension Interventions 
The American journal of medicine  2011;124(5):468.e1-468.e8.
Background
Only one-half of Americans have their blood pressure controlled and there continue to be significant racial differences in blood pressure control. The goal of this study was to examine the effectiveness of two patient-directed interventions designed to improve blood pressure control within white and non-white subgroups (49% African Americans).
Methods
Post-hoc analysis of a 2 by 2 randomized trial with two-year follow-up in 2 university-affiliated primary care clinics. Within white and non-white patients (n=634), four groups were examined: 1) usual care; 2) home blood pressure monitoring (three times per week); 3) tailored behavioral self-management intervention administered via telephone by a nurse every other month; or, 4) a combination of the two 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=0.08; diastolic blood pressure, p=0.01). Estimated trajectories indicated that among the 308 whites, there was no significant effect on blood pressure at either 12 or 24 months for any intervention compared to control group. At 12 months, the non-whites (n=328) in all three intervention groups had systolic blood pressure decreases of 5.3–5.7 mm hg compared to usual care (p<0.05). At 24 months, in the combined intervention, non-whites had sustained lower systolic blood pressure as compared to usual care (7.5 mm hg; p<0.02). A similar pattern was observed for diastolic blood pressure.
Conclusion
Combined home blood pressure monitoring and a telephone tailored-behavioral intervention appeared to be particularly effective for improving blood pressure in non-white patients.
doi:10.1016/j.amjmed.2010.11.024
PMCID: PMC3086723  PMID: 21531237
Hypertension; Lifestyle; Clinical Trial; Self-management; Adherence; Disparities
9.  Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials 
Background
Osteoarthritis (OA) of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care.
Methods / Design
One study is being conducted within the Department of Veterans Affairs (VA) health care system and will compare a Combined Patient and Provider intervention relative to usual care among n = 300 patients (10 from each of 30 primary care providers). Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider) interventions relative to usual care among n = 560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection), based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and secondary outcomes are the Short Physical Performance Test Protocol (objective physical function) and the Patient Health Questionnaire-8 (depressive symptoms). Cost effectiveness of the interventions will also be assessed.
Discussion
Results of these two studies will further our understanding of the most effective strategies for improving hip and knee OA outcomes in primary care settings.
Trial registration
NCT01130740 (VA); NCT 01435109 (NIH)
doi:10.1186/1471-2474-13-60
PMCID: PMC3433311  PMID: 22530979
Osteoarthritis; Physical activity; Weight reduction program; Pain management; Intervention study
10.  A High-Density Genome-Wide Association Screen of Sporadic ALS in US Veterans 
PLoS ONE  2012;7(3):e32768.
Following reports of an increased incidence of amyotrophic lateral sclerosis (ALS) in U.S. veterans, we have conducted a high-density genome-wide association study (GWAS) of ALS outcome and survival time in a sample of U.S. veterans. We tested ∼1.3 million single nucleotide polymorphisms (SNPs) for association with ALS outcome in 442 incident Caucasian veteran cases diagnosed with definite or probable ALS and 348 Caucasian veteran controls. To increase power, we also included genotypes from 5909 publicly-available non-veteran controls in the analysis. In the survival analysis, we tested for association between SNPs and post-diagnosis survival time in 639 Caucasian veteran cases with definite or probable ALS. After this discovery phase, we performed follow-up genotyping of 299 SNPs in an independent replication sample of Caucasian veterans and non-veterans (ALS outcome: 183 cases and 961 controls; survival: 118 cases). Although no SNPs reached genome-wide significance in the discovery phase for either phenotype, three SNPs were statistically significant in the replication analysis of ALS outcome: rs6080539 (177 kb from PCSK2), rs7000234 (4 kb from ZNF704), and rs3113494 (13 kb from LOC100506746). Two SNPs located in genes that were implicated by previous GWA studies of ALS were marginally significant in the pooled analysis of discovery and replication samples: rs17174381 in DPP6 (p = 4.4×10−4) and rs6985069 near ELP3 (p = 4.8×10−4). Our results underscore the difficulty of identifying and convincingly replicating genetic associations with a rare and genetically heterogeneous disorder such as ALS, and suggest that common SNPs are unlikely to account for a substantial proportion of patients affected by this devastating disorder.
doi:10.1371/journal.pone.0032768
PMCID: PMC3314660  PMID: 22470424
11.  Participant Evaluation of a Telephone-Based Osteoarthritis Self-Management Program, 2006-2009 
Introduction
Self-management support interventions can help improve osteoarthritis outcomes but are underused. Little is known about how participants evaluate the helpfulness of these programs. We describe participants' evaluations of a telephone-based, osteoarthritis self-management support intervention that yielded improved outcomes in a clinical trial.
Methods
Participants were 140 people in the intervention arm of the trial who completed an end-of-trial survey. We used mixed methods to describe participants' perceived helpfulness of the program and its components. We compared ratings of helpfulness according to participant characteristics and analyzed themes from open-ended responses with a constant comparison approach. We calculated Pearson correlation coefficients between perceived helpfulness and changes in pain, function, affect, and self-efficacy.
Results
The average rating of overall helpfulness on a scale from 1 to 10 was 7.6 (standard deviation, 2.3), and more than 80% of participants agreed that each component (phone calls, educational material, setting goals and action plans) was helpful. Participants had better perceived helpfulness ratings than their counterparts if they were nonwhite, had limited health literacy, had no college education, had perceived inadequate income, were older, had a spouse or were living together in a committed relationship, and had greater symptom duration and less pain. Ratings of helpfulness increased with greater improvement in outcomes. Participants frequently mentioned the health educator's calls as being helpful for staying on task with self-management behaviors.
Conclusion
Participants viewed this intervention and each of its components as helpful for improving osteoarthritis symptoms. In addition to the improvements in objective outcomes seen in the clinical trial, these results provide further support for the dissemination of self-management support interventions.
PMCID: PMC3392090  PMID: 22440547
12.  Association Between Blood Lead and the Risk of Amyotrophic Lateral Sclerosis 
American Journal of Epidemiology  2010;171(10):1126-1133.
The authors conducted a 2003–2007 case-control study including 184 cases and 194 controls to examine the association between blood lead and the risk of amyotrophic lateral sclerosis (ALS) among US veterans and to explore the influence on this association of bone turnover and genetic factors related to lead toxicokinetics. Blood lead, plasma biomarkers of bone formation (procollagen type 1 amino-terminal peptide (PINP)) and resorption (C-terminal telopeptides of type 1 collagen (CTX)), and the K59N polymorphism in the δ-aminolevulinic acid dehydratase gene, ALAD, were measured. Odds ratios and 95% confidence intervals for the association of blood lead with ALS were estimated with unconditional logistic regression after adjustment for age and bone turnover. Blood lead levels were higher among cases compared with controls (P < 0.0001, age adjusted). A doubling of blood lead was associated with a 1.9-fold increased risk of ALS (95% confidence interval: 1.3, 2.7) after adjustment for age and CTX. Additional adjustment for PINP did not alter the results. Significant lead-ALS associations were observed in substrata of PINP and CTX levels. The K59N polymorphism in the ALAD gene did not modify the lead-ALS association (P = 0.32). These results extend earlier findings by accounting for bone turnover in confirming the association between elevated blood lead level and higher risk of ALS.
doi:10.1093/aje/kwq063
PMCID: PMC2877471  PMID: 20406759
amyotrophic lateral sclerosis; bone and bones; bone resorption; lead; odds ratio; osteogenesis
13.  Association of ALS with Head Injury, Cigarette Smoking and APOE Genotypes 
Objective
An increased risk of ALS has been reported for US veterans, but the cause is unknown. Since head injury and cigarette smoking are two previously implicated environmental risk factors that are more common in military than civilian study populations, we tested their association with ALS in a US veteran study population.
Methods
We used logistic regression to examine the association of ALS with head injury and cigarette smoking in 241 incident cases and 597 controls. Since APOE is a plausible ALS candidate gene, we also tested its main effect and its statistical interaction with these environmental exposures.
Results
Cigarette smoking was not associated with ALS in this predominantly male and Caucasian population. Veterans who had experienced head injuries during the last 15 years before the reference date had an adjusted odds ratio of 2.33 (95% confidence interval 1.18–4.61), relative to veterans without any head injuries. This association was strongest in APOE-4 carriers.
Conclusions
Our results add to the body of evidence suggesting that head injuries may be a risk factor for multiple neurodegenerative diseases, including ALS. We hypothesize that the strength of association between head injuries and ALS may depend upon APOE genotype.
doi:10.1016/j.jns.2010.01.011
PMCID: PMC2840700  PMID: 20129626
case-control study; US veterans; candidate gene; gene-environment interaction; neurodegeneration
14.  Comparison of Medicine Resident Diabetes Care Between Veterans Affairs and Academic Health Care Systems 
ABSTRACT
BACKGROUND
Although others have reported national disparities in the quality of diabetes care between the Veterans Affairs (VA) and private health care delivery systems, it is not known whether these differences persist among internal medicine resident providers in academic settings.
OBJECTIVE
We compared the quality of diabetes primary care delivered by resident physicians in either a private academic health care system (AHS) or its affiliated VA health care system.
DESIGN
Cross-sectional observational study
PARTICIPANTS
We included patients who: had a diagnosis of diabetes, had >2 primary care visits with the same resident provider during 2005, and were not separately managed by an attending physician or endocrinologist. A total of 640 patients met our criteria and were included in the analysis.
MEASUREMENTS AND RESULTS
Compared to the VA, patients in the AHS were more likely to be younger, female, have fewer medications, and be treated with insulin, but had less comorbidity. Patients in the VA were more likely to be referred for an annual eye exam (94% vs. 78%), receive lipid screening (88% vs. 74%), receive proteinuria screening (63% vs. 34%), and receive a complete foot exam (85% vs. 32%) in analyses adjusted for patient demographics and comorbidities (p-value <0.001 for all comparisons). In adjusted analyses, there were no significant differences in HbA1c, blood pressure, or LDL cholesterol control.
CONCLUSIONS
In spite of similar resident providers and practice models, there were substantial differences in the diabetes quality of care delivered in the VA and AHS. Understanding how these factors influence subsequent practice patterns is an important area for study.
doi:10.1007/s11606-009-1048-z
PMCID: PMC2710481  PMID: 19551447
15.  Economic Evaluation of Home Blood Pressure Monitoring With or Without Telephonic Behavioral Self-Management in Patients With Hypertension 
American journal of hypertension  2009;23(2):142-148.
Background
The Take Control of Your Blood Pressure trial evaluated the effect of a multicomponent telephonic behavioral lifestyle intervention, patient self-monitoring, and both interventions combined compared with usual care on reducing systolic blood pressure during 24 months. The combined intervention led to a significant reduction in systolic blood pressure compared with usual care alone. We examined direct and patient time costs associated with each intervention.
Methods
We conducted a prospective economic evaluation alongside a randomized controlled trial of 636 patients with hypertension participating in each study intervention. Medical costs were estimated using electronic data representing medical services delivered within the health system. Intervention-related costs were derived using information collected during the trial, administrative records, and published unit costs.
Results
During 24 months, patients incurred a mean of $6965 (SD, $22,054) in inpatient costs and $8676 (SD, $9368) in outpatient costs, with no significant differences among the intervention groups. With base-case assumptions, intervention costs were estimated at $90 (SD, $2) for home blood pressure monitoring, $345 (SD, $64) for the behavioral intervention ($31 per telephone encounter), and $416 (SD, $93) for the combined intervention. Patient time costs were estimated at $585 (SD, $487) for home monitoring, $55 (SD, $16) for the behavioral intervention, and $741 (SD, $529) for the combined intervention.
Conclusions
Our analysis demonstrated that the interventions are cost-additive to the health care system in the short term and that patients’ time costs are nontrivial.
doi:10.1038/ajh.2009.215
PMCID: PMC2901769  PMID: 19927132
Costs and Cost Analysis; Hypertension; Patient Compliance
16.  The implementation of a translational study involving a primary care based behavioral program to improve blood pressure control: The HTN-IMPROVE study protocol (01295) 
Background
Despite the impact of hypertension and widely accepted target values for blood pressure (BP), interventions to improve BP control have had limited success.
Objectives
We describe the design of a 'translational' study that examines the implementation, impact, sustainability, and cost of an evidence-based nurse-delivered tailored behavioral self-management intervention to improve BP control as it moves from a research context to healthcare delivery. The study addresses four specific aims: assess the implementation of an evidence-based behavioral self-management intervention to improve BP levels; evaluate the clinical impact of the intervention as it is implemented; assess organizational factors associated with the sustainability of the intervention; and assess the cost of implementing and sustaining the intervention.
Methods
The project involves three geographically diverse VA intervention facilities and nine control sites. We first conduct an evaluation of barriers and facilitators for implementing the intervention at intervention sites. We examine the impact of the intervention by comparing 12-month pre/post changes in BP control between patients in intervention sites versus patients in the matched control sites. Next, we examine the sustainability of the intervention and organizational factors facilitating or hindering the sustained implementation. Finally, we examine the costs of intervention implementation. Key outcomes are acceptability and costs of the program, as well as changes in BP. Outcomes will be assessed using mixed methods (e.g., qualitative analyses--pattern matching; quantitative methods--linear mixed models).
Discussion
The study results will provide information about the challenges and costs to implement and sustain the intervention, and what clinical impact can be expected.
doi:10.1186/1748-5908-5-54
PMCID: PMC2914777  PMID: 20637095
17.  A two-stage genome-wide association study of sporadic amyotrophic lateral sclerosis 
Human Molecular Genetics  2009;18(8):1524-1532.
The cause of sporadic amyotrophic lateral sclerosis (ALS) is largely unknown, but genetic factors are thought to play a significant role in determining susceptibility to motor neuron degeneration. To identify genetic variants altering risk of ALS, we undertook a two-stage genome-wide association study (GWAS): we followed our initial GWAS of 545 066 SNPs in 553 individuals with ALS and 2338 controls by testing the 7600 most associated SNPs from the first stage in three independent cohorts consisting of 2160 cases and 3008 controls. None of the SNPs selected for replication exceeded the Bonferroni threshold for significance. The two most significantly associated SNPs, rs2708909 and rs2708851 [odds ratio (OR) = 1.17 and 1.18, and P-values = 6.98 × 10−7 and 1.16 × 10−6], were located on chromosome 7p13.3 within a 175 kb linkage disequilibrium block containing the SUNC1, HUS1 and C7orf57 genes. These associations did not achieve genome-wide significance in the original cohort and failed to replicate in an additional independent cohort of 989 US cases and 327 controls (OR = 1.18 and 1.19, P-values = 0.08 and 0.06, respectively). Thus, we chose to cautiously interpret our data as hypothesis-generating requiring additional confirmation, especially as all previously reported loci for ALS have failed to replicate successfully. Indeed, the three loci (FGGY, ITPR2 and DPP6) identified in previous GWAS of sporadic ALS were not significantly associated with disease in our study. Our findings suggest that ALS is more genetically and clinically heterogeneous than previously recognized. Genotype data from our study have been made available online to facilitate such future endeavors.
doi:10.1093/hmg/ddp059
PMCID: PMC2664150  PMID: 19193627
18.  Racial Differences in Blood Pressure Control: Potential Explanatory Factors 
Summary
Objective
The objective of the study was to identify potential explanatory factors for racial differences in blood pressure (BP) control.
Design
The design of the study was a cross-sectional study
Patients/Participants
The study included 608 patients with hypertension who were either African American (50%) or white (50%) and who received primary care in Durham, NC.
Measurements and Main Results
Baseline data were obtained from the Take Control of Your Blood pressure study and included clinical, demographic, and psychosocial variables potentially related to clinic BP measures. African Americans were more likely than whites to have inadequate baseline clinic BP control as defined as greater than or equal to 140/90 mmHg (49% versus 34%; unadjusted odds ratio [OR] 1.8; 95% confidence interval [CI] 1.3–2.5). Among factors that may explain this disparity, being older, reporting hypertension medication nonadherence, reporting a hypertension diagnosis for more than 5 years, reporting high levels of stress, being worried about hypertension, and reporting an increased number of medication side effects were related to inadequate BP control. In adjusted analyses, African Americans continue to have poor BP control relative to whites; the magnitude of the association was reduced (OR = 1.5; 95% CI 1.0–2.1). Medication nonadherence, worries about hypertension, and older age (>70) continued to be related to poor BP control.
Conclusions
In this sample of hypertensive patients, there were a number of factors associated with poor BP control that partially explained the observed racial disparity in hypertension control including age, medication nonadherence, and worry about BP. Medication nonadherence is of particular interest because it is a potentially modifiable factor that might be used to reduce the racial disparity in BP control.
doi:10.1007/s11606-008-0547-7
PMCID: PMC2324164  PMID: 18288540
racial disparity; hypertension; adherence; psychosocial
19.  Correlation of Symptoms to Function in Older Adults with Comorbidity 
Objectives
To (1) describe the relationship between symptom scores and mobility function measures, (2) assess whether symptom scores and disease scores are similarly associated with mobility function, and (3) identify clusters of symptoms that are most strongly associated with functional status in older adults
Design
Secondary analysis of cross-sectional data from three cohorts
Setting
Academic medical center
Participants
195 community-dwelling subjects with poor flexibility or cardiorespiratory fitness (fitness cohort), 211 female retirement community residents with vertebral fractures (VF cohort), and 61 subjects with Parkinson's disease (PD cohort)
Measurements
20-item self-reported symptom scale, 17-item self-reported disease scale, Short Form 36 (SF-36) Physical Functioning Scale, 5-item Nagi Disability scale, 10-meter walk time, supine to stand time
Results
Symptom scores correlated with mobility function measures (Spearman correlation coefficients range from 0.222 to 0.509) at least as strongly as, if not more strongly than did disease scores. Symptom scores remained associated with functional outcomes after controlling for disease score and demographic variables. Adding symptom scores to models that contained disease scores significantly increased the association with functional outcomes. In the fitness cohort, muscle weakness was the most explanatory single symptom, associated with an average decrease of 17.8 points on the Physical Functioning Scale. A model that included only muscle weakness, pain, and shortness of breath accounted for 21.2% of the variability in the Physical Functioning Score.
Conclusion
Symptoms represent useful indicators of disability burden in older adults and are promising targets for interventions to improve function in complex patients.
doi:10.1111/j.1532-5415.2009.02178.x
PMCID: PMC2674624  PMID: 19392960
symptom; function; disability; comorbidity
20.  Take Control of Your Blood pressure (TCYB) study: A multifactorial tailored behavioral and educational intervention for achieving blood pressure control 
Patient education and counseling  2007;70(3):338-347.
Objectives
Evaluating a randomized controlled trial involving a tailored behavioral intervention conducted to improve blood pressure control.
Methods
Adults with hypertension from two outpatient primary care clinics were randomly allocated to receive a nurse-administered behavioral intervention or usual care. In this ongoing study, patients receive the tailored behavioral intervention bi-monthly for two years via telephone; the goal of the intervention is to promote medication adherence and improve hypertension-related health behaviors. Patient factors targeted in the tailored behavioral intervention include perceived risk of hypertension and knowledge, memory, medical and social support, patients' relationship with their health care provider, adverse effects of medication therapy, weight management, exercise, diet, stress, smoking, and alcohol use.
Results
The sample randomized to the behavioral intervention consisted of 319 adults with hypertension (average age = 60.5 years; 47% African-American). A comparable sample of adults was assigned to usual care (n=317). We had a 96% retention rate for the overall sample for the first 6 months of the study (93% at 12 months). The average phone call has lasted 18 minutes (range 2 to 51 minutes). From baseline to six months, self-reported medication adherence increased by 9% in the behavioral group vs. 1% in the non-behavioral group.
Conclusion
The intervention is easily implemented and is designed to enhance adherence with prescribed hypertension regimen. The study includes both general and patient-tailored information based upon need assessment. The study design ensures internal validity as well as the ability to generalize study findings to the clinic settings.
Practice Implications
Despite knowledge of the risks and acceptable evidence, a large number of hypertensive adults still do not have their blood pressure under effective control. This study will be an important step in evaluating a tailored multibehavioral intervention focusing on improving blood pressure control.
doi:10.1016/j.pec.2007.11.014
PMCID: PMC2276731  PMID: 18164894
Behavioral Intervention; hypertension; adherence; tailored; health communication
21.  Genes and Environmental Exposures in Veterans with ALS (GENEVA): Rationale, Study Design and Demographic Characteristics 
Neuroepidemiology  2008;30(3):191-204.
Recent reports of a potentially increased risk of amyotrophic lateral sclerosis (ALS) for veterans deployed to the 1990-91 Persian Gulf War prompted the Department of Veterans Affairs to establish a National Registry of Veterans with ALS, charged with the goal of enrolling all US veterans with a neurologist-confirmed diagnosis of ALS (Allen et al., this issue). The GENEVA study (Genes and Environmental Exposures in Veterans with ALS) is a case-control study presently enrolling cases from the VA registry and a representative sample of veteran controls to evaluate the joint contributions of genetic susceptibility and environmental exposures to the risk of sporadic ALS. The GENEVA study design, recruitment strategies, and methods of collecting DNA samples and environmental risk factor information are described here, along with a summary of demographic characteristics of the participants (537 cases, 292 controls) enrolled to date.
doi:10.1159/000126911
PMCID: PMC2645711  PMID: 18421219
case-control study; recruitment methods; gene-environment interaction
22.  Study protocol: Couples Partnering for Lipid Enhancing Strategies (CouPLES) – a randomized, controlled trial 
Trials  2009;10:10.
Background
Almost 50% of Americans have elevated low-density lipoprotein cholesterol (LDL-C). The behaviors required to lower LDL-C levels may be difficult to adhere to if they are inconsistent with spouses' health practices, and, alternatively, may be enhanced by enlisting support from the spouse. This trial extends previous trials by requiring spouse enrollment, teaching spouses how to provide emotional and instrumental support, allowing patients to decide which component of the intervention they would like to receive, and having patients determine their own goals and action plans.
Methods
Veteran outpatients with above-goal LDL-C (N = 250) and their spouses are randomized, as a couple, to receive printed education materials only or the materials plus an 11-month, nurse-delivered, telephone-based intervention. The intervention contains four modules: medication adherence, diet, exercise, and patient-physician communication. Patients decide which modules they complete and in which order; modules may be repeated or omitted. Telephone calls are to patients and spouses separately and occur monthly. During each patient telephone call, patients' progress is reviewed, and patients create goals and action plans for the upcoming month. During spouse telephone calls, which occur within one week of patient calls, spouses are informed of patients' goals and action plans and devise strategies to increase emotional and instrumental support.
The primary outcome is patients' LDL-C, measured at baseline, 6 months, and 11 months. Linear mixed models will be used to test the primary hypothesis that an 11-month, telephone-based patient-spouse intervention will result in a greater reduction in LDL-C as compared to printed education materials. Various process measures, including social support, self-efficacy, medication adherence, dietary behavior, and exercise, are also assessed to explain any change, or lack thereof, in LDL-C.
Discussion
Given the social context in which self-management occurs, interventions that teach spouses to provide instrumental and emotional support may help patients initiate and adhere to behaviors that lower their LDL-C levels. Moreover, allowing patients to retain autonomy by deciding which behaviors they would like to change and how may improve adherence and clinical outcomes.
Trial Registration
The ClinicalTrials.gov registration number is NCT00321789.
doi:10.1186/1745-6215-10-10
PMCID: PMC2652451  PMID: 19200384
23.  Adverse Health Outcomes After Discharge from the Emergency Department—Incidence and Risk Factors in a Veteran Population 
Journal of General Internal Medicine  2007;22(11):1527-1531.
Background
An Emergency Department (ED) visit represents a time of significant risk for an older adult; however, little is known about adverse outcomes after an ED visit in the VA system.
Objectives
1) To describe the frequency and type of adverse health outcomes among older veterans discharged from the ED, and 2) To determine risk factors associated with adverse outcomes.
Design
Retrospective, cohort study at an academically affiliated VA medical center.
Patients
A total of 942 veterans ≥ 65 years old discharged from the ED.
Measurements and Main Results
Primary dependent variable was adverse outcome, defined as a repeat VA ED visit, hospitalization, and/or death within 90 days. Overall, 320 (34.0%) patients experienced an adverse outcome: 245 (26%) returned to the VA ED but were not admitted, 125 (13.3%) were hospitalized, and 23 (2.4%) died. In adjusted analyses, higher score on the Charlson Comorbidity Index (hazard ratio [HR] 1.11; 95% CI 1.03, 1.21), ED visit within the previous 6 months (HR 1.64; 95% CI 1.30, 2.06), hospitalization within the previous 6 months (HR 1.70, 95% CI 1.30, 2.22), and triage to the emergency unit (compared to urgent care clinic) (HR 1.76, 95% CI 1.32, 2.36) were independently associated with higher risk of adverse outcomes.
Conclusion
More than 1 in 3 older veterans discharged from the ED experienced a significant adverse outcome within 90 days of ED discharge. Identifying veterans at greatest risk for adverse outcomes after ED discharge can inform the design and targeting of interventions to reduce morbidity and costs in this group.
doi:10.1007/s11606-007-0343-9
PMCID: PMC2219800  PMID: 17828432
health outcomes; emergency department; elderly; quality of care
24.  Literacy and blood pressure – do healthcare systems influence this relationship? A cross-sectional study 
Background
Limited literacy is common among patients with chronic conditions and is associated with poor health outcomes. We sought to determine the association between literacy and blood pressure in primary care patients with hypertension and to determine if this relationship was consistent across distinct systems of healthcare delivery.
Methods
We conducted a cross-sectional study of 1224 patients with hypertension utilizing baseline data from two separate, but similar randomized controlled trials. Patients were enrolled from primary care clinics in the Veterans Affairs healthcare system (VAHS) and a university healthcare system (UHS) in Durham, North Carolina. We compared the association between literacy and the primary outcome systolic blood pressure (SBP) and secondary outcomes of diastolic blood pressure (DBP) and blood pressure (BP) control across the two different healthcare systems.
Results
Patients who read below a 9th grade level comprised 38.4% of patients in the VAHS and 27.5% of the patients in the UHS. There was a significant interaction between literacy and healthcare system for SBP. In adjusted analyses, SBP for patients with limited literacy was 1.2 mmHg lower than patients with adequate literacy in the VAHS (95% CI, -4.8 to 2.3), but 6.1 mmHg higher than patients with adequate literacy in the UHS (95% CI, 2.1 to 10.1); (p = 0.003 for test of interaction). This literacy by healthcare system interaction was not statistically significant for DBP or BP control.
Conclusion
The relationship between patient literacy and systolic blood pressure varied significantly across different models of healthcare delivery. The attributes of the healthcare delivery system may influence the relationship between literacy and health outcomes.
doi:10.1186/1472-6963-8-219
PMCID: PMC2600788  PMID: 18947408
25.  Genes and Environmental Exposures in Veterans with Amyotrophic Lateral Sclerosis: The GENEVA Study 
Neuroepidemiology  2008;30(3):191-204.
Recent reports of a potentially increased risk of amyotrophic lateral sclerosis (ALS) for veterans deployed to the 1990–1991 Persian Gulf War prompted the Department of Veterans Affairs to establish a National Registry of Veterans with ALS, charged with the goal of enrolling all US veterans with a neurologist-confirmed diagnosis of ALS. The Genes and Environmental Exposures in Veterans with ALS study (GENEVA) is a case-control study presently enrolling cases from the Department of Veterans Affairs registry and a representative sample of veteran controls to evaluate the joint contributions of genetic susceptibility and environmental exposures to the risk of sporadic ALS. The GENEVA study design, recruitment strategies, methods of collecting DNA samples and environmental risk factor information are described here, along with a summary of demographic characteristics of the participants (537 cases, 292 controls) enrolled to date.
doi:10.1159/000126911
PMCID: PMC2645711  PMID: 18421219
Amyotrophic lateral sclerosis, case-control study; GENEVA study recruitment methods; Gene-environment interaction

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