Browsing by Subject "Patient Compliance"
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Item Open Access A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation.(Health Qual Life Outcomes, 2004-05-06) Samsa, Greg; Matchar, David B; Dolor, Rowena J; Wiklund, Ingela; Hedner, Ewa; Wygant, Gail; Hauch, Ole; Marple, Cheryl Beadle; Edwards, RogerBACKGROUND: Anticoagulation can reduce quality of life, and different models of anticoagulation management might have different impacts on satisfaction with this component of medical care. Yet, to our knowledge, there are no scales measuring quality of life and satisfaction with anticoagulation that can be generalized across different models of anticoagulation management. We describe the development and preliminary validation of such an instrument - the Duke Anticoagulation Satisfaction Scale (DASS). METHODS: The DASS is a 25-item scale addressing the (a) negative impacts of anticoagulation (limitations, hassles and burdens); and (b) positive impacts of anticoagulation (confidence, reassurance, satisfaction). Each item has 7 possible responses. The DASS was administered to 262 patients currently receiving oral anticoagulation. Scales measuring generic quality of life, satisfaction with medical care, and tendency to provide socially desirable responses were also administered. Statistical analysis included assessment of item variability, internal consistency (Cronbach's alpha), scale structure (factor analysis), and correlations between the DASS and demographic variables, clinical characteristics, and scores on the above scales. A follow-up study of 105 additional patients assessed test-retest reliability. RESULTS: 220 subjects answered all items. Ceiling and floor effects were modest, and 25 of the 27 proposed items grouped into 2 factors (positive impacts, negative impacts, this latter factor being potentially subdivided into limitations versus hassles and burdens). Each factor had a high degree of internal consistency (Cronbach's alpha 0.78-0.91). The limitations and hassles factors consistently correlated with the SF-36 scales measuring generic quality of life, while the positive psychological impact scale correlated with age and time on anticoagulation. The intra-class correlation coefficient for test-retest reliability was 0.80. CONCLUSIONS: The DASS has demonstrated reasonable psychometric properties to date. Further validation is ongoing. To the degree that dissatisfaction with anticoagulation leads to decreased adherence, poorer INR control, and poor clinical outcomes, the DASS has the potential to help identify reasons for dissatisfaction (and positive satisfaction), and thus help to develop interventions to break this cycle. As an instrument designed to be applicable across multiple models of anticoagulation management, the DASS could be crucial in the scientific comparison between those models of care.Item Open Access A pilot study on mindfulness based stress reduction for smokers.(BMC complementary and alternative medicine, 2007-01-25) Davis, James M; Fleming, Michael F; Bonus, Katherine A; Baker, Timothy BBackground
Mindfulness means paying attention in the present moment, non-judgmentally, without commentary or decision-making. We report results of a pilot study designed to test the feasibility of using Mindfulness Based Stress Reduction (MBSR) (with minor modifications) as a smoking intervention.Methods
MBSR instructors provided instructions in mindfulness in eight weekly group sessions. Subjects attempted smoking cessation during week seven without pharmacotherapy. Smoking abstinence was tested six weeks after the smoking quit day with carbon monoxide breath test and 7-day smoking calendars. Questionnaires were administered to evaluate changes in stress and affective distress.Results
18 subjects enrolled in the intervention with an average smoking history of 19.9 cigarettes per day for 26.4 years. At the 6-week post-quit visit, 10 of 18 subjects (56%) achieved biologically confirmed 7-day point-prevalent smoking abstinence. Compliance with meditation was positively associated with smoking abstinence and decreases in stress and affective distress.Discussions and conclusion
The results of this study suggest that mindfulness training may show promise for smoking cessation and warrants additional study in a larger comparative trial.Item Open Access A Randomized Controlled Trial Investigating the Feasibility and Adherence to an Aerobic Training Program in Healthy Individuals.(Journal of sport rehabilitation, 2019-09) Teel, Elizabeth F; Marshall, Stephen W; Appelbaum, L Gregory; Battaglini, Claudio L; Carneiro, Kevin A; Guskiewicz, Kevin M; Register-Mihalik, Johna K; Mihalik, Jason PCONTEXT:Concussion management is moving from passive rest strategies to active interventions, including aerobic exercise therapy. Little information is available regarding the feasibility and adherence of these programs. OBJECTIVES:To determine whether an aerobic exercise training program intended for rehabilitation in people with concussion is feasible. Healthy, nonconcussed subjects were studied in this phase 1 trial. DESIGN:Phase 1 parallel-group, randomized controlled trial in a sample of healthy (nonconcussed), recreationally active university students. SETTING:Laboratory. PATIENTS:40 healthy university students. METHODS:Participants were equally randomized to acute concussion therapy intervention (ACTIVE) training or nontraining groups. All participants completed maximal cardiopulmonary exercise tests on a stationary cycle ergometer at 2 test sessions approximately 14 days apart. During this 2-week study period, ACTIVE training participants completed six 30-minute cycling sessions, progressing from 60% to 80% of the participant's individualized maximal oxygen consumption. A subset of participants (NACTIVE = 12, Nnontraining = 11) wore physical activity monitors throughout the 2-week study period. MAIN OUTCOMES MEASURES:Study protocol and randomization effectiveness, exercise safety and adherence, and progressive intensity of the ACTIVE training procedures. RESULTS:No adverse events occurred during any exercise sessions. Twelve ACTIVE training participants (60%) completed all training sessions, and every participant completed at least 4 sessions. Heart rate increased throughout the training period (P < .001), but symptom changes and training adherence remained stable despite the progressively increasing workload. ACTIVE training participants completed approximately 30 additional minutes of physical activity on training sessions days, although that was not statistically significant (P = .20). CONCLUSIONS:University-aged students were adherent to the ACTIVE training protocol. Future research should investigate the safety and feasibility of aerobic training programs in acutely concussed individuals to determine their appropriateness as a clinical rehabilitation strategy.Item Open Access Addressing barriers to optimal oral anticoagulation use and persistence among patients with atrial fibrillation: Proceedings, Washington, DC, December 3-4, 2012.(American heart journal, 2014-09) Hess, Paul L; Mirro, Michael J; Diener, Hans-Christoph; Eikelboom, John W; Al-Khatib, Sana M; Hylek, Elaine M; Bosworth, Hayden B; Gersh, Bernard J; Singer, Daniel E; Flaker, Greg; Mega, Jessica L; Peterson, Eric D; Rumsfeld, John S; Steinberg, Benjamin A; Kakkar, Ajay K; Califf, Robert M; Granger, Christopher B; Atrial Fibrillation Think-Tank ParticipantsApproximately half of patients with atrial fibrillation and with risk factors for stroke are not treated with oral anticoagulation (OAC), whether it be with vitamin K antagonists (VKAs) or novel OACs (NOACs); and of those treated, many discontinue treatment. Leaders from academia, government, industry, and professional societies convened in Washington, DC, on December 3-4, 2012, to identify barriers to optimal OAC use and adherence and to generate potential solutions. Participants identified a broad range of barriers, including knowledge gaps about stroke risk and the relative risks and benefits of anticoagulant therapies; lack of awareness regarding the potential use of NOAC agents for VKA-unsuitable patients; lack of recognition of expanded eligibility for OAC; lack of availability of reversal agents and the difficulty of anticoagulant effect monitoring for the NOACs; concerns with the bleeding risk of anticoagulant therapy, especially with the NOACs and particularly in the setting of dual antiplatelet therapy; suboptimal time in therapeutic range for VKA; and costs and insurance coverage. Proposed solutions were to define reasons for oral anticoagulant underuse classified in ways that can guide intervention and improve use, to increase awareness of stroke risk as well as the benefits and risks of OAC use via educational initiatives and feedback mechanisms, to better define the role of VKA in the current therapeutic era including eligibility and ineligibility for different anticoagulant therapies, to identify NOAC reversal agents and monitoring strategies and make knowledge regarding their use publicly available, to minimize the duration of dual antiplatelet therapy and concomitant OAC where possible, to improve time in therapeutic range for VKA, to leverage observational data sets to refine understanding of OAC use and outcomes in general practice, and to better align health system incentives.Item Open Access Adherence to diabetes guidelines for screening, physical activity and medication and onset of complications and death.(J Diabetes Complications, 2015-11) Chen, Yiqun; Sloan, Frank A; Yashkin, Arseniy PAIMS: Analyze relationships between adherence to guidelines for diabetes care - regular screening; physical activity; and medication - and diabetes complications and mortality. METHODS: Outcomes were onset of congestive heart failure (CHF), stroke, renal failure, moderate complications of lower extremities, lower-limb amputation, proliferative diabetic retinopathy (PDR), and mortality during follow-up. Participants were persons aged 65+ in the Health and Retirement Study (HRS) 2003 Diabetes Study and had Medicare claims in follow-up period (2004-8). RESULTS: Adherence to screening recommendations decreased risks of developing CHF (odds ratio (OR)=0.83; 95% confidence interval (CI): 0.72-0.96), stroke (OR=0.80; 95% CI: 0.68-0.94); renal failure (OR=0. 82; 95% CI: 0.71-0.95); and death (OR=0.86; 95% CI: 0.74-0.99). Adherence to physical activity recommendation reduced risks of stroke (OR=0.64; 95% CI: 0.45-0.90), renal failure (OR=0.71; 95% CI: 0.52-0.97), moderate lower-extremity complications (OR=0.71; 95% CI: 0.51-0.99), having a lower limb amputation (OR=0.31, 95% CI: 0.11-0.85), and death (OR=0.56, 95% CI: 0.41-0.77). Medication adherence was associated with lower risks of PDR (OR=0.35, 95% CI: 0.13-0.93). CONCLUSIONS: Adherence to screening, physical activity and medication guidelines was associated with lower risks of diabetes complications and death. Relative importance of adherence differed among outcome measures.Item Open Access Association between perceived life chaos and medication adherence in a postmyocardial infarction population.(Circulation. Cardiovascular quality and outcomes, 2013-11) Zullig, Leah L; Shaw, Ryan J; Crowley, Matthew J; Lindquist, Jennifer; Grambow, Steven C; Peterson, Eric; Shah, Bimal R; Bosworth, Hayden BBackground
The benefits of medication adherence to control cardiovascular disease (CVD) are well defined, yet multiple studies have identified poor adherence. The influence of life chaos on medication adherence is unknown. Because this is a novel application of an instrument, our preliminary objective was to understand patient factors associated with chaos. The main objective was to evaluate the extent to which an instrument designed to measure life chaos is associated with CVD-medication nonadherence.Methods and results
Using baseline data from an ongoing randomized trial to improve postmyocardial infarction (MI) management, multivariable logistic regression identified the association between life chaos and CVD-medication nonadherence. Patients had hypertension and a myocardial infarction in the past 3 years (n=406). Nearly 43% reported CVD-medication nonadherence in the past month. In simple linear regression, the following were associated with higher life chaos: medication nonadherence (β=1.86; 95% confidence interval [CI], 0.96-2.76), female sex (β=1.22; 95% CI [0.22-2.24]), minority race (β=1.72; 95% CI [0.78-2.66]), having less than high school education (β=2.05; 95% CI [0.71-3.39]), low health literacy (β=2.06; 95% CI [0.86-3.26]), and inadequate financial status (β=1.93; 95% CI [0.87-3.00]). Being married (β=-2.09, 95% CI [-3.03 to -1.15]) was associated with lower life chaos. As chaos quartile increased, patients exhibited more nonadherence. In logistic regression, adjusting for sex, race, marital status, employment, education, health literacy, and financial status, a 1-unit life chaos increase was associated with a 7% increase (odds ratio, 1.07; 95% CI [1.02-1.12]) in odds of reporting medication nonadherence.Conclusions
Our results suggest that life chaos may be an important determinant of medication adherence. Life chaos screenings could identify those at risk for nonadherence.Clinical trial registration
URL: http://www.clinicaltrials.gov. Unique identifier: NCT000901277.Item Open Access Baseline medication adherence and blood pressure in a 24-month longitudinal hypertension study.(Journal of clinical nursing, 2011-11) Shaw, R; Bosworth, HBAim and objectives. We sought to identify the feasibility and predictive validity of an easy and quick self-reported measure of medication adherence and to identify characteristics of people with hypertension that may warrant increase attentiveness by nurses to address hypertensive self-management needs. Background. Current control rates of hypertension are approximately 50%. Effective blood pressure control can be achieved in most people with hypertension through antihypertensive medication. However, hypertension control can only be achieved if the patient is adherent with their medication regimen. Patients who are non-adherent may be in need of additional intervention. Design. This secondary analysis evaluated the systolic blood pressure of patients who received usual hypertension management across 24 months at six-month intervals. Methods. A longitudinal study of 159 hypertensive patients in two primary care clinics. Results. In a sample of 159 patients receiving care in a primary care facility, baseline medication non-adherence was associated with a 6·3 mmHg increase in systolic blood pressure (pItem Open Access Effectiveness of low-dose naltrexone in the post-detoxification treatment of opioid dependence.(Journal of clinical psychopharmacology, 2007-10) Mannelli, Paolo; Patkar, Ashwin A; Peindl, Kathleen; Murray, Heather W; Wu, Li-Tzy; Hubbard, RobertBACKGROUND: The clinical use of naltrexone (NTX) in the treatment of opioid dependence has been limited because of poor compliance and inconsistent outcomes. In particular, the therapeutic benefit of extended treatment with NTX after opioid detoxification is unclear. The present study evaluated whether the augmentation with low-dose NTX during the post-detoxification treatment of opioid dependence would improve outcomes. METHODS: In an open-label naturalistic design, 435 opioid-dependent patients who had completed inpatient detoxification were offered the choice of entering 1 of the 2 outpatient treatment arms: clonidine extended treatment (CET) (clonidine + psychosocial treatment), or enhanced extended treatment (EET) (oral NTX [1-10 mg/d] + CET) for 21 days. The primary outcome measure was retention in treatment. Secondary outcomes included abstinence from opioids, dropouts, and adherence to postdischarge care. RESULTS: One hundred sixty-two patients (37.2%) accepted EET. Subjects receiving EET stayed longer in the program (F = 64.4; P = 0.000), were less likely to drop out, used less opioids, and followed through with referral to long-term outpatient treatment in a higher number, compared with patients in the CET arm (P = 0.000 in each case). The NTX + clonidine combination was safe and well tolerated. CONCLUSIONS: This preliminary study indicates the potential benefit of augmentation with low-dose NTX to improve outcomes after opioid detoxification for a preferred group of patients. Randomized controlled trials are necessary to further evaluate the role of low-dose NTX in the outpatient treatment of opioid dependence.Item Open Access Factors associated with non-adherence to three hypertension self-management behaviors: preliminary data for a new instrument.(Journal of general internal medicine, 2013-01) Crowley, Matthew J; Grubber, Janet M; Olsen, Maren K; Bosworth, Hayden BBackground
Clinicians have difficulty in identifying patients that are unlikely to adhere to hypertension self-management. Identifying non-adherence is essential to addressing suboptimal blood pressure control and high costs.Objectives
1) To identify risk factors associated with non-adherence to three key self-management behaviors in patients with hypertension: proper medication use, diet, and exercise; 2) To evaluate the extent to which an instrument designed to identify the number of risk factors present for non-adherence to each of the three hypertension self-management behaviors would be associated with self-management non-adherence and blood pressure.Design
Cross-sectional analysis of randomized trial data.Patients
Six hundred and thirty-six primary care patients with hypertension.Measurements
1) Demographic, socioeconomic, psychosocial, and health belief-related factors; 2) measures of self-reported adherence to recommended medication use, diet recommendations, and exercise recommendations, all collected at baseline assessment; 3) systolic blood pressure (SBP) and diastolic blood pressure (DBP).Results
We identified patient factors associated with measures of non-adherence to medications, diet, and exercise in hypertension. We then combined risk factors associated with ≥1 adherence measure into an instrument that generated three composite variables (medication, diet, and exercise composites), reflecting the number of risk factors present for non-adherence to the corresponding self-management behavior. These composite variables identified subgroups with higher likelihood of medication non-adherence, difficulty following diet recommendations, and difficulty following exercise recommendations. Composite variable levels representing the highest number of self-management non-adherence risk factors were associated with higher SBP and DBP.Conclusions
We identified factors associated with measures of non-adherence to recommended medication use, diet, and exercise in hypertension. We then developed an instrument that was associated with non-adherence to these self-management behaviors, as well as with blood pressure. With further study, this instrument has potential to improve identification of non-adherent patients with hypertension.Item Open Access Factors associated with persistent poorly controlled diabetes mellitus: clues to improving management in patients with resistant poor control.(Chronic illness, 2014-12) Crowley, Matthew J; Holleman, Rob; Klamerus, Mandi L; Bosworth, Hayden B; Edelman, David; Heisler, MicheleObjectives
Patients with persistent poorly controlled diabetes mellitus (PPDM), defined as an uninterrupted hemoglobin A1c >8.0% for ≥1 year despite standard care, are at high risk for complications. Additional research to define patient factors associated with PPDM could suggest barriers to improvement in this group and inform the development of targeted strategies to address these patients' resistant diabetes.Methods
We analyzed patients with type 2 diabetes from a multi-site randomized trial. We characterized patients with PPDM relative to other patients using detailed survey data and multivariable modeling.Results
Of 963 patients, 118 (12%) had PPDM, 265 (28%) were intermittently poorly controlled, and 580 (60%) were well-controlled. Patients with PPDM had younger age, earlier diabetes diagnosis, insulin use, higher antihypertensive burden, higher low-density lipoprotein cholesterol, and lower statin use relative to well-controlled patients. Among patients with objective adherence data (Veterans Affairs patients), a larger oral diabetes medication refill gap was associated with PPDM.Discussion
Strategies are needed to target-specific barriers to improvement among patients whose diabetes is resistant to standard diabetes care. Our data suggest that strategies for targeting PPDM should accommodate younger patients' lifestyles, include medication management for insulin titration and comorbid disease conditions, and address barriers to self-management adherence.Item Open Access Feasibility of integrated depression care in an HIV clinic.(Psychiatr Serv, 2011-07) Adams, Julie; Pollard, R Scott; Sikkema, Kathleen JItem Open Access HIV/AIDS-related institutional mistrust among multiethnic men who have sex with men: effects on HIV testing and risk behaviors.(Health Psychol, 2012-05) Hoyt, Michael A; Rubin, Lisa R; Nemeroff, Carol J; Lee, Joyce; Huebner, David M; Proeschold-Bell, Rae JeanOBJECTIVE: To investigate relationships between institutional mistrust (systematic discrimination, organizational suspicion, and conspiracy beliefs), HIV risk behaviors, and HIV testing in a multiethnic sample of men who have sex with men (MSM), and to test whether perceived susceptibility to HIV mediates these relationships for White and ethnic minority MSM. METHOD: Participants were 394 MSM residing in Central Arizona (M age = 37 years). Three dimensions of mistrust were examined, including organizational suspicion, conspiracy beliefs, and systematic discrimination. Assessments of sexual risk behavior, HIV testing, and perceived susceptibility to HIV were made at study entry (T1) and again 6 months later (T2). RESULTS: There were no main effects of institutional mistrust dimensions or ethnic minority status on T2 risk behavior, but the interaction of systematic discrimination and conspiracy beliefs with minority status was significant such that higher levels of systematic discrimination and more conspiracy beliefs were associated with increased risk only among ethnic minority MSM. Higher levels of systematic discrimination were significantly related to lower likelihood for HIV testing, and the interaction of organizational suspicion with minority status was significant such that greater levels of organizational suspicion were related to less likelihood of having been tested for HIV among ethnic minority MSM. Perceived susceptibility did not mediate these relationships. CONCLUSION: Findings suggest that it is important to look further into the differential effects of institutional mistrust across marginalized groups, including sexual and ethnic minorities. Aspects of mistrust should be addressed in HIV prevention and counseling efforts.Item Open Access How can innovative uses of technology be harnessed to improve medication adherence?(Expert review of pharmacoeconomics & outcomes research, 2012-04) Bosworth, Hayden BItem Open Access Hypertension Improvement Project (HIP): study protocol and implementation challenges.(Trials, 2009-02-26) Dolor, Rowena J; Yancy, William S; Owen, William F; Matchar, David B; Samsa, Gregory P; Pollak, Kathryn I; Lin, Pao-Hwa; Ard, Jamy D; Prempeh, Maxwell; McGuire, Heather L; Batch, Bryan C; Fan, William; Svetkey, Laura PBackground
Hypertension affects 29% of the adult U.S. population and is a leading cause of heart disease, stroke, and kidney failure. Despite numerous effective treatments, only 53% of people with hypertension are at goal blood pressure. The chronic care model suggests that blood pressure control can be achieved by improving how patients and physicians address patient self-care.Methods and design
This paper describes the protocol of a nested 2 x 2 randomized controlled trial to test the separate and combined effects on systolic blood pressure of a behavioral intervention for patients and a quality improvement-type intervention for physicians. Primary care practices were randomly assigned to the physician intervention or to the physician control condition. Physician randomization occurred at the clinic level. The physician intervention included training and performance monitoring. The training comprised 2 internet-based modules detailing both the JNC-7 hypertension guidelines and lifestyle modifications for hypertension. Performance data were collected for 18 months, and feedback was provided to physicians every 3 months. Patient participants in both intervention and control clinics were individually randomized to the patient intervention or to usual care. The patient intervention consisted of a 6-month behavioral intervention conducted by trained interventionists in 20 group sessions, followed by 12 monthly phone contacts by community health advisors. Follow-up measurements were performed at 6 and 18 months. The primary outcome was the mean change in systolic blood pressure at 6 months. Secondary outcomes were diastolic blood pressure and the proportion of patients with adequate blood pressure control at 6 and 18 months.Discussion
Overall, 8 practices (4 per treatment group), 32 physicians (4 per practice; 16 per treatment group), and 574 patients (289 control and 285 intervention) were enrolled. Baseline characteristics of patients and providers and the challenges faced during study implementation are presented. The HIP interventions may improve blood pressure control and lower cardiovascular disease risk in a primary care practice setting by addressing key components of the chronic care model. The study design allows an assessment of the effectiveness and cost of physician and patient interventions separately, so that health care organizations can make informed decisions about implementation of 1 or both interventions in the context of local resources.Trial registration
ClinicalTrials.gov identifier NCT00201136.Item Open Access Mobile health devices: will patients actually use them?(Journal of the American Medical Informatics Association : JAMIA, 2016-05) Shaw, Ryan J; Steinberg, Dori M; Bonnet, Jonathan; Modarai, Farhad; George, Aaron; Cunningham, Traven; Mason, Markedia; Shahsahebi, Mohammad; Grambow, Steven C; Bennett, Gary G; Bosworth, Hayden BAlthough mobile health (mHealth) devices offer a unique opportunity to capture patient health data remotely, it is unclear whether patients will consistently use multiple devices simultaneously and/or if chronic disease affects adherence. Three healthy and three chronically ill participants were recruited to provide data on 11 health indicators via four devices and a diet app. The healthy participants averaged overall weekly use of 76%, compared to 16% for those with chronic illnesses. Device adherence declined across all participants during the study. Patients with chronic illnesses, with arguably the most to benefit from advanced (or increased) monitoring, may be less likely to adopt and use these devices compared to healthy individuals. Results suggest device fatigue may be a significant problem. Use of mobile technologies may have the potential to transform care delivery across populations and within individuals over time. However, devices may need to be tailored to meet the specific patient needs.Item Open Access Nurse-led behavioral management of diabetes and hypertension in community practices: a randomized trial.(J Gen Intern Med, 2015-05) Edelman, David; Dolor, Rowena J; Coffman, Cynthia J; Pereira, Katherine C; Granger, Bradi B; Lindquist, Jennifer H; Neary, Alice M; Harris, Amy J; Bosworth, Hayden BBACKGROUND: Several trials have demonstrated the efficacy of nurse telephone case management for diabetes (DM) and hypertension (HTN) in academic or vertically integrated systems. Little is known about the real-world potency of these interventions. OBJECTIVE: To assess the effectiveness of nurse behavioral management of DM and HTN in community practices among patients with both diseases. DESIGN: The study was designed as a patient-level randomized controlled trial. PARTICIPANTS: Participants included adult patients with both type 2 DM and HTN who were receiving care at one of nine community fee-for-service practices. Subjects were required to have inadequately controlled DM (hemoglobin A1c [A1c] ≥ 7.5%) but could have well-controlled HTN. INTERVENTIONS: All patients received a call from a nurse experienced in DM and HTN management once every two months over a period of two years, for a total of 12 calls. Intervention patients received tailored DM- and HTN- focused behavioral content; control patients received non-tailored, non-interactive information regarding health issues unrelated to DM and HTN (e.g., skin cancer prevention). MAIN OUTCOMES AND MEASURES: Systolic blood pressure (SBP) and A1c were co-primary outcomes, measured at 6, 12, and 24 months; 24 months was the primary time point. RESULTS: Three hundred seventy-seven subjects were enrolled; 193 were randomized to intervention, 184 to control. Subjects were 55% female and 50% white; the mean baseline A1c was 9.1% (SD = 1%) and mean SBP was 142 mmHg (SD = 20). Eighty-two percent of scheduled interviews were conducted; 69% of intervention patients and 70% of control patients reached the 24-month time point. Expressing model estimated differences as (intervention--control), at 24 months, intervention patients had similar A1c [diff = 0.1 %, 95 % CI (-0.3, 0.5), p = 0.51] and SBP [diff = -0.9 mmHg, 95% CI (-5.4, 3.5), p = 0.68] values compared to control patients. Likewise, DBP (diff = 0.4 mmHg, p = 0.76), weight (diff = 0.3 kg, p = 0.80), and physical activity levels (diff = 153 MET-min/week, p = 0.41) were similar between control and intervention patients. Results were also similar at the 6- and 12-month time points. CONCLUSIONS: In nine community fee-for-service practices, telephonic nurse case management did not lead to improvement in A1c or SBP. Gains seen in telephonic behavioral self-management interventions in optimal settings may not translate to the wider range of primary care settings.Item Open Access Optimizing linkage and retention to hypertension care in rural Kenya (LARK hypertension study): study protocol for a randomized controlled trial.(Trials, 2014-04-27) Vedanthan, Rajesh; Kamano, Jemima H; Naanyu, Violet; Delong, Allison K; Were, Martin C; Finkelstein, Eric A; Menya, Diana; Akwanalo, Constantine O; Bloomfield, Gerald S; Binanay, Cynthia A; Velazquez, Eric J; Hogan, Joseph W; Horowitz, Carol R; Inui, Thomas S; Kimaiyo, Sylvester; Fuster, ValentinBACKGROUND: Hypertension is the leading global risk factor for mortality. Hypertension treatment and control rates are low worldwide, and delays in seeking care are associated with increased mortality. Thus, a critical component of hypertension management is to optimize linkage and retention to care. METHODS/DESIGN: This study investigates whether community health workers, equipped with a tailored behavioral communication strategy and smartphone technology, can increase linkage and retention of hypertensive individuals to a hypertension care program and significantly reduce blood pressure among them. The study will be conducted in the Kosirai and Turbo Divisions of western Kenya. An initial phase of qualitative inquiry will assess facilitators and barriers of linkage and retention to care using a modified Health Belief Model as a conceptual framework. Subsequently, we will conduct a cluster randomized controlled trial with three arms: 1) usual care (community health workers with the standard level of hypertension care training); 2) community health workers with an additional tailored behavioral communication strategy; and 3) community health workers with a tailored behavioral communication strategy who are also equipped with smartphone technology. The co-primary outcome measures are: 1) linkage to hypertension care, and 2) one-year change in systolic blood pressure among hypertensive individuals. Cost-effectiveness analysis will be conducted in terms of costs per unit decrease in blood pressure and costs per disability-adjusted life year gained. DISCUSSION: This study will provide evidence regarding the effectiveness and cost-effectiveness of strategies to optimize linkage and retention to hypertension care that can be applicable to non-communicable disease management in low- and middle-income countries. TRIAL REGISTRATION: This trial is registered with (NCT01844596) on 30 April 2013.Item Open Access Potential economic viability of two proposed rifapentine-based regimens for treatment of latent tuberculosis infection.(PLoS One, 2011) Holland, David P; Sanders, Gillian D; Hamilton, Carol D; Stout, Jason ERATIONALE: Rifapentine-based regimens for treating latent tuberculosis infection (LTBI) are being considered for future clinical trials, but even if they prove effective, high drug costs may limit their economic viability. OBJECTIVES: To inform clinical trial design by estimating the potential costs and effectiveness of rifapentine-based regimens for treatment of latent tuberculosis infection (LTBI). METHODS: We used a Markov model to estimate cost and societal benefits for three regimens for treating LTBI: Isoniazid/rifapentine daily for one month, isoniazid/rifapentine weekly for three months (self-administered and directly-observed), and isoniazid daily for nine months; a strategy of "no treatment" used for comparison. Costs, quality-adjusted life-years gained, and instances of active tuberculosis averted were calculated for all arms. RESULTS: Both daily isoniazid/rifapentine for one month and weekly isoniazid/rifapentine for three months were less expensive and more effective than other strategies under a wide variety of clinically plausibly parameter estimates. Daily isoniazid/rifapentine for one month was the least expensive and most effective regimen. CONCLUSIONS: Daily isoniazid/rifapentine for one month and weekly isoniazid/rifapentine for three months should be studied in a large-scale clinical trial for efficacy. Because both regimens performed well even if their efficacy is somewhat reduced, study designers should consider relaxing non-inferiority boundaries.Item Open Access Prevention and Control of Hypertension: JACC Health Promotion Series.(Journal of the American College of Cardiology, 2018-09) Carey, Robert M; Muntner, Paul; Bosworth, Hayden B; Whelton, Paul KHypertension, the leading risk factor for cardiovascular disease, originates from combined genetic, environmental, and social determinants. Environmental factors include overweight/obesity, unhealthy diet, excessive dietary sodium, inadequate dietary potassium, insufficient physical activity, and consumption of alcohol. Prevention and control of hypertension can be achieved through targeted and/or population-based strategies. For control of hypertension, the targeted strategy involves interventions to increase awareness, treatment, and control in individuals. Corresponding population-based strategies involve interventions designed to achieve a small reduction in blood pressure (BP) in the entire population. Having a usual source of care, optimizing adherence, and minimizing therapeutic inertia are associated with higher rates of BP control. The Chronic Care Model, a collaborative partnership among the patient, provider, and health system, incorporates a multilevel approach for control of hypertension. Optimizing the prevention, recognition, and care of hypertension requires a paradigm shift to team-based care and the use of strategies known to control BP.Item Open Access Quantifying the utility of taking pills for preventing adverse health outcomes: a cross-sectional survey.(BMJ Open, 2015-05-11) Hutchins, Robert; Pignone, Michael P; Sheridan, Stacey L; Viera, Anthony JOBJECTIVES: The utility value attributed to taking pills for prevention can have a major effect on the cost-effectiveness of interventions, but few published studies have systematically quantified this value. We sought to quantify the utility value of taking pills used for prevention of cardiovascular disease (CVD). DESIGN: Cross-sectional survey. SETTING: Central North Carolina. PARTICIPANTS: 708 healthcare employees aged 18 years and older. PRIMARY AND SECONDARY OUTCOMES: Utility values for taking 1 pill/day, assessed using time trade-off, modified standard gamble and willingness-to-pay methods. RESULTS: Mean age of respondents was 43 years (19-74). The majority of the respondents were female (83%) and Caucasian (80%). Most (80%) took at least 2 pills/day. Mean utility values for taking 1 pill/day using the time trade-off method were: 0.9972 (95% CI 0.9962 to 0.9980). Values derived from the standard gamble and willingness-to-pay methods were 0.9967 (0.9954 to 0.9979) and 0.9989 (95% CI 0.9986 to 0.9991), respectively. Utility values varied little across characteristics such as age, sex, race, education level or number of pills taken per day. CONCLUSIONS: The utility value of taking pills daily in order to prevent an adverse CVD health outcome is approximately 0.997.