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1.  Improving diabetes medication adherence: successful, scalable interventions 
Effective medications are a cornerstone of prevention and disease treatment, yet only about half of patients take their medications as prescribed, resulting in a common and costly public health challenge for the US health care system. Since poor medication adherence is a complex problem with many contributing causes, there is no one universal solution. This paper describes interventions that were not only effective in improving medication adherence among patients with diabetes, but were also potentially scalable (ie, easy to implement to a large population). We identify key characteristics that make these interventions effective and scalable. This information is intended to inform health care systems seeking proven, low resource, cost-effective solutions to improve medication adherence.
PMCID: PMC4315534  PMID: 25670885
medication adherence; diabetes mellitus; chronic disease; dissemination research; implementation research; review
2.  Medication Adherence: A Call for Action 
American heart journal  2011;162(3):412-424.
Poor adherence to efficacious cardiovascular related medications has led to considerable morbidity, mortality, and avoidable health care costs. This paper provides results of a recent think tank meeting in which various stakeholder groups representing key experts from consumers, community health providers, the academic community, decision-making government officials (FDA, NIH, etc), and industry scientists met to evaluate the current status of medication adherence and provide recommendations for improving outcomes. Below, we review the magnitude of the problem of medication adherence, prevalence, impact, and cost. We then summarize proven effective approaches and conclude with a discussion of recommendations to address this growing and significant public health issue of medication non adherence.
PMCID: PMC3947508  PMID: 21884856
3.  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.
PMCID: PMC3763915  PMID: 20937448
4.  Development of a Theoretically Driven mHealth Text Messaging Application for Sustaining Recent Weight Loss 
JMIR mHealth and uHealth  2013;1(1):e5.
Mobile phone short message service (SMS) text messaging, has the potential to serve as an intervention medium to promote sustainability of weight loss that can be easily and affordably used by clinicians and consumers.
To develop theoretically driven weight loss sustaining text messages and pilot an mHealth SMS text messaging intervention to promote sustaining recent weight loss in order to understand optimal frequency and timing of message delivery, and for feasibility and usability testing. Results from the pilot study were used to design and construct a patient privacy compliant automated SMS application to deliver weight loss sustaining messages.
We first conducted a pilot study in which participants (N=16) received a daily SMS text message for one month following a structured weight loss program. Messages were developed from diet and exercise guidelines. Following the intervention, interviews were conducted and self-reported weight was collected via SMS text messaging.
All participants (N=16) were capable of sending and receiving SMS text messages. During the phone interview at 1 month post-baseline and at 3 months post-baseline, 13/14 (93%) of participants who completed the study reported their weight via SMS. At 3 months post-baseline, 79% (11/14) participants sustained or continued to lose weight. Participants (13/14, 93%) were favorable toward the messages and the majority (10/14, 71%) felt they were useful in helping them sustain weight loss. All 14 participants who completed the interview thought SMS was a favorable communication medium and was useful to receive short relevant messages promptly and directly. All participants read the messages when they knew they arrived and most (11/14, 79%) read the messages at the time of delivery. All participants felt that at least one daily message is needed to sustain weight loss behaviors and that they should be delivered in the morning. Results were then used to develop the SMS text messaging application.
Study results demonstrated the feasibility of developing weight loss SMS text messages, and the development of an mHealth SMS text messaging application. SMS text messaging was perceived as an appropriate and accepted tool to deliver health promotion content.
PMCID: PMC4114452  PMID: 25100678
mHealth; short message service; SMS; text messaging; weight loss maintenance
5.  Racial Differences in Two Self Management Hypertension Interventions 
The American journal of medicine  2011;124(5):468.e1-468.e8.
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).
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.
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.
Combined home blood pressure monitoring and a telephone tailored-behavioral intervention appeared to be particularly effective for improving blood pressure in non-white patients.
PMCID: PMC3086723  PMID: 21531237
Hypertension; Lifestyle; Clinical Trial; Self-management; Adherence; Disparities
6.  Two Self-management Interventions to Improve Hypertension Control: A Randomized Trial 
Annals of internal medicine  2009;151(10):687-695.
Less than 40% of Americans with hypertension have adequate blood pressure (BP) control.
To compare two self-management interventions for improving BP control among hypertensive patients.
A 2 by 2 randomized trial stratified by enrollment site and patient literacy status with two-year follow-up (5/2004-1/2008).
Two university-affiliated primary care clinics.
636 patients were randomized (31% recruitment rate) among the 2060 eligible hypertensive patients.
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.
The primary outcome was BP control evaluated at six-month intervals over 24 months. 475 (75%) completed the 24-month BP follow-up.
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.
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.
Combined home BP monitoring and tailored behavioral telephone intervention improved BP control, systolic BP, and diastolic BP at 24 months relative to usual care.
PMCID: PMC2892337  PMID: 19920269
Hypertension; Lifestyle; Clinical Trial; Self-management; Adherence
7.  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.
Evaluating a randomized controlled trial involving a tailored behavioral intervention conducted to improve blood pressure control.
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.
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.
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.
PMCID: PMC2276731  PMID: 18164894
Behavioral Intervention; hypertension; adherence; tailored; health communication
9.  A model of psychosocial and cultural antecedents of blood pressure control. 
Hypertension is a major modifiable risk factor for stroke, congestive heart failure, and end-stage renal disease. Hypertension is particularly prevalent and deadly among African Americans. Effective treatment for hypertension has been available for decades, yet only one fourth of all individuals have their blood pressure under control. Despite the potential impact of hypertension, interventions to improve control have had limited success. We present a model of how to understand antecedents of blood pressure control according to three interrelated categories: patient characteristics, social and cultural environment, and medical environment. This theoretical paper was conducted using a literature review and a model to explain psychosocial antecedents of blood pressure control is presented. We conclude that improved understanding of important antecedents of blood pressure control coupled with technological advances, such as tailored interventions, provide clinicians with a tool that may lead to improved blood pressure control. These interventions will require the involvement of clinicians and consideration of sociocultural factors to be successful.
PMCID: PMC2594228  PMID: 11991336
10.  Strategic Planning to Reduce the Burden of Stroke among Veterans: Using Simulation Modeling to Inform Decision Making 
Background and Purpose
Reducing the burden of stroke is a priority for the Veterans Affairs (VA) Health System, reflected by the creation of the VA Stroke Quality Enhancement Research Initiative (QUERI). To inform the initiative's strategic planning, we estimated the relative population-level impact and efficiency of distinct approaches to improving stroke care in the United States Veteran population to inform policy and practice.
A System Dynamics stroke model of the Veteran population was constructed to evaluate the relative impact of 15 intervention scenarios including both broad and targeted primary and secondary prevention and acute care/rehabilitation on cumulative (20-year) outcomes including quality-adjusted life years (QALYs) gained, strokes prevented, stroke fatalities prevented and the number-needed-to-treat (NNT) per QALY gained.
At the population level, a broad hypertension control effort yielded the largest increase in QALYs (35,517), followed by targeted prevention addressing hypertension and anticoagulation among Veterans with prior cardiovascular disease (27,856) and hypertension control among diabetics (23,100). Adjusting QALYs gained by the number of Veterans needed to treat, thrombolytic therapy with tissue plasminogen activator was most efficient, needing 3.1 Veterans to be treated per QALY gained. This was followed by rehabilitation (3.9) and targeted prevention addressing hypertension and anticoagulation among those with prior cardiovascular disease (5.1). Probabilistic sensitivity analysis showed that the ranking of interventions was robust to uncertainty in input parameter values.
Prevention strategies tend to have larger population impacts, though interventions targeting specific high-risk groups tend to be more efficient in terms of NNT per QALY gained.
PMCID: PMC4287261  PMID: 24923722
strategic planning; comparative effectiveness; simulation model; special populations; Veterans
11.  Cognitive dysfunction and poor health literacy are common in veterans presenting with acute coronary syndrome: insights from the MEDICATION study 
Patient nonadherence to cardiac medications following acute coronary syndrome (ACS) is associated with increased risk of recurrent events. However, the prevalence of cognitive dysfunction and poor health literacy among ACS patients and their association with medication nonadherence are poorly understood.
We assessed rates of cognitive dysfunction and poor health literacy among participants of a clinical trial that tested the effectiveness of an intervention to improve medication adherence in patients hospitalized with ACS. Of 254 patients, 249 completed the Rapid Estimate of Adult Literacy in Medicine, Revised (REALM-R) survey, an assessment of risk for poor literacy, and the St Louis University Mental Status (SLUMS) exam, a tool assessing for neurocognitive deficits, during ACS hospitalization. We assessed if SLUMS or REALM-R scores were associated with medication adherence.
Based on SLUMS score, 14% of patients were categorized as having dementia, and 52% with mild neurocognitive disorder (MNCD). Based on REALM-R score of ≤6, 34% of patients were categorized as at risk for poor health literacy. There was no association between poor health literacy and medication nonadherence. Of those with MNCD, 35.5% were nonadherent, compared to 17.5% with normal cognitive function and 6.7% with dementia. In multivariable analysis, cognitive dysfunction was associated with medication nonadherence (P=0.007), mainly due to an association between MNCD and nonadherence (odds ratio =12.2, 95% confidence interval =1.9 to 243; P=0.007). Cognitive status was not associated with adherence in patients randomized to the intervention.
Cognitive dysfunction and risk for poor health literacy are common in patients hospitalized with ACS. We found an association between MNCD and medication nonadherence in the usual care group but not in the intervention group. These findings suggest efforts to screen for MNCD are needed during ACS hospitalization to identify patients at risk for nonadherence and who may benefit from an adherence intervention.
PMCID: PMC4467742  PMID: 26089651
medication adherence
13.  Innovative Interventions to Promote Behavioral Change in Overweight or Obese Individuals: A Review of the Literature 
Annals of medicine  2014;47(3):179-185.
The overweight and obesity trends have risen over the past few decades placing significant burdens on healthcare in terms of increased morbidity and cost. Behavioral change therapy is an effective treatment strategy and includes goal setting, self-monitoring, problem solving, and reinforcement tactics. Traditionally, behavior change therapy has been delivered using face-to-face counseling along with paper and pen recording of dietary intake and physical activity. The current advances in technology provide opportunities to deliver interventions using cellphones, internet and active video games. These new methods to deliver behavior change for the management and prevention of obesity are being developed in order to increase access, improve convenience, decrease cost and increase participant engagement. In this review, we present new approaches to promote behavior changes in the management of obesity. Currently available data shows promising results. However, future research is needed to address study limitations and implementation challenges of these innovative interventions.
PMCID: PMC4398644  PMID: 25011006
Obesity; weight loss; behavioral; web-based; mHealth; mobile apps; exergaming
14.  Selecting, adapting, and sustaining programs in health care systems 
Practitioners and researchers often design behavioral programs that are effective for a specific population or problem. Despite their success in a controlled setting, relatively few programs are scaled up and implemented in health care systems. Planning for scale-up is a critical, yet often overlooked, element in the process of program design. Equally as important is understanding how to select a program that has already been developed, and adapt and implement the program to meet specific organizational goals. This adaptation and implementation requires attention to organizational goals, available resources, and program cost. We assert that translational behavioral medicine necessitates expanding successful programs beyond a stand-alone research study. This paper describes key factors to consider when selecting, adapting, and sustaining programs for scale-up in large health care systems and applies the Knowledge to Action (KTA) Framework to a case study, illustrating knowledge creation and an action cycle of implementation and evaluation activities.
PMCID: PMC4404962  PMID: 25931825
program sustainability; diffusion of innovation; information dissemination; health services research; intervention studies
15.  Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY) 
Contemporary clinical trials  2014;37(2):333-341.
The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population.
To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition.
A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014.
If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss.
PMCID: PMC4139488  PMID: 24462568
Obesity; young adult; weight loss; mobile health; technology; behavioral intervention
16.  Patient–provider communication, self-reported medication adherence, and race in a postmyocardial infarction population 
Our objectives were to: 1) describe patient-reported communication with their provider and explore differences in perceptions of racially diverse adherent versus nonadherent patients; and 2) examine whether the association between unanswered questions and patient-reported medication nonadherence varied as a function of patients’ race.
We conducted a cross-sectional analysis of baseline in-person survey data from a trial designed to improve postmyocardial infarction management of cardiovascular disease risk factors.
Overall, 298 patients (74%) reported never leaving their doctor’s office with unanswered questions. Among those who were adherent and nonadherent with their medications, 183 (79%) and 115 (67%) patients, respectively, never left their doctor’s office with unanswered questions. In multivariable logistic regression, although the simple effects of the interaction term were different for patients of nonminority race (odds ratio [OR]: 2.16; 95% confidence interval [CI]: 1.19–3.92) and those of minority race (OR: 1.19; 95% CI: 0.54–2.66), the overall interaction effect was not statistically significant (P=0.24).
The quality of patient–provider communication is critical for cardiovascular disease medication adherence. In this study, however, having unanswered questions did not impact medication adherence differently as a function of patients’ race. Nevertheless, there were racial differences in medication adherence that may need to be addressed to ensure optimal adherence and health outcomes. Effort should be made to provide training opportunities for both patients and their providers to ensure strong communication skills and to address potential differences in medication adherence in patients of diverse backgrounds.
PMCID: PMC4344178  PMID: 25737633
acute myocardial infarction; hypertension; health policy and outcome research; communication
17.  Clinic variation in recruitment metrics, patient characteristics and treatment use in a randomized clinical trial of osteoarthritis management 
The Patient and PRovider Interventions for Managing Osteoarthritis (OA) in Primary Care (PRIMO) study is one of the first health services trials targeting OA in a multi-site, primary care network. This multi-site approach is important for assessing generalizability of the interventions. These analyses describe heterogeneity in clinic and patient characteristics, as well as recruitment metrics, across PRIMO study clinics.
Baseline data were obtained from the PRIMO study, which enrolled n = 537 patients from ten Duke Primary Care practices. The following items were examined across clinics with descriptive statistics: (1) Practice Characteristics, including primary care specialty, numbers and specialties of providers, numbers of patients age 55+, urban/rural location and county poverty level; (2) Recruitment Metrics, including rates of eligibility, refusal and randomization; (3) Participants’ Characteristics, including demographic and clinical data (general and OA-related); and (4) Participants’ Self-Reported OA Treatment Use, including pharmacological and non-pharmacological therapies. Intraclass correlation coefficients (ICCs) were computed for participant characteristics and OA treatment use to describe between-clinic variation.
Study clinics varied considerably across all measures, with notable differences in numbers of patients age 55+ (1,507-5,400), urban/rural location (ranging from “rural” to “small city”), and proportion of county households below poverty level (12%-26%). Among all medical records reviewed, 19% of patients were initially eligible (10%-31% across clinics), and among these, 17% were randomized into the study (13%-21% across clinics). There was considerable between-clinic variation, as measured by the ICC (>0.01), for the following patient characteristics and OA treatment use variables: age (means: 60.4-66.1 years), gender (66%-88% female), race (16%-61% non-white), low income status (5%-27%), presence of hip OA (26%-68%), presence both knee and hip OA (23%-61%), physical therapy for knee OA (24%-61%) and hip OA (0%-71%), and use of knee brace with metal supports (0%-18%).
Although PRIMO study sites were part of one primary care practice network in one health care system, clinic and patient characteristics varied considerably, as did OA treatment use. This heterogeneity illustrates the importance of including multiple, diverse sites in trials for knee and hip OA, to enhance the generalizability and evaluate potential for real-world implementation.
Trial registration
Clinical Trial Registration Number: NCT01435109
PMCID: PMC4295303  PMID: 25481809
Osteoarthritis; Health services; Multicenter study
18.  Mobile Health Messages Help Sustain Recent Weight Loss 
The American journal of medicine  2013;126(11):10.1016/j.amjmed.2013.07.001.
Using regulatory focus theory, an intervention of daily weight loss-sustaining messages was developed and tested for acceptability, feasibility, and efficacy on helping people sustain weight loss.
Participants (n = 120) were randomized to a promotion, prevention, or an attention-control text message group after completion of a weight loss program. Participants completed baseline assessments, and reported their weight at 1 and 3 months postbaseline.
Participants found the message content and intervention acceptable and valuable. A minimum of one message per day delivered at approximately 8:00 am was deemed the optimal delivery time and frequency. The sustained weight loss rate at month 3 for the control, promotion, and prevention groups was 90%, 95%, and 100%, respectively. Medium-to-large effects were observed for the promotion and prevention groups at month 1 and for prevention at month 3 relative to controls. The mean weight loss for promotion and prevention was 15 pounds, compared with 10 in the controls at month 3.
A clinically significant decrease in mean weight, higher rate of sustained weight loss, and medium-to-large effects on sustained weight loss occurred in the promotion and prevention interventions. Tools such as this text message-based intervention that are constructed and guided by evidence-based content and theoretical constructs show promise in helping people sustain healthy behaviors that can lead to improved health outcomes.
PMCID: PMC3820279  PMID: 24050486
Behavior change; Informatics; mHealth; Mobile health; Obesity; SMS; Text messaging; Weight loss
19.  Enlisting New Teachers in Clinical Environments (ENTICE); novel ways to engage clinicians 
To explore the barriers and incentives that affect primary care providers who precept students in outpatient clinics in the US.
In 2013, leadership of our large primary care group sent a 20-question survey via e-mail to all of the 180 providers within the network. The survey assessed provider demographics, precepting history, learner preferences, and other issues that might affect future decisions about teaching.
The response rate was 50% (90 providers). The top reasons for precepting in the past were enjoyment for teaching and personal interaction with learners. The most commonly cited reason for not precepting previously was a perceived lack of time followed by increased productivity demands. When questioned about the future, 65% (59 respondents) indicated that they were likely to precept within the next 6 months. A desired reduction in productivity expectations was the most commonly cited motivator, followed by anticipated monetary compensation and adjusted appointment times. A top barrier to future precepting was a belief that teaching decreases productivity and requires large amounts of time.
This survey represents an opportunity to study a change in focus for a cohort of busy clinicians who were mostly new to teaching but not new to clinical practice. The survey provides further insight into clinician educators’ perceptions regarding the education of a variety of different learners. The results align with data from previous studies in that time pressures and productivity demands transcend specific programs and learner backgrounds. This information is critical for future clerkship directors and hospital administrators in order to understand how to increase support for potential preceptors in medical education.
PMCID: PMC4199849  PMID: 25337001
clinical teaching; medical education; preceptors; primary care
20.  Tailored case management for diabetes and hypertension (TEACH-DM) in a community population: Study design and baseline sample characteristics 
Contemporary clinical trials  2013;36(1):10.1016/j.cct.2013.07.010.
Despite recognition of the benefits associated with well-controlled diabetes and hypertension, control remains suboptimal. Effective interventions for these conditions have been studied within academic settings, but interventions targeting both conditions have rarely been tested in community settings. We describe the design and baseline results of a trial evaluating a behavioral intervention among community patients with poorly-controlled diabetes and comorbid hypertension.
Tailored Case Management for Diabetes and Hypertension (TEACH-DM) is a 24-month randomized, controlled trial evaluating a telephone-delivered behavioral intervention for diabetes and hypertension versus attention control. The study recruited from nine community practices. The nurse-administered intervention targets 3 areas: 1) cultivation of healthful behaviors for diabetes and hypertension control; 2) provision of fundamentals to support attainment of healthful behaviors; and 3) identification and correction of patient-specific barriers to adopting healthful behaviors. Hemoglobin A1c and blood pressure measured at 6, 12, and 24 months are co-primary outcomes. Secondary outcomes include self-efficacy, self-reported medication adherence, exercise, and cost-effectiveness.
Of 377 randomized patients, 193 were allocated to the intervention and 184 to attention control. The cohort is balanced in terms of gender, race, education level, and income. The cohort’s mean baseline hemoglobin A1c and blood pressure are above goal, and mean baseline body mass index falls in the obese range. Baseline self-reported non-adherence is high for diabetes and hypertension medications. Trial results are pending.
If effective, the TEACH-DM intervention’s telephone-based delivery strategy and nurse administration make it well-suited for rapid implementation and broad dissemination in community settings.
PMCID: PMC3828629  PMID: 23916915
Diabetes; Hypertension; Behavioral Intervention; Telemedicine; Self-management; Case Management
21.  The Role of Home Blood Pressure Telemonitoring in Managing Hypertensive Populations 
Current hypertension reports  2013;15(4):346-355.
Hypertension is a common chronic disease affecting nearly one-third of the United States population. Many interventions have been designed to help patients manage their hypertension. With the evolving climate of healthcare, rapidly developing technology, and emphasis on delivering patient-centered care, home-based blood pressure telemonitoring is a promising tool to help patients achieve optimal blood pressure (BP) control. Home-based blood pressure telemonitoring is associated with reductions in blood pressure values and increased patient satisfaction. However, additional research is needed to understand cost-effectiveness and long-term clinical outcomes of home-based BP monitoring. We review key interventional trials involving home based BP monitoring, with special emphasis placed on studies involving additionally behavioral modification and/or medication management. Furthermore, we discuss the role of home-based blood pressure telemonitoring within the context of the patient-centered medical home and the evolving role of technology.
PMCID: PMC3743229  PMID: 23625207
Hypertension; Blood pressure monitoring; Telephone; Home-based telemonitoring; Technology; Intervention; Behavioral modification; Medication management; Healthcare costs; Patient-centric care
22.  Medication adherence: process for implementation 
Improving medication adherence is a critically important, but often enigmatic objective of patients, providers, and the overall health care system. Increasing medication adherence has the potential to reduce health care costs while improving care quality, patient satisfaction and health outcomes. While there are a number of papers that describe the benefits of medication adherence in terms of cost, safety, outcomes, or quality of life, there are limited reviews that consider how best to seamlessly integrate tools and processes directed at improving medication adherence. We will address processes for implementing medication adherence interventions with the goal of better informing providers and health care systems regarding the safe and effective use of medications.
PMCID: PMC4122551  PMID: 25114513
medication adherence; pharmacy; policy; health care systems; self-management; patient education
23.  Recruiting young adults into a weight loss trial: Report of protocol development and recruitment results 
Obesity has spread to all segments of the U.S. population. Young adults, aged 18-35, are rarely represented in clinical weight loss trials. We conducted a qualitative study to identify factors that may facilitate recruitment of young adults into a weight loss intervention trial. Participants were 33 adults aged 18-35 yrs with BMI > 25 kg/m2. Six group discussions were conducted using the nominal group technique. Health, social image, and “self”factors such as emotions, self-esteem, and confidence were reported as reasons to pursue weight loss. Physical activity, dietary intake, social support, medical intervention, and taking control (e.g. being motivated) were perceived as the best weight loss strategies. Incentives, positive outcomes, education, convenience, and social support were endorsed as reasons young adults would consider participating in a weight loss study. Incentives, advertisement, emphasizing benefits, and convenience were endorsed as ways to recruit young adults. These results informed the Cellphone Intervention for You (CITY) marketing and advertising, including message framing and advertising avenues. Implications for recruitment methods are discussed.
PMCID: PMC3765064  PMID: 23591327
Obesity; young; adults; recruitment; methods; trial
24.  PTSD is negatively associated with physical performance and physical function in older overweight military veterans 
This study examines the effect of posttraumatic stress disorder (PTSD) on function and physical performance in older overweight military Veterans with comorbid conditions. This is a secondary data analysis of older Veterans (mean age = 62.9 yr) participating in a physical activity counseling trial. Study participants with PTSD (n = 67) and without PTSD (n = 235) were identified. Self-reported physical function (36-item Short Form Health Survey) and directly measured physical performance (mobility, aerobic endurance, strength) were assessed. Multivariate analyses of variance controlling for demographic factors and psychiatric disorders demonstrated significant physical impairment among those with PTSD. PTSD was negatively associated with self-reported physical function, functioning in daily activities, and general health (p < 0.01). Those with PTSD also performed significantly worse on tests of lower-limb function (p < 0.05). Despite being significantly younger, Veterans with PTSD had comparable scores on gait speed, aerobic endurance, grip strength, and bodily pain compared with Veterans without PTSD. This study provides preliminary data for the negative association between PTSD and physical function in older military Veterans. These data highlight the importance of ongoing monitoring of physical performance among returning Veterans with PTSD and intervening in older overweight Veterans with PTSD, whose physical performance scores are indicative of accelerated risk of premature functional aging.
PMCID: PMC4062919  PMID: 24933726
aging; comorbid; function; geriatrics; health; mobility; physical performance; psychological; PTSD; SF-36
25.  Improving Blood Pressure Control through a Clinical Pharmacist Outreach Program in Diabetes Patients in Two-High Performing Health Systems: The Adherence and Intensification of Medications (AIM) Cluster Randomized Controlled Pragmatic Trial 
Circulation  2012;125(23):2863-2872.
Even in high performing health systems, some hypertensive patients with diabetes have persistent poor blood pressure (BP) control. Medication nonadherence and lack of medication intensification contribute to this poor control. We examined whether the Adherence and Intensification of Medications (AIM) intervention, a targeted pharmacist-led intervention that combined state-of-the-art elements found in efficacy studies to lower BP, could improve BP among diabetes patients with persistent hypertension and poor refill adherence or insufficient medication intensification.
Methods and Results
We conducted a prospective, multi-site cluster randomized pragmatic trial with randomization of 16 primary care teams at five medical centers (3 Veterans Affairs [VA] and 2 Kaiser Permanente [KP]) to the AIM intervention or usual care. The primary outcome was the relative change in systolic blood pressure (SBP) measurements, comparing 1,797 eligible intervention team patients to 2,303 eligible control team patients, between the 6-months preceding and the 6-months following the 14-month intervention period. We examined shorter-term changes in SBP as a secondary outcome. In our primary analysis, the intervention group SBP change from 6-months prior to 6-months after the 14-month intervention period was approximately the same as the control group, declining approximately 9 mm Hg in both groups. SBP lowering occurred more rapidly among eligible intervention team patients, with mean SBPs 2.4 mm Hg lower (95% CI: −3.4 to −1.5; p<.001) immediately after the intervention than those achieved by eligible control patients.
The AIM program more rapidly lowered SBPs among eligible intervention patients, but there was no significant difference in blood pressure between intervention and control patients 6 months following the intervention period. These findings show the importance of rigorously evaluating in different real-life clinical settings programs found in efficacy trials to be effective before urging their widespread adoption in all settings.
PMCID: PMC3999872  PMID: 22570370
blood pressure; diabetes mellitus; trials; adherence; clinical inertia

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