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.
medication adherence; diabetes mellitus; chronic disease; dissemination research; implementation research; review
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.
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.
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.
mHealth; short message service; SMS; text messaging; weight loss maintenance
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.
Hypertension; Lifestyle; Clinical Trial; Self-management; Adherence; Disparities
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.
Hypertension; Lifestyle; Clinical Trial; Self-management; Adherence
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.
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.
Behavioral Intervention; hypertension; adherence; tailored; health communication
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.
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.
Behavior change; Informatics; mHealth; Mobile health; Obesity; SMS; Text messaging; Weight loss
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.
clinical teaching; medical education; preceptors; primary care
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.
Diabetes; Hypertension; Behavioral Intervention; Telemedicine; Self-management; Case Management
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.
Hypertension; Blood pressure monitoring; Telephone; Home-based telemonitoring; Technology; Intervention; Behavioral modification; Medication management; Healthcare costs; Patient-centric care
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.
medication adherence; pharmacy; policy; health care systems; self-management; patient education
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.
Obesity; young; adults; recruitment; methods; trial
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.
aging; comorbid; function; geriatrics; health; mobility; physical performance; psychological; PTSD; SF-36
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.
blood pressure; diabetes mellitus; trials; adherence; clinical inertia
Patients with co-occurrence of hypertension, hyperlipidemia, and diabetes have an increased risk of cardiovascular disease (CVD) events. Comprehensive programs addressing both tailored patient self-management and pharmacotherapy are needed to address barriers to optimal cardiovascular risk reduction. We are examining a Clinical Pharmacy Specialist (CPS), telephone administered intervention, relying on home monitoring, with a goal of providing tailored medication and behavioral intervention to Veterans with CVD risk.
Randomized controlled trial including patients with hypertension (blood pressure (BP) > 150/100 mmHg) or elevated low density liporotein (LDL) (> 130 mg/dl). Longitudinal changes in CVD risk profile and improvement in health behaviors over time will be examined.
Given the national prevalence of CVD and the dismal rates of risk factor control; intensive, but easily disseminated interventions are required to treat this epidemic. This study will be an important step in testing the effectiveness of a behavioral and medication intervention to improve CVD control among Veterans.
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.
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.
Cross-sectional analysis of randomized trial data.
Six hundred and thirty-six primary care patients with hypertension.
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).
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.
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.
hypertension; self-management; medication adherence; diet; exercise
African Americans are significantly more likely than whites to have uncontrolled hypertension, contributing to significant disparities in cardiovascular disease and events.
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.
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.
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.
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).
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.
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.
hypertension; telemedicine; self-management; adherence; veterans
Translational medicine is attracting much attention worldwide and many translational research organizations (TROs) have been established. In China, translational medicine has developed rapidly, but faces many challenges. This study was aimed at exploring these challenges faced by emerging TROs in China.
A qualitative, multiple case study approach was used to assess the challenges faced by TROs in China. Data were collected between May and August 2012.
Eight cases were identified. Overall, four themes that characterized TROs in China emerged from analyses: 1. objectives, organizer, and funding resources, 2. participating partners and research teams, 3. management, and 4. achievements. All TROs had objectives related to translating basic discovery to clinic treatment and cultivating translational researchers. In terms of organizer and funding resources, 7 out of 8 TROs were launched only by universities and/or hospitals, and funded mostly through research grants. As for participating partners and multidisciplinary research teams, all but one of the TROs only involved biomedical research institutions who were interested in translational research, and characterized as clinical research centers; 7 out of 8 TROs involved only researchers from biomedicine and clinical disciplines and none involved disciplines related to education, ethnicity, and sociology, or engaged the community. Current management of the TROs were generally nested within the traditional research management paradigms, and failed to adapt to the tenets of translational research. Half of the TROs were at developmental stages defined as infrastructure construction and recruitment of translational researchers.
TROs in China face the challenge of attracting sustainable funding sources, widening multidisciplinary cooperation, cultivating multi-disciplinary translational researchers and adapting current research management to translational research. Greater emphasis should be placed on increasing multidisciplinary cooperation, and innovating in education programs to cultivate of translational researchers. Efforts should be made to reform research management in TROs, and establish sustainable funding resources.
Translational medicine; Translational research organization; Translational medical center; Case study
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).
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.
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).
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.
Self-management; telemedicine; chronic disease; randomized controlled trial
Hypertension is prevalent and often sub-optimally controlled; however, interventions to improve blood pressure control have had limited success.
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?
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.
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.
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.
Implementation; Hypertension; Blood pressure control; Organization
To determine whether a home-based multi-component physical activity counseling (PAC) intervention is effective in reducing glycemic measures in older prediabetic outpatients.
Design, Setting, and Participants
Controlled clinical trial of 302 overweight (body mass index 25–45 kg/m2), older (ages 60–89) outpatients with impaired glucose tolerance (fasting blood glucose 100–125 mg/dL, HbA1c <7%), randomly assigned to a PAC intervention group (n=180), compared to a Usual Care (UC) control group (n=122) and recruited through primary care clinics of the Durham VA Medical Center between September 29, 2008 and March 25, 2010.
A 12 month, home-based multi-component PAC program including one in-person baseline counseling session, regular telephone counseling, physician endorsement in clinic with monthly automated encouragement, and tailored mailed materials. All study participants, including UC, received a consult to a VA weight management program.
The primary outcome was HOMA-IR, calculated from fasting insulin and glucose levels at baseline, 3 and 12 months. Hemoglobin A1C was the secondary indicator of glycemic control. Other secondary outcomes included anthropometric measures, and self-reported physical activity, health-related quality of life, and physical function.
There were no significant differences between the PAC or Usual Care groups over time for any of the glycemic indicators. Both groups had small declines over time of approximately 6% in fasting blood glucose, p< 0.001, while other glycemic indicators remained stable. The declines in glucose were not sufficient to affect the change in HOMA-IR scores due to fluctuations in insulin over time. Endurance physical activity increased significantly in PAC group, P<0.001 compared to UC.
Home-based telephone counseling increased physical activity levels but was insufficient for improving glycemic indicators among older prediabetic outpatients.
Diabetes; Aging; Randomized Clinical Trial; Counseling; Physical Activity; Veterans; Obesity