Hypertension is one of the most important independent risk factors for chronic kidney disease (CKD) progression. The results of the recently completed ESCAPE trial highlight the importance of blood pressure control as a means to slow CKD progression, making antihypertensive nonadherence a prime target for behavioral intervention. Surprisingly, there is no research on adherence to antihypertensive medication among children either with or without CKD. Physician-adolescent communication is key for facilitating lifelong self-management skills and changes as the adolescent matures and assumes more responsibility for his/her care. However, there is a striking gap in our knowledge of physician-adolescent communication in general and specifically how it impacts regimen adherence and health outcomes. Evaluating how known risk and resilience factors and physician-adolescent communication interact through a comprehensive, longitudinal predictive model of adolescent nonadherence in CKD is an essential prelude to the development of effective, targeted adherence interventions for high-risk patients. The purpose of this study is to test 1) the impact of antihypertensive medication adherence in adolescents on blood pressure control and subsequent progression of CKD; and 2) the influence of physician-adolescent communication on medication adherence over time. This is a prospective study of 150 adolescents age 11-19 years old with CKD (Stages 1-5) who are prescribed an antihypertensive medication. Objective measurement approaches will be used to assess antihypertensive medication adherence (electronic monitoring and pharmacy refills), health outcomes (e.g., ambulatory blood pressure monitoring and biomarkers of CKD progression), and physician-adolescent communication (RIAS coding of nephrology clinic visits). Additionally, the moderating effect of known nonadherence risk and resilience factors on the association between physician-adolescent communication and adherence will be assessed. All variables will be measured at baseline, 12- and 24- months; additionally, adherence and health outcomes will be measured at 6-, 18- and 30-months. Longitudinal analyses will be used to model the change in outcomes with time-varying covariates. This will allow us to evaluate how changes in physician-adolescent communication impact adherence and then subsequent blood pressure control and CKD progression. Further, the lessons learned in this study of adolescents with CKD will add to our understanding of the impact of physician-adolescent communication across chronic illnesses.
Despite advances in asthma therapies and the wide-spread dissemination of asthma clinical guidelines, low-income, minority children have disproportionately high morbidity and mortality from asthma. The National Center for Children in Poverty has strongly argued that effective interventions to improve asthma health disparities and reduce harm must begin in early childhood. Previous efficacy studies have suggested that asthma education programs can be effective in improving overall management of asthma for preschool children. However, for these promising asthma intervention strategies to have sustainable public health impact for low-income, minority children they must be integrated within those medical, educational and social structures that serve these young high risk children, such as community clinics, schools and day care programs. Because one of the core missions of federally- funded Head Start programs is to provide preventive health services and screening to their low-income preschool students, Head Start represents an ideal community setting for disseminating early asthma education. We propose to draw on our established health and research partnership with Head Start programs in Baltimore City to test the effectiveness of this home-based asthma education intervention with demonstrated efficacy, when delivered in the context of a Head Start-wide asthma education program. We further propose to partner with Head Start to support and evaluate adoption, maintenance and dissemination of new knowledge gained from this project. Specifically we hypothesize that participants receiving the ABC intervention combined with a HS-level asthma education will have more symptom free days at the 6-, 9-, and 12-month evaluation when compared with participants in the HS- level asthma education alone. We plan to enroll of 406 children age 2-6 years old enrolled in Head Start with symptomatic asthma. Secondary outcome measures include other measures of asthma morbidity (i.e., hospitalizations, ED visits, oral steroid bursts, school absences, and caregiver quality of life). We will also evaluate the mediating effects of outcomes expectancies, self-efficacy, asthma knowledge, motivation, and asthma management practices, as well as moderator effects, such as health literacy, caregiver depression, neighborhood cohesion, family management of asthma, and Head Start adoption and dissemination of an asthma education curriculum.
In 1999, the Institute of Medicine released its report, "To Err is Human," which estimated that medical errors cause 44,000 to 98,000 deaths annually in the U.S. Healthcare associated infections (HAIs) play a major part in the complications associated with healthcare delivery, with over 2 million infections occurring annually. Much research in control of nosocomial infections and promotion of patient safety has focused on device-related infections. However, recent concerns about respiratory virus epidemics have focused attention on the problem of nosocomial spread of respiratory viruses. Preventing transmission of viral respiratory infections in the intensive care unit (ICU) is essential to promoting patient and provider safety during routine care of patients with such infections and during epidemics. Personal protective equipment (PPE) use decreases nosocomial transmission of epidemiologically important organisms and both organizational and individual healthcare worker (HCW) factors are thought to influence worker self-protective behaviors. However, research examining behavioral strategies to limit HAIs has found strikingly low HCW adherence, and little research has evaluated how both organizational factors and individual HCW factors influence adherence with respiratory precautions to prevent nosocomial respiratory virus infections. Further, patient and family attitudes and behaviors may also play an important role in HCW adherence, but the influence of patient knowledge and attitudes on HCW adherence with PPE has not been investigated. Dr. Daugherty has developed this proposal as a collaborative effort among key experts to fill this critical knowledge gap. This proposal will also serve as a key stepping stone toward Dr. Daugherty's goal of becoming an independent clinical investigator and nationally recognized leader in infection control and patient safety, focused on individual and organizational barriers that mediate PPE adherence, HAI rates, and clinical outcomes. As she seeks to achieve her goal, Dr. Daugherty will draw on key intellectual resources by working with Dr. Cynthia Rand, a renowned behavioral psychologist, Dr. Trish Perl, an expert in hospital infection control, and Dr. Peter Pronovost, a recognized authority in patient safety, among others. Dr. Daugherty will engage in a multi-faceted career development program while completing the research outlined in this proposal, under the guidance of her primary mentor, Dr. Rand, Professor of Medicine, Psychiatry, and Public Health at Johns Hopkins. This program will include three main components: 1) one-on- one research mentoring, 2) didactic training in clinical investigation, and 3) career development mentoring, in addition to the successful implementation and conduct of the proposed clinical research plan. All of the members of Dr. Daugherty's mentoring team are fully committed to providing the resources and support that she needs to build on an already productive early career and continue her transition into the fully independent clinical investigator that she hopes to become. The proposal outlined here will provide an essential venue through which to make this expectation a reality. The overall aims of this proposal are to assess the relationship between ICU organizational factors, individual HCW factors, and PPE adherence. We will also develop a novel pilot intervention to improve PPE adherence, which incorporates strategies both to decrease organizational and individual HCW adherence barriers and to empower patients and families to encourage PPE use. Our long term goal is to develop effective, reproducible strategies to lower ICU HAI rates, improve patient safety, and inform HCW and hospital preparedness for response to novel respiratory pathogens, such as SARS or 2009 H1N1 influenza. In specific aim 1, we will assess the association between ICU organizational factors and individual HCW factors on self-reported PPE adherence and directly observed PPE use across a range of ICUs. In specific aim 2, we will evaluate patient and provider barriers to and facilitators of PPE adherence for the prevention of healthcare-associated respiratory virus infections using qualitative methods, and in specific aim 3, we will develop and evaluate the impact of a novel pilot PPE adherence intervention. HAIs are a critical patient safety issue and are associated with significant morbidity and mortality. Little research has examined the influence of individual and organizational barriers to PPE use for control of nosocomial respiratory virus infections. Understanding the factors that influence HCW use of PPE is essential to promoting patient and worker safety during routine care of patients with respiratory infections and also as a model for developing protocols to protect patients and workers during respiratory virus epidemics. Healthcare associated infections are an important patient safety issue and are associated with significant harm to patients. Little research has examined the influence of organizational and individual barriers to use of personal protective equipment (PPE), such as masks, gowns, and gloves for control of respiratory virus infections in hospitals. This study will improve understanding of the factors that influence how healthcare workers use PPE, which will not only serve to promote patient and worker safety during every day care of patients with respiratory infections but also provide a model for understanding how to protect patients and workers during respiratory virus epidemics, such as SARS or H1N1 influenza.
Clinicians often do not have sufficient information and communication tools to accurately assess their patients’ adherence. Patient nonadherence is a significant contributor to poor health outcomes and increased healthcare utilization. A central goal of this study is to test a potentially effective adherence intervention for adolescents and young adults seen in outpatient clinics. The intervention strategy is to implement a comprehensive adherence program (CAP) that includes assessment of knowledge of disease, skills in performing treatment-related behaviors, and problem-solving key barriers to adherence. The study design is a 2-arm randomized controlled trial with the CF care center as the unit of randomization. Centers will be stratified on relevant center characteristics (e.g., clinic size, case mix, such as transplant center and lung function) and whether they are a member of the CF Therapeutics Development Network. Care centers will be randomly assigned to receive the CAP intervention or no intervention in year 1 of the study. Centers that receive no intervention in year 1 of the study will receive the CAP intervention in the second year of the study. Providing the intervention to all care centers in Year 2 is a valuable part of the evaluation because (1) it allows for replication of the initial intervention results without recruiting a new sample, (2) permits evaluation of the sustainability of outcomes, (3) reduces care center demoralization about being assigned to no intervention in year 1 of the study, thereby reducing data attrition, and (4) increases the likelihood of seeing changes in health outcomes.
The function of the Administrative Core is to provide administrative support, organization, coordination and efficient management of this Program. Because this Program involves multiple projects, cores, laboratories and investigators, some centralized mechanism to facilitate its smooth operation is absolutely essential. The Administrative Core will be co-directed by Drs. Gregory B. Diette Patrick N. Breysse. Dr. Elizabeth Matsui will support the Program in the role of Pediatric Health Specialist. Dr. Diette also serves as Project Leader of Project 1, while Dr. Breysse leads the Environmental Assessment Core and Dr. Matsui leads Project 2. Together they will be responsible for evaluating the progress and overall administration of the entire Program and its individual projects. The major responsibility of the Administrative Core is to ensure that the combined research and support activities contained in this application marshal their collective efforts to produce a body of science that is greater than the sum of the individual components. The most important function of the Core is to facilitate project and core interaction, coordination, and integration within the mission and theme of the ASTHMA-DIET program. The ASTHMA-DIET key personnel are associated with the Johns Hopkins University Schools of Medicine and Bloomberg School of Public Health Departments of Medicine, Pediatrics, Environmental Health Sciences, Epidemiology, and Biostatistics. The Core will coordinate the inter-project and inter-departmental collaborative arrangements and develop new arrangements as deemed necessary for the scientific progress of the Program as a whole. The Administrative Core will also provide the Projects and Cores with a periodic review of all expenditures and liaise with University Accounting and Grants administrative offices regarding grant budgets. The administrative support provided by the Administrative Core will be responsible for organizing various weekly meetings and seminars as well as the meetings of the Internal and External Advisory Committees and the Community Advisory Board. The overall goals of the Administrative Core are to ensure completion of the proposed research, training and outreach activities, and facilitate interaction and information exchange within and outside the Program.
A disproportionate number of impoverished and minority children suffer from asthma. Many of these children who should receive preventive asthma medications are not receiving them. In our prior work, we found that providers frequently misclassify asthma severity, and this misclassification leads to inadequate prescription of preventive medications. Further, once preventive medications are prescribed, many children continue to have poor asthma control. Importantly, most clinicians do not systematically screen for asthma symptoms at office visits. The goal of this project is to evaluate whether a multifaceted prompting intervention, administered in urban primary care offices, reduces morbidity among urban children with asthma. This study builds on our experience with a pilot randomized trial in 2 urban clinics, in which we found that prompting clinicians about asthma severity and care guidelines at the time of an office visit resulted in improved preventive care delivery. We propose a full scale cluster randomized trial with 510 children ages 2-12 years in 12 different practices from our Clinical and Translational Science Institute's practice-based research network. Practices will be matched into 6 pairs and then randomly assigned to either the Multifaceted Prompting Intervention (MPI) or usual care. For enrolled intervention subjects, the MPI will include a prompt for the health care provider and a simplified prompt for the caregiver, designed for use during the office visit and prepared in the waiting room on a Tablet Personal Computer by a trained research associate. These prompts are designed to stimulate communication between the caregiver and provider and will include information regarding the patient's asthma severity or level of control as well as individualized guideline-based recommendations for care. Intervention practices also will receive practice- level supports, including interactive seminars, access to educational programs and resource guides, and bi- annual feedback on their performance for the primary outcomes. We will assess the effectiveness of the intervention in reducing asthma morbidity (including symptom-free days as the primary outcome, as well as additional clinical and functional outcomes) and will assess the extent and nature of preventive care delivery (defined by the occurrence of guideline-based corrective actions at the index visit) for children in MPI and usual care practices. At study completion, the effectiveness of office-based prompting will be better defined as a sustainable means to reduce morbidity among high-risk asthmatic children. This type of intervention is widely applicable for asthma care in practices nationwide, and for management of other chronic diseases.This project may have a profound impact on public health because it presents a practical system change to promote adherence to effective asthma care guidelines. Should it prove successful in reducing symptoms and improving the health of urban children with asthma, it has the potential to serve as a model for improved asthma care in urban communities.
Patient adherence with chronic therapy is the necessary link between effective, evidence-based treatments and improved patient outcomes. However, the frequent failure of patients to adhere to long-term medication regimens remains the single greatest challenge for chronic-disease management. Many studies have linked medication non-adherence to treatment failure; unnecessary and dangerous intensification of therapy; and excess health care costs, hospitalizations, and deaths. Although some interventions have been shown to significantly enhance medication adherence, the strategies used are often complex, labor-intensive, and of variable effectiveness. Simple interventions designed to make small-but-significant improvements in population-based adherence may thus offer a novel, cost-effective, and easily-disseminated alternative to current approaches for enhancing adherence. The proposed PATIENT (Promoting Adherence To Improve the Effectiveness of CVD Therapies) study is a pragmatic RCT to compare the effectiveness of two health information technology-based, low-intensity, low-cost population-based interventions for increasing adherence to selected chronic CVD medications with known efficacy for preventing cardiovascular morbidity and mortality. An Interactive Voice Recognition (IVR) intervention will use automated speech-recognition phone calls, integrated with an electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions in a timely manner. An Enhanced IVR (IVR+) intervention will augment the IVR intervention with: EMR-based feedback to primary care providers, mailed educational material to all patients, and personalized and tailored mailed reminders to patients who fail to fill prescriptions. The target population includes adults aged 40-80 with diabetes or prevalent atherosclerotic cardiovascular disease, for whom the use of an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker (ACEI/ARB), a statin, and aspirin are all recommended therapy for secondary prevention. The primary aims of this study are to determine if, for current users of statins and ACEI/ARBs, the IVR and IVR+ interventions lead to greater adherence compared to usual care and, if so, to compare the relative effectiveness of the IVR vs. IVR+ interventions. The Practical Robust Implementation and Sustainability Model (PRISM) will serve as the guiding framework for evaluating these interventions which, if successful, could have significant Public Health applications as flexible and generalizable components of managed care and pharmacy benefits programs. The primary goal of the PATIENT study is to increase both initial use and ongoing adherence to three classes of medications used to treat diabetes or cardiovascular disease. The PATIENT interventions use interactive voice recognition, with and without supplemental personalized mailings to patients and messages to providers, to deliver medication refill reminders, educate members about their conditions, and connect members with pharmacists and their doctors. If PATIENT's methods are successful, this research should lead to reduced hospitalizations and deaths, and to increased quality of life for people with diabetes or cardiovascular disease. This research should also be broadly applicable to other diseases and treatments.
Environmental tobacco smoke (ETS) exposure has been identified as a significant threat to children's respiratory health and has been clearly linked to increased risk of asthma, bronchitis, wheeze and otitis media. ETS exposure is higher in households at or below poverty level and this same population has also been found to be at significantly increased risk for asthma morbidity, as well as other respiratory infections. Studies have reported that between 30-70% of low-income children with asthma enrolled in Head Start programs report a smoker in the home. Because of the increased health risks experienced by their students, Head Start programs have a mandate to help high-risk families improve the health of their preschool children. Further, in 2007 the Environmental Protection Agency (EPA) and the Office of Head Start announced a new initiative to promote smoke-free homes for Head Start Children. For these reasons, Head Start programs offer a timely and important venue for reaching high-risk, low-income pre-school children and intervening to reduce these children's exposure to ETS. We therefore propose to draw on our established health and research partnership with Head Start programs in Baltimore City to test the effectiveness of an ETS reduction intervention with demonstrated efficacy, when delivered in the context of an overall EPA-based Head Start ETS reduction education program. Specifically, we will conduct a randomized clinical trial of a home-delivered, motivational interviewing-based ETS reduction intervention combined with a HS-level EPA/ETS education program in reducing children's ETS exposure, compared to a HS-level EPA/ETS education program alone. We will enroll 350 HS students aged 2-5 years with a caregiver-reported smoker in the home from all 17 Baltimore City HS programs. The primary study outcome measure will be household ETS levels, as measured by home air nicotine levels at six month follow-up. Secondary outcomes include caregiver-reported home and car smoking bans, child's salivary cotinine levels, children's respiratory symptoms, caregiver smoking cessation, school absences, and health care utilization measures. In addition, at the HS level we will evaluate the degree of implementation of the HS-level EPA/ETS education program, change in the proportion of families who report smoking in home for all HS students, and change in HS staff knowledge, attitudes and practices related to ETS exposure and reduction. If successful, this demonstration and education project could have significant public health implications for school and community-based strategies to improve children's long-term respiratory health. Environmental tobacco smoke (ETS) exposure has been identified as a significant threat to children's respiratory health and has been clearly linked to increased risk of asthma, bronchitis, wheeze and otitis media. Low-income and minority children are more likely to be exposed to second-hand smoke and to suffer respiratory illnesses, such as asthma. The current study will test a behavioral intervention to reduce ETS exposure among low-income preschool children enrolled in Head Start and if successful, this project could have significant public health implications for school and community-based strategies to improve children's long-term respiratory health.
Puerto Rican children have the highest rates of asthma morbidity of any ethnic group and are more likely to die because of their asthma as compared with other children. In Puerto Rico gross disparities exist in the quality of asthma care received by poor asthmatic children compared to higher income children. As described by the Institute of Medicine, such health disparities likely result from multi-level barriers to appropriate care. Based on a conceptual model of health disparities developed by this investigative group, we propose to evaluate the effectiveness of the Pediatric Asthma Community- Based Program (PACBP), a novel, multi-level intervention designed to eliminate asthma disparities in treatment by intervening at the health policy, provider, and family level. Aim 1 will use a non-experimental pre-post comparison design to assess a historic change in medication policy (i.e., the state assuming responsibility for the cost of medication) in a pilot health region in Puerto Rico. We will use automated claims and pharmacy data one year prior to and one-and-a-half years post policy change to compare pharmacy dispensing of anti-inflammatory controller medications (ACMs), oral steroids and beta agonists (primary outcome), as well as rates of Emergency Department (ED) visits and hospital admissions (secondary outcomes) in children with persistent asthma. To examine the impact of change at the provider level, Aim 2 will use a randomized control trial (RCT) design nested within the pilot region to study the impact of a culturally-adapted version of the Easy Breather Program (EBP), a provider-focused educational intervention designed to increase guideline-based care. Using claims data, we will compare rates of ACM dispensing (primary outcome), as well as beta-agonist and oral steroid dispensing. We will also compare chart audits of guideline-based care, and provider surveys of asthma management practices. To examine the impact of change at the family level, Aim 3 will use a RCT to test a family-based asthma management intervention (FAMI), nested in clinics of the Pilot region that received the EBP. This intervention is designed to increase family knowledge, skills and self-efficacy for asthma management. The primary outcome variable for the FAMI study is symptom free days. Secondary outcomes include ACM use and quality of life, as well ED visits and hospital admissions, beta agonist and oral steroids use, and functional disability. Finally, Aim 4 will evaluate the cost effectiveness of each level of the Pediatric Asthma Community-Based Program (PACBP). The proposed study will be the first to test a culturally-adapted, community-based intervention that addresses the elimination of health disparities by intervening at the provider, family and health policy level.
We propose a practical, randomized clinical trial to test the impact of a health communication intervention designed to improve inhaled asthma controller medication adherence in 3-12 year old children with asthma in Kaiser Permanente of Colorado (KPCO), the largest health maintenance organization in the state. The Telecommunication Enhanced Adherence Management (TEAM) intervention is designed to increase communication with and support of pediatric patients and their parents by using automated telecommunication technology to: 1) allow parents more easy access to caregivers, 2) provide an immediate opportunity to request refills and inquire about their child's symptoms, and 3) provide educational and motivating messages about the importance of the child's daily asthma medication. This health- communication intervention will be delivered through state-of-the-art speech recognition (SR) technology. Advances in SR technology have made computer-generated conversation easier and more acceptable to respondents, and allow for correct interpretation of parents' spoken responses that in turn can lead to a range of appropriate SR responses. The investigative team has extensive experience using automated telecommunication technology to promote health-enhancing behavior change. The Benefit-Risk Model and Social Marketing Theory continue to guide both the objective and process of the intervention. Prospect Theory complements these and will guide development of the motivating messages to be contained in the SR intervention. This will be a Practical Clinical Trial aimed at the entire population of KPCO parents of a child receiving an inhaled corticosteroid (ICS) for asthma. It is expected that the 12-month TEAM intervention will increase ICS refill persistence and medication adherence (primary outcome) sufficient to produce significant improvement, relative to the usual-care control group, in asthma-related health outcomes as reflected in frequency of urgent care visits, prednisone use, beta2agonist use, and parent-reported symptom control and quality of life (secondary outcomes). A sub-study will randomly sample 200 families, both before and after participation in the TEAM intervention, to gather information about variables that may moderate the effectiveness of the intervention including race, socioeconomic status, illness severity, family structure, and benefit-risk perception. The presumption that prescription refilling is an accurate measure of adherence will be tested in a second sub-study that will use electronic devices to track ICS adherence. This system- based intervention has been designed using the RE-AIM framework so that it should have high reach and be consistently implemented at modest cost, and if effective, it can be maintained within KPCO as well as readily exported to other clinical healthcare settings.
Treatment advances during the past two decades in the treatment of CF have resulted in improved survival and center around preventing the loss of lung function. In 2005 the median predicted survival for people on the Cystic Fibrosis Foundation Patient Registry was 36.8 years and over 40% of all living people with CF are adults. The therapeutic treatment regimen, however, has evolved into a complex home treatment program that requires a substantial amount of patient commitment to perform and adherence to many components of CF treatment is often poor. While the regimen is efficacious in improving lung health and mortality, there is limited data on the level of adherence needed to maximize health outcomes. Similarly, there are few published adherence-promoting studies in CF and these have been limited to pediatric populations. Older adolescent and adult-focused interventions are therefore needed that target the unique challenges managing CF as one gets older and more independent. Motivational Interviewing (MI) is a promising interventional approach that uses a client-centered, non- directive approach for enhancing motivation to change health behaviors and has promising data as an effective adherence promoting intervention for adolescents and adults with other chronic illnesses. MI does not assume that health will be the most important factor motivating the client, but rather acknowledges and incorporates other motivators identified by the client. We propose to evaluate the efficacy of an Motivational Interviewing-focused intervention (MI) in improving adherence and reducing CF-related morbidity among older adolescents and adults compare to a standard CF education intervention (CFE; attention control group). Specifically, we hypothesize that MI will result in improved disease self-management and reduced CF morbidity compared to the CFE control group in a sample of 153 individuals with CF age 16+ years who are clinically stable at baseline. Our primary hypothesis is that participants receiving MI will have a higher composite medication adherence score at 12-months post-randomization (measured by pharmacy refill records) compared to the CFE group. Secondary outcomes include self-reported adherence, lung function (CF-specific percentiles of FEV1), pulmonary exacerbations, body mass index, and quality of life. This study will allow us to evaluate the longitudinal association between adherence and health outcomes. We will also evaluate the mediating effects of self-efficacy, motivation and CF knowledge on the intervention outcomes as well as moderator effects, such as age, autonomy, depression, social support, and life events.
Drug users constitute a majority of HIV-infected individuals in many poor urban areas in the U.S. Observational studies, including those from our working group, indicate that drug users underutilize antiretroviral therapy, have higher rates of non-adherence, and experience suboptimal treatment outcomes, compared to other HIV-infected demographic groups. Tuberculosis treatment with directly observed therapy (DOT) has proven effective in addressing issues currently being confronted in HIV management. However, translating the tuberculosis DOT model to HIV poses challenges because of salient differences between the two diseases and their management. Methadone maintenance is an effective treatment for opioid dependence and provides a setting in which directly administered antiretroviral therapy (DAART) may be feasible for prolonged periods of time. This approach is conceptually appealing because it facilitates the integration of the traditionally separate realms of HIV medical care and drug dependence treatment. Specific aim 1 is to conduct a randomized, controlled trial of DAART versus self-administered therapy (SAT) in 200 HIV-infected individuals receiving methadone maintenance therapy in one of three clinics in Baltimore, Maryland. Based on encouraging 3-year pilot data, we hypothesize that DAART will be associated with clinically meaningful improvements in HIV treatment outcomes compared to SAT. Our primary study outcome will be suppression of the viral load at 3, 6 and 12 months. Secondary outcomes will include changes in CD4+ cell counts, the development of antiretroviral drug resistance, retention to methadone maintenance therapy, ongoing use of drugs and alcohol, and changes in psychosocial mediators of adherence. We will perform an outcome assessment at 18 months (6 months after DAART has concluded) to assess the durability of the interventional effect. Specific aim 2 is to compare objectively-measured adherence, using electronic medication event monitors (MEMS caps), in the DAART and SAT arms. The development and rigorous assessment of strategies to optimize HIV treatment outcomes in marginalized populations is a high priority. Our research team has an established history of collaboration in this area, and brings together a wealth of research expertise in HIV treatment outcomes, substance abuse, and behavioral aspects of adherence.
Rheumatoid arthritis (RA) is a debilitating and progressive disease that affects 1-2 percent of US adults and leads to chronic pain, loss of function, disability, loss of employment, and increased mortality. Currently, a cure for RA does not exist. Ultimate goals in managing RA are to prevent or control joint damage, prevent loss of function, and decrease pain. Achieving these goals requires early diagnosis and prompt initiation of aggressive treatment. In the past 5 years, treatment of RA has changed dramatically. The introduction of anti-TNF agents (biologies), which are powerful in action though very costly, can dramatically reduce disease progression; when biologies are not used, now combinations of potent new DMARDS (disease modifying anti-rheumatic drugs) are used to aggressively halt inflammation. However, currently we know very little about adherence to new RA therapies, especially biologies and combinations of more potent DMARDS. Thus, assessing and predicting adherence, and understanding common moderating factors is essential to clinical practice and research on determinants of treatment outcomes and efforts to improve patient adherence. The goals of this research proposal are to: (1) rigorously evaluate adherence to current RA therapies overtime in a cohort of patients; (2) relate adherence to disease activity and health outcomes; and (3) explore potential effect modifiers on the relationship between adherence and outcomes. We hypothesize that adherence to therapy is suboptimal, and will vary in relation to treatment (i.e., biologies vs. DMARDS), disease (i.e., burden/severity, previous use of DMARDS) and patient characteristics (depression status, demographics). Adherence will be associated with clinical and radiographic outcomes and health status at 1 yr. Depression will be associated with increased non-adherence. To test these hypotheses, we will utilize a one year observational study of 200 RA patients seen in the Johns Hopkins Arthritis Center.
Low-income, minority teenagers have disproportionately high rates of asthma morbidity, including excess risk of emergency department (ED) care, hospitalization and death from asthma, compared to white adolescents. Research by this group and others has documented that non-adherence with asthma treatment regimens is common among high-risk, inner city families with asthma, and that this poor adherence with prescribed therapies plays a significant contributing role in asthma morbidity. Inner-city adolescents with asthma are at particular risk of non-adherence, yet this population remains understudied. While asthma self-management training has shown promise in achieving some improvement in adherence with asthma, there are few intervention studies explicitly targeting adolescents, particularly those in the inner-city. Urban children typically assume primary control over their asthma management during late childhood/early adolescence. At the same time, adolescents' efforts to achieve autonomy and peer-acceptance may result in increase health risk behaviors, including poor asthma self-management. Developmentally-appropriate asthma self-management interventions are needed that target the unique challenges of adolescence. Motivational Interviewing (Ml) is a promising interventional approach that uses a client-centered, nondirective approach for enhancing motivation to change health behaviors. Ml techniques are developmentally consistent with the needs of early adolescents. Ml does not assume that health will be the most important factor motivating the teen, but rather acknowledges and incorporates other motivators that are within the context of the teen's life, thus this intervention strategy has the flexibility to adapt to the unique life circumstances and stressors faced by urban adolescents. We propose to evaluate the relative effectiveness of a Mi-focused self-management intervention (MI+SM) compared to a self-management (SM) intervention containing asthma education and self-monitoring strategies in a sample of 226 children age 10-15 years treated for asthma in the ED. Our primary hypothesis is that the MI+SM, as compared to SM alone, will result in greater improvement in medication adherence at 3- and 6-months post-randomization, as measured by electronic medication monitoring. Secondary outcomes include self-reported medication adherence, symptoms free days, urgent health care utilization for asthma, and caregiver/adolescent quality of life.
Despite significant advances in our understanding of the pathophysiology of asthma and marked improvements in the therapies available to treat asthma, disadvantaged and minority communities still carry a disproportionate burden from asthma. The exact reasons for this phenomenon are unknown, however, a number of factors have been proposed to account for this disparity, including genetic differences in vulnerability to asthma or asthma severity, differential rates of environmental exposure (e.g. cockroaches, dust), differences in the accessibility and quality of asthma medical care for patients of differing socioeconomic status, and inadequate asthma self-management practices, including poor adherence with therapy. It is widely believed that these factors interact to cause the observed excess burden of asthma within low-income, minority populations. Howard University and Johns Hopkins University have a long and successful history of collaborative studies designed to evaluate asthma morbidity in low-income, African-American children and adults with asthma. This application draws on this rich history to propose the formal collaboration of these institutions and investigators as a part of the Howard/Hopkins Center for Reducing Asthma Disparities. Specifically, this application presents four research projects designed to collaboratively investigate factors associated with the disproportionate burden of asthma experienced by inner-city, African-American children and adults. This application includes studies that will evaluate both the underlying genetic factors that may contribute to the observed excess risk in African-American communities, as well as studies of provider-patient communication designed to assess intervention strategies for remediating this risk. In addition, an essential goal of the Howard/Hopkins Center for Reducing Asthma Disparities will be to create a culturally sensitive training environment that is truly reciprocal, and designed to both enrich and enhance the research potential and asthma management capabilities of both participating institutions.
Asthma-related morbidity and mortality are disproportionately high among low-income African-American children. The impact of this asthma burden is particularly great on very young children and their families, resulting in high rates of emergency department care, hospitalization, decreased quality of life, and the risk of fatal asthma. Our research and that of others suggests that the contributing factors to this high morbidity include under-use of asthma primary preventive care, sub-optimal medical management, and inappropriate asthma management behaviors. Despite the importance of early, regular asthma preventive care for children this goal has proved elusive. Head Start programs offer an ideal venue for accessing high-risk, low income pre-school children and improving asthma morbidity. We hypothesize that removing barriers to preventive asthma care and facilitating communication between parents and primary care providers (PCP) are necessary prerequisites to optimally influence caregivers' asthma management practices. We propose to remove barriers by use of the Breathmobile, a community-based service that is specifically designed to deliver asthma screening, and special consultation directly to families and children in high-risk neighborhoods. In addition, we will evaluate a caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy. The proposed 2x2 modified factorial study design will compare the effectiveness of a Breathmobile Intervention combined with a Facilitated Asthma Communication Intervention (FACI) to a Facilitated Asthma Communication Intervention alone, the Breathmobile Intervention alone, or a Control Group in reducing asthma morbidity and improving asthma management. We will recruit 360 Head Start students aged 3 and 4 years with symptomatic doctor-diagnosed asthma. The primary study outcome measure will by Symptom-Free Days over 18 months. Secondary outcomes include school absences, health care utilization (emergency department visits, hospitalizations, primary care visits), asthma medications, parents' asthma related quality of life, parent asthma management practices, and cost-effectiveness. We hypothesize that a Facilitated Asthma Communication Intervention combined with the Breathmobile Intervention will be most effective in improving parent and PCP management of the child's asthma and reducing asthma morbidity.
The long-term goals of this Center are to examine how exposures to environmental pollutants and allergens may relate to airway inflammation and respiratory morbidity in children with asthma living in the inner city of Baltimore, and to search for new ways to reduce asthma morbidity by reducing exposure to these agents. To accomplish these goals the Center includes both basic and applied research programs in combination with a community based intervention research project. The first project is a community based epidemiologic study of 400 children 6-12 and their homes to identify relevant airborne exposures and to examine genetic determinants of asthma morbidity resulting from these exposures. The second project is community based participatory research project that is a randomized controlled clinical trial in 120 children of the effectiveness of behavioral methods to reducing pollutant and allergen exposures and their adverse health effects. The third project examines the mechanisms by which particulate matter may exacerbate an allergen driven response in of the airways. The fourth project, conducted by a newly recruited investigator, will examine the effects of environmental particulates on the in vitro maturation of peripheral blood monocytes to dendritic cells. These projects will be supported by core facilities for data management and exposure assessment. Another core facility will increase the Center's existing community outreach and translational activities. An Administrative Core will support research and general meetings to integrate the interests and activities of the Center. A community advisory committee has contributed to both the environmental epidemiology project and the community based intervention research project planning, and has agreed to meet periodically with Center researchers to discuss the Center's findings and progress. A seven member External Advisory Committee has been recruited. Information gained by this coordinated interdisciplinary team will allow rational plans to be made for future studies to examine susceptible children and to plan even more effective interventions in future studies with collaborating families in the East Baltimore Community.
Children with a history of frequent emergency department (ED) care and hospitalizations are at the greatest risk for increased asthma morbidity including decreased quality of life, increased school absences and life threatening asthma. Cost of care in treating pediatric asthma is high. Parental and child ability to accurately communicate symptoms to the physician is critical for optimal asthma diagnosis and treatment. When linked to timely and appropriate asthma medication use, accurate physician-parent-child communication may result in decreased asthma morbidity. Early self-administration of inhaled asthma medications was reported at a mean age of 8 years for inner-city children. Despite this early age of asthma self-management, little research focuses on the child's contribution to the medical encounter. This study is designed to determine if a parent and child asthma communication intervention (ACI) will be associated with AIM 1: enhanced communication skills of the parent and child, AIM 2:reduced asthma morbidity, AIM 3: enhanced appropriate adherence to asthma medication based on pharmacy refill rates and AIM 4: demonstrate cost effectiveness as compared to children enrolled in a standard asthma education intervention (SAE). Differences in ED visits for asthma, hospital days, number of urgent and primary care visits, school absences, restricted activity, number of symptom days and nights, functional status, quality of life over the 18 month follow-up will be compared between the two groups (ACI and SAE). The University of Maryland Hospital Pediatric ED, inpatient unit and Community pediatric clinics will serve as our recruitment sites. Families of children with mild-severe persistent asthma ages 6-12 years (N=220) will be enrolled. Data analysis will include chi-square, t-tests, ANOVA and multivariate linear regression models. The Generalized Estimating Equation (GEE) will be used to address the correlation of repeated measures. Cost-effectiveness and cost benefit ratios will be generated to examine for differences in cost of care between groups. Study outcomes will provide important data on the effects of an asthma communication intervention for children with mild to severe persistent asthma, the relative cost of the intervention; and the major components required to meet the needs of children with mild to severe asthma. Study findings will improve clinical care to this vulnerable population of children as well as children with other chronic illness and will be of significant use to health care providers, researchers, insurers and policy makers and will have significant public health applicability.
Self-reports are a primary source of behavioral data. Studies by this group and others have highlighted the variable validity and reliability of self-report measures of health behaviors such as adherence with therapy. Research on self-reports of sensitive information, such as sexual behavior and drug use, suggests that mode of data collection may enhance validity of self-reports. However, no studies have determined how mode of data collection influences self-reports when an objective measure of the behavior is available. The goal of this study is to examine how assessment mode influences the validity of self-reported adherence with asthma therapy. Self-reported adherence with asthma therapy will be collected using one of three randomized assessment modes: interview, computer or telephone. Adult patients will be enrolled in a 6-month asthma education study where their inhaled medications are electronically monitored to provide an objective adherence measure. A total of 216 adults will be randomized to these three treatments. The investigators hypothesize that self-reports will have the highest validity under conditions of lowest personalization. They will also examine how interview mode influences self-reports of other behavioral and clinical outcome measures including asthma symptoms, asthma management and quality of life. Results from this study will demonstrate how data collection methods influence self-report of adherence with therapy and serve to identify optimal self-report strategies in behavioral and clinical research settings.
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Low-income, minority children have disproportionately high rates of emergency department (ED) care for asthma compared to other children. Lack of access to asthma primary care and under-treatment of asthma have been implicated as contributing factors to this excess morbidity. Preliminary research by this group suggests that poor adherence with prescribed asthma therapies may also play a significant role. In a pilot study of low-income, minority children with symptomatic asthma we observed average daily adherence with anti-inflammatory therapy ranging from 1 percent to 32 percent of prescribed use. We hypothesize that improved adherence with asthma therapy can significantly reduce emergency room use for asthma care among high-risk children. To test this hypothesis, we will evaluate the effectiveness of an intensive adherence intervention that utilizes electronic medication monitors and medication measurement for monitoring and feedback, compared to a home-based asthma education intervention, and a usual care control group. The Johns Hopkins Pediatric Emergency Department (JHPED) will serve as our recruitment site. Families of asthmatic children ages 2-12 (N=270) with two or more emergency room visits or a hospitalization for asthma care in the past 12 months will be enrolled. Baseline measures will be collected after obtaining consent and prior to randomization. Participants will be randomly assigned to: 1) an Asthma Basic Care Intervention, or 2) an Adherence Monitoring and Feedback Intervention, or 3) a Usual Care Control Group. The duration of each intervention will be three months, with two booster visits at 6 months. Follow-up measures will be collected from families at 6, 12, and 18 months. The primary outcome measure will be medical record documented emergency care for asthma at the JHPED or other emergency or urgent care facilities over the eighteen-month follow-up period. Secondary outcomes include adherence with asthma therapy based on Medicaid pharmacy claims for asthma medications, other asthma health care (urgent and primary), self-reported medication adherence, barriers to health care, school absences, restricted activity, nighttime symptoms, asthma medications, self and family asthma management, asthma management self-efficacy, functional status, and quality of life.
Low-income minority children with asthma have disproportionately high utilization rates o f emergency department (ED) and hospital care compared to other children. Early and accurate identification of asthma symptoms linked with timely and appropriate asthma medication use is associated with decreased ED visits. In young children appropriate medication use includes accurate symptom perception and nebulizer use. In a pilot study of low-income minority children with symptomatic asthma we observed overuse of home nebulizer (48 percent), underuse of metered dose inhaler (MDI) with spacers (2.7 percent) and peak flow meter (17 percent). This study is designed to determine if an intensive home Nebulizer Education Intervention (NEI) will be associated with Aim 1: reduced asthma morbidity, Aim 2 improved parent and child asthma symptom identification; Aim 3: enhanced appropriate nebulizer medication adherence and Aim 4: demonstrate cost effectiveness as compared to children enrolled in a standard asthma education intervention (SAE). Difference in ED visits for asthma, hospital days, number of urgent and primary care visits, school absences, restricted activity, nighttime symptoms, functional status, quality of life over 18 month follow-up will be compared between the two groups (NEI and SAE). The Johns Hopkins ED will serve as our recruitment site. Families of children with moderate-severe asthma, ages 2-8 years (N = 220) with > 1 emergency room visit or a hospitalization for asthma care in the past 12 months and currently using a nebulizer will be enrolled. Data analysis will include chi square test, t-tests, ANOVA, and multivariate linear regression models. The Generalized Estimating Equation (GEE) will be used to address the correlation of repeated measures. Cost-effectiveness and cost benefit ratios will be generated to examine for differences in cost of care between groups. Study outcomes will provide important data on the effects of a NEI intervention for children with moderate to severe asthma, the relative cost of the intervention, and the major components required to meet the needs of children with moderate to severe asthma. Study findings will improve clinical care to this vulnerable population of children and will be if significant use to health care providers, researchers, insurers and policy makers.
Environmental, socioeconomic, psychosocial, and familial factors in rural communities predispose children to chronic health conditions, including asthma. Asthma is the most common chronic disease of childhood, affecting 7.4 percent of children aged 5-14 years in the United States. It has a significant impact on the quality of life of these children. There is a lack of information addressing the unique needs of asthma education for rural school children. The objective of this study is to evaluate the effectiveness of a school-based asthma educational intervention on the quality of life of rural elementary school children with asthma. The specific aims are to evaluate the effectiveness of the intervention on: Aim 1: quality of life, health care utilization, asthma knowledge, self-efficacy, school absenteeism, and use of asthma medications of children in grades 1-5; Aim 2: quality of life, asthma knowledge, self-efficacy, and asthma management practices of parents/caregivers; and Aim 3: asthma knowledge, self-efficacy, asthma management, and frequency of asthma communications of school health personnel (SHP). The primary study outcome is children's quality of life. A total of 294 children in grades 1-5 with asthma from six rural counties on the Maryland Eastern Shore will be enrolled. These counties will be divided into two county groups, a standard control and an intervention, matched for total student enrollment, gender, and ethnicity. Children and parents/caregivers in the standard control group (n=147) will receive printed asthma educational/materials. SHP will receive printed and video asthma management materials and peak flow meters (PFMs). Children and parents/caregivers in the intervention group (n=147) will receive the same materials as the standard control group. In addition, children in the intervention group will receive a 4-hour A plus Asthma Children's Workshop given by SHP, My Asthma Coloring Book, bimonthly newsletters, peak flow meters, and spacer devices. Parents/caregivers will receive a one-hour workshop and a specially designed packet of educational materials about rural related asthma management. Both children and parents/caregivers will receive the services of the A+ Asthma Rural Community health Workers (CHWs). SHP in the intervention group will receive a six-hour asthma rural training, and services of the A plus Asthma Rural Nurse Consultants (RNCs) who have received special training to instruct SHP to manage childhood asthma and CHWs. A plus Asthma RNCs will assist with children's and parents'/caregivers' workshops and CHWs will make home visits to parents who missed workshops or to children with frequent school absences. Differences in outcome measures described in the specific aims will be evaluated between baseline and the end of the program during one school year using generalized linear modeling and extensions of analysis of covariance. The major hypothesis is that children in the intervention group will show significant improvements in their quality of life compared to those in the standard control group. The findings of this study will be important to clinicians, researchers, and health policy makers.
Medical advances during the past two decades in the diagnosis and treatment of individuals with Cystic Fibrosis (CF) have resulted in improved survival. As such, healthcare professionals are now treating a new population, adults, with their own barriers to successful illness management. Treatment adherence is an important factor in successful illness management. The regimen, however, is a complex home treatment program that requires time and special skills to perform. Moreover, the stress of adhering to the treatment regimen, combined with the progressive and terminal nature of CF, places an emotional burden on the individual. This is, however, an under-researched area, particularly in exploring how psychosocial factors may relate to subsequent treatment adherence. Research in this area would lead to significant improvement in the understanding of and interventions to improve the psychological adjustment, disease management, quality of life, and health outcomes for adults with CF. Thus, the specific aims of this study are to (1) evaluate the relationship between psychosocial factors (e.g., depression, anxiety, social support, and coping) and adults with CF’s levels of adherence and (2) describe and characterize adherence behaviors of adults with CF.
While increased asthma morbidity and mortality have been observed across all ethnicities, results from several studies have found that asthma morbidity has increased disproportionately in low-income African American children. Elementary school-based asthma education programs have shown promise in improving asthma management, and reducing asthma morbidity in this high-risk population, however, the fastest growing asthma risk is associated with children young than six. By elementary age many parents and children with asthma have well-established patterns of inappropriate asthma management that may be difficult to change. To date, no research has examined the impact of early intervention for asthma management in low-income, high-risk children. This project will evaluate the effectiveness of a Head Start-based early intervention for designed to improve asthma management skill and practices of parents, pre-school children and Head Start staff. The proposed intervention study will be conducted in Head Start sites in Baltimore City (N=61). We will recruit 448 parents with preschool age (3-4 years) children with asthma enrolled in these Head Start sites over 32 months. Head Start sites will be randomized to either a minimal intervention control group of the A+ Asthma early intervention program for asthma management. This social-behavioral intervention is designed to educate and assist Head Start teachers and family service coordinators to: 1) optimize classroom management of asthma, 2) educate, facilitate and reinforce appropriate parental medical and behavioral management of asthma, and 3) instruct, model and reinforce early asthma knowledge and age-appropriate skills for preschool age children. At each intervention Head Start site an A+ asthma educator will train teachers and family service coordinators to work with children and their families to achieve optimal school and home asthma management. The primary outcome study measure will be Head Start absences/days enrolled, determined by review of Head Start attendance records. Secondary outcomes include other school absences, health care utilization, asthma symptoms, asthma medications, parents' asthma-related quality of life, and parent, child and teacher asthma knowledge and management practice. Additionally, we will assess program implementation and adoption. Phone- base interviews will be conducted with parents at baseline, 6, 12, 18, and 24 months. Teachers, family service coordinator, and child measures will be collected at the beginning and end of each school year. We hypothesize that a Head Start-based early intervention for asthma management will significantly reduce school absences and emergency care for asthma, increase primary care for asthma, improve parent's asthma related quality of life, and improve asthma management practices of parents, children and Head Start staff.
Asthma morbidity is disproportionately high among African American children. In a current study 46% of minority families of children with asthma reported 1-3 emergency room visits for asthma in the previous 6 months, and 43% had been hospitalized for asthma at least once. Inadequate primary care for asthma and poor adherence to asthma medications have been implicated as important factors in the high rates of emergency room care and hospitalization. No studies have examined the relative contributions of asthma primary care and medication adherence to asthma morbidity in urban minority communities. It is not known if behavioral/educational interventions can change primary care utilization or medication adherence in these communities, nor if such changes would alter asthma morbidity. In this study we will examine the impact of two home-based asthma interventions compared to a minimal contact intervention group. The Access intervention will assist families in overcoming barriers and establishing access to primary asthma health care within the community. The Access + Adherence intervention will assist families in establishing asthma primary care and appropriate adherence to prescribed asthma medications. Specifically, we hypothesize that an adherence intervention designed to both increase access to medical care and improve asthma medication knowledge and adherence will significantly reduce emergency room use for asthma care, when compared to a home-based intervention designed exclusively to increase access to care, and a minimal contact intervention. Thirty-three elementary schools in urban Baltimore, Maryland will serve as our recruitment sites. Asthmatic children grades K-5 will be identified by school records and parent surveys. Three hundred-ninety asthmatic children with one or more emergency room visits for asthma care in the past six months will be enrolled. Baseline measures will be collected after obtaining consent and prior to school randomization. Participating schools will be randomly assigned to one of three intervention groups : 1) a Control/Minimal intervention, 2) a home-based Access intervention, 3) a home-based Access + Adherence intervention. The duration of both the Access intervention and the Access + Adherence intervention will be six months. Follow-up measures will be collected from children and families at 6, 1 2, and 18 months. The primary outcome measure will be emergency care for asthma over the eighteen month follow-up. Secondary outcomes include other access to care (urgent and primary), medication adherence, barriers to health care, school absences, restricted activity, nighttime symptoms, asthma medications, self and family asthma management, functional status, and impact on family. Additional analyses will examine the relative cost- effectiveness and cost-benefits of the two home-based interventions.