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Almost 40% of Veterans Health Administration (VHA) users have obesity. VHA's national weight management program is associated with weight loss and improved health. However, while 94% of eligible VHA users are offered weight management programs, <8% use them. We developed EMBER – a novel, Motivational Interviewing-based, self-help tool – with the goal of E nhancing M otivation for B etter E ngagement and R each for weight management. EMBER is not a weight management program; instead it engages people in existing programs by informing and guiding choices about weight management. The EMBER Trial is a randomized hybrid type 1 effectiveness implementation trial. Participants are Palo Alto or Houston VA Health Care System users with obesity who have not used a VHA weight management program in the past two years (target N = 470). Participants are randomly assigned to EMBER or an information-only control condition, after which they receive materials on paper or digitally, per their preference. The trial's primary goal is to determine whether participants randomized to EMBER are more likely to have any weight management engagement at two-month follow-up compared to those in the control condition. Secondary outcomes include 6-month retention in weight management, weight management behaviors, weight loss, quality of life, and implementation outcomes (e.g., reach, appropriateness). EMBER is the first self-directed, Motivational Interviewing-based intervention designed to increase weight management program engagement. The study takes a low-touch, population health approach that could be modified for other programs if effective. The Hybrid Type 1 design will ensure results can be scaled and sustained. • EMBER is a novel self-help intervention to increase weight management engagement. • EMBER is based on an integration of health services and health psychology theories. • The EMBER Trial's hybrid design will ensure results can be scaled and sustained. [ABSTRACT FROM AUTHOR]

Introduction In November 2016, the Integrated Addendum to ICH-GCP E6 (R2) will advise trial sponsors to develop a risk-based approach to clinical trial monitoring. This new process is commonly known as risk based monitoring (RBM). To date, a variety of tools have been developed to guide RBM. However, a gold standard approach does not exist. This review aims to identify and examine RBM tools. Methods Review of published and grey literature using a detailed search-strategy and cross-checking of reference lists. This review included academic and commercial instruments that met the Organisation for Economic Co-operation and Development (OECD) classification of RBM tools. Results Ninety-one potential RBM tools were identified and 24 were eligible for inclusion. These tools were published between 2000 and 2015. Eight tools were paper based or electronic questionnaires and 16 operated as Service as a System (SaaS). Risk associated with the investigational medicinal product (IMP), phase of the clinical trial and study population were examined by all tools and suitable mitigation guidance through on-site and centralised monitoring was provided. Conclusion RBM tools for clinical trials are relatively new, their features and use varies widely and they continue to evolve. This makes it difficult to identify the “best” RBM technique or tool. For example, equivalence testing is required to determine if RBM strategies directed by paper based and SaaS based RBM tools are comparable. Such research could be embedded within multi-centre clinical trials and conducted as a SWAT (Study within a Trial). [ABSTRACT FROM AUTHOR]

Current guidelines recommend behavioral intervention to achieve a modest weight loss (e.g., 3–5%) as a first-line obesity treatment. Online behavioral obesity treatment, delivered via the Rx Weight Loss (RxWL) program, produces clinically significant initial weight losses. However, the program's pragmatic utility in routine medical care has yet to be tested. Further, additional research is needed to determine how best to extend the RxWL program to facilitate weight loss maintenance. This paper summarizes methods for a pragmatic trial aimed at identifying optimal methods for implementation of RxWL in primary care and evaluating relative effectiveness of two approaches to weight loss maintenance. RxWL will be implemented in a network of approximately 60 primary care clinics. Implementation outcomes (program uptake and completion metrics) will be compared between a Basic Implementation Intervention consisting primarily of access to RxWL, and an Enhanced Implementation Intervention with additional training in strategies for motivating and supporting patients in their use of RxWL and online clinician support tools for tracking patient progress. Second, two intervention approaches (Monthly Lessons versus Refresher Courses) within the RxWL patient platform will be tested against an educational control condition, and effects on 1-year weight loss maintenance will be compared. This study will provide essential information about the feasibility and utility of online obesity treatment in primary care. It will provide novel information on two approaches to weight loss maintenance for patients in this setting. This project fills key gaps in evidence regarding best practices for obesity treatment in primary care. [ABSTRACT FROM AUTHOR]

Abstract Children in rural areas are disproportionately affected by pediatric obesity. Poor access to healthcare providers, lack of nutrition education, lower socioeconomic status, and fewer opportunities to be physically active are all unique barriers that contribute to this growing health concern. There are very few pediatric obesity interventions that have been developed that target this unique population. iAmHealthy is a family-based behavioral, nutrition and physical activity intervention developed with input from rural children and families that capitalizes on the innovative use of mobile health applications (mHealth). iAmHealthy is a 25-contact hour multicomponent intervention delivered over an 8-month period targeting 2nd-4th grade school children and their families. This paper describes the rationale, design, participant/school enrollment, and planned implementation of a randomized controlled trial of the iAmHealthy intervention in comparison to a monthly newsletter delivered through rural elementary schools. Child Body Mass Index z-score (BMIz) is the primary outcome, along with child 24-hour dietary recall, and child accelerometer-determined physical activity and sedentary behavior as secondary outcomes. The study will include 18 schools (with 8 children each) resulting in a final planned sample size of 144 children. This project also has a strong focus on dissemination and implementation science, and thus includes many measures related to the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance). Data collection is completed at baseline, end of intervention (8 months), and follow-up (20 months). This study is the first randomized controlled trial to deliver a rurally tailored, empirically supported, family-based behavioral intervention for pediatric obesity solely over mHealth. Registered with ClinicalTrials.gov NCT ID 03304249. [ABSTRACT FROM AUTHOR]

Abstract Background Peer support can improve health for patients with chronic conditions; however, evidence for disease prevention is less clear and peer recruitment strategies are not well described. This paper describes a study protocol to evaluate a peer support intervention to improve hypertension control and reduce cardiovascular disease (CVD) risk. Methods & research design Target enrollment for this two-site study is n = 400. Eligibility criteria include Veterans enrolled in Veterans Health Administration (VHA) primary care with poorly controlled hypertension and one other cardiovascular disease risk (smoking, overweight/obesity, or hyperlipidemia) who live in census tracts with high rates of hypertension. Enrolled participants are randomized to a home-based peer delivered self-management intervention (5 home visits and 5 phone calls with a peer health coach) versus usual care. The primary outcome is a change in systolic blood pressure (SBP) and secondary outcomes include change in CVD risk and health care use. Results Trial results are pending and participant enrollment is ongoing. We recruited peer coaches from Veterans who lived in census tracks with the highest rates of hypertension. To recruit Veteran peer coaches, we asked primary care providers (n = 41) and team nurses (n = 35) to nominate patients who they thought would be a good fit for the peer coach position (based on successful self-management and health care navigation) (n = 73 nominated from 964 patients). We interviewed 12 Veterans and trained 5 peer coaches. Conclusions Results of this trial will inform peer support programs targeted to provide community-based delivery of prevention services to patients in high-risk areas. Trial registration Clinicaltrial.gov identifier NCT02697422 Trial status Enrollment for the randomized trial phase began in September 2017 and will be complete September 2019. [ABSTRACT FROM AUTHOR]

MoodSwings 2.0 is a self-guided online intervention for bipolar disorder. The intervention incorporates technological improvements on an earlier validated version of the intervention (MoodSwings 1.0). The previous MoodSwings trial provides this study with a unique opportunity to progress previous work, whilst being able to take into consideration lesson learnt, and technological enhancements. The structure and technology of MoodSwings 2.0 are described and the relevance to other online health interventions is highlighted. An international team from Australia and the US updated and improved the programs content pursuant to changes in DSM-5, added multimedia components and included larger numbers of participants in the group discussion boards. Greater methodological rigour in this trial includes an attention control condition, quarterly telephone assessments, and red flag alerts for significant clinical change. This paper outlines these improvements, including additional security and safety measures. A 3 arm RCT is currently evaluating the enhanced program to assess the efficacy of MS 2.0; the primary outcome is change in depressive and manic symptoms. To our knowledge this is the first randomized controlled online bipolar study with a discussion board attention control and meets the key methodological criteria for online interventions. [ABSTRACT FROM AUTHOR]

Generalized anxiety disorder (GAD) is a significant yet modifiable risk factor for worse cardiovascular disease (CVD) outcomes. The treatment of GAD in an accessible manner represents an unmet need in CVD, given that patients with CVD experience numerous barriers to in-person treatment engagement. This paper presents the rationale and design for an investigation of a strategy to enhance care for patients with CVD by introducing a scalable, affordable, and system-friendly digital intervention that targets a prominent modifiable risk factor (generalized anxiety and associated worry) for negative health behaviors in CVD. In the context of a randomized clinical trial design, we describe an experimental medicine approach for evaluating the degree to which a digital cognitive behavior therapy (dCBT), relative to a waitlist control group, engages anxiety and worry outcomes in a sample of 90 adults who have experienced an acute CVD event and who have comorbid GAD symptoms. We also investigate the degree to which dCBT leads to greater changes in GAD symptoms compared to the control condition and whether reductions in these symptoms are associated with corresponding reductions in cardiac anxiety and cardiac health behaviors (including smoking, physical activity, heart-healthy diet, and medication adherence). We propose that by targeting GAD symptoms in CVD in a way that does not tax ongoing medical care provision, we have the potential to improve the uptake of effective care and address both GAD and associated health behaviors. [ABSTRACT FROM AUTHOR]

Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries. Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings. [ABSTRACT FROM AUTHOR]

Background Depression during pregnancy has been demonstrated to be predictive of low birthweight, prematurity, and postpartum depression. These adverse outcomes potentially have lasting effects on maternal and child well-being. Socio-economically disadvantaged women are twice as likely as middle-class women to meet diagnostic criteria for antenatal major depression (MDD), but have proven difficult to engage and retain in treatment. Collaborative care treatment models for depression have not been evaluated for racially/ethnically diverse, pregnant women on Medicaid receiving care in a public health system. This paper describes the design, methodology, culturally relevant enhancements, and implementation of a randomized controlled trial of depression care management compared to public health Maternity Support Services (MSS). Methods Pregnant, public health patients, > 18 years with a likely diagnosis of MDD or dysthymia, measured respectively by the Patient Health Questionnaire-9 (PHQ-9) or the Mini-International Neuropsychiatric Interview (MINI), were randomized to the intervention or to public health MSS. The primary outcome was reduction in depression severity from baseline during pregnancy to 18-months post-baseline (one-year postpartum). Baseline results 168 women with likely MDD (96.4%) and/or dysthymia (24.4%) were randomized. Average age was 27.6 years and gestational age was 22.4 weeks; 58.3% racial/ethnic minority; 71.4% unmarried; 22% no high school degree/GED; 65.3% unemployed; 42.1% making < $10,000 annually; 80.4% having recurrent depression; 64.6% PTSD, and 72% unplanned pregnancy. Conclusions A collaborative care team, including a psychiatrist, psychologist, project manager, and 3 social workers, met weekly, collaborated with the patients' obstetrics providers, and monitored depression severity using an electronic tracking system. Potential sustainability of the intervention within a public health system requires further study. [ABSTRACT FROM AUTHOR]

Managing chronic pain effectively is often challenging for health care providers and patients. Telehealth technologies can bridge geographic distance and improve patients' quality of care in communities where access to pain specialists has previously been unavailable. This paper describes the development and evaluation of a telehealth intervention (TelePain) designed to address the need for pain specialist consultation regarding pain and symptom management issues in non-academic medical centers. We describe the theoretical foundation and development of a multifaceted intervention using a cluster randomized clinical trial design. Health care providers and their patients with chronic pain are enrolled in the study. Patient participants receive the intervention (report of symptoms and receipt of a pain graph) weekly for 8 weeks and are contacted at 12 weeks for completion of post-intervention follow-up measures. Their providers attend TelePain sessions which involve a didactic presentation on an evidence-based topic related to pain management followed by patient case presentations and discussion by community clinicians. Symptom management recommendations for each patient case are made by a panel of pain specialists representing internal medicine, addiction medicine, rehabilitation medicine, anesthesiology, psychiatry, and nursing. The outcomes assessed in this randomized trial focus on pain intensity, pain's interference on function and sleep, and anxiety, depression, and cost-effectiveness. Some of the challenges and lessons that we have learned early in implementing the TelePain intervention are also reported. [ABSTRACT FROM AUTHOR]

Within the Veterans Health Administration (VHA), the largest integrated health care system in the US, approximately 8.5 million Veteran patients receive informal care. Despite a need for training, half of VHA caregivers report that they have not received training that they deemed necessary. Rigorous study is needed to identify effective ways of providing caregivers with the skills they need. This paper describes the Helping Invested Families Improve Veterans' Experience Study (HI-FIVES), an ongoing randomized controlled trial that is evaluating a skills training program designed to support caregivers of cognitively and/or functionally impaired, community-dwelling Veterans who have been referred to receive additional formal home care services. This two-arm randomized controlled trial will enroll a total of 240 caregiver-patient dyads. For caregivers in the HI-FIVES group, weekly individual phone training occurs for 3 weeks, followed by 4 weekly group training sessions, and two additional individual phone training calls. Caregivers in usual care receive information about the VA Caregiver Support Services Program services, including a hotline number. The primary outcome is the number of days a Veteran patient spends at home in the 12 months following randomization (e.g. not in the emergency department, inpatient or nursing home setting). Secondary outcomes include patient VHA health care costs, patient and caregiver satisfaction with VHA health care, and caregiver depressive symptoms. Outcomes from HI-FIVES have the potential to improve our knowledge of how to maximize the ability to maintain patients safely at home for caregivers while preventing poor mental health outcomes among caregivers. [ABSTRACT FROM AUTHOR]

Introduction In rural America cigarette smoking is prevalent, few cessation services are available, and healthcare providers lack the time and resources to help smokers quit. This paper describes the design and participant characteristics of Connect2Quit (C2Q), a randomized control trial (RCT) that tests the effectiveness and cost-effectiveness of integrated telemedicine counseling delivered by 2-way webcams mounted on desktop computers in participant's physician office examining rooms (ITM) versus quitline counseling delivered by telephone in participant's homes (Phone) for helping rural smokers quit. Methods/design C2Q was implemented in twenty primary care and safety net clinics. Integrated telemedicine consisted of real-time video counseling, delivered to patients in their primary care physician's (PCP) office. Phone counseling, was delivered to patients in their homes. All participants received educational materials and guidance in selecting cessation medications. Results The 566 participants were predominantly Caucasian (92%); 9% were Latino. Most (65%) earned < 200% of Federal Poverty Level. One out of three lacked home internet access, 40% were not comfortable using computers, and only 4% had been seen by a doctor via telemedicine in the past. Hypertension, chronic lung disease, and diabetes were highly prevalent. Participants smoked nearly a pack a day and were highly motivated to quit. Discussion C2Q is reaching a rural low-income population, with comorbid chronic diseases, that would benefit greatly from quitting smoking. ITM is a good delivery model, which integrates care by holding counseling sessions in the patient's PCP office and keeps the primary care team updated on patients' progress. [ABSTRACT FROM AUTHOR]

Abstract: Home-based telemental health (TMH) treatments have the potential to address current and future health needs of military service members, veterans, and their families, especially for those who live in rural or underserved areas. The use of home-based TMH treatments to address the behavioral health care needs of U.S. military healthcare beneficiaries is not presently considered standard of care in the Military Health System. The feasibility, safety, and clinical efficacy of home-based TMH treatments must be established before broad dissemination of home-based treatment programs can be implemented. This paper describes the design, methodology, and protocol of a clinical trial that compares in-office to home-based Behavioral Activation for Depression (BATD) treatment delivered via web-based video technology for service members and veterans with depression. This grant funded three-year randomized clinical trial is being conducted at the National Center for Telehealth and Technology at Joint-base Lewis-McChord and at the Portland VA Medical Center. Best practice recommendations regarding the implementation of in-home telehealth in the military setting as well as the cultural and contextual factors of providing in-home care to active duty and veteran military populations are also discussed. [Copyright &y& Elsevier]

Abstract: Background: As the population ages, it is increasingly important to test new models of care that improve life quality and decrease health costs. This paper presents the rationale and design for a randomized clinical trial of a novel interdisciplinary program to reduce disability among low income older adults based on a previous pilot trial of the same design showing strong effect. Methods: The CAPABLE (Community Aging in Place, Advancing Better Living for Elders) trial is a randomized controlled trial in which low income older adults with self-care disability are assigned to one of two groups: an interdisciplinary team of a nurse, occupational therapist, and handyman to address both personal and environmental risk factors for disability based on participants' functional goals, or an attention control of sedentary activities of choice. Both groups receive up to 10 home visits over 4months. Outcomes: The primary outcome is decreased disability in self-care (ADL). Secondary outcomes are sustained decrease in self care disability as well as improvement in instrumental ADLS, strength, balance, walking speed, and health care utilization. Careful cost tracking and analysis using intervention data and claims data will enable direct measurement of the cost impact of the CAPABLE approach. CAPABLE has the potential to leverage current health care spending in Medicaid waivers, Accountable Care Organizations and other capitated systems to save the health care system costs as well as improving low income older adults' ability to age at home with improved life quality. [Copyright &y& Elsevier]

Abstract: Caring letters is a suicide prevention intervention that entails the sending of brief messages that espouse caring concern to patients following discharge from treatment. First tested more than four decades ago, this intervention is one of the only interventions shown in a randomized controlled trial to reduce suicide mortality rates. Due to elevated suicide risk among patients following psychiatric hospitalization and the steady increase in suicide rates among the U.S. military personnel, it is imperative to test interventions that may help prevent suicide among high-risk military personnel and veterans. This paper describes the design, methods, study protocol, and regulatory implementation processes for a multi-site randomized controlled trial that aims to evaluate the effectiveness of a caring emails intervention for suicide prevention in the military and VA healthcare systems. The primary outcome is suicide mortality rates to be determined 24months post-discharge from index hospital stay. Healthcare re-utilization rates will also be evaluated and comprehensive data will be collected regarding suicide risk factors. Recommendations for navigating the military and VA research regulatory processes and implementing a multi-site clinical trial at military and VA hospitals are discussed. [Copyright &y& Elsevier]

Abstract: In the past decade, the cost of drug development has increased significantly. The estimates vary widely but frequently quoted numbers are staggering—it takes 10–15 years and billions of dollars to bring a drug to patients [1]. To a large extent this is due to many long, expensive and ultimately unsuccessful drug trials. While one approach to combat the low yield on investment could be to continue searching for new blockbusters, an alternative method would lead us to focus on testing new targeted treatments that have a strong underlying scientific rationale and are more likely to provide enhanced clinical benefit in population subsets defined by molecular diagnostics. Development of these new treatments, however, cannot follow the usual established path; new strategies and approaches are required for the co-development of novel therapeutics and the diagnostic. In this paper we will review, from the point of view of industry, the approaches to, and challenges of drug development strategies incorporating predictive biomarkers into clinical programs. We will outline the basic concepts behind co-development with predictive biomarkers and summarize the current regulatory paradigm. We will present guiding principles of personalized health care (PHC) development and review the statistical, strategic, regulatory and operational challenges that statisticians regularly encounter on development programs with a PHC component. Some practical recommendations for team statisticians involved in PHC drug development are included. The majority of the examples and recommendations are drawn from oncology but broader concepts apply across all therapeutic areas. [Copyright &y& Elsevier]

Abstract: Background: Women have higher rates of depression and often experience depression symptoms during critical reproductive periods, including adolescence, pregnancy, postpartum, and menopause. Collaborative care intervention models for mood disorders in patients receiving care in an OB-GYN clinic setting have not been evaluated. Study design and methodology for a randomized controlled trial of collaborative care depression management versus usual care in OB-GYN clinics and the details of the adapted collaborative care intervention and model implementation are described in this paper. Methods: Women over age 18years with clinically significant symptoms of depression, as measured by a Patient Health Questionnaire-9 (PHQ-9) score ≥10 and a clinical diagnosis of major depression or dysthymia, were randomized to the study intervention or to usual care and were followed for 18months. The primary outcome assessed was change over time in the SCL-20 depression scale between baseline and 12months. Baseline Results: Two hundred five women were randomized: 57% white, 20% African American, 9% Asian or Pacific Islander, 7% Hispanic, and 6% Native American. Mean age was 39years. 4.6% were pregnant and 7.5% were within 12months postpartum. The majority were single (52%), and 95% had at least the equivalent of a high school diploma. Almost all patients met DSM IV criteria for major depression (99%) and approximately 33% met criteria for dysthymia. Conclusions: An OB-GYN collaborative care team, including a social worker, a psychiatrist, and an OB-GYN physician, who met weekly and used an electronic tracking system for patients was the essential element of the proposed depression care treatment model described here. Further study of models that improve quality of depression care that are adapted to the unique OB-GYN setting is needed. [Copyright &y& Elsevier]

Abstract: Background: Patients requiring complex care are at high risk during the transition from one setting of care to another. Effective interventions to support care transitions have been designed but are very resource intensive. Telemonitoring has been considered as an approach to enhance care transition support, but many telemonitoring systems require special equipment or web-based interfaces to interact with patients and caregivers. Methods/design: In this paper we report our protocol for developing and testing E-Coach, an interactive voice response (IVR)-enhanced care transition intervention that monitors patients at home using their personal phone. The elements described include 1) development of an IVR monitoring system that will be based on Coleman''s four pillars of care transition support; 2) development of a web-based “dashboard” of IVR responses that alert care transition nurses (CTN) of patient/caregiver concerns after discharge and allow documentation by the CTN when patients/caregivers are called; 3) pilot testing of the IVR system by patients and providers with refinement of the system based on patient/provider input; and 4) a pragmatic protocol for formal testing through a randomized controlled trial (RCT) of the E-Coach intervention in congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD) patients admitted to a large tertiary hospital. Trial Registration: CT.gov#: NCT01135381. [Copyright &y& Elsevier]

Abstract: The patient''s perspective of treatment outcomes is increasingly important to consumers and providers of healthcare. Recent studies have shown that traditional clinical endpoints may not accurately reflect the patient experience with treatment. Often patients'' experience of their disease and associated treatment differs from the perspective of their physicians. When implemented with a clear and effective assessment strategy, patient-reported outcome (PRO) measures can be used to collect data directly from patients in the clinical setting. These data can be applied to a range of outcomes, such as treatment efficacy, safety, and patient satisfaction. Such information is valuable at various stages of drug development and can be used to understand the patient''s perspective of the treatment for evaluating the treatment benefit of new products and to engage patients to make decisions about treatment options and ultimately to support commercialization of pharmaceutical products. Recognizing the value of these data, various regulatory agencies have recently released guidelines on how to best implement these measures in clinical trials to support label claims. The purpose of this paper is to discuss the benefits of collecting PRO data for evaluating the outcomes of treatments in clinical trials, through the product life cycle. [Copyright &y& Elsevier]

Abstract: This paper describes recruitment challenges and lessons learned in conducting a randomized controlled exercise trial in the absence of direct access to a clinical population. One-hundred thirty-five wheelchair users were enrolled in a home and community-based intervention to promote exercise adoption and maintenance. Over 44months of recruitment, 355 individuals inquired about the study and 323 completed the screening process. Nearly half were determined ineligible (150/323, 46.4%), typically due to having restricted arm movement, cognitive impairment, or medical conditions that are contraindicated for unsupervised exercise. Respondents cited paid media advertisements and recruitment materials placed in health care providers'' offices most frequently as being how they learned about the study. RCT participant recruitment, particularly in the absence of direct access to a clinical population, required far more time and resources than anticipated to achieve sufficient enrollment. Nurturing relations with key gatekeepers, creating a visible public profile, and maintaining ongoing recruitment activities were essential to success. [Copyright &y& Elsevier]

Abstract: Diabetes and coronary heart disease (CHD) are two of the most prevalent medical illnesses in the US population and comorbid depression occurs in up to 20% of these patients. Guidelines for management of diabetes and CHD overlap for healthy lifestyle and disease-control recommendations. However, the majority of patients with these medical illnesses have been shown to have inadequate control of key risk factors such as blood pressure, LDL cholesterol, or blood sugar. Comorbid depression has been shown to adversely affect self-care of diabetes and CHD, and is associated with an increased risk of complications and mortality. Interventions that have improved quality and outcomes of depression care alone in patients with diabetes and CHD have not demonstrated benefits in self-care, improved disease control or morbidity and mortality. This paper describes the design and development of a new biopsychosocial intervention (TEAMcare) aimed at improving both medical disease control and depression in patients with poor control of diabetes and/or CHD who met the criteria for comorbid depression. A team approach is used with a nurse interventionist who receives weekly psychiatric and primary care physician caseload supervision in order to enhance treatment by the primary care physician. This intervention is being tested in an NIMH-funded randomized controlled trial in a large integrated health plan. [Copyright &y& Elsevier]

Abstract: Translating evidence-based research into practice requires data from clinical trials in real world settings. This paper presents “lessons learned” from the implementation of an RCT of breastfeeding promotion interventions at two busy, urban, prenatal care sites. Data were obtained via direct observations, qualitative interviews, and study statistics. Primary challenges include: time and space burdens, “research vs. service” mission conflict, and the provider learning curve for conducting interventions. Primary facilitators include: researcher presence for enhancing rapport with participants and staff, site staff labeling of both the research interview and intervention as “value added time,” and the ability of research staff to assist the clinic beyond the scope of the clinical trial. Specific suggestions are given for building collaborative bonds between the research team, clinicians, administrators, and staff in busy urban practices. [Copyright &y& Elsevier]

Abstract: The Personal Digital Assistance for Guideline Adherence (GLAD Heart) study was designed to test a strategy to improve quality of care through increased adherence to ATPIII cholesterol guidelines. This paper describes the overall study design including the multi-faceted intervention and outcome measures. Sixty-one primary care practices in NC were recruited and randomized to either a personal digital assistant-based cholesterol management intervention or an intervention similar in intensity and frequency of contact but focused on a hypertension clinical practice guideline. Installation and implementation of the technology intervention was challenging. Over the course of the study, there were 74 technical issues requiring assistance for the palm pilot from 23 participating practices. The GLAD Heart project was completed successfully with some impact on cholesterol management. Technology has the potential to improve the quality of care provided in the healthcare setting. However, potentially expensive interventions such as that conducted in GLAD Heart should undergo rigorous testing to assure their efficacy before widespread adoption. [Copyright &y& Elsevier]

Abstract: In spite of growing interest in socioeconomic differentials in health outcomes and access to health services, little has been written about methodologies for assessing the impact of equity-enhancing policies or programs. This paper describes three methodological challenges involved in designing a randomised trial with an equity outcome, and how these were met in a trial of alternative strategies to improving the uptake of benefits of a health insurance scheme among its poorest members. The Vimo SEWA trial is nested within a community-based insurance scheme in rural India. While conducting this trial, three methodological problems were encountered: (i) measuring poverty (or “wealth”, or “socioeconomic status”) (ii) assessing beneficiaries against an appropriate reference standard population and (iii) settling on an appropriate equity measure as an outcome indicator. These problems are likely to arise in any policy or program assessment that has an equity outcome. In the Vimo SEWA trial, the socioeconomic status of beneficiaries (claimants) is assessed relative to that of all scheme members living in same sub-district by applying a rapid assessment questionnaire – which reduces to an integrated index of socioeconomic status – to both a random sample of members in each sub-district, and to all claimants. The results are used to estimate the full distribution of socioeconomic status of members in each sub-district, with each member given a rank score between 0 and 100. Interpolation is used to estimate the rank scores of claimants relative to the membership base. The primary outcome measure for the trial is the mean socioeconomic rank score of claimants. In developing country settings, using an index of socioeconomic status is simpler than assessing household income or the value of household consumption. It is also relatively straightforward to compare the socioeconomic status of health program beneficiaries with a relevant reference population, although two independent surveys are required. Expressing relative wealth on a scale from zero to 100 is conceptually appealing, and the mean value of this rank score provides an equity-specific outcome measure readily integrated into the usual analytic framework for cluster-randomised trials. [Copyright &y& Elsevier]

Abstract: Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this paper, we discuss how choosing which population cluster to randomise can impact on the practicalities of recruitment in primary care. We describe strategies developed through our experiences of recruiting primary care organisations to participate in a national randomised controlled trial of a policy to provide community breastfeeding groups for pregnant and breastfeeding mothers, the BIG (Breastfeeding in Groups) trial. We propose an iterative qualitative approach to recruitment; collecting data generated through the recruitment process, identifying themes and using the constant comparative method of analysis. This can assist in developing successful recruitment strategies and contrasts with the standardised approach commonly used when recruiting individuals to participate in randomised controlled trials. Recruiting primary care population clusters to participate in trials is currently an uphill battle in Britain. It is a complex process, which can benefit from applying qualitative methods to inform trial design and recruitment strategy. Recruitment could be facilitated if health service managers were committed to supporting peer reviewed, funded and ethics committee approved research at national level. [Copyright &y& Elsevier]