The home air in agriculture pediatric intervention (HAPI) trial: Rationale and methods

BackgroundData addressing air quality effects on children with asthma in rural U.S. communities are rare. Our community engaged research partnership previously demonstrated associations between neighborhood NH₃ and ambient PM_2.5 and asthma in the agricultural lower Yakima Valley of Washington. As a next step, the partnership desired an intervention approach to address concerns about pediatric asthma in this largely Latino immigrant, farm worker community.ObjectiveThe Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM_2.5 and NH_3. We investigated the effect of this enriched approach on these exposures and asthma health measures.DesignWe randomized children with poorly controlled asthma to a control arm (current asthma education program) or an intervention arm (current asthma education program + placement of two indoor air cleaners in the family's home). Outcomes included (1) 14-day integrated samples of indoor air contaminants (PM_2.5 and NH₃) at baseline and one-year follow-up and (2) child asthma health metrics at baseline, midpoint (4–6 months) and one-year follow-up. These included the Asthma Control Test, symptoms days, clinical utilization, oral corticosteroid use, pulmonary function, fractional exhaled nitric oxide, and urinary leukotriene E₄ concentration.DiscussionTo our knowledge, this is the first randomized HEPA cleaner intervention designed to assess NH₃ as well as PM_2.5 and to evaluate health outcomes of children with asthma in an agricultural region.     

The PRImary care Screening Methods (PRISM) study: Rationale and design considerations

BackgroundPrimary care is the most frequently visited clinic type immediately prior to suicidal behavior, with nearly half of suicide decedents visiting a primary care provider within a month of their death. Data supporting the efficacy of suicide risk screening in this setting is lacking, however. Improved suicide risk screening in primary care could lead to earlier intervention and treatment.PurposeThe PRImary care Screening Methods (PRISM) study is designed to develop and evaluate the efficacy of an alert algorithm that can be used by military primary care providers to accurately identify high-risk patients, to improve the identification of high-risk patients who deny suicidal thoughts, and to quantify patient subgroups who are more likely to be missed by existing screening methods (i.e., false negatives).MethodsThe rationale of the PRISM study is discussed, along with ethical and design considerations related to the conduct of suicide prevention research. The PRISM study enrolled 2690 patients from six primary care clinics across the U.S. Patients were enrolled during routine visits to a primary care clinic, and completed a battery of self-report scales in clinic waiting rooms. Follow-up phone interviews are conducted 1, 6, and 12 months after enrollment. The primary outcome is suicide attempt.ConclusionsPRISM is the first study to prospectively examine multiple suicide risk screening methods in “real-world” military primary care clinics. Ethical and design issues were considered to ensure that human participants, especially suicidal patients, were adequately protected while minimizing the potential confounding effect of risk management protocols.     

Use of a randomized multiple baseline design: Rationale and design of the Spirited Life holistic health intervention study

Clergy suffer from high rates of obesity, chronic disease, and depression, and simultaneously underestimate the toll these take on their daily functioning. Health interventions are needed for clergy and may be tailored to their occupational context and theological beliefs. Few studies have sought to improve clergy health. No prior studies have utilized a randomized design. Spirited Life is a randomized, multiple baseline study that offered enrollment to nearly all United Methodist Church clergy in North Carolina in fall 2010. A total of 1114 clergy (response rate = 64%) enrolled. Using a multiple baseline design, we randomized participants to three cohorts. Each cohort began the health intervention in one of three consecutive years. The third cohort served as a randomized waitlist control cohort, allowing comparisons between the first and third cohorts. The two-year Spirited Life intervention consists of: 1) a theological underpinning for health stewardship based on incarnation, grace, and response and delivered during workshops; 2) the stress management program Williams LifeSkills; 3) Naturally Slim, an online weight loss program; 4) phone contact with a Wellness Advocate; and 5) $500 small grants for health goals. Metabolic syndrome is the primary endpoint. Stress and depressive severity are secondary endpoints. We measured each construct before, twice during, and at the end of the two-year intervention. Study outcomes, to be published after follow-up data are gathered, will provide evidence of the effectiveness of the combined intervention components of Spirited Life. If successful, the intervention may be considered for use with other clergy and faith populations.     

Rationale and design of a randomized trial of home electronic symptom and lung function monitoring to detect cystic fibrosis pulmonary exacerbations: The early intervention in cystic fibrosis exacerbation (eICE) trial

BackgroundAcute pulmonary exacerbations are central events in the lives of individuals with cystic fibrosis (CF). Pulmonary exacerbations lead to impaired lung function, worse quality of life, and shorter survival. We hypothesized that aggressive early treatment of acute pulmonary exacerbation may improve clinical outcomes.PurposeDescribe the rationale of an ongoing trial designed to determine the efficacy of home monitoring of both lung function measurements and symptoms for early detection and subsequent early treatment of acute CF pulmonary exacerbations.Study designA randomized, non-blinded, multi-center trial in 320 individuals with CF aged 14 years and older. The study compares usual care to a twice a week assessment of home spirometry and CF respiratory symptoms using an electronic device with data transmission to the research personnel to identify and trigger early treatment of CF pulmonary exacerbation. Participants will be enrolled in the study for 12 months. The primary endpoint is change in FEV₁ (L) from baseline to 12 months determined by a linear mixed effects model incorporating all quarterly FEV₁ measurements. Secondary endpoints include time to first acute protocol-defined pulmonary exacerbation, number of acute pulmonary exacerbations, number of hospitalization days for acute pulmonary exacerbation, time from the end of acute pulmonary exacerbation to onset of subsequent pulmonary exacerbation, change in health related quality of life, change in treatment burden, change in CF respiratory symptoms, and adherence to the study protocol.ConclusionsThis study is a first step in establishing alternative approaches to the care of CF pulmonary exacerbations. We hypothesize that early treatment of pulmonary exacerbations has the potential to slow lung function decline, reduce respiratory symptoms and improve the quality of life for individuals with CF.     

Rationale and study design of a patient-centered intervention to improve health status in chronic heart failure: The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) randomized trial

While contemporary heart failure management has led to some improvements in morbidity and mortality, patients continue to report poor health status (i.e., burdensome symptoms, impaired function, and poor quality of life). The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) trial is a NIH-funded, three-site, randomized clinical trial that examines the effect of the CASA intervention compared to usual care on the primary outcome of patient-reported health status at 6 months in patients with heart failure and poor health status. The CASA intervention involves a nurse who works with patients to treat symptoms (e.g., shortness of breath, fatigue, pain) using disease-specific and palliative approaches, and a social worker who provides psychosocial care targeting depression and adjustment to illness. The intervention uses a collaborative care team model of health care delivery and is structured and primarily phone-based to enhance reproducibility and scalability. This article describes the rationale and design of the CASA trial, including several decision points: (1) how to design a patient-centered intervention to improve health status; (2) how to structure the intervention so that it is reproducible and scalable; and (3) how to systematically identify outpatients with heart failure most likely to need and benefit from the intervention. The results should provide valuable information to providers and health systems about the use of team care to manage symptoms and provide psychosocial care in chronic illness.     

Helping mothers cope with a critically ill child: A pilot test of the COPE intervention

The purpose of this study was to pilot test the effects of a theoretically driven intervention program (COPE = Creating Opportunities for Parent Empowerment) on the coping outcomes of critically ill children and their mothers. Thirty mothers of 1- to 6-year-old children in a pediatric intensive care unit (PICU) were randomly assigned to receive COPE or a comparison program. Mothers who received the COPE program: (a) provided more support to their children during intrusive procedures; (b) provided more emotional support to their children; (c) reported less negative mood state and less parental stress related to their children's emotions and behaviors; and (d) reported fewer post-traumatic stress symptoms and less parental role change four weeks following hospitalization. Results indicate the need to educate parents regarding their children's responses as they recover from critical illness and how they can assist their children in coping with the stressful experience. © 1997 John Wiley & Sons, Inc. Res Nurs Health 20: 3–14, 1997     

A dyadic approach for a remote physical activity intervention in adults with Alzheimer's disease and their caregivers: Rationale and design for an 18-month randomized trial

Adults with Alzheimer's disease and related dementia (ADRD) and their caregivers represent a sizeable and underserved segment of the population with low levels of moderate physical activity (MPA). Options for increasing MPA in community dwelling adults with ADRD and their caregivers are limited. A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group. We will conduct an 18-month randomized trial (6 mos. Active intervention, 6 mos. Maintenance, 6 mos. no contact) to compare the effectiveness of the RGV approach with usual care, enhanced with caregiver support (EUC), for increasing MPA in 100 community dwelling adults with ADRD and their caregiver. The primary aim is to compare MPA (min/wk.), assessed by accelerometer, across the 6-mo. active intervention in adults with ADRD randomized to RGV or EUC. Secondarily, we will compare adults with ADRD and their caregivers randomized to RGV or ECU on the following outcomes across 18 mos.: MPA (min/wk.), sedentary time (min/wk.), percentage meeting 150 min/wk. MPA goal, functional fitness, activities of daily living, quality of life, residential transitions, cognitive function, and caregiver burden. Additionally, we will evaluate the influence of age, sex, BMI, attendance (exercise/support sessions), use of recorded sessions, self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers on changes in MPA in adults with ADRD and their caregiver across 18 mos.     

Cocaine Use Reduction with Buprenorphine (CURB): Rationale,design, and methodology

BackgroundEffective medications to treat cocaine dependence have not been identified. Recent pharmacotherapy trials demonstrate the potential efficacy of buprenorphine (BUP) (alone or with naltrexone) for reducing cocaine use. The National Institute on Drug Abuse Clinical Trials Network (CTN) launched the Cocaine Use Reduction with Buprenorphine (CURB) investigation to examine the safety and efficacy of sublingual BUP (as Suboxone®) in the presence of extended-release injectable naltrexone (XR-NTX, as Vivitrol®) for the treatment of cocaine dependence. This paper describes the design and rationale for this study.MethodsThis multi-site, double-blind, placebo-controlled study will randomize 300 participants across 11 sites. Participants must meet the DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. Participants are inducted onto XR-NTX after self-reporting at least 7 days of abstinence from opioids and tolerating a naloxone challenge followed by oral naltrexone and are then randomly assigned to one of three medication conditions (4 mg BUP, 16 mg BUP, or placebo) for 8 weeks. Participants receive a second injection of XR-NTX 4 weeks after the initial injection, and follow-up visits are scheduled at 1 and 3 months post-treatment. Participants receive weekly cognitive behavioral therapy (CBT). Recruitment commenced in September, 2011. Enrollment, active medication, and follow-up phases are ongoing, and recruitment is exceeding targeted enrollment rates.ConclusionsThis research using 2 medications will demonstrate whether BUP, administered in the presence of XR-NTX, reduces cocaine use in adults with cocaine dependence and opioid use disorders and will demonstrate if XR-NTX prevents development of physiologic dependence on BUP.     

Evaluation of a peer coach-led intervention to improve pain symptoms (ECLIPSE): Rationale,study design,methods, and sample characteristics

Chronic pain is prevalent, costly, and a leading cause of disability. Pain self-management (i.e., employing self-management strategies including behavioral modifications) is an effective, evidence-based treatment. However, implementation and delivery of a pain self-management model is challenging because of time and resources. Peer supported pain self-management offers a promising approach to implementing pain self-management programs using fewer clinical resources. Evaluation of a Peer Coach-Led Intervention for the Improvement of Pain Symptoms (ECLIPSE) is a randomized controlled trial testing effectiveness of peer coach-delivered pain self-management intervention versus controls receiving a class on pain and pain self-management. ECLIPSE is a Hybrid Type 1 study testing effectiveness while examining implementation factors. ECLIPSE enrolled 215 veterans randomly assigned to the peer coaching (N = 120) or control (N = 95) arm. The peer coaching intervention lasts 6 months, with patient-peer coach pairs instructed to talk twice per month. Coaches attend initial training, are provided a detailed training manual, and attend monthly booster sessions. Outcomes are assessed at baseline, 6 months, and 9 months. The primary outcome is overall pain (intensity and interference), measured by the Brief Pain Inventory (BPI). Secondary outcomes are self-efficacy, social support, pain catastrophizing, patient activation, health-related quality of life, and health care utilization. To maximize implementation potential of pain self-management, innovative delivery methods are needed that do not require additional resources from healthcare teams. A novel and promising approach is a peer-coaching model, in which patients who are successfully managing their pain offer information, ongoing support, and advice to other patients with pain.Clinical Trials Registration: NCT02380690     

Communication and coping intervention for mothers of adolescents with type 1 diabetes: Rationale and trial design

Mothers of adolescents with type 1 diabetes (T1D) experience high rates of depressive symptoms and diabetes distress, which are established risk factors for deteriorating glycemic control, problems with adherence, increased depressive symptoms, and poor quality of life in adolescents. Given that adolescents are a high-risk population for suboptimal glycemic control, novel interventions to improve outcomes in adolescents with T1D are needed. Building on effective interventions to treat depression in adults, and our own pilot work in this population, we developed a cognitive behavioral intervention, Communication & Coping, to target maternal depressive symptoms and parenting behaviors. The randomized controlled trial compares the telephone and Facebook-delivered Communication & Coping intervention, which promotes the use of adaptive coping strategies and positive parenting practices, to a diabetes education control condition on diabetes outcomes and psychosocial outcomes in adolescents with T1D. This paper describes the study rationale, trial design, and methodology.     

Tailored weight loss intervention in obese adults within primary care practice: Rationale,design, and methods of Choose to Lose

Although there are efficacious weight loss interventions that can improve health and delay onset of diabetes and hypertension, these interventions have not been translated into clinical practice. The primary objective of this study is to evaluate the effectiveness and cost effectiveness of a tailored lifestyle intervention in primary care patients. Patients were recruited by their primary care physicians and eligible participants were randomized to an enhanced intervention or standard intervention. All participants met with a lifestyle counselor to set calorie and physical activity goals and to discuss behavioral strategies at baseline, 6 and 12 months. During the first year, enhanced intervention participants receive monthly counseling phone calls to assist in attaining and maintaining their goals. Enhanced intervention participants also receive weekly mailings consisting of tailored and non-tailored print materials and videos focusing on weight loss, physical activity promotion and healthy eating. The second year focuses on maintenance with enhanced intervention participants receiving tailored and non-tailored print materials and videos regularly throughout the year. Standard intervention participants receive five informational handouts on weight loss across the two years. This enhanced intervention that consists of multiple modalities of print, telephone, and video with limited face-to-face counseling holds promise for being effective for encouraging weight loss, increasing physical activity and healthy eating, and also for being cost effective and generalizable for wide clinical use. This study will fill an important gap in our knowledge regarding the translation and dissemination of research from efficacy studies to best practices in clinical settings.     

肺移植受者居家护理需求质性研究的Meta整合

目的 系统评价和整合肺移植受者居家护理需求的质性研究,为制订以肺移植受者需求为导向的健康教育并开展延续性护理服务提供依据。 方法 检索PubMed、Embase、Web of Science、Cochrane Library、CINAHL、ProQuest、中国知网、万方数据库、维普数据库、中国生物医学文献数据库关于肺移植受者居家护理需求的质性研究,检索时限为建库至2020年8月。使用“澳大利亚乔安娜布里格斯研究所循证卫生保健中心质性研究质量评价标准（2016）”评价文献质量,采用Meta整合方法对结果进行整合。 结果 共纳入11篇研究,提炼出60个研究结果,归纳出11个新类别,最终综合为信息需求、生理需求、心理精神需求和社会需求4个整合结果。 结论 肺移植受者居家护理需求具有多样化、特殊性的特点。移植团队应高度重视肺移植受者的居家护理需求,根据需求情况为其提供居家教育、监测、肺康复指导和社会支持,进而提高肺移植受者的自我管理能力和生活质量。