Coach McLungs Intervention for Asthma
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Atrium Health
Disqualifiers: Decisional impaired, mentally incompetent
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The goal of this study is to evaluate the implementation of the Coach McLungsSM shared decision making (SDM) intervention into primary care across a large healthcare system. Coach McLungsSM is a virtual evidence-based asthma intervention with built-in asthma education and clinical decision support. All asthma patients aged 5-17 who attend these practices will be assessed for uncontrolled asthma. Asthma exacerbations attributed to emergency department visits, hospitalizations, and oral steroid use, will be evaluated to serve as surrogate measures for patient-centered asthma outcomes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the Coach McLungs treatment for asthma?
The Coach McLungs treatment, similar to the COACH program, may help reduce emergency room visits and hospital readmissions shortly after discharge for children with asthma. Additionally, using wellness coaches in asthma interventions has been found to be feasible and well-received, suggesting potential benefits in managing asthma.
12345Is Coach McLungs Intervention safe for humans?
The available research on wellness coaches in asthma interventions suggests that using wellness coaches is feasible and acceptable, with high satisfaction reported by participants. However, specific safety data for Coach McLungs Intervention itself is not provided in the available studies.
25678How does the Coach McLungs treatment for asthma differ from other treatments?
Coach McLungs is unique because it uses wellness coaches to help manage parental stress, which can improve asthma outcomes in children. This approach focuses on stress management rather than direct medical treatment, making it different from traditional asthma therapies that primarily involve medication.
2591011Eligibility Criteria
This trial is for children and teens aged 5-17 with mild to severe persistent asthma who can communicate in English or Spanish. It's not suitable for those who have decision-making impairments or are mentally incompetent.Inclusion Criteria
I speak English or Spanish.
I have been diagnosed with persistent asthma.
Exclusion Criteria
I am able to make my own health decisions.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Implementation
Implementation of the Coach McLungsSM SDM intervention into primary care practices using a stepped wedge randomized control study design
18 months
Ongoing virtual integration and training sessions
Follow-up
Participants are monitored for changes in emergency department visits, hospitalizations, and oral steroid use as surrogate measures for asthma outcomes
18 months
Participant Groups
The study tests the Coach McLungsSM intervention, a virtual tool designed to help manage asthma through education and clinical support. The effectiveness will be measured by looking at emergency visits, hospital stays, and oral steroid use due to asthma.
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Coach McLungs not yet implemented in practice
Group II: InterventionActive Control1 Intervention
Coach McLungs Implemented in Practice
Coach McLungs Intervention is already approved in United States for the following indications:
🇺🇸 Approved in United States as Coach McLungs for:
- Asthma management
- Uncontrolled asthma in pediatric patients
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Atrium HealthCharlotte, NC
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Who Is Running the Clinical Trial?
Atrium HealthLead Sponsor
Wake Forest University Health SciencesLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Clinical practice improvement: management of the patient with chronic asthma. [2019]Clinical practice improvement (CPI) includes research on practice patterns, access, utilization of resources, and patient perceptions of outcomes; development of practice guidelines; and education of both patients and providers. Using the CPI format, a team of healthcare professionals selected the management of the asthma patient as a project. The team's goals were to evaluate current practice patterns, review and recommend practice guidelines, recommend indicators to monitor patient outcomes and changes in practice patterns, and provide recommendations for implementing educational activities. A survey mailed to primary care physicians and selected specialists (allergists and pulmonologists) was used to determine present methods of managing asthma. A patient outcomes survey tool was piloted as part of the CPI process. The pilot indicated that this tool was appropriate for use in physician offices for both longitudinal and aggregate analysis of asthma patient outcomes. Patient and provider educational materials were developed and disseminated to providers.
The effect of a coaching program on asthma control and health care utilization in children with asthma. [2021]ABSRACTObjective: Poor adherence to asthma therapy is a major problem in the management of asthma. We aimed to assess if a designed coaching program in children with asthma, coming from low socioeconomic background, will reduce respiratory morbidity and health care utilization.Methods: A prospective interventional pilot study enrolling children aged 3-18 years, admitted to Soroka University Medical Center (SUMC) between October 2015 and May 2016 due to asthma exacerbation. The intervention group was part of a coaching program, which was conducted by medical and paramedical personnel and included a diagnostic and personal educational office visit and a house visit by a nurse educator for asthma. The control group comprised of demographically matched children with asthma, who were admitted to the SUMC, but did not go through any intervention. Medications purchase and health care utilization were extracted from the participants' HMO databases, during 1-year of follow-up.Results: 41 children were enrolled to the intervention group, with 63 children as a control group. No differences were found in asthma-related drugs purchase, number of clinic visits, ER admissions and hospitalizations during the follow-up year, although the intervention group showed a trend towards having a shorter length of stay (2.3 vs. 4.5 days, Cohen's D = 0.44, p = 0.06). The intervention group demonstrated subjective improvement in asthma control, as reflected in Asthma Control Test questionnaires.Conclusions: In this pilot study of coaching program for children with asthma coming from low income families, no decrease in health care utilization was shown. Larger and longer intervention programs are needed.
Does participation in the community outreach for asthma care and healthy lifestyles (COACH) program alter subsequent use of hospital services for children discharged with asthma? [2021]Introduction: Transition from hospital to home is a challenging time for children with asthma and their caregivers because of the high risk for reutilization of acute hospital services. Detecting effective quality improvement initiatives to reduce utilization of urgent services in children discharged with asthma is an important clinical and public health question. This study was designed to identify the role of a multimodal, nurse-driven, inpatient initiated Community Outreach for Asthma Care and Healthy lifestyles (COACH) program on subsequent use of hospital services for pediatric patients with asthma.Methods: We utilized comparative effectiveness design to identify the difference in recurrent emergency department (ED) visits and/or admissions within 12-months after discharge between patients with asthma who engaged in the COACH program (Intervention group) and those who did not (Comparison group). We used administrative databases of hospitals included in the Meridian Health system to identify the number of and time to asthma-related readmissions and ED re-attendances.Results: We found no difference in the rate or number of recurrent hospital-based services used within 12 months, but found a reduction in ED re-visitation and/or readmission within 30 days for COACH program participants prior to and after adjustment for age, race/ethnicity, insurance status, and clinical presentation (Odd Ratio 0.44, 95% Confidence Interval 0.20, 0.93).Conclusion: Participation in the COACH program decreases the likelihood for subsequent use of hospital services within a month of discharge for children with asthma. Enhanced post-discharge interactions with families may reduce long-term reuse of hospital-based services for COACH program participants.
[The role of written action plans in the management of asthma]. [2021]The Written Action Plan is a tool designed to help people with asthma to manage their condition when they experience an exacerbation. Asthma guidelines are consistent in their recommendation that action plans are useful for all people with asthma, but implementation is not systematic. The evidence base for such plans is limited because of methodological biases, but does support their effectiveness. The recommended action plan involves different color-coded zones which advise patients to adjust their management, such as increasing the level of daily treatment, or introducing oral corticosteroids based on symptoms and peak expiratory flow measurements. Recommendations are much less clear as to how to encourage patients to adopt and take ownership of their plan, although they all recommend that written action plans be incorporated into therapeutic education programs. The published literature shows that those caring for people with asthma may not support action plans because they are uncomfortable with the necessary educational posture and as a consequence of this they are under-utilized by patients. Patient-centered therapeutic education principles help us understand both how to encourage the patient want to have a written action plan and how to co-create it with them so that it is useful and meaningful in their life in order to make it more than just a disconnected tool.
Wellness coaches in intervention delivery: pediatric asthma as an example. [2022]Asthma is the most common chronic illness among children, and parental psychosocial stress is a well-documented mediator of poor pediatric asthma outcomes. However, few interventions have targeted parental stress as a means for improving child asthma outcomes. The purpose of the study is to describe the feasibility and acceptability of the use of wellness coaches in a parent-focused stress management intervention in pediatric asthma. Data on the feasibility of wellness coach recruitment and training, intervention delivery and fidelity, and acceptability are provided from a randomized controlled trial intervention group sample of 107 African American parents of children aged 4-12 years (M = 6.6 years) with persistent asthma. Implementation of intervention strategies is described. Two wellness coaches were recruited and trained, and they conducted the four-session intervention for the study. The majority (79%) of possible intervention sessions were completed. The fidelity ratings of coach implementation of the intervention were high and indicated that 92%-95% of target intervention content was covered during the sessions. Participants reported high acceptability of working with the wellness coaches. Use of wellness coaches in a parent-focused stress management pediatric asthma intervention was feasible and acceptable. Using wellness coaches for parent interventions may be applicable across other pediatric conditions and has the potential to change clinical practice.
Inpatient asthma education program. [2022]Asthma is the second leading admitting diagnosis at Children's Hospital Boston (CHB), having an impact on many patients and families annually. To improve education for parents of patients hospitalized with asthma and increase health care providers' completion of individualized asthma action plans (AAPs), nurse experts established a comprehensive inpatient asthma education program based on the 2007 National Heart, Lung and Blood Institute/National Asthma Education and Prevention Program (NHLBI/NAEPP) guidelines. These guidelines recommend that caregivers teach and reinforce asthma education at every opportunity across the health care continuum. The paradigm of asthma education now embraces approaches that promote self-management (Shah, Roydhouse, & Sawyer, 2008), and AAPs are a key strategy in self-management education (Jones, 2008). The CHB inpatient program, led by the inpatient asthma nurse practitioner (IANP), combines several teaching strategies for parents and facilitates completion of individualized AAPs. Data collected since the start of the program show tremendous improvement in education and compliance with completion of individual AAPs before discharge.
Guideline-defining asthma clinical trials of the National Heart, Lung, and Blood Institute's Asthma Clinical Research Network and Childhood Asthma Research and Education Network. [2018]Because of an increasing prevalence, morbidity, and mortality associated with asthma, the National Heart, Lung, and Blood Institute created the Asthma Clinical Research Network and the Childhood Asthma Research and Education Network to improve public health. The objectives of these clinical research networks are to conduct multiple, well-designed clinical trials for rapid evaluation of new and existing therapeutic approaches to asthma and to disseminate laboratory and clinical findings to the health care community. These trials comprise a large proportion of the data driving the treatment guidelines established and reviewed by the National Asthma Education and Prevention Program. This article will review the basic design and major findings of selected Asthma Clinical Research Network and Childhood Asthma Research and Education Network trials involving both adults and children with asthma. Collectively, these studies have helped refine the therapeutic role of existing controller medications, establish standard models for side-effect evaluation and risk-benefit models, validate symptom-based assessments for asthma control, and identify baseline characteristics that might predict individual patient responses. Remaining challenges include shaping the role of novel therapeutics in future guidelines, incorporating pharmacogenomic data in treatment decisions, and establishing better implementation strategies for translation to community settings, all with the goal of reducing the asthma burden on society.
Asthma self-management education among youths and adults--United States, 2003. [2008]Asthma is a prevalent chronic respiratory disease and major cause of morbidity in the United States. However, with appropriate medication, medical care, and self-management, most asthma symptoms are preventable. Recent evidence indicates that asthma self-management education is effective in improving outcomes of chronic asthma. Guidelines issued by the National Asthma Education and Prevention Program (NAEPP) specify essential components of asthma management, including patient education, objective monitoring of symptoms, and avoiding asthma triggers. Healthy People 2010 objectives include increasing the proportion of persons with asthma who receive formal patient education from 8% to 30% (objective 24-6) and who receive care according to NAEPP guidelines (objective 24-7). The National Health Interview Survey (NHIS) routinely includes questions that assess asthma status. In 2003, the survey included a series of questions designed to reflect clinical best practices for asthma and to serve as a baseline assessment for progress toward national respiratory health objectives. These questions have not been repeated in any NHIS since 2003 but are scheduled to be included in the 2008 NHIS. To characterize asthma education among youths and adults with current asthma by selected demographic characteristics, CDC analyzed data from the 2003 NHIS. This report describes the results of that analysis, which indicated that the prevalence of asthma education varied by sex, age group, race/ethnicity, and health insurance status. The findings also suggest that a substantial proportion of youths and adults with current asthma lack the education necessary for effective self-management and control of asthma symptoms.
The Inner-City Asthma Intervention asthma counselor program: a collaborative model between physician and social worker to help empower families. [2019]The Inner-City Asthma Intervention (ICAI) asthma counselor program was modeled after interventions proven to be effective by the National Cooperative Inner-City Asthma Study (NCICAS) with inner-city children with asthma. The objective of the ICAI program was to translate and implement the NCICAS intervention into the real-world setting.
[Outcome of structured asthma education in childhood and adolescence]. [2009]From 1988 onwards inpatient asthma training courses have been conducted in Berlin and Osnabrück. A controlled study on asthma training was carried out from 1990 to 1992 at both centres with the support of the Robert Bosch Foundation. In the first intervention group a subsequent training course of 6 months' duration was conducted with the inclusion and participation of the relevant family doctors in addition to the main training course. Scrutiny of the result was done before (T1), directly after (T2) and 12 months subsequent to the training course (T3). Improvements are seen in somatic data or cost-relevant data (emergency referral to the hospital or family physician, inpatient hospital periods, referral because of mild obstruction, days of non-attendance in school due to illness, severity of asthma, incidence of symptoms, stress endurance in sports). There is also a marked improvement in the self-assessment ability of the children and in the management of asthma, as well as a decrease in the asthma-specific feeling of anxiety. Self-reliance and independence, as well as early intervention, are improved as seen by the parents, whereas on the other hand unfavourable factors such as arguments on the proper asthma therapy are diminished. Especially with regard to confidence in controls on the state of health or disease there are significant changes that are more marked in the group subjected to subsequent training than in the group without such additional training, compared with the control group. Structured asthma training exercises a strongly positive effect on the daily management of asthma bronchiale by the families on different planes of coping with the disease. These effects are enhanced by subsequent aftercare by the family physician. Intensive care in the asthma outpatient wards alone does not sufficiently modify the factors contributing to good coping with the disease.
A telephone coaching intervention to improve asthma self-management behaviors. [2022]Long recognizing that asthma, one of the most common chronic childhood diseases, is difficult to manage, the National Asthma Education Prevention Program developed clinical practice guidelines to assist health care providers, particularly those in the primary care setting. Yet, maintenance asthma care still fails to meet national standards. Therefore, in an attempt to improve and support asthma self-management behaviors for parents of children 5 to 12 years of age with persistent asthma, a novel nurse telephone coaching intervention was tested in a randomized, controlled trial. A detailed description of the intervention is provided along with parent satisfaction results, an overview of the training used to prepare the nurses, and a discussion of the challenges experienced and lessons learned.