Redesigning Ambulatory Care Delivery to Enhance Asthma Control in Children
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Asthma
- 发起方
- University of Utah
- 入组人数
- 926
- 试验地点
- 1
- 主要终点
- Patient Quality of Life (QOL), Compared Mean QOL Change From Baseline at Each Follow-up Assessment Between the Clinics Assigned to the Intensive and Standard e-AT Interventions
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
The investigators have developed a tool to facilitate asthma self-management in children, the electronic-AsthmaTracker (e-AT). The e-AT changes ambulatory asthma care delivery to a new model that is continuous and proactive, focusing on prevention and control, rather than reactive and focusing on management of asthma attacks. The e-AT 1) engages parents in weekly monitoring of their child's chronic asthma symptoms, 2) guides parents to recognize warning signs of asthma attacks in order to prompt appropriate interventions and timely visits to Primary Care Providers, and 3) provides Primary Care Providers with real-time, objective patient data to assess the effectiveness of asthma therapy and prompt adjustments. In a preliminary study of the paper-based version of the AT, frequent users had significantly fewer emergency department (ED) and hospital visits. Parent comments during the e-AT pilot testing revealed that the tool was useful in helping them manage their child's asthma and were interested in assessing the tool's effectiveness and in identifying and addressing barriers to their sustained use of the e-AT.
Improving asthma control in children will be facilitated by broad e-AT dissemination, and by identifying and addressing critical factors that contribute to parent sustained participation in self-management. The investigators propose to assess the effectiveness of the new ambulatory care model supported by the e-AT and conduct an e-AT process evaluation, assessing barriers and facilitators of sustained parent use. The investigators will engage parents throughout this study to identify and address themes that matter to them. The target population is children with persistent asthma, ages 2-17 years. The investigators have engaged 10 parents since conception of this project, from the planning to design and validation of the paper-AT, and the design and pilot testing of the e-AT. Input from parents was received through 3 iterative focus groups (one for the paper-AT and 2 for the e-AT) and facilitated discussions to inform the development of this proposal including research objectives and outcome measures. In addition, the investigators have recruited other key stakeholders for whom the results of the research will be relevant.
详细描述
Through the following specific aims, the investigators will: Aim 1: Assess the effectiveness of the new ambulatory care model, by comparing outcomes at the 1.a. child (child's quality of life (QOL), asthma control, missed school days), 1.b.parent (satisfaction, parent missed work days) and 1.c. clinic (ED/hospital visits) levels, between clinics randomly assigned to either the standard e-AT intervention vs. intensive e-AT intervention. 1.d. Use non randomized comparisons to determine the effectiveness of the e-AT relative to a control group (usual care) in which the e-AT was not used Aim 2: Assess the association of QOL, asthma control, and ED/hospital admissions with the prior frequency of e-AT use and assess if the association differs between parent subgroups (high vs. low literacy, Medicaid vs. private insurance, and frequent vs. less frequent e-AT users). Aim 3: Determine the association of demographic, socio-economic, behavioral, and technology factors with sustained parent participation in asthma self-management. The outcome measures are: Primary Outcome: 1. Child quality of life (QOL) Secondary Outcomes: 2. Child asthma control 3. Child interrupted/missed school days 4. Child use of oral steroids (surrogate measure of an asthma exacerbation) 5. Parent satisfaction with care 6. Parent interruption/missed work days 7. Clinics: ED/Hospital admissions
研究者
入排标准
入选标准
- 未提供
排除标准
- •As this is a pragmatic trial assessing evidence of the e-AT in a real clinical environment, no patients will be excluded as long as they meet inclusion criteria. However, during the time of analysis, we will conduct a sub-analysis, comparing the effectiveness of the new care model among patients with or without co-morbid conditions that may affect measured asthma outcomes. These include patients with a history or increased risk of pulmonary disease (cystic fibrosis, bronco-pulmonary dysplasia, aspiration pneumonia, severe Cerebral Palsy (CP) with aspiration risk, technology dependency (gastrostomy tube, tracheostomy), history of congenital heart disease requiring surgical correction or with complicating congestive heart failure requiring medical management, immunodeficiency (including patients on immunosuppressants), and malignancies.
结局指标
主要结局
Patient Quality of Life (QOL), Compared Mean QOL Change From Baseline at Each Follow-up Assessment Between the Clinics Assigned to the Intensive and Standard e-AT Interventions
时间窗: Quality of Life assessed at baseline, then compared to 3 months, 6 months, and 12 months after intervention.
Patient QOL and missed school days was collected longitudinally through surveys of the study population defined above. The QOL questionnaire included the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) and was used at baseline (at first assessment), 3, 6, and 12 months in the study. Items within QOL scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning.
Patient Quality of Life (QOL), Overall Longitudinal Change (From Baseline) Within All Subjects (Who Received the e-AT Intervention)
时间窗: Average Baseline QOL was compared to QOL scores at 3, 6 and 12 month follow-up QOL
Patient QOL and missed school days was collected longitudinally through surveys of the study population defined above. The QOL questionnaire included the Integrated Therapeutics Group Child Asthma Short Form - ITG-CASF and was used at baseline (at first assessment), 3, 6, and 12 months in the study. Items within scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning.
次要结局
- Parent Satisfaction With Care, Overall (Change Overtime From Baseline to 12 Months)(Satisfaction at 1 year following e-AT use was compared to baseline satisfaction scores)
- Parent Interrupted/Missed Work Days, Standard vs Intensive(Interrupted/missed work days were measured baseline 3, 6, and 12 months)
- Parent Satisfaction With Care, Standard vs Intensive(Changes in satisfaction was compared between 12 month follow-up and baseline satisfaction across Standard and Intensive interventions)
- Child Interrupted/Missed School Days, Standard vs Intensive(Interrupted/missed school days were collected at baseline, 3, 6, and 12 month follow-ups)
- Oral Steroid Use, Early vs. Late Patients(1 year)
- ED/Hospital Admission, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Used the e-AT)(3-month period prior to the late clinics starting the e-AT)
- Child Asthma Control Overall (Comparing Change of Asthma Control From Baseline to Quarter 1, Quarter 2, Quarter 3 and Quarter 4)(baseline ACT scores were compared to quarters 1, 2, 3, 4.)
- Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime)(1 year)
- ED/Hospital Admission, Early vs. Late Patients(1 year following e-AT use for early and late starting patients)
- Emergency Department (ED)/Hospitalization, Standard vs Intensive(Change in 1 year ED/hospital admission between 12-month prior and 12 month post e-AT use)
- Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime)(1 year)
- ED/Hospital Admissions, e-AT Overall (Pre vs. Post e-AT Use Within Subjects That Received the e-AT Intervention)(1 year)
- Asthma Control Change, Standard vs Intensive(Average baseline ACT scores compared to average ACT scores at quarter 1, 2, 3 and 4, and between Standard vs. Intensive)
- Use of Oral Steroid, Overall(1 year)
- Oral Steroid Use, e-AT vs Usual Care(1 year)
- Oral Steroid Use, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Started the e-AT)(3 month period prior to the late clinics starting the e-AT)
- ED/Hospital Admissions, e-AT vs Usual Care(1 year)