N/A
N=926
Redesigning Ambulatory Care Delivery to Enhance Asthma Control in Children
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02409277 ↗Enrolled (actual)
926
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: 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 — 8.55; 7.64; 8.37; 5.78 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental: Standard vs Intensive e-AT Intervention (Other)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
8.55; 7.64; 8.37; 5.78; 9.39; 9.29 | — |
| PRIMARY Patient Quality of Life (QOL), Overall Longitudinal Change (From Baseline) Within All Subjects (Who Received the e-AT Intervention) |
79.07; 90.98; 90.04; 90.64 | — |
| SECONDARY Parent Satisfaction With Care, Standard vs Intensive |
4.63; 4.63; 4.38; 4.54 | — |
| SECONDARY Child Interrupted/Missed School Days, Standard vs Intensive |
435; 129; 114; 60; 87; 30 | — |
| SECONDARY Parent Interrupted/Missed Work Days, Standard vs Intensive |
176; 56; 44; 14; 42; 15 | — |
| SECONDARY Asthma Control Change, Standard vs Intensive |
2.55; 1.78; 3.09; 2.18; 3.26; 2.18 | — |
| SECONDARY Emergency Department (ED)/Hospitalization, Standard vs Intensive |
53; 18; 21; 8 | — |
| SECONDARY Parent Satisfaction With Care, Overall (Change Overtime From Baseline to 12 Months) |
4.66; 4.46 | — |
| SECONDARY Child Asthma Control Overall (Comparing Change of Asthma Control From Baseline to Quarter 1, Quarter 2, Quarter 3 and Quarter 4) |
18.85; 22.28; 22.82; 22.81; 22.97 | — |
| SECONDARY Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime) |
1.91; 0.80; 0.52; 0.79 | — |
| SECONDARY Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime) |
0.72; 0.27; 0.25; 0.20 | — |
| SECONDARY ED/Hospital Admissions, e-AT Overall (Pre vs. Post e-AT Use Within Subjects That Received the e-AT Intervention) |
0.22; 0.09 | — |
| SECONDARY Use of Oral Steroid, Overall |
0.74; 0.51 | — |
| SECONDARY ED/Hospital Admission, Early vs. Late Patients |
0.10; 0.18 | — |
| SECONDARY Oral Steroid Use, Early vs. Late Patients |
0.53; 0.53 | — |
| SECONDARY ED/Hospital Admission, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Used the e-AT) |
2; 0 | — |
| SECONDARY Oral Steroid Use, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Started the e-AT) |
4; 0 | — |
| SECONDARY ED/Hospital Admissions, e-AT vs Usual Care |
0.59; 0.23; 0.24; 0.24 | — |
| SECONDARY Oral Steroid Use, e-AT vs Usual Care |
2.02; 1.87; 1.41; 1.99 | — |
Summary
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.
Eligibility Criteria
Facility Eligibility
Clinics are eligible for participation if they meet the following criteria:
- Primary care clinics with the clinical leadership to adopt use of e-AT for asthma management.
- Have patients between 2 and 17 years of age with persistent asthma.
- Ability of the facility to accommodate patient enrollment and training about use of e-AT.
Patient Inclusion Criteria
- Children ages 2 through 17 years and their parents (main parents or caregiver)
- English speakers
- Children who received or are receiving asthma treatment (at participating clinics).
- Parents have Internet access
- Children with persistent asthma.
Patient Exclusion Criteria:
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.
Data sourced from ClinicalTrials.gov (NCT02409277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.