Asthma
Conditions
Keywords
Self-Management, Asthma
Brief 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.
Detailed description
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
Interventions
OTHERExperimental: Standard vs Intensive e-AT Intervention
Patients will be self-monitoring their symptoms weekly using the e-AT, either the Standard or Intensive versions of the e-AT, completing the Asthma Control Test. As patients complete their assessments each week, the clinics will be able to see how each patient is doing, and follow-up when a patient is showing high symptoms for that week, potentially avoiding Emergency Room visit, and/or hospitalization.
Sponsors
Patient-Centered Outcomes Research Institute
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
We initially enrolled 327 randomized (at the clinic level) participants who received the e-AT interventions overall, including 267 participants receiving the standard intervention and 60 receiving the intensive intervention. We also included another set of 599 non-randomized matched controls of patients with persistent asthma retrieved electronically from non-participating clinics. This is why we stated that 926 subjects (327+599) overall were included.
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
Facility Eligibility Clinics are eligible for participation if they meet the following criteria: 1. Primary care clinics with the clinical leadership to adopt use of e-AT for asthma management. 2. Have patients between 2 and 17 years of age with persistent asthma. 3. Ability of the facility to accommodate patient enrollment and training about use of e-AT. Patient Inclusion Criteria 1. Children ages 2 through 17 years and their parents (main parents or caregiver) 2. English speakers 3. Children who received or are receiving asthma treatment (at participating clinics). 4. Parents have Internet access 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent Interrupted/Missed Work Days, Standard vs Intensive | Interrupted/missed work days were measured baseline 3, 6, and 12 months | Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study. Number of parent interrupted/missed work days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted. |
| 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 | Asthma control information was collected weekly through the e-AT for 1 year. Asthma control was measured using the Asthma Control Test (ACT), which had a score ranging from 5 to 25, with 5 being poor control and 25 being optimal control. The analysis compared the mean change in scores from baseline to quarters 1, 2, 3, and 4. |
| 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 | ED and hospital admissions were evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. We evaluated number ED and hospital admissions 12 months prior to intervention and 12 months post intervention |
| 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 satisfaction data was collected using a modified version of patient satisfaction survey developed and validated by Varni et al. at baseline and at 12 months in the study. The scale ranged from 1-5, with 1=Very Dissatisfied and 5=Very Satisfied. |
| 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. | Asthma control information was collected through the e-AT, comparing change of asthma control from baseline to quarter 1, quarter 2, quarter 3 and quarter 4. Asthma control was measured using the Asthma Control Test (ACT), which scale ranged from 5-25, with 5=poorly controlled and 25=well controlled. Each patient submitted an ACT score weekly for 12 months. |
| Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime) | 1 year | Number of child interrupted/missed school days were collected longitudinally (information includes mean at baseline, 3, 6, and 12 months in the study). |
| Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime) | 1 year | Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: Information includes mean at baseline, 3, 6, and 12 months in the study. |
| 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 | Parent satisfaction data was collected at baseline and at 12 months in the study. The scale ranges from 1-5, with 1 being Very Dissatisfied and 5 Very Satisfied. |
| Use of Oral Steroid, Overall | 1 year | Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Comparison was made between prior and post e-AT (both interventions) overall. |
| ED/Hospital Admission, Early vs. Late Patients | 1 year following e-AT use for early and late starting patients | ED and hospital admission was evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Analyses (at the patient level) comparing the rates of ED/hospital admissions between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of ED/hospital admissions for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT. |
| Oral Steroid Use, Early vs. Late Patients | 1 year | Oral steroid use data was collected through Intermountain Healthcare claims data and clinics prescribing oral steroid. Oral steroid use was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Analyses (at the patient level) comparing the rates oral steroid use between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of oral steroid use for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT. |
| 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 | ED and hospital admission evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants. |
| 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 | Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants |
| ED/Hospital Admissions, e-AT vs Usual Care | 1 year | Non randomized comparison of ED and hospital admissions between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods. |
| Oral Steroid Use, e-AT vs Usual Care | 1 year | Non randomized comparison of use of oral steroid between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods. |
| ED/Hospital Admissions, e-AT Overall (Pre vs. Post e-AT Use Within Subjects That Received the e-AT Intervention) | 1 year | ED/hospital re-admission data were compared between prior and post 12 month period (for both intensive and standard interventions overall) when e-AT was administered. |
| Child Interrupted/Missed School Days, Standard vs Intensive | Interrupted/missed school days were collected at baseline, 3, 6, and 12 month follow-ups | Number of child interrupted/missed school days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study. Number of child interrupted/missed school days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard e-AT Intervention Patients in Standard e-AT intervention group will be using the standard version of e-AT. | 267 |
| Intensive e-AT Intervention Participants in the intensive e-AT intervention group will be using an enhanced version of the standard e-AT, i.e. addition of progress bar indicating the patients' status of completing 4 scores in a month, fireworks when they reach 100% on the progress bar, a leaderboard to compare their own status among other e-AT users. | 60 |
| Usual Care (Non-Randomized Cohort) Both arms (Intensive and standard e-AT interventions) will be compared to each other as well as to a non-randomized cohort who did not receive the e-AT interventions. These non-randomized cohort will be matched 2:1 to each randomized individuals. | 599 |
| Total | 926 |
Baseline characteristics
| Characteristic | Usual Care (Non-Randomized Cohort) | Total | Standard e-AT Intervention | Intensive e-AT Intervention |
|---|---|---|---|---|
| Age, Categorical <=18 years | 599 Participants | 926 Participants | 267 Participants | 60 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.04 years STANDARD_DEVIATION 3.86 | 7.97 years STANDARD_DEVIATION 3.89 | 8.12 years STANDARD_DEVIATION 3.99 | 7.18 years STANDARD_DEVIATION 8.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 72 Participants | 116 Participants | 40 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 520 Participants | 789 Participants | 216 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 21 Participants | 11 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 11 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 15 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 33 Participants | 9 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 9 Participants | 16 Participants | 7 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 40 Participants | 20 Participants | 6 Participants |
| Race (NIH/OMB) White | 537 Participants | 811 Participants | 223 Participants | 51 Participants |
| Region of Enrollment United States | 599 Participants | 926 Participants | 267 Participants | 60 Participants |
| Sex: Female, Male Female | 228 Participants | 361 Participants | 110 Participants | 23 Participants |
| Sex: Female, Male Male | 371 Participants | 565 Participants | 157 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 267 | 0 / 60 | 0 / 599 |
| serious Total, serious adverse events | 0 / 267 | 0 / 60 | 0 / 599 |
Outcome results
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
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.
Time frame: Quality of Life assessed at baseline, then compared to 3 months, 6 months, and 12 months after intervention.
Population: We enrolled 327, 2 clinics with only 1 patient enrolled were excluded, leaving 325 patients. Of 325, 7 did not provide baselines and were excluded, leaving 318 (261 standard vs. 57 intensive) participants. Row numbers differ due to different number of participants completing 3, 6, and 12 months follow-ups, due to withdrawal and loss to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard e-AT Intervention | 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 | 3 Months Follow-up vs Baseline | 8.55 Units on a scale | Standard Error 0.97 |
| Standard e-AT Intervention | 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 | 6 Months Follow-up compared vs Baseline | 8.37 Units on a scale | Standard Error 0.86 |
| Standard e-AT Intervention | 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 | 12 Months Follow-up vs Baseline | 9.39 Units on a scale | Standard Error 0.76 |
| Intensive e-AT Intervention | 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 | 3 Months Follow-up vs Baseline | 7.64 Units on a scale | Standard Error 2.53 |
| Intensive e-AT Intervention | 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 | 6 Months Follow-up compared vs Baseline | 5.78 Units on a scale | Standard Error 1.94 |
| Intensive e-AT Intervention | 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 | 12 Months Follow-up vs Baseline | 9.29 Units on a scale | Standard Error 1.8 |
Primary
Patient Quality of Life (QOL), Overall Longitudinal Change (From Baseline) Within All Subjects (Who Received the e-AT 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 scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning.
Time frame: Average Baseline QOL was compared to QOL scores at 3, 6 and 12 month follow-up QOL
Population: The numbers analyzed in the rows are different due to different number of participants completing the surveys throughout 3, 6, and 12 months. This was due to withdrawal from the study or loss to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard e-AT Intervention | Patient Quality of Life (QOL), Overall Longitudinal Change (From Baseline) Within All Subjects (Who Received the e-AT Intervention) | Baseline | 79.07 units (points) on a scale, range 0-100 | Standard Deviation 14.2 |
| Standard e-AT Intervention | Patient Quality of Life (QOL), Overall Longitudinal Change (From Baseline) Within All Subjects (Who Received the e-AT Intervention) | 3 Months | 90.98 units (points) on a scale, range 0-100 | Standard Deviation 9.54 |
| Standard e-AT Intervention | Patient Quality of Life (QOL), Overall Longitudinal Change (From Baseline) Within All Subjects (Who Received the e-AT Intervention) | 6 Months | 90.04 units (points) on a scale, range 0-100 | Standard Deviation 11.12 |
| Standard e-AT Intervention | Patient Quality of Life (QOL), Overall Longitudinal Change (From Baseline) Within All Subjects (Who Received the e-AT Intervention) | 12 Months | 90.64 units (points) on a scale, range 0-100 | Standard Deviation 10.34 |
Secondary
Asthma Control Change, Standard vs Intensive
Asthma control information was collected weekly through the e-AT for 1 year. Asthma control was measured using the Asthma Control Test (ACT), which had a score ranging from 5 to 25, with 5 being poor control and 25 being optimal control. The analysis compared the mean change in scores from baseline to quarters 1, 2, 3, and 4.
Time frame: Average baseline ACT scores compared to average ACT scores at quarter 1, 2, 3 and 4, and between Standard vs. Intensive
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard e-AT Intervention | Asthma Control Change, Standard vs Intensive | Qtr 1 vs baseline | 2.55 mean score (points) change | Standard Error 0.12 |
| Standard e-AT Intervention | Asthma Control Change, Standard vs Intensive | Qtr 2 vs baseline | 3.09 mean score (points) change | Standard Error 0.1 |
| Standard e-AT Intervention | Asthma Control Change, Standard vs Intensive | Qtr 3 vs baseline | 3.26 mean score (points) change | Standard Error 0.09 |
| Standard e-AT Intervention | Asthma Control Change, Standard vs Intensive | Qtr 4 vs baseline | 3.33 mean score (points) change | Standard Error 0.1 |
| Intensive e-AT Intervention | Asthma Control Change, Standard vs Intensive | Qtr 4 vs baseline | 3.30 mean score (points) change | Standard Error 0.22 |
| Intensive e-AT Intervention | Asthma Control Change, Standard vs Intensive | Qtr 1 vs baseline | 1.78 mean score (points) change | Standard Error 0.35 |
| Intensive e-AT Intervention | Asthma Control Change, Standard vs Intensive | Qtr 3 vs baseline | 2.18 mean score (points) change | Standard Error 0.23 |
| Intensive e-AT Intervention | Asthma Control Change, Standard vs Intensive | Qtr 2 vs baseline | 2.18 mean score (points) change | Standard Error 0.3 |
Secondary
Child Asthma Control Overall (Comparing Change of Asthma Control From Baseline to Quarter 1, Quarter 2, Quarter 3 and Quarter 4)
Asthma control information was collected through the e-AT, comparing change of asthma control from baseline to quarter 1, quarter 2, quarter 3 and quarter 4. Asthma control was measured using the Asthma Control Test (ACT), which scale ranged from 5-25, with 5=poorly controlled and 25=well controlled. Each patient submitted an ACT score weekly for 12 months.
Time frame: baseline ACT scores were compared to quarters 1, 2, 3, 4.
Population: Patients were told to submit an ACT score once a week for 12 months. 311 patients completed at least one ACT score for a total number of 11418 ACT scores submitted using e-AT by all e-AT users (during study period).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard e-AT Intervention | Child Asthma Control Overall (Comparing Change of Asthma Control From Baseline to Quarter 1, Quarter 2, Quarter 3 and Quarter 4) | Baseline | 18.85 Score (points) ranging from 5-25 | Standard Deviation 5.49 |
| Standard e-AT Intervention | Child Asthma Control Overall (Comparing Change of Asthma Control From Baseline to Quarter 1, Quarter 2, Quarter 3 and Quarter 4) | Quarter 1 | 22.28 Score (points) ranging from 5-25 | Standard Deviation 3.25 |
| Standard e-AT Intervention | Child Asthma Control Overall (Comparing Change of Asthma Control From Baseline to Quarter 1, Quarter 2, Quarter 3 and Quarter 4) | Quarter 2 | 22.82 Score (points) ranging from 5-25 | Standard Deviation 2.95 |
| Standard e-AT Intervention | Child Asthma Control Overall (Comparing Change of Asthma Control From Baseline to Quarter 1, Quarter 2, Quarter 3 and Quarter 4) | Quarter 3 | 22.81 Score (points) ranging from 5-25 | Standard Deviation 2.98 |
| Standard e-AT Intervention | Child Asthma Control Overall (Comparing Change of Asthma Control From Baseline to Quarter 1, Quarter 2, Quarter 3 and Quarter 4) | Quarter 4 | 22.97 Score (points) ranging from 5-25 | Standard Deviation 2.76 |
Secondary
Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime)
Number of child interrupted/missed school days were collected longitudinally (information includes mean at baseline, 3, 6, and 12 months in the study).
Time frame: 1 year
Population: The numbers analyzed in the rows are different due to different number of participants completing the surveys throughout 3, 6, and 12 months. This was due to either compliance, withdrawal or loss to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard e-AT Intervention | Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime) | Baseline | 1.91 Number of days (interrupted or missed) | Standard Deviation 5.18 |
| Standard e-AT Intervention | Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime) | 3 Months Follow-up | 0.80 Number of days (interrupted or missed) | Standard Deviation 2.07 |
| Standard e-AT Intervention | Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime) | 6 Months Follow-up | 0.52 Number of days (interrupted or missed) | Standard Deviation 1.34 |
| Standard e-AT Intervention | Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime) | 12 Months Follow-up | 0.79 Number of days (interrupted or missed) | Standard Deviation 2.06 |
Secondary
Child Interrupted/Missed School Days, Standard vs Intensive
Number of child interrupted/missed school days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study. Number of child interrupted/missed school days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted.
Time frame: Interrupted/missed school days were collected at baseline, 3, 6, and 12 month follow-ups
Population: We had 261 Standard and 57 Intensive e-AT who completed baseline survey. Numbers in the row differ due to different number of participants who completed 3, 6, and 12 months surveys, due to participant compliance, withdrawal or loss-to-follow-up. 3, 6, and 12 month measurements were compared to Baseline, between Standard vs Intensive interventions
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard e-AT Intervention | Child Interrupted/Missed School Days, Standard vs Intensive | Baseline | 435 Number of interrupted/missed school days |
| Standard e-AT Intervention | Child Interrupted/Missed School Days, Standard vs Intensive | 3 Months Follow-up | 114 Number of interrupted/missed school days |
| Standard e-AT Intervention | Child Interrupted/Missed School Days, Standard vs Intensive | 6 Months Follow-up | 87 Number of interrupted/missed school days |
| Standard e-AT Intervention | Child Interrupted/Missed School Days, Standard vs Intensive | 12 Months Follow-up | 129 Number of interrupted/missed school days |
| Intensive e-AT Intervention | Child Interrupted/Missed School Days, Standard vs Intensive | 12 Months Follow-up | 37 Number of interrupted/missed school days |
| Intensive e-AT Intervention | Child Interrupted/Missed School Days, Standard vs Intensive | Baseline | 129 Number of interrupted/missed school days |
| Intensive e-AT Intervention | Child Interrupted/Missed School Days, Standard vs Intensive | 6 Months Follow-up | 30 Number of interrupted/missed school days |
| Intensive e-AT Intervention | Child Interrupted/Missed School Days, Standard vs Intensive | 3 Months Follow-up | 60 Number of interrupted/missed school days |
Secondary
ED/Hospital Admission, Early vs. Late Patients
ED and hospital admission was evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Analyses (at the patient level) comparing the rates of ED/hospital admissions between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of ED/hospital admissions for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT.
Time frame: 1 year following e-AT use for early and late starting patients
Population: Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Patients) assesses e-AT efficacy, comparing outcomes between period patients were under the e-AT vs periods other patients were not using the e-AT.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard e-AT Intervention | ED/Hospital Admission, Early vs. Late Patients | 0.10 number of ED/Hospital admission | Standard Deviation 0.38 |
| Intensive e-AT Intervention | ED/Hospital Admission, Early vs. Late Patients | 0.18 number of ED/Hospital admission | Standard Deviation 0.1 |
Secondary
ED/Hospital Admission, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Used the e-AT)
ED and hospital admission evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants.
Time frame: 3-month period prior to the late clinics starting the e-AT
Population: Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Clinics) assesses e-AT efficacy, comparing outcomes between period clinics were under the e-AT vs periods other clinics were not using the e-AT.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard e-AT Intervention | ED/Hospital Admission, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Used the e-AT) | 2 number of ED/Hospital admission |
| Intensive e-AT Intervention | ED/Hospital Admission, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Used the e-AT) | 0 number of ED/Hospital admission |
Secondary
ED/Hospital Admissions, e-AT Overall (Pre vs. Post e-AT Use Within Subjects That Received the e-AT Intervention)
ED/hospital re-admission data were compared between prior and post 12 month period (for both intensive and standard interventions overall) when e-AT was administered.
Time frame: 1 year
Population: Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard e-AT Intervention | ED/Hospital Admissions, e-AT Overall (Pre vs. Post e-AT Use Within Subjects That Received the e-AT Intervention) | 0.22 number of ED/hospital admission | Standard Deviation 0.6 |
| Intensive e-AT Intervention | ED/Hospital Admissions, e-AT Overall (Pre vs. Post e-AT Use Within Subjects That Received the e-AT Intervention) | 0.09 number of ED/hospital admission | Standard Deviation 0.35 |
Secondary
ED/Hospital Admissions, e-AT vs Usual Care
Non randomized comparison of ED and hospital admissions between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods.
Time frame: 1 year
Population: Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) e-AT participants and 599 matched controls retrieved electronically from non-participating clinics.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard e-AT Intervention | ED/Hospital Admissions, e-AT vs Usual Care | Prior | 0.59 Rate per 1000-days | Standard Deviation 1.64 |
| Standard e-AT Intervention | ED/Hospital Admissions, e-AT vs Usual Care | Post | 0.24 Rate per 1000-days | Standard Deviation 0.97 |
| Intensive e-AT Intervention | ED/Hospital Admissions, e-AT vs Usual Care | Prior | 0.23 Rate per 1000-days | Standard Deviation 1.01 |
| Intensive e-AT Intervention | ED/Hospital Admissions, e-AT vs Usual Care | Post | 0.24 Rate per 1000-days | Standard Deviation 0.97 |
Secondary
Emergency Department (ED)/Hospitalization, Standard vs Intensive
ED and hospital admissions were evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. We evaluated number ED and hospital admissions 12 months prior to intervention and 12 months post intervention
Time frame: Change in 1 year ED/hospital admission between 12-month prior and 12 month post e-AT use
Population: Number of pre- and post e-AT ED and hospital admissions were compared between standard and intensive groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard e-AT Intervention | Emergency Department (ED)/Hospitalization, Standard vs Intensive | Prior | 53 Number of ED/hospital admissions |
| Standard e-AT Intervention | Emergency Department (ED)/Hospitalization, Standard vs Intensive | Post | 21 Number of ED/hospital admissions |
| Intensive e-AT Intervention | Emergency Department (ED)/Hospitalization, Standard vs Intensive | Prior | 18 Number of ED/hospital admissions |
| Intensive e-AT Intervention | Emergency Department (ED)/Hospitalization, Standard vs Intensive | Post | 8 Number of ED/hospital admissions |
Secondary
Oral Steroid Use, Early vs. Late Patients
Oral steroid use data was collected through Intermountain Healthcare claims data and clinics prescribing oral steroid. Oral steroid use was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Analyses (at the patient level) comparing the rates oral steroid use between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of oral steroid use for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT.
Time frame: 1 year
Population: Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Patients) assesses e-AT efficacy, comparing outcomes between period patients were under the e-AT vs periods other patients were not using the e-AT.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard e-AT Intervention | Oral Steroid Use, Early vs. Late Patients | 0.53 number of oral steroid use | Standard Deviation 0.99 |
| Intensive e-AT Intervention | Oral Steroid Use, Early vs. Late Patients | 0.53 number of oral steroid use | Standard Deviation 0.92 |
Secondary
Oral Steroid Use, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Started the e-AT)
Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants
Time frame: 3 month period prior to the late clinics starting the e-AT
Population: Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Clinics) assesses e-AT efficacy, comparing outcomes between period clinics were under the e-AT vs periods other clinics were not using the e-AT.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard e-AT Intervention | Oral Steroid Use, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Started the e-AT) | 4 number of oral steroid use |
| Intensive e-AT Intervention | Oral Steroid Use, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Started the e-AT) | 0 number of oral steroid use |
Secondary
Oral Steroid Use, e-AT vs Usual Care
Non randomized comparison of use of oral steroid between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods.
Time frame: 1 year
Population: Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) e-AT participants and 599 matched controls retrieved electronically from non-participating clinics.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard e-AT Intervention | Oral Steroid Use, e-AT vs Usual Care | Prior | 2.02 Rate per 1000-days | Standard Deviation 3.14 |
| Standard e-AT Intervention | Oral Steroid Use, e-AT vs Usual Care | Post | 1.41 Rate per 1000-days | Standard Deviation 2.6 |
| Intensive e-AT Intervention | Oral Steroid Use, e-AT vs Usual Care | Prior | 1.87 Rate per 1000-days | Standard Deviation 3.12 |
| Intensive e-AT Intervention | Oral Steroid Use, e-AT vs Usual Care | Post | 1.99 Rate per 1000-days | Standard Deviation 7.89 |
Secondary
Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime)
Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: Information includes mean at baseline, 3, 6, and 12 months in the study.
Time frame: 1 year
Population: The numbers analyzed in the rows are different due to different number of participants completing the surveys throughout 3, 6, and 12 months. This was due to either compliance, withdrawal or loss to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard e-AT Intervention | Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime) | Baseline | 0.72 Number of days (interrupted or missed) | Standard Deviation 1.89 |
| Standard e-AT Intervention | Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime) | 3 Months Follow-up | 0.27 Number of days (interrupted or missed) | Standard Deviation 0.99 |
| Standard e-AT Intervention | Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime) | 6 Months Follow-Up | 0.25 Number of days (interrupted or missed) | Standard Deviation 1.02 |
| Standard e-AT Intervention | Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime) | 12 Months Follow-up | 0.20 Number of days (interrupted or missed) | Standard Deviation 0.83 |
Secondary
Parent Interrupted/Missed Work Days, Standard vs Intensive
Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study. Number of parent interrupted/missed work days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted.
Time frame: Interrupted/missed work days were measured baseline 3, 6, and 12 months
Population: We had 261 Standard and 57 Intensive e-AT who completed baseline survey. Numbers in the row differ due to different number of participants who completed 3, 6, and 12 months surveys, due to participant compliance, withdrawal or loss-to-follow-up. 3, 6, and 12 month measurements were compared to Baseline, between Standard vs Intensive interventions
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard e-AT Intervention | Parent Interrupted/Missed Work Days, Standard vs Intensive | Baseline | 176 Number of interrupted/missed work days |
| Standard e-AT Intervention | Parent Interrupted/Missed Work Days, Standard vs Intensive | 3 Months Follow-up | 44 Number of interrupted/missed work days |
| Standard e-AT Intervention | Parent Interrupted/Missed Work Days, Standard vs Intensive | 6 Months Follow-up | 42 Number of interrupted/missed work days |
| Standard e-AT Intervention | Parent Interrupted/Missed Work Days, Standard vs Intensive | 12 Months Follow-up | 23 Number of interrupted/missed work days |
| Intensive e-AT Intervention | Parent Interrupted/Missed Work Days, Standard vs Intensive | 12 Months Follow-up | 18 Number of interrupted/missed work days |
| Intensive e-AT Intervention | Parent Interrupted/Missed Work Days, Standard vs Intensive | Baseline | 56 Number of interrupted/missed work days |
| Intensive e-AT Intervention | Parent Interrupted/Missed Work Days, Standard vs Intensive | 6 Months Follow-up | 15 Number of interrupted/missed work days |
| Intensive e-AT Intervention | Parent Interrupted/Missed Work Days, Standard vs Intensive | 3 Months Follow-up | 14 Number of interrupted/missed work days |
Secondary
Parent Satisfaction With Care, Overall (Change Overtime From Baseline to 12 Months)
Parent satisfaction data was collected using a modified version of patient satisfaction survey developed and validated by Varni et al. at baseline and at 12 months in the study. The scale ranged from 1-5, with 1=Very Dissatisfied and 5=Very Satisfied.
Time frame: Satisfaction at 1 year following e-AT use was compared to baseline satisfaction scores
Population: We had 318 participants who have completed the baseline satisfaction survey, and 208 who completed 12 months follow-up survey, due to participants withdrawing from the study and loss to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard e-AT Intervention | Parent Satisfaction With Care, Overall (Change Overtime From Baseline to 12 Months) | Baseline | 4.66 units (points) on a scale (from 1-5) | Standard Deviation 0.51 |
| Standard e-AT Intervention | Parent Satisfaction With Care, Overall (Change Overtime From Baseline to 12 Months) | 12 months Follow-up | 4.46 units (points) on a scale (from 1-5) | Standard Deviation 0.53 |
Secondary
Parent Satisfaction With Care, Standard vs Intensive
Parent satisfaction data was collected at baseline and at 12 months in the study. The scale ranges from 1-5, with 1 being Very Dissatisfied and 5 Very Satisfied.
Time frame: Changes in satisfaction was compared between 12 month follow-up and baseline satisfaction across Standard and Intensive interventions
Population: We had 261 in Standard e-AT and 57 in Intensive e-AT who completed baseline survey, and 166 in Standard e-AT and 42 in Intensive e-AT completed the 12 Months Follow-up Survey. This is due to participant withdrawal and loss to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Standard e-AT Intervention | Parent Satisfaction With Care, Standard vs Intensive | Baseline | 4.63 units (points) on a scale (from 1-5) |
| Standard e-AT Intervention | Parent Satisfaction With Care, Standard vs Intensive | 12 months Follow-up | 4.38 units (points) on a scale (from 1-5) |
| Intensive e-AT Intervention | Parent Satisfaction With Care, Standard vs Intensive | Baseline | 4.63 units (points) on a scale (from 1-5) |
| Intensive e-AT Intervention | Parent Satisfaction With Care, Standard vs Intensive | 12 months Follow-up | 4.54 units (points) on a scale (from 1-5) |
Secondary
Use of Oral Steroid, Overall
Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Comparison was made between prior and post e-AT (both interventions) overall.
Time frame: 1 year
Population: Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard e-AT Intervention | Use of Oral Steroid, Overall | 0.74 number of oral steroid use | Standard Deviation 1.15 |
| Intensive e-AT Intervention | Use of Oral Steroid, Overall | 0.51 number of oral steroid use | Standard Deviation 0.95 |