Trial Outcomes & Findings for Redesigning Ambulatory Care Delivery to Enhance Asthma Control in Children (NCT NCT02409277)

NCT ID: NCT02409277

Last Updated: 2020-02-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 926 participants
• Primary outcome timeframe: Quality of Life assessed at baseline, then compared to 3 months, 6 months, and 12 months after intervention.
• Results posted on: 2020-02-05

Participant Flow

Participant milestones

Measure	Standard e-Asthma Tracker (e-AT) Intervention Patients in Standard e-AT intervention group will be using the standard version of e-AT	Intensive e-Asthma Tracker (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.	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.
Overall Study STARTED	267	60	599
Overall Study 3 Months Follow-up	178	40	599
Overall Study 6 Months Follow-up	182	42	599
Overall Study 12 Months Follow-up	167	43	599
Overall Study COMPLETED	167	43	599
Overall Study NOT COMPLETED	100	17	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Redesigning Ambulatory Care Delivery to Enhance Asthma Control in Children

Baseline characteristics by cohort

Measure	Standard e-AT Intervention n=267 Participants Patients in Standard e-AT intervention group will be using the standard version of e-AT.	Intensive e-AT Intervention n=60 Participants 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.	Usual Care (Non-Randomized Cohort) n=599 Participants 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.	Total n=926 Participants Total of all reporting groups
Age, Categorical <=18 years	267 Participants n=5 Participants	60 Participants n=7 Participants	599 Participants n=5 Participants	926 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	8.12 years STANDARD_DEVIATION 3.99 • n=5 Participants	7.18 years STANDARD_DEVIATION 8.12 • n=7 Participants	8.04 years STANDARD_DEVIATION 3.86 • n=5 Participants	7.97 years STANDARD_DEVIATION 3.89 • n=4 Participants
Sex: Female, Male Female	110 Participants n=5 Participants	23 Participants n=7 Participants	228 Participants n=5 Participants	361 Participants n=4 Participants
Sex: Female, Male Male	157 Participants n=5 Participants	37 Participants n=7 Participants	371 Participants n=5 Participants	565 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=5 Participants	4 Participants n=7 Participants	72 Participants n=5 Participants	116 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	216 Participants n=5 Participants	53 Participants n=7 Participants	520 Participants n=5 Participants	789 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	21 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	11 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	7 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	1 Participants n=7 Participants	23 Participants n=5 Participants	33 Participants n=4 Participants
Race (NIH/OMB) White	223 Participants n=5 Participants	51 Participants n=7 Participants	537 Participants n=5 Participants	811 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants	40 Participants n=4 Participants
Region of Enrollment United States	267 Participants n=5 Participants	60 Participants n=7 Participants	599 Participants n=5 Participants	926 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Standard e-AT Intervention n=261 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention n=57 Participants Participants in the intensive e-AT intervention group 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.
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	7.64 Units on a scale Standard Error 2.53
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	5.78 Units on a scale Standard Error 1.94
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	9.29 Units on a scale Standard Error 1.80

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Standard e-AT Intervention n=318 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention Participants in the intensive e-AT intervention group 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.
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 14.20	—
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	—
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	—
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 outcome

Timeframe: 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.

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".

Outcome measures

Measure	Standard e-AT Intervention n=261 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention n=57 Participants Participants in the intensive e-AT intervention group 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.
Parent Satisfaction With Care, Standard vs Intensive Baseline	4.63 units (points) on a scale (from 1-5) Interval 4.49 to 4.77	4.63 units (points) on a scale (from 1-5) Interval 4.49 to 4.77
Parent Satisfaction With Care, Standard vs Intensive 12 months Follow-up	4.38 units (points) on a scale (from 1-5) Interval 4.23 to 4.53	4.54 units (points) on a scale (from 1-5) Interval 4.35 to 4.72

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Standard e-AT Intervention n=261 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention n=57 Participants Participants in the intensive e-AT intervention group 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.
Child Interrupted/Missed School Days, Standard vs Intensive 12 Months Follow-up	129 Number of interrupted/missed school days	37 Number of interrupted/missed school days
Child Interrupted/Missed School Days, Standard vs Intensive Baseline	435 Number of interrupted/missed school days	129 Number of interrupted/missed school days
Child Interrupted/Missed School Days, Standard vs Intensive 3 Months Follow-up	114 Number of interrupted/missed school days	60 Number of interrupted/missed school days
Child Interrupted/Missed School Days, Standard vs Intensive 6 Months Follow-up	87 Number of interrupted/missed school days	30 Number of interrupted/missed school days

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Standard e-AT Intervention n=261 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention n=57 Participants Participants in the intensive e-AT intervention group 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.
Parent Interrupted/Missed Work Days, Standard vs Intensive Baseline	176 Number of interrupted/missed work days	56 Number of interrupted/missed work days
Parent Interrupted/Missed Work Days, Standard vs Intensive 3 Months Follow-up	44 Number of interrupted/missed work days	14 Number of interrupted/missed work days
Parent Interrupted/Missed Work Days, Standard vs Intensive 6 Months Follow-up	42 Number of interrupted/missed work days	15 Number of interrupted/missed work days
Parent Interrupted/Missed Work Days, Standard vs Intensive 12 Months Follow-up	23 Number of interrupted/missed work days	18 Number of interrupted/missed work days

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Standard e-AT Intervention n=261 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention n=57 Participants Participants in the intensive e-AT intervention group 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.
Asthma Control Change, Standard vs Intensive Qtr 1 vs baseline	2.55 mean score (points) change Standard Error 0.12	1.78 mean score (points) change Standard Error 0.35
Asthma Control Change, Standard vs Intensive Qtr 2 vs baseline	3.09 mean score (points) change Standard Error 0.10	2.18 mean score (points) change Standard Error 0.30
Asthma Control Change, Standard vs Intensive Qtr 4 vs baseline	3.33 mean score (points) change Standard Error 0.10	3.30 mean score (points) change Standard Error 0.22
Asthma Control Change, Standard vs Intensive Qtr 3 vs baseline	3.26 mean score (points) change Standard Error 0.09	2.18 mean score (points) change Standard Error 0.23

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Standard e-AT Intervention n=261 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention n=57 Participants Participants in the intensive e-AT intervention group 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.
Emergency Department (ED)/Hospitalization, Standard vs Intensive Prior	53 Number of ED/hospital admissions	18 Number of ED/hospital admissions
Emergency Department (ED)/Hospitalization, Standard vs Intensive Post	21 Number of ED/hospital admissions	8 Number of ED/hospital admissions

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Standard e-AT Intervention n=318 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention Participants in the intensive e-AT intervention group 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.
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	—
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 outcome

Timeframe: 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).

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.

Outcome measures

Measure	Standard e-AT Intervention n=11418 ACT scores Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention Participants in the intensive e-AT intervention group 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.
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	—
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	—
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	—
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	—
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 outcome

Timeframe: 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.

Number of child interrupted/missed school days were collected longitudinally (information includes mean at baseline, 3, 6, and 12 months in the study).

Outcome measures

Measure	Standard e-AT Intervention n=318 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention Participants in the intensive e-AT intervention group 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.
Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime) Baseline	1.91 Number of days (interrupted or missed) Standard Deviation 5.18	—
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	—
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	—
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	Standard e-AT Intervention n=318 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention Participants in the intensive e-AT intervention group 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.
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	—
Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime) Baseline	0.72 Number of days (interrupted or missed) Standard Deviation 1.89	—
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	—
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	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Standard e-AT Intervention n=325 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention n=325 Participants Participants in the intensive e-AT intervention group 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.
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 0.60	0.09 number of ED/hospital admission Standard Deviation 0.35

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Standard e-AT Intervention n=325 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention n=325 Participants Participants in the intensive e-AT intervention group 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.
Use of Oral Steroid, Overall	0.74 number of oral steroid use Standard Deviation 1.15	0.51 number of oral steroid use Standard Deviation 0.95

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Standard e-AT Intervention n=234 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention n=91 Participants Participants in the intensive e-AT intervention group 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.
ED/Hospital Admission, Early vs. Late Patients	0.10 number of ED/Hospital admission Standard Deviation 0.38	0.18 number of ED/Hospital admission Standard Deviation 0.10

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Standard e-AT Intervention n=234 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention n=91 Participants Participants in the intensive e-AT intervention group 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.
Oral Steroid Use, Early vs. Late Patients	0.53 number of oral steroid use Standard Deviation 0.99	0.53 number of oral steroid use Standard Deviation 0.92

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Standard e-AT Intervention n=206 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention n=119 Participants Participants in the intensive e-AT intervention group 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.
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	0 number of ED/Hospital admission

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Standard e-AT Intervention n=206 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention n=119 Participants Participants in the intensive e-AT intervention group 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.
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	0 number of oral steroid use

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Standard e-AT Intervention n=325 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention n=599 Participants Participants in the intensive e-AT intervention group 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.
ED/Hospital Admissions, e-AT vs Usual Care Prior	0.59 Rate per 1000-days Standard Deviation 1.64	0.23 Rate per 1000-days Standard Deviation 1.01
ED/Hospital Admissions, e-AT vs Usual Care Post	0.24 Rate per 1000-days Standard Deviation 0.97	0.24 Rate per 1000-days Standard Deviation 0.97

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Standard e-AT Intervention n=325 Participants Patients in Standard e-AT intervention group using the standard version of e-AT.	Intensive e-AT Intervention n=599 Participants Participants in the intensive e-AT intervention group 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.
Oral Steroid Use, e-AT vs Usual Care Post	1.41 Rate per 1000-days Standard Deviation 2.60	1.99 Rate per 1000-days Standard Deviation 7.89
Oral Steroid Use, e-AT vs Usual Care Prior	2.02 Rate per 1000-days Standard Deviation 3.14	1.87 Rate per 1000-days Standard Deviation 3.12

Adverse Events

Standard e-AT Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intensive e-AT Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care (Non-Randomized Cohort)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Flory Nkoy

University of Utah

Phone: 801-662-3660

Email: flory.nkoy@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place