Trial Outcomes & Findings for Informing Policy to Implement Pediatric Family Engagement in Meaningful Use Stage 3 (NCT NCT01966068)

NCT ID: NCT01966068

Last Updated: 2016-10-17

Results Overview

Implementation success was measure by comparing the of the number of enrolled families (parent/guardian) who logged on to the MyAsthma Portal once (adoption) with the number of enrolled families (parent/guardian) who logged on more than once (sustained use). Parents/guardians were asked to log on and complete the same survey on the MyAsthma Portal 3 times during a 6 month period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

294 participants

Primary outcome timeframe

Up to 6 Months

Results posted on

2016-10-17

Participant Flow

Subjects were recruited from 2 practice-based research networks. To ensure low-income children were represented, practices were required to have at least 20% insured by Medicaid or the Children's Health Insurance Program. 9,133 families were invited to enroll.

294 parents/guardians of 294 children consented to participate in the study. Of these, 237 logged onto the MyAsthma portal at least once.

Participant milestones

Participant milestones
Measure
MyAsthma Web Portal
The portal, MyAsthma, provided asthma education, collected patient-reported outcomes, evaluated medication use and side effects, and tracked parents' concerns and goals. Parents logged into the web portal each month, and the information entered by parents was shared through the electronic health record with the child's primary care provider.
Overall Study
STARTED
294
Overall Study
Used the MyAsthma Portal at Least Once
237
Overall Study
Use the MyAsthma Portal More Than Once
156
Overall Study
COMPLETED
156
Overall Study
NOT COMPLETED
138

Reasons for withdrawal

Reasons for withdrawal
Measure
MyAsthma Web Portal
The portal, MyAsthma, provided asthma education, collected patient-reported outcomes, evaluated medication use and side effects, and tracked parents' concerns and goals. Parents logged into the web portal each month, and the information entered by parents was shared through the electronic health record with the child's primary care provider.
Overall Study
Withdrawal by Subject
57
Overall Study
Lost to Follow-up
81

Baseline Characteristics

Informing Policy to Implement Pediatric Family Engagement in Meaningful Use Stage 3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
MyAsthma Web Portal Sustained Use
n=156 Participants
Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys more than once
MyAsthma Web Portal Adoption
n=81 Participants
Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys only once
Total
n=237 Participants
Total of all reporting groups
Age, Continuous
38.1 years
STANDARD_DEVIATION 5.5 • n=5 Participants
37.1 years
STANDARD_DEVIATION 6.5 • n=7 Participants
37.6 years
STANDARD_DEVIATION 6.0 • n=5 Participants
Age, Customized
6-9 Years
115 participants
n=5 Participants
60 participants
n=7 Participants
175 participants
n=5 Participants
Age, Customized
10-12 Years
41 participants
n=5 Participants
21 participants
n=7 Participants
62 participants
n=5 Participants
Sex: Female, Male
Female
71 Participants
n=5 Participants
30 Participants
n=7 Participants
101 Participants
n=5 Participants
Sex: Female, Male
Male
85 Participants
n=5 Participants
51 Participants
n=7 Participants
136 Participants
n=5 Participants
Race/Ethnicity, Customized
White
89 participants
n=5 Participants
55 participants
n=7 Participants
144 participants
n=5 Participants
Race/Ethnicity, Customized
Black/African American
54 participants
n=5 Participants
21 participants
n=7 Participants
75 participants
n=5 Participants
Race/Ethnicity, Customized
Asian
4 participants
n=5 Participants
0 participants
n=7 Participants
4 participants
n=5 Participants
Race/Ethnicity, Customized
Other
7 participants
n=5 Participants
4 participants
n=7 Participants
11 participants
n=5 Participants
Race/Ethnicity, Customized
Unkown
2 participants
n=5 Participants
1 participants
n=7 Participants
3 participants
n=5 Participants
Parent Education
High School or Less
17 participants
n=5 Participants
17 participants
n=7 Participants
34 participants
n=5 Participants
Parent Education
Some College/Associates
46 participants
n=5 Participants
35 participants
n=7 Participants
81 participants
n=5 Participants
Parent Education
Bachelor's or Higher
93 participants
n=5 Participants
29 participants
n=7 Participants
122 participants
n=5 Participants
Parent Employment Status
Working Outside the Home
111 participants
n=5 Participants
46 participants
n=7 Participants
157 participants
n=5 Participants
Parent Employment Status
Self-Employed
5 participants
n=5 Participants
8 participants
n=7 Participants
13 participants
n=5 Participants
Parent Employment Status
Working Without Pay
25 participants
n=5 Participants
18 participants
n=7 Participants
43 participants
n=5 Participants
Parent Employment Status
Unemployed
15 participants
n=5 Participants
9 participants
n=7 Participants
24 participants
n=5 Participants
Parent's Relation to Child
Mother
149 participants
n=5 Participants
79 participants
n=7 Participants
228 participants
n=5 Participants
Parent's Relation to Child
Other
7 participants
n=5 Participants
2 participants
n=7 Participants
9 participants
n=5 Participants
Child's Asthma Severity
Intermittent
37 participants
n=5 Participants
12 participants
n=7 Participants
49 participants
n=5 Participants
Child's Asthma Severity
Mild Persistent
39 participants
n=5 Participants
12 participants
n=7 Participants
51 participants
n=5 Participants
Child's Asthma Severity
Moderate/Severe Persistent
17 participants
n=5 Participants
2 participants
n=7 Participants
19 participants
n=5 Participants
Child's Asthma Severity
Unknown
63 participants
n=5 Participants
55 participants
n=7 Participants
118 participants
n=5 Participants
Medical Practice Setting
Urban
44 participants
n=5 Participants
20 participants
n=7 Participants
64 participants
n=5 Participants
Medical Practice Setting
Rural
29 participants
n=5 Participants
23 participants
n=7 Participants
52 participants
n=5 Participants
Medical Practice Setting
Suburban
83 participants
n=5 Participants
38 participants
n=7 Participants
121 participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 Months

Population: Analysis population included every subject (parent/guardian) who logged on to the MyAsthma Web Portal at least once.

Implementation success was measure by comparing the of the number of enrolled families (parent/guardian) who logged on to the MyAsthma Portal once (adoption) with the number of enrolled families (parent/guardian) who logged on more than once (sustained use). Parents/guardians were asked to log on and complete the same survey on the MyAsthma Portal 3 times during a 6 month period.

Outcome measures

Outcome measures
Measure
MyAsthma Web Portal Sustained Use
n=237 Participants
Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys more than once
MyAsthma Portal Adoption
n=237 Participants
Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys only once.
Difference Between Number of Families Who Adopted MyAsthma Portal Use and Number of Families With Sustained Use
156 participants
81 participants

Adverse Events

MyAsthma Web Portal

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

Alexander Fiks, MD, MSCE

Children's Hospital of Philadelphia

Phone: 267-426-2304

Results disclosure agreements

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