NCT01966068

Brief Summary

This study will enroll parents/guardians of children who receive treatment at one of the pediatric primary care practice settings in the Pediatric Research in Office Settings (PROS) network or at the Children's Hospital of Philadelphia's Pediatric Research Consortium (PeRC) network. The study will use an evidence-based conceptual model to study determinants of implementation success, implementation outcomes, and health care outcomes resulting from implementing an already functional, electronic health record (EHR)-linked asthma portal, MyAsthma. The study will measure the portal's feasibility and determine the impact on providing asthma education and fostering patient engagement as well as the ability to collect patient-reported outcomes for children, evaluate medication use and side effects and track parents' preferences and goals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 21, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 30, 2016

Completed
Last Updated

October 17, 2016

Status Verified

August 1, 2016

Enrollment Period

1.3 years

First QC Date

October 11, 2013

Results QC Date

July 13, 2016

Last Update Submit

August 30, 2016

Conditions

Keywords

AsthmaPediatricsHealth TechnologyMeaningful Use Stage-3Web Portal

Outcome Measures

Primary Outcomes (1)

  • Difference Between Number of Families Who Adopted MyAsthma Portal Use and Number of Families With Sustained Use

    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.

    Up to 6 Months

Study Arms (1)

MyAsthma Web Portal

EXPERIMENTAL

The portal, MyAsthma, will provide asthma education, collect patient-reported outcomes, evaluate medication use and side effects, and track parents' concerns and goals. Parents will log into the web portal each month (for a total of 3 portal visits in 6 months), and the information entered by parents will be shared through the electronic health record with the child's primary care provider.

Other: MyAsthma Web Portal

Interventions

Parents will log on to the MyAsthma Web Portal up to three different times over a 6 month period. During each portal visit, parents will be asked to complete a survey which will include questions regarding their views on treatment preferences, goals, asthma control, and medications for their child with asthma.

MyAsthma Web Portal

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parent/guardian of a child who:
  • Is between the ages of 6-12 years old
  • Has a diagnosis of asthma on his/her problem list at the time of recruitment
  • Has had an office visit with asthma as a diagnosis within the past 12 months
  • Must be able to speak and read English

You may not qualify if:

  • Child has not had an office visit for asthma with in the last 12 months
  • Parent or guardian does not speak or read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pediatrick Research in Office Settings (PROS)

Elk Grove Village, Illinois, 60007, United States

Location

Pediatric Research Consortium of the Children's Hospital of Philadelphia (PeRC)

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Fiks AG, DuRivage N, Mayne SL, Finch S, Ross ME, Giacomini K, Suh A, McCarn B, Brandt E, Karavite D, Staton EW, Shone LP, McGoldrick V, Noonan K, Miller D, Lehmann CU, Pace WD, Grundmeier RW. Adoption of a Portal for the Primary Care Management of Pediatric Asthma: A Mixed-Methods Implementation Study. J Med Internet Res. 2016 Jun 29;18(6):e172. doi: 10.2196/jmir.5610.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Limitations and Caveats

Enrollment occurred in practices across 11 states, yet more than half of practices were within a single health system thus affecting generalizability. This study also includes a relatively short follow-up period.

Results Point of Contact

Title
Alexander Fiks, MD, MSCE
Organization
Children's Hospital of Philadelphia

Study Officials

  • Alexander Fiks, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2013

First Posted

October 21, 2013

Study Start

October 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

October 17, 2016

Results First Posted

August 30, 2016

Record last verified: 2016-08

Locations