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

August 30, 2016 updated by: Children's Hospital of Philadelphia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study uses a newly published, evidence-based conceptual model to study the determinants of implementation success, implementation outcomes, and health care outcomes resulting from implementing an asthma portal, MyAsthma, in the national, Agency for Health Care Research and Quality(AHRQ)-funded, Center for Pediatric Practice Research and Learning. Technically, the portal will be implemented with 2 innovative approaches that facilitate rapid cycle evaluation in multiple Electronic Health Records (EHRs). Although many patient portals are simple vehicles for transferring information about upcoming appointments, test results or laboratory findings, the asthma portal in this project extends this basic functionality to provide asthma education, collect patient-reported outcomes, evaluate medication use and side effects, and track parents' preferences and goals. Because asthma is an AHRQ priority condition which addresses three AHRQ priority criteria (children, low income, and special health care needs), our study will use this population to focus on stage 3 Meaningful Use (MU3) objectives. It is the hope that by conducting this study, translational knowledge will be gained to make recommendations for practice implementation and actionable policy statements.

Study Type

Interventional

Enrollment (Actual)

294

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Pediatrick Research in Office Settings (PROS)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Pediatric Research Consortium of the Children's Hospital of Philadelphia (PeRC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria For Parents/Guardians:

  1. 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
  2. Must be able to speak and read English

Exclusion Criteria For Parents/Guardians:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MyAsthma Web Portal
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference Between Number of Families Who Adopted MyAsthma Portal Use and Number of Families With Sustained Use
Time Frame: Up to 6 Months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

Agency for Healthcare Research and Quality (AHRQ)
American Academy of Pediatrics
DARTNet Institute

Investigators

  • Principal Investigator: Alexander Fiks, MD, MSCE, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

October 16, 2013

First Posted (Estimate)

October 21, 2013

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-010285

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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