AsthmaNCT01966068
Informing Policy to Implement Pediatric Family Engagement in Meaningful Use Stage 3
A study testing MyAsthma Web Portal in people with Asthma, run by Children's Hospital of Philadelphia at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- MyAsthma Web Portal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Child has not had an office visit for asthma with in the last 12 months
- Parent or guardian does not speak or read English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pediatrick Research in Office Settings (PROS)
Elk Grove Village, Illinois, 60007
Pediatric Research Consortium of the Children's Hospital of Philadelphia (PeRC)
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- MyAsthma Web Portal
- Keywords
- Asthma, Pediatrics, Health Technology, Meaningful Use Stage-3, Web Portal
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyAsthma Web PortalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MyAsthma Web Portal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), American Academy of Pediatrics, DARTNet Institute
- Responsible party
- Sponsor
- Investigators
- Alexander Fiks, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966068
- Sponsor's protocol ID
- 13-010285
- Status last verified
- Aug 2016
- First submitted
- 11 Oct 2013
- Last updated
- 17 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27357835
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informing Policy to Implement Pediatric Family Engagement in Meaningful Use Stage 3
- ClinicalTrials.gov ID
- NCT01966068
- Acronym / sponsor ID
- 13-010285
- Conditions
- Asthma
- Keywords
- Asthma, Pediatrics, Health Technology, Meaningful Use Stage-3, Web Portal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), American Academy of Pediatrics, DARTNet Institute
- Study start
- Oct 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Oct 2013 (estimated)
- Results
- Posted 30 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyAsthma Web Portal | Experimental | Other: MyAsthma Web PortalThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Parent/guardian of a child who:
- Must be able to speak and read English
Key exclusion criteria (2 listed)
- Child has not had an office visit for asthma with in the last 12 months
- Parent or guardian does not speak or read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyAsthma Web PortalParents 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. | Other | MyAsthma Web Portal |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27357835Fiks 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Fiks, MD, MSCE principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyAsthma Web Portal in people with Asthma, run by Children's Hospital of Philadelphia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference Between Number of Families Who Adopted MyAsthma Portal Use and Number of Families With Sustained Use (time frame: Up to 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01966068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.