NCT01715389

Brief Summary

This pilot intervention study will test the feasibility and acceptability and explore the outcomes of a primary care-based shared decision making (SDM) electronic medical record (EMR)-based portal that provides education, elicits and tracks patients/families' treatment concerns and goals, assesses symptoms and asthma control over time, and provides decision support to clinicians and families.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 29, 2015

Status Verified

June 1, 2015

Enrollment Period

1.5 years

First QC Date

October 10, 2012

Last Update Submit

June 26, 2015

Conditions

Keywords

AsthmaGoalsShared Decision MakingPatient PortalElectronic Medical Record

Outcome Measures

Primary Outcomes (1)

  • Acceptability of the intervention to parents and clinicians

    Parents and clinicians will be asked a series of open-ended questions regarding themes including satisfaction, acceptability and unintended consequences of using the portal for intervention subjects and using MyChart in general for control subjects. Subjects will also be asked a series of Likert-scaled questions related to satisfaction.

    24 months

Secondary Outcomes (10)

  • Shared decision making

    Baseline

  • Parent Activation

    0 months, 3 months, 6 months

  • Goal Attainment

    0 months, 3 months, 6 months then Monthly

  • Asthma-Related Quality of Life

    0 months, 6 months

  • Asthma Control

    0 months, 6 months

  • +5 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Parents in the intervention group will use the MyAsthma Patient Portal to receive enhanced educational information on asthma and its treatment, identify concerns and goals related to asthma treatment, track progress toward goals and management of concerns monthly, and track asthma symptoms monthly. Clinicians seeing intervention families at office visits will have access to information from the portal including concerns, goals, progress toward goals, and tracking of asthma symptoms.

Other: MyAsthma Patient Portal

Control

NO INTERVENTION

The control group will be signed up for MyChart but not use the MyAsthma Patient Portal. This group will be referred to asthma educational content on the CHOP website, complete study measures and otherwise, receive standard care.

Interventions

Parents in the intervention group will use the MyAsthma Patient Portal to receive enhanced educational information on asthma and its treatment, identify concerns and goals related to asthma treatment, track progress toward goals and management of concerns monthly, and track asthma symptoms monthly. Clinicians seeing intervention families at office visits will have access to information from the portal including concerns, goals, progress toward goals, and tracking of asthma symptoms.

Intervention

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parents/legal guardians of children aged 6-12 with persistent asthma, currently receiving chronic maintenance therapy, cared for at a study practice, with consistent access to a computer with an internet connection where they feel comfortable accessing MyChart (patient portal)
  • Clinician at study site

You may not qualify if:

  • parents non-english speaking
  • child's primary care provider at the time of enrollment is a pediatric resident

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alexander G Fiks, MD, MSCF

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 29, 2012

Study Start

November 1, 2012

Primary Completion

May 1, 2014

Study Completion

March 1, 2015

Last Updated

June 29, 2015

Record last verified: 2015-06

Locations