We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of a Shared Decision Making Portal for Pediatric Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01715389
First Posted: October 29, 2012
Last Update Posted: June 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
  Purpose
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.

Condition Intervention
Asthma Other: MyAsthma Patient Portal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Shared Decision Making Portal for Pediatric Asthma

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Acceptability of the intervention to parents and clinicians [ Time Frame: 24 months ]
    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.


Secondary Outcome Measures:
  • Shared decision making [ Time Frame: Baseline ]
    Joint participation in decision-making will be measured by the Observing Parent Involvement (OPTION) scale.

  • Parent Activation [ Time Frame: 0 months, 3 months, 6 months ]
    Parent activation will be measured by the Parent Patient Activation Measure (PPAM).

  • Goal Attainment [ Time Frame: 0 months, 3 months, 6 months then Monthly ]
    Parents will identify one or more goals at the study start. Progress toward the goal(s) will be assessed at 3 and 6 month follow-up using Likert-scaled items for the control group, and monthly through use of the portal for the intervention group.

  • Asthma-Related Quality of Life [ Time Frame: 0 months, 6 months ]
    Asthma-related quality of life will be measured using The Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF)

  • Asthma Control [ Time Frame: 0 months, 6 months ]
    Asthma control will be assessed using the Pediatric Asthma Control Tool (PACT)

  • Asthma-related Utilization [ Time Frame: 3 months, 6 months ]

    Utilization will be measured by parent report and chart review by the research team of the following:

    Any primary care or subspecialty outpatient encounters relevant to asthma care, asthma-specific acute primary care visits or Urgent Care Center visits, asthma-specific Emergency Room visits, asthma-specific hospital admissions.


  • Asthma Medication Adherence/Receipt [ Time Frame: 6 months ]
    Prescribed medications for the treatment and management of asthma Type and number of prescriptions for asthma

  • Feasibility of Recruitment [ Time Frame: 24 months ]
    The feasibility of recruitment will be assessed by examining the proportion of all families contacted who meet enrollment criteria and the proportion of families meeting enrollment criteria who enroll.

  • Feasibility of Follow-up [ Time Frame: 24 months ]
    The feasibility of follow-up will be assessed by the proportion of enrolled families who complete each study measure.

  • Feasibility of Portal Use [ Time Frame: 24 months ]
    The feasibility of portal use will be assessed by the level of research team/other outside support needed.


Enrollment: 81
Study Start Date: November 2012
Study Completion Date: March 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention

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

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.

No Intervention: Control
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • parents non-english speaking
  • child's primary care provider at the time of enrollment is a pediatric resident
  • not meeting inclusion criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715389


Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Alexander G Fiks, MD, MSCF Children's Hospital of Philadelphia
  More Information

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01715389     History of Changes
Other Study ID Numbers: 12-009407
First Submitted: October 10, 2012
First Posted: October 29, 2012
Last Update Posted: June 29, 2015
Last Verified: June 2015

Keywords provided by Children's Hospital of Philadelphia:
Asthma
Goals
Shared Decision Making
Patient Portal
Electronic Medical Record

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases