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Evaluation of a Shared Decision Making Portal for Pediatric Asthma

This study is currently recruiting participants.
Verified November 2012 by Children's Hospital of Philadelphia
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01715389
First received: October 10, 2012
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of a Shared Decision Making Portal for Pediatric Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Parent activation will be measured by the Parent Patient Activation Measure (PPAM).

  • Goal Attainment [ Time Frame: 0 months, 3 months, 6 months then Monthly ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Asthma control will be assessed using the Pediatric Asthma Control Tool (PACT)

  • Asthma-related Utilization [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Prescribed medications for the treatment and management of asthma Type and number of prescriptions for asthma

  • Feasibility of Recruitment [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The feasibility of portal use will be assessed by the level of research team/other outside support needed.


Estimated Enrollment: 140
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 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

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parents/legal guardians of children aged 6-12 with moderate or severe 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715389

Contacts
Contact: Alexander G Fiks, MD, MSCE 267-426-2304 fiks@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alexander G Fiks, MD, MSCE     267-426-2304     fiks@email.chop.edu    
Sponsors and Collaborators
Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01715389     History of Changes
Other Study ID Numbers: 12-009407
Study First Received: October 10, 2012
Last Updated: November 12, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013