Evaluation of a Shared Decision Making Portal for Pediatric Asthma

Asthma Clinical Trial

Official title:

Evaluation of a Shared Decision Making Portal for Pediatric Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715389
• Other study ID #: 12-009407
• Status: Completed
• Phase: N/A
• First received: October 10, 2012
• Last updated: June 26, 2015
• Start date: November 2012
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Shared decision making	Joint participation in decision-making will be measured by the Observing Parent Involvement (OPTION) scale.	Baseline	No
Secondary	Parent Activation	Parent activation will be measured by the Parent Patient Activation Measure (PPAM).	0 months, 3 months, 6 months	No
Secondary	Goal Attainment	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.	0 months, 3 months, 6 months then Monthly	No
Secondary	Asthma-Related Quality of Life	Asthma-related quality of life will be measured using The Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF)	0 months, 6 months	No
Secondary	Asthma Control	Asthma control will be assessed using the Pediatric Asthma Control Tool (PACT)	0 months, 6 months	No
Secondary	Asthma-related Utilization	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.	3 months, 6 months	No
Secondary	Asthma Medication Adherence/Receipt	Prescribed medications for the treatment and management of asthma Type and number of prescriptions for asthma	6 months	No
Secondary	Feasibility of Recruitment	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.	24 months	No
Secondary	Feasibility of Follow-up	The feasibility of follow-up will be assessed by the proportion of enrolled families who complete each study measure.	24 months	No
Secondary	Feasibility of Portal Use	The feasibility of portal use will be assessed by the level of research team/other outside support needed.	24 months	No