Feedback System of PROMS in Children With Burns

Not Applicable

• Conditions: Burns
• Interventions: Device: iPads

• Registration Number: NCT02607852
• Lead Sponsor: Stephanie Romo

Brief Summary

The primary objective of the overall study is to determine the feasibility and usefulness of a feedback system that delivers BOQ results to physicians in "real time" during outpatient encounters using iPads.

Detailed Description

The primary objective of this pilot study is to ascertain the feasibility and usefulness of a feedback system that provides clinicians with parent-proxy reported outcomes measure data during routine outpatient encounters for burn treatment.

The secondary objective of this first phase of the study is to determine clinicians' and parents perception of the experience of completing the BOQ+P and/or the usefulness of the information that was provided to the clinician and parent/guardians(s). For this reason we will collect a brief debriefing questionnaire from physicians and another from parents.

Study Timeline

• Study Start: 2015-04-08
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-18
• Primary Completion: 2016-12-31
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Children between the ages of 0 and 18 years of age, receiving outpatient burn care at Shriners Hospitals for Children - Boston with total body surface area burn of ≥ 5% and/or a burn injury to face, hands, feet or genitalia. English or Spanish speaking and literate

Exclusion Criteria

• Clinician overriding a patient to serve on the study because of medical/psychiatric problems that might in the opinion of the clinician overwhelm the goals/purposes of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	iPads	Patients between the ages of 5-18 years. They will complete the 5-18 version of the BOQ on iPads or through the HTTPS Tonic link.
Arm B	iPads	Patients between the ages of 0-4 years. They will complete the 0-4 version of the BOQ and appropriate Pediatric Symptom Checklists (i.e. baby or preschool) on iPads or through the HTTPS Tonic link.

Primary Outcome Measures

Name	Time	Method
Responses to Clinician Debriefing Questionnaires	Participants will participate for the duration of one outpatient visit, an expected average of 3 hours.	After viewing the BOQ feedback and seeing the patient, the clinicians will rate whether or not they found the BOQ+P data useful. The measure includes 5 Likert-Scale questions and 1 open-ended question that asks for their feedback about the system.

Trial Locations

Locations (1)

Shriners Hospitals for Children- Boston; 🇺🇸 Boston, Massachusetts, United States