Back to resultsFeedback System of PROMS in Children With Burns
Primary Purpose
Burns
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iPads
Sponsored by
About this trial
This is an interventional screening trial for Burns focused on measuring Patient Reported Outcomes Measure, Burns
Eligibility Criteria
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.
Sites / Locations
- Shriners Hospitals for Children- Boston
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Arm A
Arm B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Responses to Clinician Debriefing Questionnaires
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02607852
Brief Title
Feedback System of PROMS in Children With Burns
Official Title
System for Feedback of Patient Reported Outcomes in Children With Burns
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 8, 2015 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephanie Romo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Patient Reported Outcomes Measure, Burns
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm A: Patients 5-18 years old Arm B: Patients 0-4 years old
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Other
Arm Description
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 Title
Arm B
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
iPads
Intervention Description
The current study will help determine if using Burn Outcomes Questionnaire and 17- item Pediatric Symptom Checklist (PSC-17) feedback data, collected on iPads or online, over the course of patient treatment will be useful for the physicians and ultimately impact the recovery of the patient.
Primary Outcome Measure Information:
Title
Responses to Clinician Debriefing Questionnaires
Description
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.
Time Frame
Participants will participate for the duration of one outpatient visit, an expected average of 3 hours.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Sheridan, MD
Organizational Affiliation
Shriners Hospitals for Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospitals for Children- Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feedback System of PROMS in Children With Burns
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