Feedback System of PROMS in Children With Burns

Burns Clinical Trial

Official title:

System for Feedback of Patient Reported Outcomes in Children With Burns

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02607852
• Other study ID #: BOS1501
• Secondary ID: 20170611
• Status: Active, not recruiting
• Phase: N/A
• First received: August 17, 2015
• Last updated: June 21, 2017
• Start date: April 8, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2017
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• iPads
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.

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children- Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Stephanie Romo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will participate for the duration of one outpatient visit, an expected average of 3 hours.