Feedback System of PROMS in Children With Burns

NCT02607852 | Unknown

• 2 other identifiers: BOS150120170611
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Patient Reported Outcomes Measure; Burns

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Arm A

OTHER

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.

Device: iPads

Arm B

OTHER

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.

Device: iPads

Interventions

iPads DEVICE

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.

Arm A; Arm B

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stephanie Romo: lead

Study Sites (1)

Shriners Hospitals for Children- Boston

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Robert L Sheridan, MD

  Shriners Hospitals for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Technician

Model Details: Arm A: Patients 5-18 years old Arm B: Patients 0-4 years old

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: November 18, 2015
• Study Start: April 8, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2017
• Last Updated: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)