Feedback System of PROMS in Children With Burns

NCT ID: NCT02607852

Last Updated: 2017-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-08

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Burns

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Arm A: Patients 5-18 years old Arm B: Patients 0-4 years old
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Arm A

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.

Group Type OTHER

iPads

Intervention Type 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 B

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.

Group Type OTHER

iPads

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stephanie Romo

OTHER

Sponsor Role lead

Responsible Party

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Stephanie Romo

Clinical Research Technician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Robert L Sheridan, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospitals for Children

Locations

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Shriners Hospitals for Children- Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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20170611

Identifier Type: OTHER

Identifier Source: secondary_id

BOS1501

Identifier Type: -

Identifier Source: org_study_id

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