Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors

March 5, 2019 updated by: Ronald G. Tompkins, Massachusetts General Hospital
The purpose of this study is to establish an expected recovery trajectory (recovery model) in terms of physical and psychological function of the pediatric burn patient.

Study Overview

Status

Completed

Conditions

Detailed Description

The successful advancement of treatment for burns allows us now to save lives of children who sustain massive burn injuries. The purpose of this study is to establish an expected recovery trajectory (recovery model) in terms of the physical and psychological function for pediatric burn patients by assessing prospectively the outcomes of burn children who are treated at the four Shriners Hospitals for Children (SHC) burns hospitals. The study hopes to develop valid benchmarking of outcomes between the four hospitals and therefore, best practices will be utilized. This recovery trajectory will be used as a benchmark for functional and psychosocial outcomes following burn injury.

  • Participants in the study complete a series of self reporting questionnaires over a forty-eight month period. There are a total of nine time points during the forty-eight month commitment when questionnaires are given to parent and/or guardian and patients if they are 11 years or older.
  • Patients who undergo a reconstructive surgical procedure during their enrollment will fill a set of questionnaires related to the effects of the surgical procedure on their long-term recovery. The surgical procedure is not an intervention because of the study, it is part of their long-term follow-up care after their acute phase. There will be a pre-op and a six and twelve month post-op questionnaire.
  • The aim of this study is to develop an expected trajectory recovery model in terms of physical and psychological functioning. Analysis of the data using validated burn specific questionnaires will allow benchmarking of outcomes between the four Shriners Burns Hospitals. We aim to determine predictors of positive outcomes and focus on them as a standard of practice.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Shriners Hospital for Children - Sacramento
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Shriners Hospital for Children - Boston
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Shriners Hospital for Children - Cincinnati
    • Texas
      • Galveston, Texas, United States, 77550
        • Shriners Hospital for Children - Galveston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to Shriners Hospitals-Boston,MA Cincinnati,OH, Galveston,TX and Sacramento, CA burn hospitals with a diagnosis of burn injury.

Description

Inclusion Criteria:

  • Pediatric burn patients 18 years or less at time of injuries.
  • All high risk patients admitted for burn treatment with injuries >/= 20% total body surface area (tbsa), </= 20% tbsa to critical areas: hands, feet, face, and genitalia.
  • All low risk </= 20% to non critical areas.
  • Electrical, flame, scald, and chemical burns of at least a second degree nature.
  • English and Spanish speaking patients admitted to Shriners Hospital within 30 days of injury

Exclusion Criteria:

  • First degree burns
  • Patients admitted >30 days post acute injury.
  • Patients that speak a language other than English or Spanish.
  • Patients who decline to be in the study.
  • Patients with a non-burn injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Shriners Hospitals for Children

Investigators

  • Principal Investigator: Ronald G. Tompkins, MD, ScD, MGH, Shriners Burn Hospital-Boston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 13, 2005

First Posted (Estimate)

October 17, 2005

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001-P-000452/19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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