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Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Massachusetts General Hospital.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Shriners Hospitals for Children
Information provided by (Responsible Party):
Ronald G. Tompkins, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00239668
First received: October 13, 2005
Last updated: May 2, 2012
Last verified: May 2012
  Purpose
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.

Condition
Burn

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Estimated Enrollment: 3000
Study Start Date: March 2000
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239668

Locations
United States, California
Shriners Hospital for Children - Sacramento
Sacramento, California, United States, 95817
United States, Massachusetts
Shriners Hospital for Children - Boston
Boston, Massachusetts, United States, 02114
United States, Ohio
Shriners Hospital for Children - Cincinnati
Cincinnati, Ohio, United States, 45229
United States, Texas
Shriners Hospital for Children - Galveston
Galveston, Texas, United States, 77550
Sponsors and Collaborators
Massachusetts General Hospital
Shriners Hospitals for Children
Investigators
Principal Investigator: Ronald G. Tompkins, MD, ScD MGH, Shriners Burn Hospital-Boston
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ronald G. Tompkins, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00239668     History of Changes
Other Study ID Numbers: 2001-P-000452/19 
Study First Received: October 13, 2005
Last Updated: May 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Burns
Functional
Psychosocial
Recovery
Long-term
Pediatric
Surgical
Outcomes
Benchmarking

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on December 02, 2016