Streamlining Trauma Research Evaluation With Advanced Measurement

NCT02079714 | Completed DMC

• 1 other identifier: 1R01AR064066-01
• Study Type: observational
• Target: 1,065
• Locations: 1 country
• Sites: 44

Brief Summary

The STREAM Study is a prospective longitudinal observational outcomes study that will examine the reliability, validity and responsiveness of the PROMIS tools for clinical research following orthopaedic trauma.

Conditions

Orthopaedic Trauma

Keywords

Orthopaedic Trauma; Injury

Outcome Measures

Primary Outcomes (1)

• Reliability and Validity

  The primary endpoint for this study is the reliability and construct validity of the PROMIS CAT instruments.

  9 months

Secondary Outcomes (3)

• Responsiveness

  9 months

• Data Completion

  9 months

• Participant Burden

  9 months

Study Arms (1)

Questionnaire

All STREAM Study participants will be complete a series of computer adaptive testing (CAT) questions covering all core and exploratory domains, once written informed consent is obtained. Administration of these surveys will follow completion of all other follow-up activities related to the main METRC study in which they were originally enrolled. Identical surveys will be repeated at the 6 month study visit. At the final 12 month study visit, participants will complete the CAT survey for the six core domains, and will also complete a randomly assigned subset of items from the total item bank across these six core domains. At any visit, if the CAT cannot be administered, respondents will instead complete paper surveys of the short form for each domain.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Orthopaedic trauma patients who are currently enrolled in the PAIN, FIXIT, OUTLET, OXYGEN, VANCO or TAOS METRC studies. These studies look at outcomes following injuries to the foot, ankle, tibia etc.

Any patient participating in the FIXIT, OUTLET, TAOS, OXYGEN, VANCO or Pain studies returning for a 3 month follow-up visit is eligible for participation in the proposed STREAM study. Respondents who are unable to give informed consent (or would require a proxy) at the time of the 3 month visit will be excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead

Study Sites (44)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 80203, United States

Location

University of Miami Ryder Trauma Center

Miami, Florida, 33101, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Orthoindy at St Vincent

Indianapolis, Indiana, 42260, United States

Location

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

OrthoIndy / Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71130, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Orthopaedic Associates of Michigan, Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Hennepin County Medical Center / Regions Hospital

Minneapolis, Minnesota, 55415, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

St. Louis Medical Center

St Louis, Missouri, 63110, United States

Location

Jamaica Hospital Medical Center

Jamaica, New York, 11418, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1070, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Grant Medical Center

Columbus, Ohio, 43215, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Penn State University M.S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

York Hospital

York, Pennsylvania, 17405, United States

Location

Rhode Island Hospital, Brown University

Providence, Rhode Island, 02903, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

San Antonio Miliary Medical Center

Fort Sam Houston, Texas, 78234-6315, United States

Location

University of Texas Health Science Center - Houston

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

University of Washington Harborview

Seattle, Washington, 98104, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: March 6, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: October 1, 2020
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

US (44)