Streamlining Trauma Research Evaluation With Advanced Measurement
a study on Orthopaedic Trauma
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.
Streamlining Trauma Research Evaluation With Advanced Measurement: STREAM Study
Objective: As part of the NIH Roadmap initiative, PROMIS (patient reported outcomes measurement information system) has developed tools, including item banks, short forms and computer-adaptive tests (CATs) that can help standardize measurement for many health-related quality of life domains. These PROMIS tools are being tested in large general population samples across the lifespan. The overall goal of the present study is to assess the performance and research utility of these new tools in new patient populations for future comparative effectiveness research projects. The proposed project will examine the reliability, validity and responsiveness of the PROMIS tools for clinical research following orthopaedic trauma.
Specific Aim 1: Examine the measurement properties of existing PROMIS CATs and item banks in patients with orthopaedic trauma. Investigators will incorporate ten (six core and four exploratory) PROMIS short form and CATs into the longitudinal data collection of five ongoing orthopaedic trauma clinical trials and administer an expanded data collection interview at the time of their last study follow up which will be used to:
1a: Evaluate reliability and construct validity of the PROMIS CATs
1b: Compare measurement precision of the six existing item banks when applied in an orthopaedic trauma population versus the general population.
- c: Identify items from existing PROMIS item banks that function differently in our population compared with the general population.
Specific Aim 2: Examine the responsiveness of existing PROMIS domains in patients with orthopaedic trauma. Specifically, investigators will:
- a: Examine the responsiveness of PROMIS domains against expected clinical recovery in this population.
2b: Examine the responsiveness of PROMIS domains against well-defined clinical inflection points in the recovery process, such as infections, non-unions, flap failures, and other complications.
2c: Examine the responsiveness of PROMIS domains against treatment effects observed for interventions being studied in these trials, which include a psychosocial intervention, a pharmacologic intervention, and a device. These trials are being evaluated using widely used traditional outcome measurement tools.
Specific Aim 3: Study the integration of the PROMIS tools within the data collection infrastructure of METRC. Key feasibility components examined will be integration with our distributed electronic data capture system (REDCap), and use of the CAT technology across dozens of trauma centers and orthopaedic trauma clinics.
3a. Compare the rate of use of CAT-based assessment versus short-form data collection 3b: Compare the data completeness using existing METRC approaches, CAT and short form PROMIS instruments 3c: Compare respondent burden using existing METRC approaches, CAT and short form PROMIS instruments.
Study design: The STREAM study is a multi-center, prospective longitudinal observational study to evaluate the reliability, validity and responsiveness of PROMIS tools in orthopaedic trauma patients.
Orthopaedic Trauma Injury Wounds and Injuries
For people ages 18–80
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.
- University of California San Francisco Medical Center accepting new patients
San Francisco, California, 94143, United States
- Naval Medical Center San Diego accepting new patients
San Diego, California, 92134, United States
- University of Washington Harborview accepting new patients
Seattle, Washington, 98104, United States
- Denver Health and Hospital Authority accepting new patients
Denver, Colorado, 80203, United States
- University of Oklahoma accepting new patients
Oklahoma City, Oklahoma, 73104, United States
- San Antonio Miliary Medical Center accepting new patients
Ft. Sam Houston, Texas, 78234-6315, United States
- University of Texas Southwestern Medical Center accepting new patients
Dallas, Texas, 75390, United States
- University of Kansas Medical Center accepting new patients
Kansas City, Kansas, 66160, United States
- University of Texas Health Science Center - Houston accepting new patients
Houston, Texas, 77030, United States
- Hennepin County Medical Center / Regions Hospital accepting new patients
Minneapolis, Minnesota, 55415, United States
- Louisiana State University Health Sciences Center accepting new patients
Shreveport, Louisiana, 71130, United States
- Barnes Jewish Hospital accepting new patients
St Louis, Missouri, 63110, United States
- St. Louis Medical Center accepting new patients
St. Louis, Missouri, 63110, United States
- University of Wisconsin accepting new patients
Madison, Wisconsin, 53792, United States
- University of Mississippi Medical Center accepting new patients
Jackson, Mississippi, 39216, United States
- Louisiana State University accepting new patients
New Orleans, Louisiana, 70112, United States
- Vanderbilt Medical Center accepting new patients
Nashville, Tennessee, 37232, United States
- Orthoindy at St Vincent accepting new patients
Indianapolis, Indiana, 42260, United States
- Eskenazi Hospital accepting new patients
Indianapolis, Indiana, 46202, United States
- OrthoIndy / Methodist Hospital accepting new patients
Indianapolis, Indiana, 46202, United States
- Orthopaedic Associates of Michigan, Spectrum Health accepting new patients
Grand Rapids, Michigan, 49503, United States
- University of Alabama at Birmingham accepting new patients
Birmingham, Alabama, 35294, United States
- Grant Medical Center accepting new patients
Columbus, Ohio, 43215, United States
- MetroHealth Medical Center accepting new patients
Cleveland, Ohio, 44109, United States
- Mission Hospital accepting new patients
Asheville, North Carolina, 28801, United States
- Allegheny General Hospital accepting new patients
Pittsburgh, Pennsylvania, 15212, United States
- University of Pittsburgh Medical Center accepting new patients
Pittsburgh, Pennsylvania, 15213, United States
- Carolinas Medical Center accepting new patients
Charlotte, North Carolina, 28204, United States
- Wake Forest University Baptist Medical Center accepting new patients
Winston-Salem, North Carolina, 27157-1070, United States
- Tampa General Hospital accepting new patients
Tampa, Florida, 33606, United States
- University of Virginia accepting new patients
Charlottesville, Virginia, 22908, United States
- Duke University Hospital accepting new patients
Durham, North Carolina, 27710, United States
- Orlando Regional Medical Center terminated
Orlando, Florida, 32806, United States
- Walter Reed National Military Medical Center accepting new patients
Bethesda, Maryland, 20889, United States
- Geisinger Health System accepting new patients
Danville, Pennsylvania, 17822, United States
- Penn State University M.S. Hershey Medical Center accepting new patients
Hershey, Pennsylvania, 17033, United States
- York Hospital accepting new patients
York, Pennsylvania, 17405, United States
- University of Maryland Medical Center accepting new patients
Baltimore, Maryland, 21201, United States
- Naval Medical Center Portsmouth accepting new patients
Portsmouth, Virginia, 23708, United States
- St. Luke's University Health Network withdrawn
Bethlehem, Pennsylvania, 18015, United States
- University of Pennsylvania accepting new patients
Philadelphia, Pennsylvania, 19104, United States
- University of Miami Ryder Trauma Center accepting new patients
Miami, Florida, 33101, United States
- Jamaica Hospital Medical Center accepting new patients
Jamaica, New York, 11418, United States
- Rhode Island Hospital, Brown University accepting new patients
Providence, Rhode Island, 02903, United States
- Boston Medical Center accepting new patients
Boston, Massachusetts, 02118, United States
- accepting new patients
- Start Date
- Completion Date
- Major Extremity Trauma Research Consortium
- Study Type
- Last Updated
- December 2016
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02079714.