Streamlining Trauma Research Evaluation With Advanced Measurement

Orthopaedic Trauma Clinical Trial

— STREAM  

Official title:

Streamlining Trauma Research Evaluation With Advanced Measurement: STREAM Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079714
• Other study ID #: 1R01AR064066-01
• Status: Completed
• Start date: January 2014
• Est. completion date: October 2020

Study information

• Verified date: March 2023
• Source: Major Extremity Trauma Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

1. 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:

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1065
• Est. completion date: October 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Orthopaedic Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Mission Hospital	Asheville	North Carolina
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Grant Medical Center	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Geisinger Health System	Danville	Pennsylvania
United States	Denver Health and Hospital Authority	Denver	Colorado
United States	Duke University Hospital	Durham	North Carolina
United States	San Antonio Miliary Medical Center	Fort Sam Houston	Texas
United States	Orthopaedic Associates of Michigan, Spectrum Health	Grand Rapids	Michigan
United States	Penn State University M.S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Texas Health Science Center - Houston	Houston	Texas
United States	Eskenazi Hospital	Indianapolis	Indiana
United States	OrthoIndy / Methodist Hospital	Indianapolis	Indiana
United States	Orthoindy at St Vincent	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Jamaica Hospital Medical Center	Jamaica	New York
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Miami Ryder Trauma Center	Miami	Florida
United States	Hennepin County Medical Center / Regions Hospital	Minneapolis	Minnesota
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	Louisiana State University	New Orleans	Louisiana
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Orlando Regional Medical Center	Orlando	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia
United States	Rhode Island Hospital, Brown University	Providence	Rhode Island
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	St. Louis Medical Center	Saint Louis	Missouri
United States	Naval Medical Center San Diego	San Diego	California
United States	University of California San Francisco Medical Center	San Francisco	California
United States	University of Washington Harborview	Seattle	Washington
United States	Louisiana State University Health Sciences Center	Shreveport	Louisiana
United States	Tampa General Hospital	Tampa	Florida
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Major Extremity Trauma Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability and Validity	The primary endpoint for this study is the reliability and construct validity of the PROMIS CAT instruments.	9 months
Secondary	Responsiveness	Responsiveness against clinical recovery, inflection points and effective interventions.	9 months
Secondary	Data Completion	Data completeness in CAT-based instruments vs short form paper-based data collection	9 months
Secondary	Participant Burden	Respondent burden, as indicated by time to complete instrument, which will be recorded by the CAT, and manually recorded at start/stop time on the paper short forms	9 months