Streamlining Trauma Research Evaluation With Advanced Measurement (STREAM)

Streamlining Trauma Research Evaluation With Advanced Measurement: STREAM Study

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.

Study Overview

• Status: Completed
• Conditions: Orthopaedic Trauma

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1065

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center San Diego
    • San Francisco, California, United States, 94143
      • University of California San Francisco Medical Center
  • Colorado
    • Denver, Colorado, United States, 80203
      • Denver Health and Hospital Authority
  • Florida
    • Miami, Florida, United States, 33101
      • University of Miami Ryder Trauma Center
    • Orlando, Florida, United States, 32806
      • Orlando Regional Medical Center
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Hospital
    • Indianapolis, Indiana, United States, 46202
      • OrthoIndy / Methodist Hospital
    • Indianapolis, Indiana, United States, 42260
      • Orthoindy at St Vincent
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University
    • Shreveport, Louisiana, United States, 71130
      • Louisiana State University Health Sciences Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Orthopaedic Associates of Michigan, Spectrum Health
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center / Regions Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital
    • Saint Louis, Missouri, United States, 63110
      • St. Louis Medical Center
  • New York
    • Jamaica, New York, United States, 11418
      • Jamaica Hospital Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital
    • Winston-Salem, North Carolina, United States, 27157-1070
      • Wake Forest University Baptist Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Columbus, Ohio, United States, 43215
      • Grant Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Health System
    • Hershey, Pennsylvania, United States, 17033
      • Penn State University M.S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • York, Pennsylvania, United States, 17405
      • York Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital, Brown University
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Fort Sam Houston, Texas, United States, 78234-6315
      • San Antonio Miliary Medical Center
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center - Houston
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Portsmouth, Virginia, United States, 23708
      • Naval Medical Center Portsmouth
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington Harborview
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University Of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability and Validity	The primary endpoint for this study is the reliability and construct validity of the PROMIS CAT instruments.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responsiveness	Responsiveness against clinical recovery, inflection points and effective interventions.	9 months
Data Completion	Data completeness in CAT-based instruments vs short form paper-based data collection	9 months
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

Collaborators and Investigators

• Sponsor: Major Extremity Trauma Research Consortium

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Injury; Orthopaedic Trauma
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 1R01AR064066-01 (U.S. NIH Grant/Contract)