Clinical trial NCT02079714: Streamlining Trauma Research Evaluation With Advanced Measurement
Official title: Streamlining Trauma Research Evaluation With Advanced Measurement: STREAM Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopaedic Trauma
Keywords: Orthopaedic Trauma
Injury
Lead sponsor: Major Extremity Trauma Research Consortium
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 1065
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reliability and Validity
timeFrame: 9 months
Secondary outcomes:
measure: Responsiveness
timeFrame: 9 months
measure: Data Completion
timeFrame: 9 months
measure: Participant Burden
timeFrame: 9 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Miami
country: United States
facility: University of Miami Ryder Trauma Center
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Indianapolis
country: United States
facility: Orthoindy at St Vincent
state: Indiana
city: Indianapolis
country: United States
facility: Eskenazi Hospital
state: Indiana
city: Indianapolis
country: United States
facility: OrthoIndy / Methodist Hospital
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan, Spectrum Health
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center / Regions Hospital
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Medical Center
state: Missouri
city: Jamaica
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: Grant Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State University M.S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital, Brown University
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: San Antonio Miliary Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center - Houston
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
city: Seattle
country: United States
facility: University of Washington Harborview
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References: