Streamlining Trauma Research Evaluation With Advanced Measurement



Status:Active, not recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 80
Updated:11/7/2018
Start Date:January 2014
End Date:October 2019

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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.

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.

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.
We found this trial at
44
sites
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Ashoke Sathy, MD
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Jason Lowe, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Michael J Bosse, MD
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Charlotte, NC
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Joshua Gary, MD
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: George Russell, MD
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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1414 Kuhl Avenue
Orlando, Florida 32806
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Orlando, FL
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620 John Paul Jones Cir
Portsmouth, Virginia 23708
(757) 953-5008
Principal Investigator: Christopher Smith, MD
Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
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Portsmouth, VA
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34800 Bob Wilson Dr,
San Diego, California 92134
(619) 532-6400
Principal Investigator: James E Toledano, MD, MC, USN
Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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San Diego, CA
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Hassan Mir, MD
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Asheville, North Carolina 28801
Principal Investigator: Harold Frisch, MD
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Robert O'Toole, MD
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Baltimore, MD
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Wade Gordon, MD
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Boston, Massachusetts 02118
Principal Investigator: Paul Tornetta, MD
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: David Weiss, MD
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Heather A Vallier, MD
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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111 S Grant Ave
Columbus, Ohio 43215
(614) 566-9000
Principal Investigator: Benjamin Taylor, MD
Grant Medical Center Founded in 1900 in Columbus' downtown, Grant has grown into one of...
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Danville, Pennsylvania 17822
Principal Investigator: Michael Suk, MD
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Denver, Colorado 80204
Principal Investigator: David Hak, MD
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Durham, North Carolina 27705
Principal Investigator: Rachel Reilly, MD
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3551 Roger Brooke Drive
Fort Sam Houston, Texas 78234
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Grand Rapids, Michigan 49503
Principal Investigator: Terrence Endres, MD
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Grand Rapids, MI
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Hershey, Pennsylvania 17033
Principal Investigator: J Spence Reid, MD
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Indianapolis, Indiana 42260
Principal Investigator: Renn Crichlow, MD
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Indianapolis, Indiana 46202
Principal Investigator: Brian Mullis, MD
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Indianapolis, Indiana 46202
Principal Investigator: Todd McKinley, MD
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Jamaica, New York 11418
Principal Investigator: Sanjit Konda, MD
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Michael Tilley, MD
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Christopher Doro, MD
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Miami, Florida 33101
Principal Investigator: Gregory A Zych, DO
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Minneapolis, Minnesota 55415
Principal Investigator: Andrew Schmidt, MD
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Nashville, Tennessee 37212
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New Orleans, Louisiana 70112
Principal Investigator: Peter Krause, MD
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: David Teague, MD
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: John Esterhai, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: Gregory Altman, MD
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Andrew Evans, MD
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Providence, Rhode Island 02903
Principal Investigator: Roman Hayda, MD
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Saint Louis, Missouri 63110
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321 South Newstead Avenue
Saint Louis, Missouri 63110
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
Principal Investigator: Theodore Miclau, MD
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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Seattle, Washington 98104
Principal Investigator: Conor Kleweno, MD
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Shreveport, Louisiana 71130
Principal Investigator: Todd Jaeblon, MD
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Principal Investigator: Eben Carroll, MD
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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York, Pennsylvania 17315
Principal Investigator: Thomas DiPasquale, MD
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