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Streamlining Trauma Research Evaluation With Advanced Measurement (STREAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02079714
Recruitment Status : Active, not recruiting
First Posted : March 6, 2014
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Major Extremity Trauma Research Consortium

Tracking Information
First Submitted Date February 24, 2014
First Posted Date March 6, 2014
Last Update Posted Date July 11, 2019
Study Start Date January 2014
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 4, 2014)
Reliability and Validity [ Time Frame: 9 months ]
The primary endpoint for this study is the reliability and construct validity of the PROMIS CAT instruments.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 4, 2014)
  • Responsiveness [ Time Frame: 9 months ]
    Responsiveness against clinical recovery, inflection points and effective interventions.
  • Data Completion [ Time Frame: 9 months ]
    Data completeness in CAT-based instruments vs short form paper-based data collection
  • Participant Burden [ Time Frame: 9 months ]
    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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Streamlining Trauma Research Evaluation With Advanced Measurement
Official Title Streamlining Trauma Research Evaluation With Advanced Measurement: STREAM Study
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Orthopaedic Trauma
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: March 4, 2014)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2019
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02079714
Other Study ID Numbers 1R01AR064066-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Major Extremity Trauma Research Consortium
Study Sponsor Major Extremity Trauma Research Consortium
Collaborators Not Provided
Investigators Not Provided
PRS Account Major Extremity Trauma Research Consortium
Verification Date November 2018