Orthopaedic TraumaSTREAMNCT02079714
Streamlining Trauma Research Evaluation With Advanced Measurement
An observational study of Orthopaedic Trauma, run by Major Extremity Trauma Research Consortium at 44 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orthopaedic Trauma
- How many people
- 1,065 participants
- Where
- 44 sitesUnited States
- Study dates
- Jan 2014to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Mission Hospital
Asheville, North Carolina, 28801
University of Maryland Medical Center
Baltimore, Maryland, 21201
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston Medical Center
Boston, Massachusetts, 02118
Carolinas Medical Center
Charlotte, North Carolina, 28204
University of Virginia
Charlottesville, Virginia, 22908
MetroHealth Medical Center
Cleveland, Ohio, 44109
Grant Medical Center
Columbus, Ohio, 43215
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Geisinger Health System
Danville, Pennsylvania, 17822
Denver Health and Hospital Authority
Denver, Colorado, 80203
Duke University Hospital
Durham, North Carolina, 27710
San Antonio Miliary Medical Center
Fort Sam Houston, Texas, 78234-6315
Orthopaedic Associates of Michigan, Spectrum Health
Grand Rapids, Michigan, 49503
Penn State University M.S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Texas Health Science Center - Houston
Houston, Texas, 77030
Orthoindy at St Vincent
Indianapolis, Indiana, 42260
Eskenazi Hospital
Indianapolis, Indiana, 46202
OrthoIndy / Methodist Hospital
Indianapolis, Indiana, 46202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Jamaica Hospital Medical Center
Jamaica, New York, 11418
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Wisconsin
Madison, Wisconsin, 53792
University of Miami Ryder Trauma Center
Miami, Florida, 33101
Hennepin County Medical Center / Regions Hospital
Minneapolis, Minnesota, 55415
Vanderbilt Medical Center
Nashville, Tennessee, 37232
Louisiana State University
New Orleans, Louisiana, 70112
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Orlando Regional Medical Center
Orlando, Florida, 32806
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
Rhode Island Hospital, Brown University
Providence, Rhode Island, 02903
Naval Medical Center San Diego
San Diego, California, 92134
University of California San Francisco Medical Center
San Francisco, California, 94143
University of Washington Harborview
Seattle, Washington, 98104
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71130
Barnes Jewish Hospital
St Louis, Missouri, 63110
St. Louis Medical Center
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-1070
York Hospital
York, Pennsylvania, 17405
About this study
Official title: 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.
Read the 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.
- 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:
- 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.
- Conditions
- Orthopaedic Trauma
- Keywords
- Orthopaedic Trauma, Injury
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Reliability and Validity
The primary endpoint for this study is the reliability and construct validity of the PROMIS CAT instruments.
Measured: 9 months
Secondary outcomes (3)
Responsiveness
Responsiveness against clinical recovery, inflection points and effective interventions.
Measured: 9 months
Data Completion
Data completeness in CAT-based instruments vs short form paper-based data collection
Measured: 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2019
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,065 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079714
- Sponsor's protocol ID
- 1R01AR064066-01
- Acronym
- STREAM
- Status last verified
- Mar 2023
- First submitted
- 24 Feb 2014
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Streamlining Trauma Research Evaluation With Advanced Measurement: STREAM Study
- ClinicalTrials.gov ID
- NCT02079714
- Acronym / sponsor ID
- STREAM / 1R01AR064066-01
- Conditions
- Orthopaedic Trauma
- Keywords
- Orthopaedic Trauma, Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,065 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2019 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability and Validity
Time frame: 9 months
The primary endpoint for this study is the reliability and construct validity of the PROMIS CAT instruments.
3 secondary outcomes
Responsiveness
Time frame: 9 months
Data Completion
Time frame: 9 months
Participant Burden
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopaedic Trauma, run by Major Extremity Trauma Research Consortium at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability and Validity (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023; AzTrials last refreshed its copy on 28 Oct 2026.