Traumatic Brain InjuryNCT05628207
Evaluation of the SCALED (SCaling AcceptabLE cDs)
An observational study of Traumatic Brain Injury and Venous Thromboembolism, run by University of Minnesota at 1 site in United States.
Trial summary
This project will adapt a currently deployed Clinical Decision Support (CDS) system to deliver a VTE prevention guideline for adult patients with traumatic brain injury (TBI). We believe this is an ideal PCOR use case given PCORI's continued effort to combat VTE in trauma and our experience previously implementing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Venous Thromboembolism
- What is being tested?
- Observational
- How many people
- 15,000 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2023to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: All patients age 18 and older admitted with a TBI will be eligible for inclusion.
Who may be able to join
- age 18 and older
- admitted with a TBI
Who cannot join
- Patients who die within 24 hours of hospital admission and patients documented as "comfort cares" during the first 72 hours of hospitalization or with mild TBI will be excluded from final analysis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Evaluation of the SCALED (SCaling AcceptabLE cDs) Approach for the Implementation of Interoperable CDS for Venous Thromboembolism Prevention - CDS Data
This project will adapt a currently deployed Clinical Decision Support (CDS) system to deliver a VTE prevention guideline for adult patients with traumatic brain injury (TBI). We believe this is an ideal PCOR use case given PCORI's continued effort to combat VTE in trauma and our experience previously implementing this guideline. The Our overall goal is to successfully scale, evaluate, and maintain an interoperable TBI CDS across 7 total institutions.
- Conditions
- Traumatic Brain Injury, Venous Thromboembolism
- Being tested
- Observational, Observational-control
- Medical subject headings
- Brain Injuries, Traumatic, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
There is no intervention, the hospitals will adopt a CDS system which prompts users to follow best practice guidelines.
Observational-controlOther
There is no intervention, the hospitals will not use the CDS system.
| Study group | Role | What they receive |
|---|---|---|
| 4 hospitals using CDS TBI | healthcare system leveraging the rigorous approach, SCALED (SCaling AcceptabLE cDs), to guide CDS scaling across the system in VTE prevention. Receives: Other: Observational | |
| 3 hospitals not using CDS TBI (control) | healthcare system not leveraging the rigorous approach, SCALED (SCaling AcceptabLE cDs), to guide CDS scaling across the system in VTE prevention. Receives: Other: Observational-control |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary effectiveness outcome
VTE event rate
Measured: 2 years and a half
Evaluate implementation strategy guided by the EPIS Implementation
the number of patients that received treatment according to the best practice guideline and the % adherence to the guideline per site
Measured: 2 years and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start16 May 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628207
- Sponsor's protocol ID
- HRP-595
- Status last verified
- Sep 2026
- First submitted
- 16 Nov 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tignanelli CJ, Shah S, Vock D, Siegel L, Serrano C, Haut E, Switzer S, Martin CL, Rizvi R, Peta V, Jenkins PC, Lemke N, Thyvalikakath T, Osheroff JA, Torres D, Vawdrey D, Callcut RA, Butler M, Melton GB. A pragmatic, stepped-wedge, hybrid type II trial of interoperable clinical decision support to improve venous thromboembolism prophylaxis for patients with traumatic brain injury. Implement Sci. 2024 Aug 5;19(1):57. doi: 10.1186/s13012-024-01386-4.
PubMed 39103955
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the SCALED (SCaling AcceptabLE cDs) Approach for the Implementation of Interoperable CDS for Venous Thromboembolism Prevention - CDS Data
- ClinicalTrials.gov ID
- NCT05628207
- Acronym / sponsor ID
- HRP-595
- Conditions
- Traumatic Brain Injury, Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 16 May 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 28 Nov 2022 (actual)
- 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.
This project will adapt a currently deployed Clinical Decision Support (CDS) system to deliver a VTE prevention guideline for adult patients with traumatic brain injury (TBI). We believe this is an ideal PCOR use case given PCORI's continued effort to combat VTE in trauma and our experience previously implementing this guideline. The Our overall goal is to successfully scale, evaluate, and maintain an interoperable TBI CDS across 7 total institutions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 hospitals using CDS TBI | – | Other: Observationalhealthcare system leveraging the rigorous approach, SCALED (SCaling AcceptabLE cDs), to guide CDS scaling across the system in VTE prevention. |
| 3 hospitals not using CDS TBI (control) | – | Other: Observational-controlhealthcare system not leveraging the rigorous approach, SCALED (SCaling AcceptabLE cDs), to guide CDS scaling across the system in VTE prevention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients age 18 and older admitted with a TBI will be eligible for inclusion.
Key inclusion criteria (2 listed)
- age 18 and older
- admitted with a TBI
Key exclusion criteria (1 listed)
- Patients who die within 24 hours of hospital admission and patients documented as "comfort cares" during the first 72 hours of hospitalization or with mild TBI will be excluded from final analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalThere is no intervention, the hospitals will adopt a CDS system which prompts users to follow best practice guidelines. | Other | 4 hospitals using CDS TBI |
| Observational-controlThere is no intervention, the hospitals will not use the CDS system. | Other | 3 hospitals not using CDS TBI (control) |
Primary outcome
primary effectiveness outcome
Time frame: 2 years and a half
VTE event rate
Evaluate implementation strategy guided by the EPIS Implementation
Time frame: 2 years and a half
the number of patients that received treatment according to the best practice guideline and the % adherence to the guideline per site
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 39103955Tignanelli CJ, Shah S, Vock D, Siegel L, Serrano C, Haut E, Switzer S, Martin CL, Rizvi R, Peta V, Jenkins PC, Lemke N, Thyvalikakath T, Osheroff JA, Torres D, Vawdrey D, Callcut RA, Butler M, Melton GB. A pragmatic, stepped-wedge, hybrid type II trial of interoperable clinical decision support to improve venous thromboembolism prophylaxis for patients with traumatic brain injury. Implement Sci. 2024 Aug 5;19(1):57. doi: 10.1186/s13012-024-01386-4.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Venous Thromboembolism, run by University of Minnesota at 1 site 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?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
primary effectiveness outcome (time frame: 2 years and a half). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05628207, which also lists 1 linked publication.
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 2 Oct 2026.