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NCT02769338: PREVENT

Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms

Completed NA Results posted Last updated 13 December 2023
What this trial tests

NA trial testing Quality Improvement Program in Transient Ischemic Attack in 2,292 participants. Completed in 30 September 2020.

Timeline
1 June 2016
Primary endpoint
1 June 2020
30 September 2020

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposehealth services research
Enrollment2,292
Start date1 June 2016
Primary completion1 June 2020
Estimated completion30 September 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Eligibility, any sex, with Transient Ischemic Attack or Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Effectiveness: Without-fail Care Rate Primary · Over the course of One Year active implementation

Teams at the 6 intervention sites will be given both the QI program (to improve care) and eCQM data (to monitor the care they are delivering to their patients). The primary effectiveness outcome is the proportion of Veterans who received all of the guideline-concordant processes of care for which they are eligible referred to as the "Without-Fail" care rate. Determined by analysis of electronic medical record data.

GroupValue95% CI
QI With External Facilitation95
Control363
Recurrent Vascular Events Secondary · 90-days from presentation

The recurrent event endpoint included: congestive heart failure, myocardial infarction/acute coronary syndrome, ischemic stroke, TIA, ventricular arrhythmia, or death from any cause

GroupValue95% CI
QI With External Facilitation16
Control96
The Group Organization (GO) Score Secondary · Measured at the end of the one-year active implementation period

The GO Score refers to the Group Organization Score for improving TIA care quality; it is a measure of team activation and cohesion. The GO score is measured on a scale of 0-10 based on specific practices in place during a given time period and scored by the evaluation team. A score of 0-3 indicates the absence of a facility-wide approach; 4-5 reflects a developing facility-wide approach; 6-7 denotes basic proficiency with the presence of a comprehensive facility-wide program; and 8-10 indicates the presence of a mature, facility-wide system that can sustain key personnel turnover. The GO Scor

GroupValue95% CI
Active Implementation Sites6.67± 1.374
Number of Quality Improvement Activities Completed Secondary · One-year active implementation period

The number of implementation activities completed during the one-year active implementation period

GroupValue95% CI
Active Implementation Sites26.5± 8.078
Program Satisfaction Secondary · Measured at the end of the one-year active implementation period

Overall staff satisfaction with the program was assessed with a single question with the response scale ranging from 1 to 7 where 7 indicated "extremely satisfied." Program satisfaction was measured only at the six PREVENT intervention sites.

GroupValue95% CI
Active Implementation Sites6.23± 0.75

Sponsor's own description

This program will seek to implement a quality improvement program to improve the care of Veterans with TIA or minor stroke at 6 Veteran Health Administration Hospitals. The investigators will evaluate the implementation and effectiveness of the quality improvement program.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Quality of Care for Veterans With Transient Ischemic Attack and Minor Stroke.
    Bravata DM, Myers LJ, Arling G, Miech EJ, et al · · 2018 · cited 25× · PMID 29404578 · DOI 10.1001/jamaneurol.2017.4648
  2. The protocol-guided rapid evaluation of veterans experiencing new transient neurological symptoms (PREVENT) quality improvement program: rationale and methods.
    Bravata DM, Myers LJ, Homoya B, Miech EJ, et al · · 2019 · cited 20× · PMID 31747879 · DOI 10.1186/s12883-019-1517-x
  3. Assessment of the Protocol-Guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) Program for Improving Quality of Care for Transient Ischemic Attack: A Nonrandomized Cluster Trial.
    Bravata DM, Myers LJ, Perkins AJ, Zhang Y, et al · · 2020 · cited 19× · PMID 32897372 · DOI 10.1001/jamanetworkopen.2020.15920
  4. Empowering Implementation Teams with a Learning Health System Approach: Leveraging Data to Improve Quality of Care for Transient Ischemic Attack.
    Rattray NA, Damush TM, Miech EJ, Homoya B, et al · · 2020 · cited 16× · PMID 32875510 · DOI 10.1007/s11606-020-06160-y
  5. Implementation Evaluation of a Complex Intervention to Improve Timeliness of Care for Veterans with Transient Ischemic Attack.
    Damush TM, Miech EJ, Rattray NA, Homoya B, et al · · 2021 · cited 15× · PMID 33145694 · DOI 10.1007/s11606-020-06100-w
  6. Multi-tiered external facilitation: the role of feedback loops and tailored interventions in supporting change in a stepped-wedge implementation trial.
    Penney LS, Damush TM, Rattray NA, Miech EJ, et al · · 2021 · cited 11× · PMID 34315540 · DOI 10.1186/s43058-021-00180-3
  7. The Perils of a "My Work Here is Done" perspective: a mixed methods evaluation of sustainment of an evidence-based intervention for transient ischemic attack.
    Bravata DM, Miech EJ, Myers LJ, Perkins AJ, et al · · 2022 · cited 8× · PMID 35787273 · DOI 10.1186/s12913-022-08207-8
  8. Seeding Structures for a Community of Practice Focused on Transient Ischemic Attack (TIA): Implementing Across Disciplines and Waves.
    Penney LS, Homoya BJ, Damush TM, Rattray NA, et al · · 2021 · cited 8× · PMID 32875499 · DOI 10.1007/s11606-020-06135-z

Verify or expand the search:

Other recruiting trials for Transient Ischemic Attack

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02769338.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing