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Clinical Trials/NCT02769338
NCT02769338
Completed
Not Applicable

Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) (QUE 15-280)

VA Office of Research and Development1 site in 1 country2,292 target enrollmentJune 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transient Ischemic Attack
Sponsor
VA Office of Research and Development
Enrollment
2292
Locations
1
Primary Endpoint
Effectiveness: Without-fail Care Rate
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

Aim 1. To develop a quality improvement program to improve the care of Veterans with TIA or minor stroke that can be deployed nationwide. The program will include multiple components: a reporting system that is based on validated electronic quality measures (eCQMs) that will allow staff to monitor the time-sensitive processes of care and outcomes of their population of Veterans with TIA or minor stroke; clinical protocols to improve the timeliness and completeness of care; professional education materials; and clinical note templates for use by nursing and pharmacy staff. Lessons learned at the individual sites engaged in the quality improvement program will be shared across sites by use of a web-based platform and a virtual collaborative. We will assess end user's assessment of the program and its core elements. Aim 2. To evaluate the effectiveness of the Aim 1 QI intervention program for Veterans with TIA or minor stroke against usual care. Teams at the 6 intervention sites will be given the quality improvement program components. 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. Aim 3. To evaluate the implementation of the QI intervention program across the 6 participating sites. The two primary implementation outcomes will be the number of implementation activities completed during the one-year active implementation period and the final level of team organization (defined as the Group Organization (GO Score)) for improving TIA care at the end of the 12-month active implementation period. Secondary Aim To evaluate the sustainability of the program. Sustainability will be evaluated over a one-year period that begins immediately after the one-year active implementation period. We will compare the Without-Fail rate in the sustainability period to the baseline period and the post-implementation period.

Registry
clinicaltrials.gov
Start Date
June 1, 2016
End Date
September 30, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • This program will seek VA hospitals that are self-designated as either a VHA Primary Stroke Center or a Limited Hours Stroke Facility or Supporting Stroke Center.
  • Eligibility for staff interviews is based on involvement in the QI intervention and willingness to participate.

Exclusion Criteria

  • Unwilling to participate

Outcomes

Primary Outcomes

Effectiveness: Without-fail Care Rate

Time Frame: 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.

Secondary Outcomes

  • Recurrent Vascular Events(90-days from presentation)
  • Number of Quality Improvement Activities Completed(One-year active implementation period)
  • Program Satisfaction(Measured at the end of the one-year active implementation period)
  • The Group Organization (GO) Score(Measured at the end of the one-year active implementation period)

Study Sites (1)

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