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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Transient Ischemic Attack, Stroke

Intervention / Treatment
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* Other: Quality Improvement Program


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped-wedge
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QI with External Facilitation<br>Receive external facilitation to support implementation of the quality improvement program | Other: Quality Improvement Program<br>* The Intervention is a QI Program that will include multiple components as described above.<br>* Other names: QI Intervention;|
| No Intervention: Control<br>Non-Intervention VA Medical Centers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness: Without-fail Care Rate | 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. | Over the course of One Year active implementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent Vascular Events | The recurrent event endpoint included: congestive heart failure, myocardial infarction/acute coronary syndrome, ischemic stroke, TIA, ventricular arrhythmia, or death from any cause | 90-days from presentation | 
| The Group Organization (GO) Score | 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 Score was measured only among the N=6 PREVENT sites. | Measured at the end of the one-year active implementation period | 
| Number of Quality Improvement Activities Completed | The number of implementation activities completed during the one-year active implementation period | One-year active implementation period | 
| Program Satisfaction | 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. | Measured at the end of the one-year active implementation period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implementation, Quality Improvement, Stroke, Transient Ischemic Attack, TIA, Systems Redesign, QI Intervention