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

Not Applicable

Completed

• Conditions: Transient Ischemic Attack; Stroke
• Interventions: Other: Quality Improvement Program

• Registration Number: NCT02769338
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Study Start: 2016-06-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-09-30
• Results First Submitted: 2021-08-12
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-14
• Last Update Submitted: 2023-03-14
• Results First Posted: 2023-12-13
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2292

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.

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Exclusion Criteria

• Unwilling to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
QI with External Facilitation	Quality Improvement Program	Receive external facilitation to support implementation of the quality improvement program

Primary Outcome Measures

Name	Time	Method
Effectiveness: Without-fail Care Rate	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 Outcome Measures

Name	Time	Method
Recurrent Vascular Events	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
Number of Quality Improvement Activities Completed	One-year active implementation period	The number of implementation activities completed during the one-year active implementation period
Program Satisfaction	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.
The Group Organization (GO) Score	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 Score was measured only among the N=6 PREVENT sites.

Trial Locations

Locations (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN; 🇺🇸 Indianapolis, Indiana, United States