Trial Outcomes & Findings for Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (NCT NCT02769338)
NCT ID: NCT02769338
Last Updated: 2023-12-13
Results Overview
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.
COMPLETED
NA
2292 participants
Over the course of One Year active implementation
2023-12-13
Participant Flow
Unit of analysis: VA hospitals
Participant milestones
| Measure |
QI With External Facilitation
Receive external facilitation to support implementation of the quality improvement program
Quality Improvement Program: The Intervention is a QI Program that will include multiple components as described above.
|
Control
Non-Intervention VA Medical Centers
|
|---|---|---|
|
Baseline Period
STARTED
|
162 6
|
973 36
|
|
Baseline Period
COMPLETED
|
162 6
|
973 36
|
|
Baseline Period
NOT COMPLETED
|
0 0
|
0 0
|
|
Active Implementation Period
STARTED
|
189 6
|
968 36
|
|
Active Implementation Period
COMPLETED
|
189 6
|
968 36
|
|
Active Implementation Period
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Not all patients were eligible for the process measures that were included in the without-fail rate.
Baseline characteristics by cohort
| Measure |
QI With External Facilitation
n=6 Number of units (VA hospitals)
Receive external facilitation to support implementation of the quality improvement program
Quality Improvement Program: The Intervention is a QI Program that will include multiple components as described above.
|
Control
n=36 Number of units (VA hospitals)
Non-Intervention VA Medical Centers
|
Total
n=42 Number of units (VA hospitals)
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.9 years
STANDARD_DEVIATION 11.2 • n=162 Participants
|
71.7 years
STANDARD_DEVIATION 11.3 • n=973 Participants
|
71.4 years
STANDARD_DEVIATION 11.3 • n=1135 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=162 Participants
|
53 Participants
n=973 Participants
|
61 Participants
n=1135 Participants
|
|
Sex: Female, Male
Male
|
154 Participants
n=162 Participants
|
920 Participants
n=973 Participants
|
1074 Participants
n=1135 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=162 Participants
|
45 Participants
n=973 Participants
|
63 Participants
n=1135 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
144 Participants
n=162 Participants
|
928 Participants
n=973 Participants
|
1072 Participants
n=1135 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=162 Participants
|
0 Participants
n=973 Participants
|
0 Participants
n=1135 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=162 Participants
|
4 Participants
n=973 Participants
|
5 Participants
n=1135 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=162 Participants
|
5 Participants
n=973 Participants
|
5 Participants
n=1135 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=162 Participants
|
0 Participants
n=973 Participants
|
0 Participants
n=1135 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=162 Participants
|
145 Participants
n=973 Participants
|
182 Participants
n=1135 Participants
|
|
Race (NIH/OMB)
White
|
116 Participants
n=162 Participants
|
770 Participants
n=973 Participants
|
886 Participants
n=1135 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=162 Participants
|
0 Participants
n=973 Participants
|
0 Participants
n=1135 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=162 Participants
|
49 Participants
n=973 Participants
|
57 Participants
n=1135 Participants
|
|
The Without-Fail Rate
|
58 Participants
n=158 Participants • Not all patients were eligible for the process measures that were included in the without-fail rate.
|
345 Participants
n=893 Participants • Not all patients were eligible for the process measures that were included in the without-fail rate.
|
403 Participants
n=1051 Participants • Not all patients were eligible for the process measures that were included in the without-fail rate.
|
PRIMARY outcome
Timeframe: Over the course of One Year active implementationPopulation: During the active implementation period, there were N=189 patients at the intervention sites, 176 of whom were eligible for the without-fail measure; and there were N=968 patients at the control sites, 869 of whom were eligible for the without-fail measure.
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.
Outcome measures
| Measure |
QI With External Facilitation
n=176 Participants
Receive external facilitation to support implementation of the quality improvement program
Quality Improvement Program: The Intervention is a QI Program that will include multiple components as described above.
|
Control
n=869 Participants
Non-Intervention VA Medical Centers
|
|---|---|---|
|
Effectiveness: Without-fail Care Rate
|
95 Participants
|
363 Participants
|
SECONDARY outcome
Timeframe: 90-days from presentationPopulation: The data presented represents the total sample for intervention sites and control sites during the active implementation period.
The recurrent event endpoint included: congestive heart failure, myocardial infarction/acute coronary syndrome, ischemic stroke, TIA, ventricular arrhythmia, or death from any cause
Outcome measures
| Measure |
QI With External Facilitation
n=189 Participants
Receive external facilitation to support implementation of the quality improvement program
Quality Improvement Program: The Intervention is a QI Program that will include multiple components as described above.
|
Control
n=968 Participants
Non-Intervention VA Medical Centers
|
|---|---|---|
|
Recurrent Vascular Events
|
16 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: Measured at the end of the one-year active implementation periodPopulation: The GO score is assessed at the facility level.
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.
Outcome measures
| Measure |
QI With External Facilitation
n=6 Number of units (VA hospitals)
Receive external facilitation to support implementation of the quality improvement program
Quality Improvement Program: The Intervention is a QI Program that will include multiple components as described above.
|
Control
Non-Intervention VA Medical Centers
|
|---|---|---|
|
The Group Organization (GO) Score
|
6.67 units on the GO Score
Standard Deviation 1.374
|
—
|
SECONDARY outcome
Timeframe: One-year active implementation periodPopulation: The six sites that implemented the PREVENT program
The number of implementation activities completed during the one-year active implementation period
Outcome measures
| Measure |
QI With External Facilitation
n=6 Number of units (VA hospitals)
Receive external facilitation to support implementation of the quality improvement program
Quality Improvement Program: The Intervention is a QI Program that will include multiple components as described above.
|
Control
Non-Intervention VA Medical Centers
|
|---|---|---|
|
Number of Quality Improvement Activities Completed
|
26.5 number of activities per year
Standard Deviation 8.078
|
—
|
SECONDARY outcome
Timeframe: Measured at the end of the one-year active implementation periodPopulation: Six PREVENT intervention sites
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.
Outcome measures
| Measure |
QI With External Facilitation
n=6 Number of units (VA hospitals)
Receive external facilitation to support implementation of the quality improvement program
Quality Improvement Program: The Intervention is a QI Program that will include multiple components as described above.
|
Control
Non-Intervention VA Medical Centers
|
|---|---|---|
|
Program Satisfaction
|
6.23 units on a scale
Standard Deviation 0.75
|
—
|
Adverse Events
QI With External Facilitation
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place