Stroke, Transient Ischemic Attack
Conditions
Keywords
Implementation, Quality Improvement, Stroke, Transient Ischemic Attack, TIA, Systems Redesign, QI Intervention
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.
Interventions
The Intervention is a QI Program that will include multiple components as described above.
Sponsors
VA Office of Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Stepped-wedge
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 162 |
| 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. | 6 |
| Control Non-Intervention VA Medical Centers | 973 |
| Control Non-Intervention VA Medical Centers | 36 |
| Total | 1,177 |
Baseline characteristics
| Characteristic | QI With External Facilitation | Total | Control |
|---|---|---|---|
| Age, Continuous | 69.9 years STANDARD_DEVIATION 11.2 | 71.4 years STANDARD_DEVIATION 11.3 | 71.7 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 63 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 144 Participants | 1072 Participants | 928 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 182 Participants | 145 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 57 Participants | 49 Participants |
| Race (NIH/OMB) White | 116 Participants | 886 Participants | 770 Participants |
| Sex: Female, Male Female | 8 Participants | 61 Participants | 53 Participants |
| Sex: Female, Male Male | 154 Participants | 1074 Participants | 920 Participants |
| The Without-Fail Rate | 58 Participants | 403 Participants | 345 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 36 |
| other Total, other adverse events | 0 / 6 | 0 / 36 |
| serious Total, serious adverse events | 0 / 6 | 0 / 36 |
Outcome results
Primary
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.
Time frame: Over the course of One Year active implementation
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QI With External Facilitation | Effectiveness: Without-fail Care Rate | 95 Participants |
| Control | Effectiveness: Without-fail Care Rate | 363 Participants |
Secondary
Number of Quality Improvement Activities Completed
The number of implementation activities completed during the one-year active implementation period
Time frame: One-year active implementation period
Population: The six sites that implemented the PREVENT program
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI With External Facilitation | Number of Quality Improvement Activities Completed | 26.5 number of activities per year | Standard Deviation 8.078 |
Secondary
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.
Time frame: Measured at the end of the one-year active implementation period
Population: Six PREVENT intervention sites
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI With External Facilitation | Program Satisfaction | 6.23 units on a scale | Standard Deviation 0.75 |
Secondary
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
Time frame: 90-days from presentation
Population: The data presented represents the total sample for intervention sites and control sites during the active implementation period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QI With External Facilitation | Recurrent Vascular Events | 16 Participants |
| Control | Recurrent Vascular Events | 96 Participants |
Secondary
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.
Time frame: Measured at the end of the one-year active implementation period
Population: The GO score is assessed at the facility level.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI With External Facilitation | The Group Organization (GO) Score | 6.67 units on the GO Score | Standard Deviation 1.374 |