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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QI with External Facilitation | Experimental | Receive external facilitation to support implementation of the quality improvement program |
|
| Control | No Intervention | Non-Intervention VA Medical Centers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality Improvement Program | Other | The Intervention is a QI Program that will include multiple components as described above. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn M. Bravata, MD | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Teresa M. Damush, PhD | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana | 46202-2884 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32875499 | Background | Penney LS, Homoya BJ, Damush TM, Rattray NA, Miech EJ, Myers LJ, Baird S, Cheatham A, Bravata DM. Seeding Structures for a Community of Practice Focused on Transient Ischemic Attack (TIA): Implementing Across Disciplines and Waves. J Gen Intern Med. 2021 Feb;36(2):313-321. doi: 10.1007/s11606-020-06135-z. Epub 2020 Sep 1. | |
| 32875510 |
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Investigators interested in examining PREVENT project data should contact the PI, Dr. Dawn Bravata.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | Non-Intervention VA Medical Centers |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Period |
| |||||||||||||
| Active Implementation Period |
|
There were 6 intervention sites and 36 control sites and two time periods (baseline and active implementation). Different patients were cared for at the sites during the two time periods. During baseline, there were N=162 PREVENT intervention patients and N=973 patients at control sites. During the active implementation period, there were N=189 patients at PREVENT intervention sites and N=968 at control sites.
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Over the course of One Year active implementation |
|
The active study period for each site was of variable duration ranging from 19-37 months; it began with the baseline interview and ended on September 2020.
Adverse Events were monitored on a hospital level. Facility staff were the subjects of this research, the primary risk was breach of confidentiality which was not observed during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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PREVENT was implemented within VA facilities, which may limit generalizability. There may be diagnostic uncertainty when making a diagnosis of TIA. Because the intervention included multiple components, we are unable to estimate the unique associations of each specific element. Neither site selection nor allocation to waves was randomized. Although a 6-site sample provided adequate power for the detection of changes in processes of care, the study was not powered to detect changes in outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dawn M. Bravata | Department of Veterans Affairs | 317-988-2676 | Dawn.Bravata2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2020 | Sep 16, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002546 | Ischemic Attack, Transient |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Stepped-wedge
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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 |
| Rattray NA, Damush TM, Miech EJ, Homoya B, Myers LJ, Penney LS, Ferguson J, Giacherio B, Kumar M, Bravata DM. Empowering Implementation Teams with a Learning Health System Approach: Leveraging Data to Improve Quality of Care for Transient Ischemic Attack. J Gen Intern Med. 2020 Nov;35(Suppl 2):823-831. doi: 10.1007/s11606-020-06160-y. Epub 2020 Sep 1. |
| 31317805 | Background | Li J, Zhang Y, Myers LJ, Bravata DM. Power calculation in stepped-wedge cluster randomized trial with reduced intervention sustainability effect. J Biopharm Stat. 2019;29(4):663-674. doi: 10.1080/10543406.2019.1633658. Epub 2019 Jul 18. |
| 31747879 | Background | Bravata DM, Myers LJ, Homoya B, Miech EJ, Rattray NA, Perkins AJ, Zhang Y, Ferguson J, Myers J, Cheatham AJ, Murphy L, Giacherio B, Kumar M, Cheng E, Levine DA, Sico JJ, Ward MJ, Damush TM. The protocol-guided rapid evaluation of veterans experiencing new transient neurological symptoms (PREVENT) quality improvement program: rationale and methods. BMC Neurol. 2019 Nov 20;19(1):294. doi: 10.1186/s12883-019-1517-x. |
| 32897372 | Result | Bravata DM, Myers LJ, Perkins AJ, Zhang Y, Miech EJ, Rattray NA, Penney LS, Levine D, Sico JJ, Cheng EM, Damush TM. Assessment of the Protocol-Guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) Program for Improving Quality of Care for Transient Ischemic Attack: A Nonrandomized Cluster Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2015920. doi: 10.1001/jamanetworkopen.2020.15920. |
| 33145694 | Result | Damush TM, Miech EJ, Rattray NA, Homoya B, Penney LS, Cheatham A, Baird S, Myers J, Austin C, Myers LJ, Perkins AJ, Zhang Y, Giacherio B, Kumar M, Murphy LD, Sico JJ, Bravata DM. Implementation Evaluation of a Complex Intervention to Improve Timeliness of Care for Veterans with Transient Ischemic Attack. J Gen Intern Med. 2021 Feb;36(2):322-332. doi: 10.1007/s11606-020-06100-w. Epub 2020 Nov 3. |
| 33980224 | Result | Damush TM, Penney LS, Miech EJ, Rattray NA, Baird SA, Cheatham AJ, Austin C, Sexson A, Myers LJ, Bravata DM. Acceptability of a complex team-based quality improvement intervention for transient ischemic attack: a mixed-methods study. BMC Health Serv Res. 2021 May 12;21(1):453. doi: 10.1186/s12913-021-06318-2. |
| 40556841 | Derived | Baird SA, Damush TM, Rattray NA, Penney LS, Miech EJ, Homoya BJ, Ferguson J, Myers LJ, Bravata DM. Using a "Kickoff" to build implementation partner teams and action plans for active implementation of a quality improvement project. Front Health Serv. 2025 Jun 10;5:1580653. doi: 10.3389/frhs.2025.1580653. eCollection 2025. |
| 35820867 | Derived | Myers LJ, Perkins AJ, Zhang Y, Bravata DM. Identifying transient ischemic attack (TIA) patients at high-risk of adverse outcomes: development and validation of an approach using electronic health record data. BMC Neurol. 2022 Jul 12;22(1):256. doi: 10.1186/s12883-022-02776-1. |
| 35787273 | Derived | Bravata DM, Miech EJ, Myers LJ, Perkins AJ, Zhang Y, Rattray NA, Baird SA, Penney LS, Austin C, Damush TM. The Perils of a "My Work Here is Done" perspective: a mixed methods evaluation of sustainment of an evidence-based intervention for transient ischemic attack. BMC Health Serv Res. 2022 Jul 4;22(1):857. doi: 10.1186/s12913-022-08207-8. |
| 34315540 | Derived | Penney LS, Damush TM, Rattray NA, Miech EJ, Baird SA, Homoya BJ, Myers LJ, Bravata DM. Multi-tiered external facilitation: the role of feedback loops and tailored interventions in supporting change in a stepped-wedge implementation trial. Implement Sci Commun. 2021 Jul 27;2(1):82. doi: 10.1186/s43058-021-00180-3. |
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Non-Intervention VA Medical Centers |
| BG002 | Total | Total of all reporting groups |
| Number of units (VA hospitals) |
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| years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| The Without-Fail Rate | Not all patients were eligible for the process measures that were included in the without-fail rate. | Count of Participants | Participants | Participants |
|
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| OG001 | Control | Non-Intervention VA Medical Centers |
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| 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 | The data presented represents the total sample for intervention sites and control sites during the active implementation period. | Posted | Count of Participants | Participants | 90-days from presentation |
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|
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| 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. | The GO score is assessed at the facility level. | Posted | Mean | Standard Deviation | units on the GO Score | Measured at the end of the one-year active implementation period | Number of units (VA hospitals) | Number of units (VA hospitals) |
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|
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| Secondary | Number of Quality Improvement Activities Completed | The number of implementation activities completed during the one-year active implementation period | The six sites that implemented the PREVENT program | Posted | Mean | Standard Deviation | number of activities per year | One-year active implementation period | Number of units (VA hospitals) | Number of units (VA hospitals) |
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| 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. | Six PREVENT intervention sites | Posted | Mean | Standard Deviation | units on a scale | Measured at the end of the one-year active implementation period | Number of units (VA hospitals) | Number of units (VA hospitals) |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Control | Non-Intervention VA Medical Centers | 0 | 36 | 0 | 36 | 0 | 36 |
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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