Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms
NCT ID: NCT02769338
Last Updated: 2023-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2292 participants
INTERVENTIONAL
2016-06-01
2020-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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
No interventions assigned to this group
Interventions
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Quality Improvement Program
The Intervention is a QI Program that will include multiple components as described above.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligibility for staff interviews is based on involvement in the QI intervention and willingness to participate.
Exclusion Criteria
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Dawn M. Bravata, MD
Role: PRINCIPAL_INVESTIGATOR
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Teresa M. Damush, PhD
Role: PRINCIPAL_INVESTIGATOR
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Locations
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Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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QUX 16-006
Identifier Type: -
Identifier Source: org_study_id