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

NCT02769338 | Completed Results DMC

• 1 other identifier: QUX 16-006
• Study Type: interventional
• Target: 2,292
• Locations: 1 country
• Sites: 1

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.

Conditions

Transient Ischemic Attack; Stroke

Keywords

Implementation; Quality Improvement; Stroke; Transient Ischemic Attack; TIA; Systems Redesign; QI Intervention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Recurrent Vascular Events

  90-days from presentation

• The Group Organization (GO) Score

  Measured at the end of the one-year active implementation period

• Number of Quality Improvement Activities Completed

  One-year active implementation period

• Program Satisfaction

  Measured at the end of the one-year active implementation period

Study Arms (2)

QI with External Facilitation

EXPERIMENTAL

Receive external facilitation to support implementation of the quality improvement program

Other: Quality Improvement Program

Control

NO INTERVENTION

Non-Intervention VA Medical Centers

Interventions

Quality Improvement Program OTHER

The Intervention is a QI Program that will include multiple components as described above.

Also known as: QI Intervention

QI with External Facilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unwilling to participate

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (11)

• 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.

  PMID: 32875499 BACKGROUND

• 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.

  PMID: 32875510 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.

  PMID: 31317805 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.

  PMID: 31747879 BACKGROUND

• 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.

  PMID: 32897372 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.

  PMID: 33145694 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.

  PMID: 33980224 RESULT

• 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.

  PMID: 40556841 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.

  PMID: 35820867 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.

  PMID: 35787273 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.

  PMID: 34315540 DERIVED

MeSH Terms

Conditions

Ischemic Attack, Transient; Stroke

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Dawn M. Bravata
• Organization: Department of Veterans Affairs

Dawn.Bravata2@va.gov

317-988-2676

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Stepped-wedge

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 11, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: September 30, 2020
• Last Updated: December 13, 2023
• Results First Posted: December 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)