Clinical trial NCT02769338: Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms
Official title: Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) (QUE 15-280)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transient Ischemic Attack
Stroke
Keywords: Implementation
Quality Improvement
Stroke
Transient Ischemic Attack
TIA
Systems Redesign
QI Intervention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-05-11
Enrollment: 2292
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness: Without-fail Care Rate
timeFrame: Over the course of One Year active implementation
Secondary outcomes:
measure: Recurrent Vascular Events
timeFrame: 90-days from presentation
measure: The Group Organization (GO) Score
timeFrame: Measured at the end of the one-year active implementation period
measure: Number of Quality Improvement Activities Completed
timeFrame: One-year active implementation period
measure: Program Satisfaction
timeFrame: Measured at the end of the one-year active implementation period
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Dawn M. Bravata, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Teresa M. Damush, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.