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

Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) (QUE 15-280)

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Transient Ischemic Attack
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 2292
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202-2884
      • Richard L. Roudebush VA Medical Center, Indianapolis, IN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QI with External Facilitation; Receive external facilitation to support implementation of the quality improvement program	Other: Quality Improvement Program; The Intervention is a QI Program that will include multiple components as described above.; Other Names: QI Intervention
No Intervention: Control; Non-Intervention VA Medical Centers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Satisfaction-Staff Interview	The clinician satisfaction with the QI program will be determined by qualitative analysis of transcribed/coded semi-structured interview. Each interviewed staff will be interviewed two times over the course of the study.	Up to 2 one hour interviews occurring once at baseline (within 6 months of start of 1 year implementation) and once at final (within 6 months of end of 1 year implementation)
Provider Assessment of Program-Staff Interview	Provider assessment of the QI program, training, and eCQM program in terms of usability, complexity, and relative advantage will be determined by qualitative analysis of transcribed/coded semi-structured interview	Up to 2 one hour interviews occurring once at baseline (within 6 months of start of 1 year implementation) and once at final (within 6 months of finish of 1 year implementation)
Adaptability -Staff Interview	The adaptability of the program over the course of the study will be gained through qualitative mixed method analysis of transcribed interviews held at baseline and at the final phase of the one year active implementation period.	Up to 2 one hour interviews occurring once at baseline (within 6 months of start of 1 year implementation) and once at final (within 6 months of end of 1 year implementation)
Number of completed quality improvement activities	The total of number of completed quality improvement activities will be calculated for each of the participating sites. This will be used as an implementation outcome.	One year active implementation period
Group Organization (GO) Score for Providing TIA care	The GO score for providing TIA care will be calculated for each participating site at Baseline and again at the end of the active implementation period. This will be used as an implementation outcome.	One year of active implementation period
Group Organization (GO) Score for Improving TIA Care	The GO score for improving TIA care will be calculated for each participating site at Baseline and again at the end of the active implementation period. This will be used as an implementation outcome.	One year of active implementation period

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Teresa M. Damush, PhD, Richard L. Roudebush VA Medical Center, Indianapolis, IN; Principal Investigator: Dawn M. Bravata, MD, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimated): May 11, 2016

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Implementation; TIA; Quality Improvement; Transient Ischemic Attack; Systems Redesign; QI Intervention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: QUX 16-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Investigators interested in examining PREVENT project data should contact the PI, Dr. Dawn Bravata.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No