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

• ClinicalTrials.gov Identifier: NCT02769338
• Recruitment Status: Completed
• First Posted: May 11, 2016
• Last Update Posted: October 20, 2020
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Transient Ischemic Attack; Stroke	Other: Quality Improvement Program	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Stepped-wedge
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) (QUE 15-280)
• Actual Study Start Date: June 1, 2016
• Actual Primary Completion Date: June 1, 2020
• Actual Study Completion Date: September 30, 2020

Arms and Interventions

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 Name: QI Intervention
No Intervention: Control; Non-Intervention VA Medical Centers

Outcome Measures

Primary Outcome Measures :

1. Effectiveness: Without-fail care rate [ Time Frame: Over the course of One Year active implementation ]
   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.

Secondary Outcome Measures :

1. Effectiveness: Recurrent vascular event rate [ Time Frame: 90-days after presentation for TIA ]
   A measure of recurrent event rate following the index TIA or minor stroke. Determined by analysis of electronic medical record data.

Other Outcome Measures:

1. Clinician Satisfaction-Staff Interview [ Time Frame: 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) ]
   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.
2. Provider Assessment of Program-Staff Interview [ Time Frame: 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) ]
   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
3. Adaptability -Staff Interview [ Time Frame: 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) ]
   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.
4. Number of completed quality improvement activities [ Time Frame: One year active implementation period ]
   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.
5. Group Organization (GO) Score for Providing TIA care [ Time Frame: One year of active implementation period ]
   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.
6. Group Organization (GO) Score for Improving TIA Care [ Time Frame: One year of active implementation period ]
   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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Indiana

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, United States, 46202-2884

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02769338
• Other Study ID Numbers: QUX 16-006
• First Posted: May 11, 2016
• Last Update Posted: October 20, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Investigators interested in examining PREVENT project data should contact the PI, Dr. Dawn Bravata.

• 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

Keywords provided by VA Office of Research and Development:

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

Additional relevant MeSH terms:

Ischemic Attack, Transient; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia