Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT)
Primary Purpose
Transient Ischemic Attack, Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality Improvement Program
Sponsored by
About this trial
This is an interventional health services research trial for Transient Ischemic Attack focused on measuring Implementation, Quality Improvement, Stroke, Transient Ischemic Attack, TIA, Systems Redesign, QI Intervention
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
Sites / Locations
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
QI with External Facilitation
Control
Arm Description
Receive external facilitation to support implementation of the quality improvement program
Non-Intervention VA Medical Centers
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Effectiveness: Recurrent vascular event rate
A measure of recurrent event rate following the index TIA or minor stroke. Determined by analysis of electronic medical record data.
Full Information
NCT ID
NCT02769338
First Posted
April 28, 2016
Last Updated
October 16, 2020
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02769338
Brief Title
Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms
Acronym
PREVENT
Official Title
Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) (QUE 15-280)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Ischemic Attack, Stroke
Keywords
Implementation, Quality Improvement, Stroke, Transient Ischemic Attack, TIA, Systems Redesign, QI Intervention
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Stepped-wedge
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QI with External Facilitation
Arm Type
Experimental
Arm Description
Receive external facilitation to support implementation of the quality improvement program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Non-Intervention VA Medical Centers
Intervention Type
Other
Intervention Name(s)
Quality Improvement Program
Other Intervention Name(s)
QI Intervention
Intervention Description
The Intervention is a QI Program that will include multiple components as described above.
Primary Outcome Measure Information:
Title
Effectiveness: Without-fail care rate
Description
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.
Time Frame
Over the course of One Year active implementation
Secondary Outcome Measure Information:
Title
Effectiveness: Recurrent vascular event rate
Description
A measure of recurrent event rate following the index TIA or minor stroke. Determined by analysis of electronic medical record data.
Time Frame
90-days after presentation for TIA
Other Pre-specified Outcome Measures:
Title
Clinician Satisfaction-Staff Interview
Description
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.
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)
Title
Provider Assessment of Program-Staff Interview
Description
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
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)
Title
Adaptability -Staff Interview
Description
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.
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)
Title
Number of completed quality improvement activities
Description
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.
Time Frame
One year active implementation period
Title
Group Organization (GO) Score for Providing TIA care
Description
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.
Time Frame
One year of active implementation period
Title
Group Organization (GO) Score for Improving TIA Care
Description
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.
Time Frame
One year of active implementation period
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn M. Bravata, MD
Organizational Affiliation
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Teresa M. Damush, PhD
Organizational Affiliation
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Investigators interested in examining PREVENT project data should contact the PI, Dr. Dawn Bravata.
Citations:
PubMed Identifier
35820867
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.
Results Reference
derived
PubMed Identifier
35787273
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.
Results Reference
derived
PubMed Identifier
34315540
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.
Results Reference
derived
PubMed Identifier
33980224
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.
Results Reference
derived
PubMed Identifier
33145694
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.
Results Reference
derived
PubMed Identifier
32897372
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.
Results Reference
derived
PubMed Identifier
31747879
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.
Results Reference
derived
Learn more about this trial
Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms
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