Secondary stroke prevention through pathway management
| ISRCTN | ISRCTN43724416 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43724416 |
| Secondary identifying numbers | MDT22040 |
- Submission date
- 22/09/2022
- Registration date
- 12/10/2022
- Last edited
- 27/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Every year, more than 795,000 people in the United States have a stroke. Stroke-related costs in the United States came to nearly $46 billion between 2014 and 2015. These totals include the cost of health care services, medicines to treat stroke, and missed days of work. Stroke is a leading cause of serious long-term disability and reduces mobility in more than half of stroke survivors aged 65 and over. In February 2020, the Global Research Report looked at ICM adoption barriers for cryptogenic stroke. Of over 100 cardiologists/electrophysiologists and neurologists in the United States, 70% reported having significant care pathway challenges; 50% reported having no existing care pathway. A clinical need for care pathway creation exists. The intention of the DiVERT Stroke II Study (derived from DiVERT Phase I study learnings) is to evaluate how a multi-disciplinary care pathway affects short-term clinical and economic outcomes.
Who can participate?
Patients 18 years of age or older with a cryptogenic stroke or large artery atherosclerosis or small vessel occlusion hospitalization between 2023-2024 at participating clinical study sites.
What does the study involve?
The DiVERT Stroke II study care pathway is prospective, and patient data collection is retrospective, similarly, to DiVERT Stroke Phase I (ISRCTN87407792) data collection. The purpose of the study is to assess the DiVERT Stroke II study care pathway at hospitals that participated in DiVERT Stroke Phase I. The study will investigate care pathway adherence and evaluate short-term clinical and economic outcomes. Medtronic will conduct a qualitative and quantitative assessment of stroke hospitalizations at the participating clinical study sites.
What are the possible benefits and risks of participating?
The information gained from this study may result in the improvement of stroke care by developing and utilizing pathways in the future. Because data will be retrospectively collected and de-identified by the sites before retrieval at Medtronic, there are no known foreseeable risks.
Where is this study run from?
Medtronic (USA)
When is the study starting and how long is it expected to run for?
June 2022 to January 2025
Who is funding the study?
Medtronic (USA)
Who is the main contact?
Jessica Mikacevich, jessica.m.mikacevich@medtronic.com
Contact information
Public
8200 Coral Sea Street Northeast
Mounds View
55112
United States of America
| Phone | +1 651 315 2719 |
|---|---|
| jessica.m.mikacevich@medtronic.com |
Scientific
8200 Coral Sea Street Northeast
Mounds View
55112
United States of America
| Phone | +1 612 219 7361 |
|---|---|
| dalia.m.richmond@medtronic.com |
Study information
| Study design | Multicenter interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | SeconDary Stroke PreVEntion ThRough Pathway ManagemenT (DiVERT Stroke Phase II) |
| Study acronym | DiVERT Stroke Phase II |
| Study objectives | Current study hypothesis as of 23/08/2023: Medtronic will conduct a qualitative and quantitative assessment of stroke hospitalizations at the participating clinical study sites. This assessment will evaluate short-term clinical and economic outcomes and pathway adherence of the DiVERT Stroke II study care pathway. _____ Previous study hypothesis: Medtronic will conduct a qualitative and quantitative assessment of stroke hospitalizations at the participating clinical study sites. This assessment will evaluate short-term clinical and economic outcomes and pathway adherence of the DiVERT Stroke Phase II care pathway. |
| Ethics approval(s) | 1. Approved 29/08/2022, WCG IRB (1019 39th Ave SE, Suite 120, Puyallup, WA 98374, USA; +1 855 818 2289; clientservices@wcgirb.com), ref: 20224624 2. Approved 21/03/2023, WCG IRB (1019 39th Ave SE, Suite 120, Puyallup, WA 98374, USA; +1 855 818 2289; clientservices@wcgirb.com), ref: 20224624 3. Approved 31/07/2023, WCG IRB (1019 39th Ave SE, Suite 120, Puyallup, WA 98374, USA; +1 855 818 2289; clientservices@wcgirb.com), ref: 20224624 4. Approved 06/04/2023, USF Research & Innovation – Research Integrity & Compliance IRB (3702 Spectrum Blvd Suite 165 Tampa, FL 33612, USA; +1 813 974 5638; RSCH-arc@usf.edu) |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | Current interventions as of 23/08/2023: The DiVERT Stroke II study care pathway will enable physicians to use stroke etiology, presentation characteristics, neuroimaging factors and other clinical risk factors to recommend no cardiac monitoring, external cardiac monitoring, or internal cardiac monitoring. The stroke care pathway leverages current standard of care best practices and poses no safety risks for participating clinical study sites due to the quality improvement nature of the clinical study. All other care aspects including follow-up activity will remain the same as the standard of care. No referral methods will be utilized. No randomization process will be utilized. No screening methods will be utilized. _____ Previous interventions: The DiVERT Stroke Phase II care pathway will enable physicians to use stroke etiology, presentation characteristics, neuroimaging factors and other clinical risk factors to recommend no cardiac monitoring, external cardiac monitoring, or internal cardiac monitoring. The stroke care pathway leverages current standard of care best practices and poses no safety risks for participating clinical study sites due to the quality improvement nature of the clinical study. All other care aspects including follow-up activity will remain the same as the standard of care. No referral methods will be utilized. No randomization process will be utilized. No screening methods will be utilised. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 23/08/2023: 1. The following information will be collected within 180 days prior to the index stroke hospitalization from patient records and measured through chart review: 1.1. Medical history 1.2. Alcohol consumption 1.3. CHA2DS2 VASc Score (if congestive heart failure +1, if hypertension +1, if age ≥75 +2, if diabetes +1, if previous stroke +2, if vascular disease +1, if age 65 to 74 +1, and if sex category (female) +1) (most recent within 180 days prior to index hospitalization, if available) 1.4. Lab Tests: CRP (C-reactive protein), BNP (brain natriuretic peptide) (most recent within 180 days prior to index hospitalization, if available) 2. The following information will be collected during the index stroke hospitalization from patient records: 2.1. Hospitalization Dates measured by admission and discharge dates 2.2. Neurology diagnostic testing measured through chart review 2.3. EP Consultation measured through chart review 2.4. Short-term/external monitors, wearables, and/or ICM recommendation (if applicable/available) measured through DiVERT Stroke Phase II Care Pathway and chart review 2.5. Short-term/external monitors, wearables, and/or ICM use (if applicable/available) measured through DiVERT Stroke Phase II Care Pathway and chart review 3. The following information will be collected at follow-up visits through 180 days post-index stroke hospitalization (i.e., discharge) from patient records and measured through chart review: 3.1. Discharge location (SNF (skilled nursing facility), inpatient, home, etc.) 3.2. Prescribed stroke-related follow-up cadence (office and remote) 3.3. Stroke-related follow-up dates 3.4. Neurology diagnostic testing 4. Economic information to be collected from patient records and measured via claims data and chart review include: 4.1. Total cost of stroke diagnostic work-up for index hospitalization and through 180 days of follow-up 4.2. Total cost of index stroke hospitalization 4.3. Total cost short-term/external monitoring 4.4. Total cost pre- and post-ICM insertion 4.5. Total cost of care 30, 60, 90, 180 days post-stroke, including cardiovascular disease and AF healthcare utilization costs 4.6. Total cost of stroke readmissions and stroke recurrences, including healthcare utilization _____ Previous primary outcome measure: 1. The following information will be collected within 180 days prior to the index stroke hospitalization from patient records and measured through chart review: 1.1. Medical history 1.2. Alcohol consumption 1.3. CHA2DS2 VASc Score (if congestive heart failure +1, if hypertension +1, if age ≥75 +2, if diabetes +1, if previous stroke +2, if vascular disease +1, if age 65 to 74 +1, and if sex category (female) +1) (most recent within 180 days prior to index hospitalization, if available) 1.4. Lab Tests: CRP (C-reactive protein), BNP (brain natriuretic peptide) (most recent within 180 days prior to index hospitalization, if available) 2. The following information will be collected during the index stroke hospitalization from patient records: 2.1. Hospitalization Dates measured by admission and discharge dates 2.2. Neurology diagnostic testing measured through chart review 2.3. EP Consultation measured through chart review 2.4. Short-term/external monitors, wearables, and/or ICM recommendation (if applicable/available) measured through DiVERT Stroke II study Care Pathway and chart review 2.5. Short-term/external monitors, wearables, and/or ICM use (if applicable/available) measured through DiVERT Stroke II study Care Pathway and chart review 3. The following information will be collected at follow-up visits through 180 days post-index stroke hospitalization (i.e., discharge) from patient records and measured through chart review: 3.1. Discharge location (SNF (skilled nursing facility), inpatient, home, etc.) 3.2. Prescribed stroke-related follow-up cadence (office and remote) 3.3. Stroke-related follow-up dates 3.4. Neurology diagnostic testing 4. Economic information to be collected from patient records and measured via claims data and chart review include: 4.1. Total cost of stroke diagnostic work-up for index hospitalization and through 180 days of follow-up 4.2. Total cost of index stroke hospitalization 4.3. Total cost short-term/external monitoring 4.4. Total cost pre- and post-ICM insertion 4.5. Total cost of care 30, 60, 90, 180 days post-stroke, including cardiovascular disease and AF healthcare utilization costs 4.6. Total cost of stroke readmissions and stroke recurrences, including healthcare utilization |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 10/06/2022 |
| Completion date | 20/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | We anticipate there will be 1,500 patients included in the analysis cohort. If sample size is less than 1,500 patients, summary statistics will be provided. The number of subjects captured retrospectively will be dependent on the number of subjects at the site that meet the inclusion criteria. |
| Total final enrolment | 1756 |
| Key inclusion criteria | Current inclusion criteria as of 23/08/2023: 1. Patients with a cryptogenic stroke or large artery atherosclerosis or small vessel occlusion hospitalization between 2023 and 2024 2. Age ≥18 years _____ Previous inclusion criteria: 1. Patients with a cryptogenic stroke or large artery atherosclerosis or small vessel occlusion hospitalization between 2022 and 2024 2. Age ≥18 years |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 21/08/2023 |
| Date of final enrolment | 31/10/2024 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Overland Park
66215
United States of America
Overland Park
66211
United States of America
Austin
78705
United States of America
Charleston
29406
United States of America
Nashville
37203
United States of America
Kansas City
64132
United States of America
Tampa
33606
United States of America
Sponsor information
Industry
8200 Coral Sea Street Northeast
Mounds View
55112
United States of America
| Phone | +1 612 219 7361 |
|---|---|
| karah.neisen@medtronic.com | |
| Website | http://www.medtronic.com/us-en/index.html |
"ROR" |
https://ror.org/00grd1h17 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medtronic Inc.
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. The protocol and the statistical analysis plan will be publicly available at study completion, or earlier upon request 2. Primary study results will be submitted for publication after the primary objective is met 3. Planned publication targets include: high-impact peer-reviewed journals, neurology conferences, cardiology conferences 4. Planned publication types include but are not limited to: primary publications, ancillary publications, and design publications in the format of manuscripts, abstracts, and posters |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as this is a retrospective data pull based on inclusion/exclusion criteria |
Editorial Notes
27/01/2025: Total final enrolment added. The intention to publish date was changed from 31/05/2025 to 31/10/2025.
14/08/2024: The following changes were made:
1. The recruitment end date was changed from 21/08/2024 to 31/10/2024.
2. The intention to publish date was changed from 31/01/2025 to 31/05/2025.
07/05/2024: The public contact was changed.
08/11/2023: The recruitment end date was changed from 01/08/2024 to 21/08/2024.
23/08/2023: The following changes were made to the trial record:
1. The ethics approvals 2-4 were added.
2. The overall end date was changed from 01/08/2024 to 20/01/2025.
3. The interventions were changed.
4. The primary outcome measure was changed.
5. The study hypothesis was changed.
6. The target number of participants was changed from "The number of subjects enrolled in this study will be dependent on the number of subjects at the participating sites that meet the inclusion and exclusion criteria over the duration of the trial." to "We anticipate there will be 1,500 patients included in the analysis cohort. If sample size is less than 1,500 patients, summary statistics will be provided. The number of subjects captured retrospectively will be dependent on the number of subjects at the site that meet the inclusion criteria."
7. The total target enrollment was changed from 5400 to 1500.
8. The inclusion criteria were changed.
9. The recruitment start date was changed from 01/11/2022 to 21/08/2023.
10. The recruitment end date was changed from 26/04/2024 to 01/08/2024.
11. The study participating centre University of South Florida Health including Tampa General Hospital was added.
12. The plain English summary was updated to reflect these changes.
11/07/2023: The overall study end date was changed from 26/04/2024 to 01/08/2024.
06/04/2023: The recruitment end date was changed from 28/04/2023 to 26/04/2024.
09/02/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/11/2023 to 28/04/2023.
2. The contact was changed.
30/09/2022: Trial's existence confirmed by WCG IRB.
