The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION) trial protocol [clinicaltrials.gov identifier: NCT00931788]
<p>Abstract</p> <p>Background</p> <p>Survivors of transient ischemic attack (TIA) or stroke are at high risk for recurrent vascular events and aggressive treatment of vascular risk factors can reduce this risk. However, vascular risk factors, especially hypertension and...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2010-04-01
|
| Series: | Implementation Science |
| Online Access: | http://www.implementationscience.com/content/5/1/27 |
| _version_ | 1830145201896685568 |
|---|---|
| author | Tsuyuki Ross Thompson Ann Fradette Miriam Padwal Rajdeep S Majumdar Sumit R McAlister Finlay A Grover Steven A Dean Naeem Shuaib Ashfaq |
| author_facet | Tsuyuki Ross Thompson Ann Fradette Miriam Padwal Rajdeep S Majumdar Sumit R McAlister Finlay A Grover Steven A Dean Naeem Shuaib Ashfaq |
| author_sort | Tsuyuki Ross |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Survivors of transient ischemic attack (TIA) or stroke are at high risk for recurrent vascular events and aggressive treatment of vascular risk factors can reduce this risk. However, vascular risk factors, especially hypertension and high cholesterol, are not managed optimally even in those patients seen in specialized clinics. This gap between the evidence for secondary prevention of stroke and the clinical reality leads to suboptimal patient outcomes. In this study, we will be testing a pharmacist case manager for delivery of stroke prevention services. We hypothesize this new structure will improve processes of care which in turn should lead to improved outcomes.</p> <p>Methods</p> <p>We will conduct a prospective, randomized, controlled open-label with blinded ascertainment of outcomes (PROBE) trial. Treatment allocation will be concealed from the study personnel, and all outcomes will be collected in an independent and blinded manner by observers who have not been involved in the patient's clinical care or trial participation and who are masked to baseline measurements. Patients will be randomized to control or a pharmacist case manager treating vascular risk factors to guideline-recommended target levels. Eligible patients will include all adult patients seen at stroke prevention clinics in Edmonton, Alberta after an ischemic stroke or TIA who have uncontrolled hypertension (defined as systolic blood pressure (BP) > 140 mm Hg) or dyslipidemia (fasting LDL-cholesterol > 2.00 mmol/L) and who are not cognitively impaired or institutionalized. The primary outcome will be the proportion of subjects who attain 'optimal BP and lipid control'(defined as systolic BP < 140 mm Hg and fasting LDL cholesterol < 2.0 mmol/L) at six months compared to baseline; 12-month data will also be collected for analyses of sustainability of any effects. A variety of secondary outcomes related to vascular risk and health-related quality of life will also be collected.</p> <p>Conclusions</p> <p>Nearly one-quarter of those who survive a TIA or minor stroke suffer another vascular event within a year. If our intervention improves the provision of secondary prevention therapies in these patients, the clinical (and financial) implications will be enormous.</p> |
| first_indexed | 2024-12-17T10:20:06Z |
| format | Article |
| id | doaj.art-eb3e65eb73e24979a7fecd87794acb99 |
| institution | Directory Open Access Journal |
| issn | 1748-5908 |
| language | English |
| last_indexed | 2024-12-17T10:20:06Z |
| publishDate | 2010-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Implementation Science |
| spelling | doaj.art-eb3e65eb73e24979a7fecd87794acb992022-12-21T21:52:50ZengBMCImplementation Science1748-59082010-04-01512710.1186/1748-5908-5-27The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION) trial protocol [clinicaltrials.gov identifier: NCT00931788]Tsuyuki RossThompson AnnFradette MiriamPadwal Rajdeep SMajumdar Sumit RMcAlister Finlay AGrover Steven ADean NaeemShuaib Ashfaq<p>Abstract</p> <p>Background</p> <p>Survivors of transient ischemic attack (TIA) or stroke are at high risk for recurrent vascular events and aggressive treatment of vascular risk factors can reduce this risk. However, vascular risk factors, especially hypertension and high cholesterol, are not managed optimally even in those patients seen in specialized clinics. This gap between the evidence for secondary prevention of stroke and the clinical reality leads to suboptimal patient outcomes. In this study, we will be testing a pharmacist case manager for delivery of stroke prevention services. We hypothesize this new structure will improve processes of care which in turn should lead to improved outcomes.</p> <p>Methods</p> <p>We will conduct a prospective, randomized, controlled open-label with blinded ascertainment of outcomes (PROBE) trial. Treatment allocation will be concealed from the study personnel, and all outcomes will be collected in an independent and blinded manner by observers who have not been involved in the patient's clinical care or trial participation and who are masked to baseline measurements. Patients will be randomized to control or a pharmacist case manager treating vascular risk factors to guideline-recommended target levels. Eligible patients will include all adult patients seen at stroke prevention clinics in Edmonton, Alberta after an ischemic stroke or TIA who have uncontrolled hypertension (defined as systolic blood pressure (BP) > 140 mm Hg) or dyslipidemia (fasting LDL-cholesterol > 2.00 mmol/L) and who are not cognitively impaired or institutionalized. The primary outcome will be the proportion of subjects who attain 'optimal BP and lipid control'(defined as systolic BP < 140 mm Hg and fasting LDL cholesterol < 2.0 mmol/L) at six months compared to baseline; 12-month data will also be collected for analyses of sustainability of any effects. A variety of secondary outcomes related to vascular risk and health-related quality of life will also be collected.</p> <p>Conclusions</p> <p>Nearly one-quarter of those who survive a TIA or minor stroke suffer another vascular event within a year. If our intervention improves the provision of secondary prevention therapies in these patients, the clinical (and financial) implications will be enormous.</p>http://www.implementationscience.com/content/5/1/27 |
| spellingShingle | Tsuyuki Ross Thompson Ann Fradette Miriam Padwal Rajdeep S Majumdar Sumit R McAlister Finlay A Grover Steven A Dean Naeem Shuaib Ashfaq The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION) trial protocol [clinicaltrials.gov identifier: NCT00931788] Implementation Science |
| title | The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION) trial protocol [clinicaltrials.gov identifier: NCT00931788] |
| title_full | The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION) trial protocol [clinicaltrials.gov identifier: NCT00931788] |
| title_fullStr | The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION) trial protocol [clinicaltrials.gov identifier: NCT00931788] |
| title_full_unstemmed | The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION) trial protocol [clinicaltrials.gov identifier: NCT00931788] |
| title_short | The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION) trial protocol [clinicaltrials.gov identifier: NCT00931788] |
| title_sort | preventing recurrent vascular events and neurological worsening through intensive organized case management prevention trial protocol clinicaltrials gov identifier nct00931788 |
| url | http://www.implementationscience.com/content/5/1/27 |
| work_keys_str_mv | AT tsuyukiross thepreventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT thompsonann thepreventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT fradettemiriam thepreventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT padwalrajdeeps thepreventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT majumdarsumitr thepreventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT mcalisterfinlaya thepreventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT groverstevena thepreventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT deannaeem thepreventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT shuaibashfaq thepreventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT tsuyukiross preventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT thompsonann preventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT fradettemiriam preventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT padwalrajdeeps preventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT majumdarsumitr preventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT mcalisterfinlaya preventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT groverstevena preventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT deannaeem preventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 AT shuaibashfaq preventingrecurrentvasculareventsandneurologicalworseningthroughintensiveorganizedcasemanagementpreventiontrialprotocolclinicaltrialsgovidentifiernct00931788 |