Adapting Tools to Implement Stroke Risk Management to Veterans (TOOLS)
| Tracking Information | |||||
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| First Received Date ICMJE | July 18, 2006 | ||||
| Last Updated Date | February 13, 2013 | ||||
| Start Date ICMJE | January 2009 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Provider based outcomes: guideline adherent treatment, medication management at stroke discharge, 3 and 6 mos. Risk factor screening, examination of CPRS records during hospitalization or following 6 mos. Lifestyle counseling, examination of CPRS records [ Time Frame: One year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Provider based outcomes guideline adherent treatment, medication management at stroke discharge, 3 and 6 mos. Risk factor screening, examination of CPRS records during hospitalization or following 6 mos. Lifestyle counseling, examination of CPRS record | ||||
| Change History | Complete list of historical versions of study NCT00355147 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Patient demographics, BL; depression symptoms at BL, 3 & 6 mos; other co morbidities at 6 mos. [ Time Frame: One year ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Patient demographics, BL; depression symptoms at BL, 3 & 6 mos; other co morbidities at 6 mos. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Adapting Tools to Implement Stroke Risk Management to Veterans | ||||
| Official Title ICMJE | Adapting Tools to Implement Stroke Risk Management to Veterans | ||||
| Brief Summary | The purpose of this study is to evaluate the local adaptation of existing stroke prevention tools into practice. A stroke prevention program is a collection of materials including written materials like pamphlets and brochures, videotapes and training guides for stroke survivors and for the doctors that provide care for them. Other tools that may be used in a stroke prevention program include devices that help patients monitor medical symptoms at home like home blood pressure machines or blood sugar monitors and messaging devices that allow reporting symptoms from home to a health care provider. |
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| Detailed Description | Stroke affects at least 15,000 veterans each year, and this number will likely increase as the veteran population ages. According to the AHA, the prevalence of stroke is expected to double by 2020 with the increased proportion of older adults nationwide. Our preliminary QUERI work indicates that stroke risk factors are often undermanaged in VHS. This proposed study of a stroke risk factor management program may benefit the VHS in several ways. First, it offers VHS a systematic program for reduction in stroke risk factors leading to better health for our veterans and a reduction in inpatient and outpatient rehabilitation and home health services for these events. Second, the VSPP takes into account the varied resources and services offered in VAMCs across the nation, allowing the program to be tailored both to a given facility and to the individual veteran's needs and readiness to change. Importantly, the program could allow all VA facilities to offer guideline-concurrent stroke risk reduction programs and therefore increase compliance with VA/DoD, AHA, and JCAHO stroke care guidelines and improve their quality of stroke care. Comparison(s): We will compare two regionally matched facilities on rates of secondary stroke prevention guideline care during the course of the study at the intervention sites. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Arm 1
None
Interventions:
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| Publications * | Damush TM, Jackson GL, Powers BJ, Bosworth HB, Cheng E, Anderson J, Guihan M, LaVela S, Rajan S, Plue L. Implementing evidence-based patient self-management programs in the Veterans Health Administration: perspectives on delivery system design considerations. J Gen Intern Med. 2010 Jan;25 Suppl 1:68-71. Review. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 189 | ||||
| Estimated Completion Date | December 2013 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00355147 | ||||
| Other Study ID Numbers ICMJE | IAB 05-297, 0608-01B, 1009001684 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Indiana University | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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