Tailored Communication to Reduce Cardiovascular Risk
| Tracking Information | |||||
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| First Received Date ICMJE | January 27, 2011 | ||||
| Last Updated Date | September 27, 2012 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Comparative Outcomes: Intervention Group LDL reduction Compared to Control Group LDL reduction [ Time Frame: 9 months ] [ Designated as safety issue: No ] Significant LDL cholesterol reduction at 9 months Definition: Percentage of patients with LDL-C repeated and which is at least 30 mg/dl lower than baseline |
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| Original Primary Outcome Measures ICMJE |
Comparative Outcomes: Intervention Compared to Control [ Time Frame: 9 months ] [ Designated as safety issue: No ] Significant LDL cholesterol reduction at 9 months Definition: Percentage of patients with LDL-C repeated and which is at least 30 mg/dl lower than baseline |
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| Change History | Complete list of historical versions of study NCT01286311 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Tailored Communication to Reduce Cardiovascular Risk | ||||
| Official Title ICMJE | Tailored Communication to Reduce Cardiovascular Risk | ||||
| Brief Summary | The primary goal of the trial is to test the feasibility and efficacy of a cardiovascular disease quality improvement system that couples EMR-based patient identification with individually tailored patient messages. The study will test the hypothesis that that a tailored patient-directed approach to cardiovascular risk reduction integrated into patients' primary care delivery site will improve control of elevated low-density lipoprotein cholesterol and other card iac risk factors more than routine care alone for patients at intermediate or high risk for cardiovascular disease. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Direct-to-patient tailored cardiovascular risk message system
Patient informational mailings |
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| Study Arm (s) |
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| Publications * | Persell SD, Lloyd-Jones DM, Friesema EM, Cooper AJ, Baker DW. Electronic health record-based patient identification and individualized mailed outreach for primary cardiovascular disease prevention: a cluster randomized trial. J Gen Intern Med. 2013 Apr;28(4):554-60. doi: 10.1007/s11606-012-2268-1. Epub 2012 Nov 11. | ||||
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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 | ||||
| Estimated Enrollment ICMJE | 422 | ||||
| Estimated Completion Date | January 2013 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
LDL cholesterol >= 130 mg/dl and estimated Framingham Risk Score 10-20% LDL cholesterol >= 100 mg/dl and estimated Framingham Risk Score >20% LDL cholesterol >= 160 mg/dl and estimated Framingham Risk Score 5% to <10%. Exclusion Criteria:
LDL cholesterol >= 130 mg/dl and estimated Framingham Risk Score 10-20% LDL cholesterol >= 100 mg/dl and estimated Framingham Risk Score >20% LDL cholesterol >= 160 mg/dl and estimated Framingham Risk Score 5% to <10%. |
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| Gender | Both | ||||
| Ages | 40 Years to 79 Years | ||||
| 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 | NCT01286311 | ||||
| Other Study ID Numbers ICMJE | Reducing CV Risk, K08HS015647 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Stephen Persell, Northwestern University | ||||
| Study Sponsor ICMJE | Northwestern University | ||||
| Collaborators ICMJE | Agency for Healthcare Research and Quality (AHRQ) | ||||
| Investigators ICMJE |
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| Information Provided By | Northwestern University | ||||
| Verification Date | September 2012 | ||||
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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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