Evaluation of a Navigator-Nurse Care Team on the Management of High Blood Pressure and Cardiovascular Disease Risk
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR): Evaluation of a Navigator-Nurse Care Team on Hypertension and Cardiovascular Disease Risk|
- Change in SBP level [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: Yes ]
- Percentage of participants with BP control by JNC-7 guidelines, adherence with BP medications, lipid control, change of HgbA1c for participants with diabetes, and change in smoking status/BMI [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: Yes ]
- Utilization of urgent care visits/emergency department/hospitalizations [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Study Completion Date:||August 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Patient navigator-nurse disease management intervention
Behavioral: Patient Navigator - Nurse Team Intervention
The patient navigator-nurse disease management intervention for treating hypertension and its associated cardiovascular risk factors will use information obtained in earlier phases of the LUCHAR grant: i.e., algorithms, risk factor profiles, and qualitative data from focus groups and interviews. The study will test the effect of this intervention on blood pressure control and utilization of hospital services in adult patients with hypertension.
No Intervention: 2
Usual clinical care
This study represents one phase of a large partnership grant with The Colorado Health Outcomes Program of the University of Colorado at Denver Health Sciences Center (UCDHSC) and Denver Health and Hospital Authority (DH). The overarching goal of Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR) is to improve the primary and secondary prevention of cardiovascular disease (CVD) in Hispanics through a comprehensive research program aimed at (1) increasing awareness of CVD risk in the Hispanic community and increasing participation of high risk Hispanics in the health care system, (2) developing more effective models of care delivery for high risk patients in a health system, and (3) identifying markers that will more effectively identify Hispanic patients at high risk of CVD than current approaches based on traditional risk factors.
This trial has been designed to assess the effectiveness of a quality improvement project which focuses on the hypertensive multiracial underserved population within the Denver Health system. In addition, we are hoping at study end to have developed and validate this project as an efficient and sustainable approach to improving blood pressure control and controlling cardiovascular risk factors, especially in the vulnerable patient population served at Denver Health.
The objective of this quality improvement program is to conduct a randomized, primary care-based, efficacy trial evaluating the effectiveness of a patient navigator-nurse disease management intervention for treating hypertension and its associated cardiovascular risk factors using information obtained in earlier phases of the LUCHAR grant: i.e., algorithms, risk factor profiles, and qualitative data from focus groups and interviews. The study is designed to test the hypothesis that a patient navigator-nurse assisted intervention will improve blood pressure (BP) in vulnerable hypertensive patients, compared with usual clinical care.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523536
|United States, Colorado|
|East Adult Clinic, Denver Health|
|Denver, Colorado, United States, 80204|
|Principal Investigator:||Raymond O. Estacio, MD||Denver Health, University of Colorado at Denver Health Sciences Center|