Evaluation of a Navigator-Nurse Care Team on the Management of High Blood Pressure and Cardiovascular Disease Risk

This study has been completed.
Sponsor:
Collaborators:
University of Colorado, Denver
Information provided by (Responsible Party):
Ed Havranek, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT00523536
First received: August 30, 2007
Last updated: August 29, 2013
Last verified: April 2009

August 30, 2007
August 29, 2013
May 2007
June 2009   (final data collection date for primary outcome measure)
Change in SBP level [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: Yes ]
Change in SBP level [ Time Frame: Measured at Year 1 ]
Complete list of historical versions of study NCT00523536 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Utilization of urgent care visits/emergency department/hospitalizations [ Time Frame: Measured at Year 1 ]
Not Provided
Not Provided
 
Evaluation of a Navigator-Nurse Care Team on the Management of High Blood Pressure and Cardiovascular Disease Risk
Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR): Evaluation of a Navigator-Nurse Care Team on Hypertension and Cardiovascular Disease Risk

The purpose of this trial is to study the effect of a patient navigator-nurse team in improving the management of hypertension and other cardiovascular disease risk factors in a health care system taking care of a vulnerable, mostly Latino population.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Hypertension
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.
  • Experimental: 1
    Patient navigator-nurse disease management intervention
    Intervention: Behavioral: Patient Navigator - Nurse Team Intervention
  • No Intervention: 2
    Usual clinical care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
August 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Active patients from the Target Adult Health Clinic
  • Identified with a diagnosis of hypertension
  • Uncontrolled hypertension (2 of 3 last BP measurements above target BP range; target BP is defined at 140/90 or 130/80 mm Hg for people with diabetes or kidney disease)

Exclusion Criteria:

  • Pregnant or breastfeeding
  • End-stage kidney disease requiring dialysis
  • Co-morbid illness with life expectancy less than 12 months
  • Institutionalized individuals because of the potentially confounding factors due to severe co-morbidity or other medical conditions
Both
21 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00523536
486, U01HL079160, U01 HL079160-03
No
Ed Havranek, Denver Health and Hospital Authority
Denver Health and Hospital Authority
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Colorado, Denver
Principal Investigator: Raymond O. Estacio, MD Denver Health, University of Colorado at Denver Health Sciences Center
Denver Health and Hospital Authority
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP