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
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Patient Navigator - Nurse Team Intervention

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • Change in SBP level [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 800
Study Start Date: May 2007
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523536

Locations
United States, Colorado
East Adult Clinic, Denver Health
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
University of Colorado, Denver
Investigators
Principal Investigator: Raymond O. Estacio, MD Denver Health, University of Colorado at Denver Health Sciences Center
  More Information

No publications provided

Responsible Party: Ed Havranek, Physician, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT00523536     History of Changes
Other Study ID Numbers: 486, U01HL079160, U01 HL079160-03
Study First Received: August 30, 2007
Last Updated: August 29, 2013
Health Authority: United States: Federal Government

Keywords provided by Denver Health and Hospital Authority:
High Blood Pressure
Cardiovascular

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014