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

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigator - Nurse Team Intervention
Sponsored by
Denver Health and Hospital Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring High Blood Pressure, Cardiovascular

Eligibility Criteria

21 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • East Adult Clinic, Denver Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Patient navigator-nurse disease management intervention

Usual clinical care

Outcomes

Primary Outcome Measures

Change in SBP level

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
Utilization of urgent care visits/emergency department/hospitalizations

Full Information

First Posted
August 30, 2007
Last Updated
August 29, 2013
Sponsor
Denver Health and Hospital Authority
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT00523536
Brief Title
Evaluation of a Navigator-Nurse Care Team on the Management of High Blood Pressure and Cardiovascular Disease Risk
Official Title
Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR): Evaluation of a Navigator-Nurse Care Team on Hypertension and Cardiovascular Disease Risk
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Denver Health and Hospital Authority
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
High Blood Pressure, Cardiovascular

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patient navigator-nurse disease management intervention
Arm Title
2
Arm Type
No Intervention
Arm Description
Usual clinical care
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigator - Nurse Team Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in SBP level
Time Frame
Measured at Year 1
Secondary Outcome Measure Information:
Title
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
Title
Utilization of urgent care visits/emergency department/hospitalizations
Time Frame
Measured at Year 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond O. Estacio, MD
Organizational Affiliation
Denver Health, University of Colorado at Denver Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Adult Clinic, Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States

12. IPD Sharing Statement

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

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