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

D

Denver Health and Hospital Authority

Status

Completed

Conditions

Hypertension

Treatments

Behavioral: Patient Navigator - Nurse Team Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00523536
U01HL079160 (U.S. NIH Grant/Contract)
U01HL079160-03 (U.S. NIH Grant/Contract)
486

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 patients

Sex

All

Ages

21 to 74 years old

Volunteers

No 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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

800 participants in 2 patient groups

1
Experimental group
Description:
Patient navigator-nurse disease management intervention
Treatment:
Behavioral: Patient Navigator - Nurse Team Intervention
2
No Intervention group
Description:
Usual clinical care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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