Enhancing Use of Hydroxyurea In Sickle Cell Disease Using Patient Navigators

Summary

Multi-phase, patient navigator-based program in the Richmond and Tidewater regions of Virginia to demonstrate:

1. the feasibility of using patient navigators to improve the percentage of children and adult (age 15 and older) patients with sickle cell disease (SCD) in SCD specialty care
2. the efficacy of using patient navigators to improve hydroxyurea (HU) (re-)initiation and adherence among adult patients with SCD eligible for HU

(Patient navigators may also be known as public health workers.)

Conditions

• Sickle Cell Disease

Interventions

BEHAVIORAL

Patient Navigator

A specially trained (SCD knowledgable) Patient Navigator will act as a liaison who assists participants in increasing adherence to HU through disease education, addressing barriers to care and improving adherence to HU. PN utilize various techniques geared toward the individual patients needs. Interventions utilized by a PN include improving disease management skills, educational materials about disease, HU adherence, motivational interviewing, care coordination and social support.

BEHAVIORAL

Recruitment into Specialty Care

A specially trained (SCD knowledgeable) Patient Navigator will act as a liaison to participants in increasing adherence to Hydroxyurea. Interventions utilized by a PN include teaching disease management skills, addressing barriers to care, disease education, HU management, motivational interviewing, care coordination and social support.

Sponsors & Collaborators

• Eastern Virginia Medical School

  collaborator OTHER

• Children's Hospital of The King's Daughters

  collaborator OTHER

• Virginia Department of Health

  collaborator OTHER_GOV

• James Madison University

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Virginia Commonwealth University

  lead OTHER

Principal Investigators

• Wally R Smith, MD · Virginia Commonwealth University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2018-07-07

Completion

2018-12-31

Countries

• United States

Study Locations