Enhancing Use of Hydroxyurea In Sickle Cell Disease Using Patient Navigators

N/ACompletedNCT02197845

Virginia Commonwealth University353 enrolled

Overview

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.)

The state of Virginia, including the Virginia Department of Health and three academic medical centers and one federally qualified health center, plans a two-phase demonstration, first of improvement in the percentage of adults with SCD who are in SCD specialty care (Phase I), then of improvement in adherence to HU of eligible SCD adults (Phase II). Both phases will use existing academic SCD providers, and an innovative, multimodal strategy, featuring specially trained SCD patient navigators (PNs), that addresses barriers to care and to HU use. In Phase I we will demonstrate the feasibility of utilizing PNs to overcome patient access barriers to SCD care. In Phase II we will test the efficacy of PNs for overcoming barriers to acceptance of and adherence with HU therapy. Patients will be randomized to a PN arm or to a usual care arm. Providers will implement NIH guidelines for HU eligibility and prescribing in both arms. All HU eligible patients will be offered HU at each clinical visit. Among patients prescribed HU, if a maximum tolerated dose (MTD, defined in end points) has not been reached, providers will dose escalate every 8-12 weeks to MTD, rather than to clinical effect, before declaring treatment success or failure. This project will be critically important and impactful by demonstrating the feasibility of a statewide community-based strategy to assist vulnerable SCD adults in obtaining SCD specialty care and likely prolonging life, a model that other states could adopt.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

353

Conditions

Sickle Cell Disease

Interventions

Patient NavigatorBEHAVIORAL

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.

Recruitment into Specialty CareBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

PHASE I: Inclusion Criteria: * Patient Self Report of Sickle Cell Disease (Genotypes: Hb SS, SC, SBoThal, SB+Thal) * 15 years or older * Virginia resident Exclusion Criteria: -Visited one of a pre-selected list of sickle cell specialists in Virginia within the last 6 months PHASE II: Inclusion Criteria: * Sickle Cell Disease (SCD) patient (Genotypes: SS or SBoThal) * Eligible for Hydroxyurea (according to NIH guidelines) * 15 years or older * Virginia resident Exclusion Criteria: * Pregnancy * Enrollment in scheduled chronic transfusion program * SCD Genotype: Hb SC and SB+Thal)

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Phase I: Percent of enrolled Phase I subjects who complete a provider visit by 3 months post enrollment

Time frame: 3 months

Phase II: Increase in fetal hemoglobin (HbF) as measured by hemoglobin electrophoresis