Enhancing Use of Hydroxyurea In Sickle Cell Disease Using Patient Navigators

Not Applicable

Completed

• Conditions: Sickle Cell Disease
• Interventions: Behavioral: Patient Navigator; Behavioral: Recruitment into Specialty Care

• Registration Number: NCT02197845
• Lead Sponsor: Virginia Commonwealth University

Brief 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.)

Detailed Description

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-23
• Primary Completion: 2018-07-07
• Study Completion: 2018-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 353

Inclusion Criteria

• Patient Self Report of Sickle Cell Disease (Genotypes: Hb SS, SC, SBoThal, SB+Thal)
• 15 years or older
• Virginia resident

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase II: Patient Navigator Arm	Patient Navigator	Participants in the Phase II Experimental Arm follow routine clinical care and are assigned a Patient Navigator. A specially trained (SCD specefic)PN will work with participants for one year. Participants will be contacted by their Navigator weekly for the first 6 months, then biweekly for the second 6 months.
Phase I: Recruitment into Specialty Care	Recruitment into Specialty Care	Participants in the Phase I Experimental Arm are enrolled into SCD specialty care. PN's will contact patient up to 3 times to assure patients have had an initial visit by 3 months time.

Primary Outcome Measures

Name	Time	Method
Phase I: Percent of enrolled Phase I subjects who complete a provider visit by 3 months post enrollment	3 months
Phase II: Increase in fetal hemoglobin (HbF) as measured by hemoglobin electrophoresis	Baseline, 6 months, 1 year

Secondary Outcome Measures

Name	Time	Method
Phase II: Mean corpuscular volume	Baseline, 6 months, 1 year
Phase II: Patient activation measures	Baseline, 6 months, 1 year	Patient Activation Measure
Phase II: Number of emergency department and hospital visits	Baseline, 6 months, 1 year
Phase II: Percent of patients achieving either maximum tolerated dose (MTD) or maximum dose	Baseline, 6 months, 1 year	Maximum tolerated dose (MTD) is the daily single oral dose that can be maintained for at least 16 weeks without toxicity (\< 3 x l09 neutrophils/L, \<100 x l09 platelets/L, \< 125 x l09 reticulocytes/L, 20% drop in \[Hb\] or an absolute value of \<4.5 g/dL, 50% rise in creatinine or absolute increase of \>0.4 mg/dL, 100% rise in ALT,GI disturbance, or rash or hair loss not attributable to other causes). Maximum dose is 35 mg/kg.
Phase II: Reticulocyte count	Baseline, 6 months, 1 year
Phase II: Measures of adherence to HU	Baseline, 6 months, 1 year	For patients prescribed HU, clinical research coordinators will assess HU prescription refills from pill counts, pharmacy records, and self-report at baseline, 6 months, and 1 year. Patient navigators will regularly assess their patients' HU adherence by conducting pill counts at home visits.
Phase II: White blood cell count	Baseline, 6 months, 1 year
Phase II: Patient knowledge measures	1 year	Assessment of Sickle Cell Knowledge - University of Florida (UF-ASCK) (unpublished)
Phase II: Total hemoglobin	Baseline, 6 months, 1 year
Phase II: Quality of life measures	Baseline, 6 months, 1 year	Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me), Patient Reported Outcomes Measurement Information System (PROMIS)
Phase II: Health care knowledge and skills, self-efficacy, sickle cell stress measures	Baseline, 6 months, 1 year	Sickle Cell Transition intervention Program (TIP) Survey (non-validated)
Phase II: Associated pain conditions and comorbidities	Baseline, 6 months, 1 year	Chart Review, Self Report and Surveys: Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me), Patient Reported Outcomes Measurement Information System (PROMIS)
Phase II: Blood transfusion measures (if applicable)	6 months, 1 year	Chart review
Phase II: Patient Navigator Satisfaction (if applicable)	1 year	Patient Navigator Satisfaction Surveys, 12 month follow up, Patient Study Experience Review for Patient Navigators
Phase II: Social support measures	Baseline, 6 months, 1 year	Sickle Cell Transition intervention Program (TIP) Survey (non-validated) and Multidimensional Scale of Perceived Social Support
Phase II: Coping strategies	Baseline, 6 months, 1 year	Coping Strategies Questionnaire for SCD

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States