Enhancing Use of Hydroxyurea In Sickle Cell Disease Using Patient Navigators

Sickle Cell Disease Clinical Trial

— SHiP HU  

Official title:

Enhancing Use of Hydroxyurea In Sickle Cell Disease Using Patient Navigators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197845
• Other study ID #: HM14641
• Secondary ID: 1R18HL112737-01
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: December 31, 2018
• Est. primary completion date: July 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (6)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Children's Hospital of The King's Daughters, Eastern Virginia Medical School, James Madison University, National Heart, Lung, and Blood Institute (NHLBI), Virginia Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: Percent of enrolled Phase I subjects who complete a provider visit by 3 months post enrollment		3 months
Primary	Phase II: Increase in fetal hemoglobin (HbF) as measured by hemoglobin electrophoresis		Baseline, 6 months, 1 year
Secondary	Phase II: Measures of adherence to HU	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.	Baseline, 6 months, 1 year
Secondary	Phase II: Percent of patients achieving either maximum tolerated dose (MTD) or maximum dose	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.	Baseline, 6 months, 1 year
Secondary	Phase II: Number of emergency department and hospital visits		Baseline, 6 months, 1 year
Secondary	Phase II: Mean corpuscular volume		Baseline, 6 months, 1 year
Secondary	Phase II: Total hemoglobin		Baseline, 6 months, 1 year
Secondary	Phase II: White blood cell count		Baseline, 6 months, 1 year
Secondary	Phase II: Reticulocyte count		Baseline, 6 months, 1 year
Secondary	Phase II: Quality of life measures	Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me), Patient Reported Outcomes Measurement Information System (PROMIS)	Baseline, 6 months, 1 year
Secondary	Phase II: Patient activation measures	Patient Activation Measure	Baseline, 6 months, 1 year
Secondary	Phase II: Patient knowledge measures	Assessment of Sickle Cell Knowledge - University of Florida (UF-ASCK) (unpublished)	1 year
Secondary	Phase II: Health care knowledge and skills, self-efficacy, sickle cell stress measures	Sickle Cell Transition intervention Program (TIP) Survey (non-validated)	Baseline, 6 months, 1 year
Secondary	Phase II: Social support measures	Sickle Cell Transition intervention Program (TIP) Survey (non-validated) and Multidimensional Scale of Perceived Social Support	Baseline, 6 months, 1 year
Secondary	Phase II: Coping strategies	Coping Strategies Questionnaire for SCD	Baseline, 6 months, 1 year
Secondary	Phase II: Associated pain conditions and comorbidities	Chart Review, Self Report and Surveys: Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me), Patient Reported Outcomes Measurement Information System (PROMIS)	Baseline, 6 months, 1 year
Secondary	Phase II: Blood transfusion measures (if applicable)	Chart review	6 months, 1 year
Secondary	Phase II: Patient Navigator Satisfaction (if applicable)	Patient Navigator Satisfaction Surveys, 12 month follow up, Patient Study Experience Review for Patient Navigators	1 year