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Completed

NCT Number: NCT02197845

Enhancing Use of Hydroxyurea In Sickle Cell Disease Using Patient Navigators

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.)

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Thalassemia beta-Thalassemia

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Patient Navigator

Behavioral

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.

Other names: Public Health Worker, Community Health Worker

Recruitment into Specialty Care

Behavioral

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.

Other names: Sickle Cell Disease Specialty Care

Primary outcomes

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

    Time frame: 3 months

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

    Time frame: Baseline, 6 months, 1 year

Secondary outcomes

  1. Phase II: Measures of adherence to HU

    Time frame: 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.

  2. Phase II: Percent of patients achieving either maximum tolerated dose (MTD) or maximum dose

    Time frame: 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.

  3. Phase II: Number of emergency department and hospital visits

    Time frame: Baseline, 6 months, 1 year

  4. Phase II: Mean corpuscular volume

    Time frame: Baseline, 6 months, 1 year

  5. Phase II: Total hemoglobin

    Time frame: Baseline, 6 months, 1 year

  6. Phase II: White blood cell count

    Time frame: Baseline, 6 months, 1 year

  7. Phase II: Reticulocyte count

    Time frame: Baseline, 6 months, 1 year

  8. Phase II: Quality of life measures

    Time frame: Baseline, 6 months, 1 year

    Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me), Patient Reported Outcomes Measurement Information System (PROMIS)

  9. Phase II: Patient activation measures

    Time frame: Baseline, 6 months, 1 year

    Patient Activation Measure

  10. Phase II: Patient knowledge measures

    Time frame: 1 year

    Assessment of Sickle Cell Knowledge - University of Florida (UF-ASCK) (unpublished)

  11. Phase II: Health care knowledge and skills, self-efficacy, sickle cell stress measures

    Time frame: Baseline, 6 months, 1 year

    Sickle Cell Transition intervention Program (TIP) Survey (non-validated)

  12. Phase II: Social support measures

    Time frame: Baseline, 6 months, 1 year

    Sickle Cell Transition intervention Program (TIP) Survey (non-validated) and Multidimensional Scale of Perceived Social Support

  13. Phase II: Coping strategies

    Time frame: Baseline, 6 months, 1 year

    Coping Strategies Questionnaire for SCD

  14. Phase II: Associated pain conditions and comorbidities

    Time frame: 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)

  15. Phase II: Blood transfusion measures (if applicable)

    Time frame: 6 months, 1 year

    Chart review

  16. Phase II: Patient Navigator Satisfaction (if applicable)

    Time frame: 1 year

    Patient Navigator Satisfaction Surveys, 12 month follow up, Patient Study Experience Review for Patient Navigators

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • 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

Registry information

Acronym: SHiP HU

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jul 23, 2014
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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