Enhancing Use of Hydroxyurea In Sickle Cell Disease Using Patient Navigators

NCT02197845 | Completed DMC

• 2 other identifiers: HM146411R18HL112737-01
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 2.the efficacy of using patient navigators to improve hydroxyurea (HU) (re-)initiation and adherence among adult patients with SCD eligible for HU

Conditions

Sickle Cell Disease

Keywords

sickle cell disease; hydroxyurea; patient navigator; community health worker; public health worker; fetal hemoglobin; health services research

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• Phase II: Measures of adherence to HU

  Baseline, 6 months, 1 year

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

  Baseline, 6 months, 1 year

• Phase II: Number of emergency department and hospital visits

  Baseline, 6 months, 1 year

• Phase II: Mean corpuscular volume

  Baseline, 6 months, 1 year

• Phase II: Total hemoglobin

  Baseline, 6 months, 1 year

Study Arms (3)

Phase I: Recruitment into Specialty Care

EXPERIMENTAL

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.

Behavioral: Recruitment into Specialty Care

Phase II: Patient Navigator Arm

EXPERIMENTAL

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.

Behavioral: Patient Navigator

Phase II: Passenger Arm

NO INTERVENTION

No Intervention. Participants in the Phase II Passenger Arm follow routine clinical care.

Interventions

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.

Also known as: Public Health Worker, Community Health Worker

Phase II: Patient Navigator Arm

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.

Also known as: Sickle Cell Disease Specialty Care

Phase I: Recruitment into Specialty Care

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (3)

• McClish D, Okhomina V, Pascale A, Valrie C, Sisler I, Villella A, Smith W. Vaso-occlusive crisis pain intensity, frequency, and duration: which best correlates with health-related quality of life in adolescents and adults with sickle cell disease? Pain. 2024 Jan 1;165(1):135-143. doi: 10.1097/j.pain.0000000000003011. Epub 2023 Aug 11.

  PMID: 37578485 DERIVED

• Smith WR, Valrie C, Sisler I. Structural Racism and Impact on Sickle Cell Disease: Sickle Cell Lives Matter. Hematol Oncol Clin North Am. 2022 Dec;36(6):1063-1076. doi: 10.1016/j.hoc.2022.08.008.

  PMID: 36400531 DERIVED

• Sisler I, McClish DK, Valrie C, Villella A, Smith WR. Satisfaction and access to care for adults and adolescents with sickle cell disease: ASCQ-Me quality of care and the SHIP-HU study. Pediatr Blood Cancer. 2022 Dec;69(12):e29948. doi: 10.1002/pbc.29948. Epub 2022 Sep 24.

  PMID: 36151945 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell; beta-Thalassemia

Interventions

Patient Navigation; Community Health Workers

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Thalassemia

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Wally R Smith, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 23, 2014
• Study Start: October 1, 2012
• Primary Completion: July 7, 2018
• Study Completion: December 31, 2018
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)