Sickle Cell Anemia WE CARE

NCT03716726 | Completed Results

• 2 other identifiers: H-382141R01HL141774-01A1
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This mixed-methods study aims to understand the implementation of a previously tested, efficacious social determinants of health (SDoH) screening and referral intervention in the outpatient pediatric hematology setting; qualitatively assess possible mechanisms for such interventions on improving child health; and obtain population-specific empirical estimates to plan a large-scale clinical trial.

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease; Social Determinants of Health; Unmet Social Needs; WE CARE

Outcome Measures

Primary Outcomes (2)

• Number of Emergency Department (ED)/Acute Care Visits

  Data on number of ED visits and acute care visits abstracted from the EHR.

  12 months

• Parental Enrollment in Community Resources

  Self-reported enrollment in a new community resource, where "yes" indicates enrollment in a new resource, and "no" indicates no enrollment in a new resource.

  12 months

Secondary Outcomes (7)

• Personal Health Questionnaire Depression Scale (PHQ-8)

  12 months

• Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months

  12 months

• Vaso-occlusive Episodes

  12 months

• Prescriptions for Sickle Cell Disease

  12 months

• Hemoglobin Values Related to Medication Adherence

  12 months

Study Arms (2)

Intervention-WE CARE

EXPERIMENTAL

The WE CARE SDoH Screening Survey will be given at all visits by the front desk staff to all parents of Sickle Cell Anemia patients who present to the pediatric hematology clinic. They will also be provided the Family Resource Book. Clinical team members (i.e. medical assistants and providers) will be trained to review the WE CARE Social Determinants of Health survey at visits and to provide community resource information sheets to parents with needs. The completed surveys will be scanned into the electronic health record (EHR).

Behavioral: WE CARE SDoH Screening Survey; Behavioral: Family Resource Book

Control-Standard of Care

EXPERIMENTAL

Standard of care for pediatric patients with sickle cell anemia will be delivered.

Other: Standard of care

Interventions

WE CARE SDoH Screening Survey BEHAVIORAL

The survey will be given at all visits by the front desk staff to all parents of SCA patients. It consists of 12 questions designed to: (1) briefly identify 6 unmet material needs (e.g., childcare, employment, food security, household heat, housing inadequate education) by self-report and (2) using a family-centered approach, determine whether parents would like assistance with each problem Parents wanting help will receive a resource referral. Clinical team members will be trained to review the WE CARE SDoH survey at visits and to provide community resource information sheets to parents with needs. Completed surveys will be scanned into the EHR

Intervention-WE CARE

Family Resource Book BEHAVIORAL

The Family Resource book will contain one-page information sheets listing community resources (e.g., food pantries) and their contact information (i.e. telephone number) for each specific material need (e.g., food insecurity). Information sheets will be specific to each site and written at, or below, the 8th grade level. For parents with an identified need, providers will be instructed to give an information sheet. The book will contain six separate tabs, one for each unmet need, and will contain multiple copies of the information sheets. The Family Resource Book will be made available in each exam room. The investigators will work with each practice to create a Family Resource Book prior to study initiation.

Intervention-WE CARE

Standard of care OTHER

Usual outpatient care for pediatric patients with sickle cell anemia will be provided.

Control-Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult parents of children with SCA (0-12 years of age) who take a daily medication (penicillin or hydroxyurea)to
• English or Spanish speaking

You may not qualify if:

• Foster parents

Sponsors & Collaborators

• Boston Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Patricia Kavanagh, MD
• Organization: Boston Medical Center

Patricia.Kavanagh@bmc.org

617-414-3573

Study Officials

• Arvin Garg, MD MPH

  University of Massachusetts Medical School, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic pilot cluster RCT to examine the implementation of WE CARE as standard of care in two of the four outpatient pediatric hematology clinics.

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 23, 2018
• Study Start: January 21, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 26, 2024
• Results First Posted: March 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)