Sickle Cell Anemia WE CARE

Not Applicable

Completed

Conditions: Sickle Cell Disease

Interventions: Behavioral: WE CARE SDoH Screening Survey
Other: Standard of care
Behavioral: Family Resource Book

Registration Number: NCT03716726

Lead Sponsor: Boston Medical Center

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.

Detailed Description: Social determinants of health (SDoH)-the conditions in which people are born, grow, work, live, and age-are key drivers of health and health disparities. Children with medical complexity are particularly at-risk given their high healthcare need and utilization. Although the American Academy of Pediatrics and payers such as the Centers for Medicaid and Medicare Services are now recommending medical providers screen for SDoH at visits, studies have not yet demonstrated the impact of SDoH screening and referral interventions on improving child health and have fallen short of exploring potential mechanisms by which such interventions could improve health outcomes. Children with sickle cell anemia (SCA) are an ideal population in which to study the impact of SDoH interventions given the high prevalence of poverty and unmet material needs among this population and the disease's significant morbidity and mortality. This proposal addresses a timely clinically- and policy-relevant research gap by: (1) implementing a SDoH intervention in two outpatient pediatric hematology clinics and gathering preliminary data to assess its impact on child health; and (2) characterizing the potential mechanisms by which addressing SDoH may lead to improved health outcomes. The research team has developed, tested, and implemented a SDOH intervention (WE CARE) which relies on existing clinical processes to screen for unmet material needs and refer parents to community services; efficacy data demonstrates its positive impact on parental receipt of community resources. The investigators now propose conducting a pragmatic pilot cluster randomized controlled trial (RCT) to examine the implementation of WE CARE as standard of care in two of the four hematology clinics. To preliminarily examine outcomes,100 parents of children with SCA (25 per site) will be recruited and followed for one year in order to explore how addressing unmet social needs within the delivery of medical care may improve healthcare utilization and health outcomes. Given the limitations of applying existing theoretical frameworks to culturally diverse populations such as those with SCA, the investigators will also employ a mixed methods approach to characterizing how SDoH influences disease management processes. The specific aims are to: (1) Implement WE CARE in two pediatric hematology clinics in order to field test key study logistics and understand the facilitators and barriers to implementation and accelerate its adoption; (2) Obtain population-specific empirical estimates of study parameters to plan a large-scale multi-site cluster RCT of WE CARE that will definitely assess its impact on improving health outcomes for children with SCA; and (3) Qualitatively assess possible mechanisms linking SDoH interventions to improved health outcomes. It has significant implications for child health policy and is a critical step in potentially transforming the delivery of healthcare for medically complex children.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 112

Inclusion Criteria

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

Exclusion Criteria

Foster parents

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention-WE CARE	WE CARE SDoH Screening Survey	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).
Control-Standard of Care	Standard of care	Standard of care for pediatric patients with sickle cell anemia will be delivered.
Intervention-WE CARE	Family Resource Book	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).

Primary Outcome Measures

Name	Time	Method
Parental Enrollment in Community Resources	12 months	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.
Number of Emergency Department (ED)/Acute Care Visits	12 months	Data on number of ED visits and acute care visits abstracted from the EHR.

Secondary Outcome Measures

Name	Time	Method
Personal Health Questionnaire Depression Scale (PHQ-8)	12 months	Patient Health Questionnaire depression scale (PHQ-8) is an 8 item instrument with possible responses for each item of 0=Not at all, 1=Several days 2= More than half the days, 3=Nearly every day. The range of scores is 0 to 24. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months	12 months	Self-reported measure of effective and ineffective ways to cope with a stressful life event. 28 total items (list of coping behaviors) scored on a 4-point Likert scale from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot). There are 14 coping behaviors for the 28 items and scores for each of the 14 can range from 1-8.
Vaso-occlusive Episodes	12 months	Number of painful vaso-occlusive episodes (VOE) requiring an ED or acute care clinic visit
Prescriptions for Sickle Cell Disease	12 months	Data on prescriptions written and filled for hydroxyurea and penicillin will be collected through EHR review. . Number of days covered by prescriptions will be reported
Hemoglobin Values Related to Medication Adherence	12 months	Laboratory markers commonly affected by hydroxyurea medication from the CBC (complete blood count) include hemoglobin and hemoglobin F levels, white blood cell and absolute neutrophil counts, and mean corpuscular volume. Each wil be abstracted from the medical records.
White Blood Cell and Absolute Neutrophil Counts Related to Medication Adherence	12 months	Laboratory markers commonly affected by hydroxyurea medication from the CBC (complete blood count) including hemoglobin and hemoglobin F levels, white blood cell and absolute neutrophil counts, and mean corpuscular volume. Each will be abstracted from medical records.
Mean Corpuscular Volume Values Related to Medication Adherence	12 months	Laboratory markers commonly affected by hydroxyurea medication from the CBC (complete blood count) including hemoglobin and hemoglobin F levels, white blood cell and absolute neutrophil counts, and mean corpuscular volume (MCV) will be abstracted from medical records. MCV is a measure of the average volume of a red blood corpuscle (or red blood cell).