SCAWECARE: Sickle Cell Anemia WE CARE

Sponsor
Boston Medical Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03716726
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
215
1
2
22.3
9.6

Study Details

Study Description

Brief Summary

This mixed-methods study aims to understand the implementation of a previously tested, efficacious 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: WE CARE SDoH Screening Survey
  • Behavioral: Family Resource Book
  • Other: Standard of care
N/A

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
215 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Pragmatic pilot cluster RCT to examine the implementation of WE CARE as standard of care in two of the four outpatient pediatric hematology clinics.Pragmatic pilot cluster RCT to examine the implementation of WE CARE as standard of care in two of the four outpatient pediatric hematology clinics.
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Understanding and Addressing the Social Determinants of Health for Families of Children With Sickle Cell Anemia Within Pediatric Hematology
Actual Study Start Date :
Jan 21, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention-WE CARE

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.

Behavioral: WE CARE SDoH Screening Survey
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

Behavioral: Family Resource Book
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.

Experimental: Control-Standard of Care

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

Other: Standard of care
Usual outpatient care for pediatric patients with sickle cell anemia will be provided.

Outcome Measures

Primary Outcome Measures

  1. Emergency department reliance (EDR) [12 months]

    EDR is calculated as follows: # clinic visits kept / (# clinic visits kept + # ED visits). Data on number of clinic- and ED visits will be collected from the EHR.

  2. Change in parental enrollment in community resources [Baseline and 3, 6, 9, and 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.

Secondary Outcome Measures

  1. Vaso-occlusive episodes [12 months]

    Data on number of vaso-occlusive episodes will be collected from the EHR.

  2. Change in hair cortisol concentrations [Baseline, 12 months]

    Laboratory processing of hair samples gathered from parents in order to measure concentration of hair cortisol, an accepted biomarker for assessing long-term activity of the hypothalamic-pituitary-adrenocortical axis and chronic stress. Higher concentrations of hair cortisol indicate higher levels of chronic stress.

  3. Baseline PedsQL + Sickle Cell Disease Module [Baseline]

    Self-reported sickle cell disease-related quality of life. 42 items comprising 9 dimensions of health-related quality of life, including: pain and hurt, pain impact, pain management, worry I, worry II, emotions, treatment, communication I, and communication II. Each item will be scored on a 5-point Likert scale from 0 (Never) to 4 (Almost always). Some items will be reverse-scored, so that higher scores indicate lower problems.

  4. 12-month PedsQL + Sickle Cell Disease Module [12 months]

    Self-reported sickle cell disease-related quality of life. 42 items comprising 9 dimensions of health-related quality of life, including: pain and hurt, pain impact, pain management, worry I, worry II, emotions, treatment, communication I, and communication II. Each item will be scored on a 5-point Likert scale from 0 (Never) to 4 (Almost always). Some items will be reverse-scored, so that higher scores indicate lower problems.

  5. Change in Personal Health Questionnaire Depression Scale (PHQ-8) [Baseline, 12 months]

    Self-reported indicators of depression. 8 items scored on a 4-point Likert scale from 0 (Not at all) to 3 (Nearly every day). Items are summed providing a severity score of 0 to 24, where higher numbers indicate more severity.

  6. Change in the Coping Health Inventory for Parents [Baseline, 12 months]

    Self-reported measure of a parent's response to managing demands when a child has a serious or chronic medical condition. 45 items (list of coping behaviors) scored on a 4-point Likert scale from 0 (Not helpful) to 3 (Extremely helpful). For each unused coping behavior, parents will record reason for not using coping behavior ("Chose not to use it" or "Not possible"). Higher scores indicate use of more helpful coping behaviors.

  7. Prescriptions for sickle cell disease [12 months]

    Data on prescriptions written and filled for hydroxyurea and penicillin will be collected through EHR review.

  8. CBC 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 will be abstracted from medical records.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adult parents who bring their children with SCA (0-12 years of age) to pediatric hematology clinic

  • English or Spanish speaking

Exclusion Criteria:
  • Foster parents

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston Medical Center Boston Massachusetts United States 02118

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Arvin Garg, MD MPH, University of Massachusetts Medical School, Worcester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT03716726
Other Study ID Numbers:
  • H-38214
  • 1R01HL141774-01A1
First Posted:
Oct 23, 2018
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Boston Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2022