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Sickle Cell Anemia WE CARE (SCAWECARE)

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ClinicalTrials.gov Identifier: NCT03716726
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Boston Medical Center

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
Sickle Cell Disease Behavioral: WE CARE SDoH Screening Survey Behavioral: Family Resource Book Other: Standard of care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

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.




Primary Outcome Measures :
  1. Emergency department reliance (EDR) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]
    Data on number of vaso-occlusive episodes will be collected from the EHR.

  2. Change in hair cortisol concentrations [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716726


Contacts
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Contact: Arvin Garg, MD MPH 617- 414-3817 arvin.garg@bmc.org
Contact: Michelle Pellicer, MPH Michelle.Pellicer@bmc.org

Sponsors and Collaborators
Boston Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Arvin Garg, MD MPH Boston Medical Center

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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT03716726     History of Changes
Other Study ID Numbers: H-38214
1R01HL141774-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Medical Center:
Sickle Cell Disease
Social Determinants of Health
Unmet Social Needs
WE CARE

Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn