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Sickle Cell Anemia WE CARE (SCAWECARE)

Primary Purpose

Sickle Cell Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WE CARE SDoH Screening Survey
Family Resource Book
Standard of care
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sickle Cell Disease focused on measuring Sickle Cell Disease, Social Determinants of Health, Unmet Social Needs, WE CARE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention-WE CARE

Control-Standard of Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Number of emergency department (ED) visits
Data on number of ED visits will be collected from the EHR.
Change in 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.

Secondary Outcome Measures

Vaso-occlusive episodes
Data on number of vaso-occlusive episodes will be collected from the EHR.
Change in hair cortisol concentrations
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.
Baseline PedsQL + Sickle Cell Disease Module
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.
12-month PedsQL + Sickle Cell Disease Module
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.
Change in Personal Health Questionnaire Depression Scale (PHQ-8)
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.
Change in the Coping Health Inventory for Parents
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.
Prescriptions for sickle cell disease
Data on prescriptions written and filled for hydroxyurea and penicillin will be collected through EHR review.
CBC values related to medication adherence
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.

Full Information

First Posted
October 19, 2018
Last Updated
July 17, 2023
Sponsor
Boston Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03716726
Brief Title
Sickle Cell Anemia WE CARE
Acronym
SCAWECARE
Official Title
Understanding and Addressing the Social Determinants of Health for Families of Children With Sickle Cell Anemia Within Pediatric Hematology
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
Sickle Cell Disease, Social Determinants of Health, Unmet Social Needs, WE CARE

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention-WE CARE
Arm Type
Experimental
Arm Description
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.
Arm Title
Control-Standard of Care
Arm Type
Experimental
Arm Description
Standard of care for pediatric patients with sickle cell anemia will be delivered.
Intervention Type
Behavioral
Intervention Name(s)
WE CARE SDoH Screening Survey
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Family Resource Book
Intervention Description
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 Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Usual outpatient care for pediatric patients with sickle cell anemia will be provided.
Primary Outcome Measure Information:
Title
Number of emergency department (ED) visits
Description
Data on number of ED visits will be collected from the EHR.
Time Frame
12 months
Title
Change in parental enrollment in community resources
Description
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.
Time Frame
Baseline and 3, 6, 9, and 12 months
Secondary Outcome Measure Information:
Title
Vaso-occlusive episodes
Description
Data on number of vaso-occlusive episodes will be collected from the EHR.
Time Frame
12 months
Title
Change in hair cortisol concentrations
Description
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.
Time Frame
Baseline, 12 months
Title
Baseline PedsQL + Sickle Cell Disease Module
Description
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.
Time Frame
Baseline
Title
12-month PedsQL + Sickle Cell Disease Module
Description
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.
Time Frame
12 months
Title
Change in Personal Health Questionnaire Depression Scale (PHQ-8)
Description
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.
Time Frame
Baseline, 12 months
Title
Change in the Coping Health Inventory for Parents
Description
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.
Time Frame
Baseline, 12 months
Title
Prescriptions for sickle cell disease
Description
Data on prescriptions written and filled for hydroxyurea and penicillin will be collected through EHR review.
Time Frame
12 months
Title
CBC values related to medication adherence
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arvin Garg, MD MPH
Organizational Affiliation
University of Massachusetts Medical School, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Sickle Cell Anemia WE CARE

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