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 : February 25, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||215 participants|
|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)|
|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 :||April 2020|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||December 2022|
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.
- 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.
- 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.
- Vaso-occlusive episodes [ Time Frame: 12 months ]Data on number of vaso-occlusive episodes will be collected from the EHR.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Arvin Garg, MD MPHfirstname.lastname@example.org|
|Contact: Annelise Brochier, MPHemail@example.com|
|Principal Investigator:||Arvin Garg, MD MPH||Boston Medical Center|