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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL141774-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention-WE CARE | Experimental | 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). |
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| Control-Standard of Care | Experimental | Standard of care for pediatric patients with sickle cell anemia will be delivered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WE CARE SDoH Screening Survey | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Emergency Department (ED)/Acute Care Visits | Data on number of ED visits and acute care visits abstracted from the EHR. | 12 months |
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Personal Health Questionnaire Depression Scale (PHQ-8) | 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arvin Garg, MD MPH | University of Massachusetts Medical School, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Control-Standard of Care | Standard of care for pediatric patients with sickle cell anemia will be delivered. Standard of care: Usual outpatient care for pediatric patients with sickle cell anemia will be provided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Completed Baseline Assessment |
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| 12 Months Followup |
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Parents of children with sickle cell anemia ages 0-12 years of age taking at least one daily medication who completed baseline assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention-WE CARE | Received WE CARE screener and referral program |
| BG001 | Control-Standard of Care | Received standard of care |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Emergency Department (ED)/Acute Care Visits | Data on number of ED visits and acute care visits abstracted from the EHR. | EHR data abstraction was done at 12 months for all participants who completed the baseline assessment. | Posted | Median | Full Range | number of visits | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Kavanagh, MD | Boston Medical Center | 617-414-3573 | Patricia.Kavanagh@bmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2019 | Dec 1, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 22, 2018 | Jul 17, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Pragmatic pilot cluster RCT to examine the implementation of WE CARE as standard of care in two of the four outpatient pediatric hematology clinics.
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| Family Resource Book | Behavioral | 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. |
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| Standard of care | Other | Usual outpatient care for pediatric patients with sickle cell anemia will be provided. |
|
| Brief COPE (Coping Orientation to Problems Experienced Inventory) at 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. | 12 months |
| Vaso-occlusive Episodes | Number of painful vaso-occlusive episodes (VOE) requiring an ED or acute care clinic visit | 12 months |
| Prescriptions for Sickle Cell Disease | 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 | 12 months |
| Hemoglobin Values Related to Medication Adherence | 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. | 12 months |
| White Blood Cell and Absolute Neutrophil Counts 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. Each will be abstracted from medical records. | 12 months |
| Mean Corpuscular Volume 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 (MCV) will be abstracted from medical records. MCV is a measure of the average volume of a red blood corpuscle (or red blood cell). | 12 months |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline | 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. | Median | Inter-Quartile Range | scores on a scale |
|
| Patient Health Questionnaire 8 (PHQ-8) | 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. | Parents of children with sickle cell anemia ages 0-12 years of age taking at least one daily medication who completed baseline assessment. Missing PHQ-8 data from 3 participants in WE CARE group. | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
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| Primary | 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. | Data are missing for 3 participants in the control arm. | Posted | Count of Participants | Participants | 12 months |
|
|
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| Secondary | Personal Health Questionnaire Depression Scale (PHQ-8) | 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. | Data are missing for 1 intervention participant and 4 control participants. | Posted | Count of Participants | Participants | 12 months |
|
|
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| Secondary | Brief COPE (Coping Orientation to Problems Experienced Inventory) at 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. | Data are missing for 1 participant in the intervention arm and 4 participants in the control arm | Posted | Median | Inter-Quartile Range | score on a scale | 12 months |
|
|
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| Secondary | Vaso-occlusive Episodes | Number of painful vaso-occlusive episodes (VOE) requiring an ED or acute care clinic visit | EHR data abstraction was done at 12 months for all participants who completed the baseline assessment. | Posted | Median | Inter-Quartile Range | number of episodes | 12 months |
|
|
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| Secondary | Prescriptions for Sickle Cell Disease | 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 | EHR data abstraction was done at 12 months for all participants who completed the baseline assessment except for 1 participant in the intervention group and for 2 participants in the control group; for those 3 participants the data are missing. | Posted | Median | Inter-Quartile Range | days | 12 months |
|
|
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| Secondary | Hemoglobin Values Related to Medication Adherence | 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. | EHR data abstraction was done at 12 months for all participants who completed the baseline assessment. | Posted | Median | Inter-Quartile Range | g/dL | 12 months |
|
|
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| Secondary | White Blood Cell and Absolute Neutrophil Counts 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. Each will be abstracted from medical records. | EHR data abstraction was done at 12 months for all participants who completed the baseline assessment. | Posted | Median | Inter-Quartile Range | cells per dL | 12 months |
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|
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| Secondary | Mean Corpuscular Volume 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 (MCV) will be abstracted from medical records. MCV is a measure of the average volume of a red blood corpuscle (or red blood cell). | EHR data abstraction was done at 12 months for all participants who completed the baseline assessment. | Posted | Median | Inter-Quartile Range | femtoliters (10^15; fl) | 12 months |
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| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Control-Standard of Care | Standard of care for pediatric patients with sickle cell anemia will be delivered. Standard of care: Usual outpatient care for pediatric patients with sickle cell anemia will be provided. | 0 | 49 | 0 | 49 | 0 | 49 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Employment |
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| Housing |
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| Food |
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| Education |
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| Utilities |
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| Severe (≥ 20 points) |
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| Denial |
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| Substance use |
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| Use of emotional support |
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| Use of instrumental support |
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| Behavioral engagement |
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| Venting |
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| Positive reframing |
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| Planning |
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| Humor |
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| Acceptance |
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| Religion |
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| Self-blame |
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