Sickle Cell DiseaseSCAWECARENCT03716726
Sickle Cell Anemia WE CARE
A study testing WE CARE SDoH Screening Survey and Family Resource Book in people with Sickle Cell Disease, run by Boston Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- WE CARE SDoH Screening Survey and Family Resource Book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2021to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult parents of children with SCA (0-12 years of age) who take a daily medication (penicillin or hydroxyurea)to
- English or Spanish speaking
Who cannot join
- Foster parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding and Addressing the Social Determinants of Health for Families of Children With Sickle Cell Anemia Within Pediatric Hematology
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.
Read the 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 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.
- Conditions
- Sickle Cell Disease
- Being tested
- WE CARE SDoH Screening Survey, Family Resource Book, Standard of care
- Keywords
- Sickle Cell Disease, Social Determinants of Health, Unmet Social Needs, WE CARE
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WE CARE SDoH Screening SurveyBehavioural
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
Family Resource BookBehavioural
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.
Standard of careOther
Usual outpatient care for pediatric patients with sickle cell anemia will be provided.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: WE CARE SDoH Screening Survey; Behavioral: Family Resource Book |
| Control-Standard of Care | Experimental | Standard of care for pediatric patients with sickle cell anemia will be delivered. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Emergency Department (ED)/Acute Care Visits
Data on number of ED visits and acute care visits abstracted from the EHR.
Measured: 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.
Measured: 12 months
Secondary outcomes (7)
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.
Measured: 12 months
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.
Measured: 12 months
Vaso-occlusive Episodes
Number of painful vaso-occlusive episodes (VOE) requiring an ED or acute care clinic visit
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start21 Jan 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Arvin Garg, MD MPH, Principal investigator, University of Massachusetts Medical School, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716726
- Sponsor's protocol ID
- H-38214
- Other IDs
- 1R01HL141774-01A1
- Acronym
- SCAWECARE
- Status last verified
- Feb 2024
- First submitted
- 19 Oct 2018
- Last updated
- 26 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Addressing the Social Determinants of Health for Families of Children With Sickle Cell Anemia Within Pediatric Hematology
- ClinicalTrials.gov ID
- NCT03716726
- Acronym / sponsor ID
- SCAWECARE / H-38214
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease, Social Determinants of Health, Unmet Social Needs, WE CARE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 26 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention-WE CARE | Experimental | Behavioral: WE CARE SDoH Screening Survey, Behavioral: Family Resource BookThe 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). |
| Control-Standard of Care | Experimental | Other: Standard of careStandard of care for pediatric patients with sickle cell anemia will be delivered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult parents of children with SCA (0-12 years of age) who take a daily medication (penicillin or hydroxyurea)to
- English or Spanish speaking
Key exclusion criteria (1 listed)
- Foster parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WE CARE SDoH Screening SurveyThe 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 | Behavioural | Intervention-WE CARE |
| Family Resource BookThe 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. | Behavioural | Intervention-WE CARE |
| Standard of careUsual outpatient care for pediatric patients with sickle cell anemia will be provided. | Other | Control-Standard of Care |
Primary outcome
Number of Emergency Department (ED)/Acute Care Visits
Time frame: 12 months
Data on number of ED visits and acute care visits abstracted from the EHR.
Parental Enrollment in Community Resources
Time frame: 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.
7 secondary outcomes
Personal Health Questionnaire Depression Scale (PHQ-8)
Time frame: 12 months
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Time frame: 12 months
Vaso-occlusive Episodes
Time frame: 12 months
Prescriptions for Sickle Cell Disease
Time frame: 12 months
Hemoglobin Values Related to Medication Adherence
Time frame: 12 months
White Blood Cell and Absolute Neutrophil Counts Related to Medication Adherence
Time frame: 12 months
Mean Corpuscular Volume Values Related to Medication Adherence
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arvin Garg, MD MPH principal investigator
University of Massachusetts Medical School, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WE CARE SDoH Screening Survey and Family Resource Book in people with Sickle Cell Disease, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Emergency Department (ED)/Acute Care Visits (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.