Trial Outcomes & Findings for Sickle Cell Anemia WE CARE (NCT NCT03716726)
NCT ID: NCT03716726
Last Updated: 2024-03-26
Results Overview
Data on number of ED visits and acute care visits abstracted from the EHR.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
12 months
Results posted on
2024-03-26
Participant Flow
Unit of analysis: Clinics
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Completed Baseline Assessment
STARTED
|
51 2
|
61 2
|
|
Completed Baseline Assessment
COMPLETED
|
41 2
|
49 2
|
|
Completed Baseline Assessment
NOT COMPLETED
|
10 0
|
12 0
|
|
12 Months Followup
STARTED
|
41 2
|
49 2
|
|
12 Months Followup
COMPLETED
|
31 2
|
32 2
|
|
12 Months Followup
NOT COMPLETED
|
10 0
|
17 0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Completed Baseline Assessment
Did not complete baseline assessment
|
10
|
12
|
|
12 Months Followup
Lost to Follow-up
|
10
|
17
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Intervention-WE CARE
n=41 Participants
Received WE CARE screener and referral program
|
Control-Standard of Care
n=49 Participants
Received standard of care
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
n=41 Participants
|
36 years
n=49 Participants
|
37 years
n=90 Participants
|
|
Sex/Gender, Customized
Female
|
29 Participants
n=41 Participants
|
43 Participants
n=49 Participants
|
72 Participants
n=90 Participants
|
|
Sex/Gender, Customized
Male
|
7 Participants
n=41 Participants
|
6 Participants
n=49 Participants
|
13 Participants
n=90 Participants
|
|
Sex/Gender, Customized
Unknown
|
5 Participants
n=41 Participants
|
0 Participants
n=49 Participants
|
5 Participants
n=90 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=41 Participants
|
9 Participants
n=49 Participants
|
14 Participants
n=90 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=41 Participants
|
40 Participants
n=49 Participants
|
70 Participants
n=90 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=41 Participants
|
0 Participants
n=49 Participants
|
6 Participants
n=90 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=41 Participants
|
36 Participants
n=49 Participants
|
65 Participants
n=90 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=41 Participants
|
1 Participants
n=49 Participants
|
3 Participants
n=90 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=41 Participants
|
8 Participants
n=49 Participants
|
10 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=41 Participants
|
4 Participants
n=49 Participants
|
12 Participants
n=90 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=41 Participants
|
49 participants
n=49 Participants
|
90 participants
n=90 Participants
|
|
Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline
Self distraction
|
3 scores on a scale
n=41 Participants
|
4 scores on a scale
n=49 Participants
|
3.5 scores on a scale
n=90 Participants
|
|
Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline
Active coping
|
5 scores on a scale
n=41 Participants
|
5 scores on a scale
n=49 Participants
|
5 scores on a scale
n=90 Participants
|
|
Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline
Denial
|
2 scores on a scale
n=41 Participants
|
2 scores on a scale
n=49 Participants
|
2 scores on a scale
n=90 Participants
|
|
Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline
Substance use
|
2 scores on a scale
n=41 Participants
|
2 scores on a scale
n=49 Participants
|
2 scores on a scale
n=90 Participants
|
|
Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline
Use of emotional support
|
4 scores on a scale
n=41 Participants
|
4 scores on a scale
n=49 Participants
|
4 scores on a scale
n=90 Participants
|
|
Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline
Use of instrumental support
|
4 scores on a scale
n=41 Participants
|
4 scores on a scale
n=49 Participants
|
4 scores on a scale
n=90 Participants
|
|
Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline
Behavioral disengagement
|
2 scores on a scale
n=41 Participants
|
2 scores on a scale
n=49 Participants
|
2 scores on a scale
n=90 Participants
|
|
Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline
Venting
|
2 scores on a scale
n=41 Participants
|
3 scores on a scale
n=49 Participants
|
3 scores on a scale
n=90 Participants
|
|
Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline
Positive reframing
|
5.5 scores on a scale
n=41 Participants
|
5 scores on a scale
n=49 Participants
|
5 scores on a scale
n=90 Participants
|
|
Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline
Planning
|
4 scores on a scale
n=41 Participants
|
4 scores on a scale
n=49 Participants
|
4 scores on a scale
n=90 Participants
|
|
Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline
Humor
|
2 scores on a scale
n=41 Participants
|
2 scores on a scale
n=49 Participants
|
2 scores on a scale
n=90 Participants
|
|
Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline
Acceptance
|
5.5 scores on a scale
n=41 Participants
|
5 scores on a scale
n=49 Participants
|
5 scores on a scale
n=90 Participants
|
|
Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline
Religion
|
6 scores on a scale
n=41 Participants
|
6 scores on a scale
n=49 Participants
|
6 scores on a scale
n=90 Participants
|
|
Brief Coping Orientation to Problems Experienced (COPE) Inventory at Baseline
Self blame
|
2 scores on a scale
n=41 Participants
|
2 scores on a scale
n=49 Participants
|
2 scores on a scale
n=90 Participants
|
|
Patient Health Questionnaire 8 (PHQ-8)
None (0-9 points)
|
33 Participants
n=38 Participants • 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.
|
42 Participants
n=49 Participants • 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.
|
75 Participants
n=87 Participants • 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.
|
|
Patient Health Questionnaire 8 (PHQ-8)
Major (10-19 points)
|
5 Participants
n=38 Participants • 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.
|
5 Participants
n=49 Participants • 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.
|
10 Participants
n=87 Participants • 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.
|
|
Patient Health Questionnaire 8 (PHQ-8)
Severe (≥ 20 points)
|
0 Participants
n=38 Participants • 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.
|
2 Participants
n=49 Participants • 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.
|
2 Participants
n=87 Participants • 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.
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: EHR data abstraction was done at 12 months for all participants who completed the baseline assessment.
Data on number of ED visits and acute care visits abstracted from the EHR.
Outcome measures
| Measure |
Intervention-WE CARE
n=41 Participants
Received WE CARE screener and referral program
|
Control-Standard of Care
n=49 Participants
Received standard of care
|
|---|---|---|
|
Number of Emergency Department (ED)/Acute Care Visits
|
0 number of visits
Interval 0.0 to 4.0
|
1 number of visits
Interval 1.0 to 10.0
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data are missing for 3 participants in the control arm.
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.
Outcome measures
| Measure |
Intervention-WE CARE
n=31 Participants
Received WE CARE screener and referral program
|
Control-Standard of Care
n=29 Participants
Received standard of care
|
|---|---|---|
|
Parental Enrollment in Community Resources
Any new resource
|
9 Participants
|
11 Participants
|
|
Parental Enrollment in Community Resources
Child care
|
1 Participants
|
2 Participants
|
|
Parental Enrollment in Community Resources
Employment
|
1 Participants
|
0 Participants
|
|
Parental Enrollment in Community Resources
Housing
|
1 Participants
|
1 Participants
|
|
Parental Enrollment in Community Resources
Food
|
1 Participants
|
1 Participants
|
|
Parental Enrollment in Community Resources
Education
|
1 Participants
|
2 Participants
|
|
Parental Enrollment in Community Resources
Utilities
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data are missing for 1 intervention participant and 4 control participants.
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.
Outcome measures
| Measure |
Intervention-WE CARE
n=30 Participants
Received WE CARE screener and referral program
|
Control-Standard of Care
n=28 Participants
Received standard of care
|
|---|---|---|
|
Personal Health Questionnaire Depression Scale (PHQ-8)
None (0-9 points)
|
28 Participants
|
25 Participants
|
|
Personal Health Questionnaire Depression Scale (PHQ-8)
Major (10-19 points)
|
1 Participants
|
3 Participants
|
|
Personal Health Questionnaire Depression Scale (PHQ-8)
Severe (≥ 20 points)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data are missing for 1 participant in the intervention arm and 4 participants in the control arm
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.
Outcome measures
| Measure |
Intervention-WE CARE
n=30 Participants
Received WE CARE screener and referral program
|
Control-Standard of Care
n=28 Participants
Received standard of care
|
|---|---|---|
|
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Self-distraction
|
2 score on a scale
Interval 2.0 to 4.0
|
3.5 score on a scale
Interval 2.0 to 5.0
|
|
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Active copying
|
4 score on a scale
Interval 3.0 to 6.0
|
5 score on a scale
Interval 2.5 to 6.5
|
|
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Denial
|
2 score on a scale
Interval 2.0 to 2.0
|
2 score on a scale
Interval 2.0 to 2.5
|
|
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Substance use
|
2 score on a scale
Interval 2.0 to 2.0
|
2 score on a scale
Interval 2.0 to 2.0
|
|
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Use of emotional support
|
3 score on a scale
Interval 2.0 to 5.0
|
4 score on a scale
Interval 2.0 to 6.0
|
|
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Use of instrumental support
|
2 score on a scale
Interval 2.0 to 2.0
|
4 score on a scale
Interval 2.0 to 5.0
|
|
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Behavioral engagement
|
2 score on a scale
Interval 2.0 to 2.0
|
2 score on a scale
Interval 2.0 to 2.0
|
|
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Venting
|
2 score on a scale
Interval 2.0 to 3.0
|
2 score on a scale
Interval 2.0 to 4.0
|
|
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Positive reframing
|
4.5 score on a scale
Interval 2.0 to 5.0
|
4 score on a scale
Interval 2.5 to 5.0
|
|
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Planning
|
4 score on a scale
Interval 2.0 to 6.0
|
4 score on a scale
Interval 2.5 to 6.0
|
|
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Humor
|
2 score on a scale
Interval 2.0 to 2.0
|
2 score on a scale
Interval 2.0 to 2.0
|
|
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Acceptance
|
6 score on a scale
Interval 3.0 to 8.0
|
6 score on a scale
Interval 3.5 to 8.0
|
|
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Religion
|
4.5 score on a scale
Interval 3.0 to 7.0
|
6.5 score on a scale
Interval 2.5 to 7.5
|
|
Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months
Self-blame
|
2 score on a scale
Interval 2.0 to 3.0
|
2 score on a scale
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: EHR data abstraction was done at 12 months for all participants who completed the baseline assessment.
Number of painful vaso-occlusive episodes (VOE) requiring an ED or acute care clinic visit
Outcome measures
| Measure |
Intervention-WE CARE
n=41 Participants
Received WE CARE screener and referral program
|
Control-Standard of Care
n=49 Participants
Received standard of care
|
|---|---|---|
|
Vaso-occlusive Episodes
|
1 number of episodes
Interval 0.0 to 1.0
|
1 number of episodes
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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
Outcome measures
| Measure |
Intervention-WE CARE
n=40 Participants
Received WE CARE screener and referral program
|
Control-Standard of Care
n=47 Participants
Received standard of care
|
|---|---|---|
|
Prescriptions for Sickle Cell Disease
Penicillin
|
365 days
Interval 30.0 to 365.0
|
196 days
Interval 126.0 to 331.0
|
|
Prescriptions for Sickle Cell Disease
Hydroxurea
|
365 days
Interval 90.0 to 365.0
|
258 days
Interval 126.0 to 313.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: EHR data abstraction was done at 12 months for all participants who completed the baseline assessment.
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.
Outcome measures
| Measure |
Intervention-WE CARE
n=41 Participants
Received WE CARE screener and referral program
|
Control-Standard of Care
n=49 Participants
Received standard of care
|
|---|---|---|
|
Hemoglobin Values Related to Medication Adherence
|
9.3 g/dL
Interval 8.8 to 10.0
|
8.8 g/dL
Interval 7.9 to 9.9
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: EHR data abstraction was done at 12 months for all participants who completed the baseline assessment.
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.
Outcome measures
| Measure |
Intervention-WE CARE
n=41 Participants
Received WE CARE screener and referral program
|
Control-Standard of Care
n=49 Participants
Received standard of care
|
|---|---|---|
|
White Blood Cell and Absolute Neutrophil Counts Related to Medication Adherence
White blood cell count (per dL)
|
8.6 cells per dL
Interval 6.8 to 12.6
|
9.0 cells per dL
Interval 6.8 to 13.5
|
|
White Blood Cell and Absolute Neutrophil Counts Related to Medication Adherence
Absolute neutrophil count (per dL)
|
3.5 cells per dL
Interval 2.0 to 5.3
|
3.4 cells per dL
Interval 2.5 to 5.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: EHR data abstraction was done at 12 months for all participants who completed the baseline assessment.
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).
Outcome measures
| Measure |
Intervention-WE CARE
n=41 Participants
Received WE CARE screener and referral program
|
Control-Standard of Care
n=49 Participants
Received standard of care
|
|---|---|---|
|
Mean Corpuscular Volume Values Related to Medication Adherence
|
96 femtoliters (10^15; fl)
Interval 89.5 to 102.5
|
90.1 femtoliters (10^15; fl)
Interval 82.6 to 94.9
|
Adverse Events
Intervention-WE CARE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control-Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place