Metadata Catalog

Study Detail

Study ID	1010
Name	South Carolina Sickle Cell Disease Access to Care Pilot Program
Contact Email	Alan.Anderson@prismahealth.org
Acronym	(SC)2
Period	ongoing
Design	Registry Study
Study PI	Julie Kanter
Institution	Medical University of South Carolina
URL	https://medicine.musc.edu/departments/pediatrics/research/sickle-cell-research
CTGovID	NA
Funding Agency	Doris Duke

Overview	(SC)2 is designed to use collective impact methodology to harness the current efforts of the sickle cell disease (SCD) stakeholders to create disease-specific medical homes for individuals living with SCD in South Carolina.The goals are to enhance access to care for affected individuals, educate local providers to develop knowledge and self-efficacy in treating and managing SCD, and improve cost of care through increased quality of care.
Focus Areas	1. Enhanced access to disease modifying medication 2. Improving transfusion utilization 3. Increased evidence based screening and preventative care 4. Acute care utilization
Outcomes	1. Longitudinal biologic data collection including demographics, radiologic assessments, anthropomorphic and laboratory values to improve the understanding of sickle cell disease and the relationship of the environment on patient health and well-being. 2. Acute care information and prescription refill history will be collected in order to improve individual patients’ disease management and provide population health information for patients with sickle cell disease in South Carolina. This data will also be utilized for quality assessment of the (SC)² program and for quality improvement activities. 3. We will collect patient reported outcomes including previously validated pain reporting and quality of life tools to ensure patient satisfaction and input in the (SC)² program. 4. Utilize the ECHO model to improve the quality and quantity of knowledge of providers in providing care for individuals with sickle cell disease. 5. Each patient will receive a customized individual care plan including pain medication plan available to all treating providers to enhance patient-specific treatment.

Data Location	MUSC
Biospecimen Available	Blood; DNA; Plasma; Serum; Urine;
Data Consent	Patients will consent to the acquisition of data for statistical assessment and for permission to share individualized treatment protocols with outside providers for continuity of care.
Biospecimen Consent	The patients will be asked if they are willing to participate in an optional Bio-Repository. There is no maximal amount of time in which samples can be stored but individuals consenting for the biorepository can opt for withdrawal at any time.
Contact Consent	Yes, with permission on consent
Genomic Data	No

Age Range	0-99
No. Participants	500
Inclusion Criteria	1. Potential subjects will be identified either from patients already seen at MUSC or who are referred to MUSC Pediatric Hematology/Oncology for treatment of sickle cell disease. 2. Patients included will be those of all ages with a diagnosis of sickle cell disease. 3. The majority of individuals living with sickle cell disease in South Carolina are African-American with limited exceptions which are why the targeted enrollment is almost entirely black/African-American. Children (<12 years of age) will be included since they also have sickle cell disease (parental consent will be required for children <18 with assent from the patients >12 years of age.
Exclusion Criteria	No patients will be excluded due to co-morbidities. Only patients unable to consent who do not have a designated care-giver will be excluded.

Study Documentation Select All	1. SC2 codebook 2. SC2 protocol Amd 14 pv 3Jul2019 clean copy-4
Forms Select All	1. HydroxyureaUsage_SC2PatientNee 2. LaboratoryReportingForm_SC2Pat 3. MedicalAbstractionForm_SC2Pati 4. MedicalAbstractionForm_SC2Regi 5. SC2PatientNeedsAssessmentSurve

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Clinical status (182)

Behavior (0)

Blood (6)

Data Element	Variables
Acute Anemic Episode
Aplastic Crisis
Bleeding
Other Blood Problem
Sickle Cell Disease	diagnosis dx_age_1a2ca3 SCD_DIAG scd_phenotype scd_phenotype_other SCD_TYPE

Cancer (0)

Cardiovascular (15)

Data Element	Variables
Aneurysm
Cardiac Failure	mr_scd_q52_1 mr_scd_q52_date scd_q52_1 scd_q52_2 scd_q52_3
Cardiovascular Problem	mr_scd_q57_1 mr_scd_q57_date mr_scd_q57b_1 mr_scd_q57b_date scd_q57_1 scd_q57_2 scd_q57_3 scd_q57b_1 scd_q57b_2 scd_q57b_3
Heart Problem

Digestive (5)

Data Element	Variables
Gastrointestinal Problem	mr_scd_q55_1 mr_scd_q55_date scd_q55_1 scd_q55_2 scd_q55_3
Hepatitis
Liver Problem

Endocrine (5)

Data Element	Variables
Diabetes Mellitus	mr_scd_q67_1 mr_scd_q67_date scd_q67_1 scd_q67_2 scd_q67_3
Endocrine Problem

Family MedHx (0)

General Health (0)

Genitourinary (5)

Data Element	Variables
Genitourinary Problem
Kidney Problem
Priapism	mr_scd_q48_1 mr_scd_q48_date scd_q48_1 scd_q48_2 scd_q48_3
Renal Dialysis History

Immune (12)

Data Element	Variables
Fever
HIV Infection
Immune Problem	mr_scd_q58_1 mr_scd_q58_date scd_q58_1 scd_q58_2 scd_q58_3
Infection	mr_scd_q62_1 mr_scd_q62_3 mr_scd_q62_date scd_q62_1 scd_q62_2 scd_q62_3 scd_q62_4
Vaccination

Lymphatic (25)

Data Element	Variables
Sarcoidosis	mr_scd_q61_1 mr_scd_q61_date scd_q61_1 scd_q61_2 scd_q61_3
Spleen Problem	mr_scd_q56_1 mr_scd_q56_date mr_scd_q56a_1 mr_scd_q56a_date mr_scd_q56b_1 mr_scd_q56b_date mr_scd_q56c_1 mr_scd_q56c_date scd_q56_1 scd_q56_2 scd_q56_3 scd_q56a_1 scd_q56a_2 scd_q56a_3 scd_q56b_1 scd_q56b_2 scd_q56b_3 scd_q56c_1 scd_q56c_2 scd_q56c_3

Medical Event (0)

Medical History (0)

Mental Health (0)

Musculoskeletal (20)

Data Element	Variables
Musculoskeletal Problem
Osteomyelitis	mr_scd_q45_1 mr_scd_q45_date scd_q45_1 scd_q45_2 scd_q45_3
Osteonecrosis	mr_scd_q43_1 mr_scd_q43_date scd_q43_1 scd_q43_2 scd_q43_3
Rheumatic Diseases	mr_scd_q59_1 mr_scd_q59_date mr_scd_q60_1 mr_scd_q60_date scd_q59_1 scd_q59_2 scd_q59_3 scd_q60_1 scd_q60_2 scd_q60_3

Neurodevelopmental (0)

Neurologic (25)

Data Element	Variables
Meningitis
Neurologic Event
Seizure
Stroke	mr_scd_q49_1 mr_scd_q49_date mr_scd_q49a_1 mr_scd_q49a_date mr_scd_q49b_1 mr_scd_q49b_date mr_scd_q49d_1 mr_scd_q49d_date scd_q49_1 scd_q49_2 scd_q49_3 scd_q49a_1 scd_q49a_2 scd_q49a_3 scd_q49b_1 scd_q49b_2 scd_q49b_3 scd_q49d_1 scd_q49d_2 scd_q49d_3
Transient Ischemic Attack	mr_scd_q49c_1 mr_scd_q49c_date scd_q49c_1 scd_q49c_2 scd_q49c_3

Nutritional and Metabolic (5)

Data Element	Variables
Nutritional and Metabolic	mr_scd_q68_1 mr_scd_q68_date scd_q68_1 scd_q68_2 scd_q68_3

Ocular (5)

Data Element	Variables
Ocular Problem
Sickle Retinopathy	mr_scd_q66_1 mr_scd_q66_date scd_q66_1 scd_q66_2 scd_q66_3

Oral (0)

Pain (19)

Data Element	Variables
Abdominal Pain
General Pain
Headache
Management	freq_pain_ed freq_pain_hosp qualityofcareadults_emergencyroom_doctorsnurses_believepain_past12months qualityofcareadults_emergencyroom_doctorsnurses_helppain_past12months qualityofcareadults_emergencyroom_painattackcrisis_past12months qualityofcareadults_emergencyroom_wait_paintreated_past12months qualityofcareadults_painattackcrisis_manage_home_past12months
Pain Attack	freq_pain_home freq_pain_home_days freq_pain_home_epi pain_interference_1 pain_interference_2 pain_interference_3 pain_interference_4
Skeletal and Joint Pain	mr_scd_q44_1 mr_scd_q44_date scd_q44_1 scd_q44_2 scd_q44_3

Reproductive (0)

Respiratory (25)

Data Element	Variables
Acute Chest Syndrome	mr_scd_q53_1 mr_scd_q53_date scd_q53_1 scd_q53_2 scd_q53_3
Asthma	mr_scd_q54_1 mr_scd_q54_date scd_q54_1 scd_q54_2 scd_q54_3
Lung Disease	mr_scd_q51_1 mr_scd_q51_date mr_scd_q57a_1 mr_scd_q57a_date scd_q51_1 scd_q51_2 scd_q51_3 scd_q57a_1 scd_q57a_2 scd_q57a_3
Other Respiratory Problem	mr_scd_q64_1 mr_scd_q64_date scd_q64_1 scd_q64_2 scd_q64_3

Skin (5)

Data Element	Variables
Skin Problem	mr_scd_q65_1 mr_scd_q65_date scd_q65_1 scd_q65_2 scd_q65_3

Sleep (0)

Surgery History (5)

Data Element	Variables
Cardiovascular
Digestive
Genitourinary
Lymphatic	mr_scd_q56d_1 mr_scd_q56d_date scd_q56d_1 scd_q56d_2 scd_q56d_3
Musculoskeletal
Ocular
Respiratory
Surgery History

Demographics (25)

Demographics (10)

Data Element	Variables
Address
Age	age age_coded birthdate birthdate_coded
Ethnic Group	ethnicity_self_id ethnicity_self_id_ancestry
Gender	gender
Language	language_health_material language_to_provider
National Origin
Nuclear Family
Race	ptethicity

Social Determinants of Health (SDoH) (0)

Socioeconomic Status (15)

Data Element	Variables
Annual Income	annual_income
Education	household_edu_attainment self_edu_attainment
Employment Status	cur_employ_stat_other current_employment_status
Household
Insurance	health_insurance medicaid_state mr_scd_q74_1 mr_scd_q74_2 scd_q74_1 scd_q74_2 scd_q75_1 state_plan state_plan_name
Marital Status	martial_status

Environmental Exposure (0)

Exposure (0)

Health Care (68)

Acute Care Utilization (19)

Data Element	Variables
Facility Type	med_er mr_med_er mr_med_er_12 mr_med_er_13 mr_med_er_14 mr_med_er_15 mr_med_er_16 mr_med_er_17 mr_med_er_18 mr_med_er_19 mr_med_er_20 q14a q14b
Provider Type
Quality of Care	qualityofcareadults_emergencyroom_oftencare_soonwanted_past12months qualityofcareadults_emergencyroom_oftendoctors_care_past12months qualityofcareadults_emergencyroom_oftennurses_care_past12months qualityofcareadults_emergencyroom_oftensatisfied_care_past12months qualityofcareadults_emergencyroom_rightaway_past12months qualityofcareadults_emergencyroom_clerksreceptionists_courtesyrespect_past12months
Visit

Healthcare utilization (16)

Data Element	Variables
Country of Care
Facility Type
Quality of Care	qualityofcareadults_emergencyroom_delayavoidcare_past12months qualityofcareadults_enoughtime_doctornurse_usuallysee_past12months qualityofcareadults_explainthings_doctornurse_usuallysee_past12months qualityofcareadults_frequency_get_appointment_past12months qualityofcareadults_health_insurance_avoid_care qualityofcareadults_listencarefully_doctornurse_usuallysee_past12months qualityofcareadults_ratingcare_received_past12months qualityofcareadults_satisfiedcare_doctornurse_usuallysee_past12months qualityofcareadults_satisfiedcarereceived_appointment_past12months qualityofcareadults_visits_doctornurse_usuallysee_past12months qualityofcareadults_bad_experiences_emergencyroom qualityofcareadults_courtesyrespect_doctornurse_usuallysee_past12months qualityofcareadults_doctor_appointment_past12months qualityofcareadults_doctornurse_usuallysee qualityofcareadults_doctornurse_usuallysee_knowaffects_personally qualityofcareadults_doctornurse_usuallysee_treatlot_patients

Health Services (0)

Hospitalization (33)

Data Element	Variables
Final Diagnosis
Hospitalization	med_hospital med_hospital_day mr_med_hospital mr_med_hospital_12 mr_med_hospital_13 mr_med_hospital_14 mr_med_hospital_15 mr_med_hospital_16 mr_med_hospital_17 mr_med_hospital_18 mr_med_hospital_19 mr_med_hospital_20 mr_med_hospital_day mr_med_hospital_day_12 mr_med_hospital_day_13 mr_med_hospital_day_14 mr_med_hospital_day_15 mr_med_hospital_day_16 mr_med_hospital_day_17 mr_med_hospital_day_18 mr_med_hospital_day_19 mr_med_hospital_day_20
ICU	med_icu mr_med_icu mr_med_icu_12 mr_med_icu_13 mr_med_icu_14 mr_med_icu_15 mr_med_icu_16 mr_med_icu_17 mr_med_icu_18 mr_med_icu_19 mr_med_icu_20

SCD Management (0)

Imaging (0)

Angiogram (0)

CT Scan (0)

Echocardiogram (0)

Electrocardiogram (ECG) (0)

Electrodiagnosis (0)

General Imaging (0)

MRI/MRA (0)

Nuclear Medicine Imaging (0)

PET scan (0)

Transcranial Doppler (TCD) (0)

Ultrasound (0)

X-Ray (0)

Parent/Caretaker (0)

Demographics (0)

Psychosocial (0)

Quality of Life (0)

Quality of Life (9)

General Health (0)

Pain (0)

Patient Functioning (4)

Data Element	Variables
Cognitive Functioning
Emotional Functioning	efficacy_6 efficacy_9
Physical Functioning	efficacy_2 efficacy_5
School Functioning
Social Functioning

SCD (5)

Data Element	Variables
SCD Impact
SCD Management	effica2y_3 efficacy_1 efficacy_4 efficacy_7 efficacy_8

Tests (109)

Biopsy (0)

Blood (74)

Data Element	Variables
Blood Differential Test	lab_available10 lab_available11 lab_available12 lab_available13
Blood Gases
Blood Smear
Blood Typing
Coagulation Test
Complete Blood Count	lab_available1 lab_available2 lab_available3 lab_available4 lab_available5 lab_available6 lab_available7 lab_available8 lab_available9 lab1 lab10 lab11 lab12 lab13a lab13b lab2 lab3 lab4 lab5 lab6 lab7 lab8 lab9
Comprehensive Metabolic Panel (CMP)	lab_available14 lab_available15 lab_available27 lab_available28 lab_available29 lab_available30 lab_available31 lab_available32 lab_available33 lab_available36 lab_available41 lab_available42 lab14 lab15 lab27 lab28 lab29 lab30 lab31 lab32 lab33 lab34 lab36 lab40 lab41 lab42
Enzyme	lab_available34
General
Hemoglobin Electrophoresis	alpha_test dx_basis dx_confirm lab_available50 lab_available51 lab50a lab50b lab50c lab50d lab50e lab50f lab50g lab51a lab51b lab51c lab51d lab51e lab51f lab51g
Iron	lab_available40

Cardiovascular (0)

Genitourinary (12)

Data Element	Variables
Genitourinary Test
Urine Test	lab_available43 lab_available45 lab_available48 lab_available49 lab_date43 lab_date45 lab_date48 lab_date49 lab43 lab45 lab48 lab49

Immune (0)

Microbiology Culture (0)

Musculoskeletal (0)

Neurologic (0)

Ocular (3)

Data Element	Variables
Eye exam	mr_eye_date mr_eye_exam mr_eye_result

Other (0)

Physical Exam (20)

Data Element	Variables
Abdomen
Anthropometrics	mr_weight mr_weight_date weight weight_date
Cardiovascular
Extremities
General
Liver
Reproductive
Respiratory
Spleen
Vital signs	bp_date bp_diastolic bp_systolic heart_date heart_rate hypertensive_meds mr_bp_date mr_bp_diastolic mr_bp_systolic mr_heart_date mr_heart_rate mr_hypertensive_meds mr_spo2 mr_spo2_date spo2 spo2_date

Reproductive (0)

Respiratory (0)

Therapeutics (37)

Medication (20)

Data Element	Variables
Antibiotics
Asthma
Blood Medication History
Cardiovascular
Compliance
Current Medication
Depression Medication History
Hydroxyurea	hydory_dose hydrox_stop hydroxy_decline hydroxy_decline_other hydroxy_past hydroxy_stop_other hydroxy_usage_date hydroxy_use
Medication	med_17 med_18 med_19 med_20 med_21 med25 mr_med_17 mr_med_18 mr_med_19 mr_med_20 mr_med_21 mr_med25
Neurologic Medication History
Pain
SCD Medication
Sildenafil
Supplements

Surgery (0)

Transfusion (17)

Data Element	Variables
Blood Transfusion	med_transfusions mr_med_transfusions mr_med_transfusions_12 mr_med_transfusions_13 mr_med_transfusions_14 mr_med_transfusions_15 mr_med_transfusions_16 mr_med_transfusions_17 mr_med_transfusions_18 mr_med_transfusions_19 mr_med_transfusions_20
Chronic Transfusion
Transfusion Complications	current_reaction_sym_other current_reaction_symptoms med_transfusion_reaction mr_current_reaction_sym_other mr_current_reaction_symptoms mr_med_transfusion_reaction

Transplantation (0)

Treatment (0)

Study Publications

Needs Assessment for Patients with Sickle Cell Disease in South Carolina, 2012.

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Functional Exercise Capacity (0)

Mental Health (0)

Neurodevelopment (0)

Neuropsychological (0)

Pain (4)

Data Element	Variables
ASCQ-Me Pain Episode
ASCQ-Me Pain Impact
Brief Pain Inventory (BPI)
PROMIS Neuropathic Pain Quality
PROMIS Nociceptive Pain Quality
PROMIS Pain Interference	pain_interference_1 pain_interference_2 pain_interference_3 pain_interference_4

Physical Exam (0)

Psychosocial (0)

Quality of Care (27)

Data Element	Variables
ASCQ-Me Quality of Care (QOC)	qualityofcareadults_bad_experiences_emergencyroom qualityofcareadults_courtesyrespect_doctornurse_usuallysee_past12months qualityofcareadults_doctor_appointment_past12months qualityofcareadults_doctornurse_usuallysee qualityofcareadults_doctornurse_usuallysee_knowaffects_personally qualityofcareadults_doctornurse_usuallysee_treatlot_patients qualityofcareadults_emergencyroom_clerksreceptionists_courtesyrespect_past12months qualityofcareadults_emergencyroom_delayavoidcare_past12months qualityofcareadults_emergencyroom_doctorsnurses_believepain_past12months qualityofcareadults_emergencyroom_doctorsnurses_helppain_past12months qualityofcareadults_emergencyroom_oftencare_soonwanted_past12months qualityofcareadults_emergencyroom_oftendoctors_care_past12months qualityofcareadults_emergencyroom_oftennurses_care_past12months qualityofcareadults_emergencyroom_oftensatisfied_care_past12months qualityofcareadults_emergencyroom_painattackcrisis_past12months qualityofcareadults_emergencyroom_rightaway_past12months qualityofcareadults_emergencyroom_wait_paintreated_past12months qualityofcareadults_enoughtime_doctornurse_usuallysee_past12months qualityofcareadults_explainthings_doctornurse_usuallysee_past12months qualityofcareadults_frequency_get_appointment_past12months qualityofcareadults_health_insurance_avoid_care qualityofcareadults_listencarefully_doctornurse_usuallysee_past12months qualityofcareadults_painattackcrisis_manage_home_past12months qualityofcareadults_ratingcare_received_past12months qualityofcareadults_satisfiedcare_doctornurse_usuallysee_past12months qualityofcareadults_satisfiedcarereceived_appointment_past12months qualityofcareadults_visits_doctornurse_usuallysee_past12months
Patient Satisfaction Questionnaire (PSQ)

Quality of Life (0)

Sleep (0)

Technology Support (0)

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