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| ID | Type | Description | Link |
|---|---|---|---|
| PCORI-1403-11888 | Other Grant/Funding Number | PCORI |
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The Emergency Department has been the standard location where patients with Sickle Cell Disease (SCD) go to seek care for the treatment of acute painful events. Vaso- Occlusive Crisis (VOC) is the most common complication of SCD,
The purpose of this study is to compare patient centered outcomes for patients being treated for an uncomplicated VOC in Infusion Centers (IC) and Emergency Departments (ED) in four locations around the United States.
Emergency Department care is marked by long delays, lack of efficacy, and conflict. A sub-specialty Infusion Center staffed by expert clinicians and delivering individualized care can improve care quality while reducing costs. The study will examine whether care provided in an Infusion Center (IC) is more patient centered and efficient than care provided in an Emergency Department (ED) for adults with Sickle Cell Disease (SCD) and uncomplicated Vaso-Occlusive Crisis (VOC).
Sites will prospectively enroll patients in VOC seen in participating centers from either the EDs or the ICs. Specific data from the acute visits (e.g. Times of arrival, time to first dose of analgesic, etc) will be captured. This study will compare: pain management, disposition of subjects (home or admission) and patient experiences of care delivery in both settings. Subjects will complete surveys/questionnaires to asses subjects' experiences in the setting where care was provided.
The four sites to participate in the study are Baltimore, Maryland (Johns Hopkins Hospital), Cleveland, Ohio (Cleveland Medical Center), Milwaukee, Wisconsin (Medical College of Wisconsin), and Baton Rouge, Louisiana (Our Lady of the Lake Hospital). A maximum of 500 subjects will participate in the study. Participants will be enrolled for 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients With SCD | Patients treated for uncomplicated VOC in ICs and EDs. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered | Time is recorded from the time the patient arrives for pain treatment at either the ED or IC until the time the patient is dosed with pain medication administered parenterally. Guideline recommendations are that patients receive non-oral pain medication within 60 minutes of arrival. | Within 6 hours after arrival |
| Measure | Description | Time Frame |
|---|---|---|
| Disposition From Acute Care Visit | Odds for admission to the hospital versus discharge to home (ED vs IC) | Day 1 of admission |
| Pain Reassessment Within 30 Minutes of First Dose of Parenteral Pain Medication Administered |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects with SCD inclusive of genotypes homozygous and compound heterozygous sickle hemoglobin. In the United States, SCD primarily afflicts African-American and Hispanic-American populations. Patients will be enrolled prior to a vaso-occlusive crisis and data will be collected from patients' acute visit(s) at either the Emergency Department or at an Infusion center (4 participating sites).
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| Name | Affiliation | Role |
|---|---|---|
| Sophie Lanzkron, MD, MHS | Johns Hopkins University, Division of Hematology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady of the Lake Hospital | Baton Rouge | Louisiana | 70809 | United States | ||
| Cleveland Medical Center at University Hospitals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20331952 | Background | Hassell KL. Population estimates of sickle cell disease in the U.S. Am J Prev Med. 2010 Apr;38(4 Suppl):S512-21. doi: 10.1016/j.amepre.2009.12.022. | |
| 7993409 | Background | Platt OS, Brambilla DJ, Rosse WF, Milner PF, Castro O, Steinberg MH, Klug PP. Mortality in sickle cell disease. Life expectancy and risk factors for early death. N Engl J Med. 1994 Jun 9;330(23):1639-44. doi: 10.1056/NEJM199406093302303. |
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There are a total of 483 adult patients with sickle cell disease (SCD) enrolled from the end of April 2015 to December, 2016. 145 from Johns Hopkins (JH), 101 from Case Western (CW), 110 from Our Lady of the Lake Hospital (OLL) and 127 from Blood Center of Wisconsin (BCW). Four hundred forty two patients have completed 18 months follow up
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaso-Occlusive Crisis (VOC) in Patients With SCD | Patients treated for uncomplicated Vaso-Occlusive Crisis (VOC) in ICs and EDs. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VOC in Patients With SCD | Patients treated for uncomplicated VOC in ICs and EDs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | age of participant in years |
| 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 | Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered | Time is recorded from the time the patient arrives for pain treatment at either the ED or IC until the time the patient is dosed with pain medication administered parenterally. Guideline recommendations are that patients receive non-oral pain medication within 60 minutes of arrival. | Not all participants enrolled in the study visited the ED or the IC for uncomplicated vaso-occlusive crisis. The total number of subjects analyzed exceeds the total number of subjects because the same subject could visit the ED or IC one or more times. | Posted | Mean | 95% Confidence Interval | minutes | Within 6 hours after arrival | number of visits | number of visits |
|
Participants were followed for 18 months
No adverse events were collected since observational study.
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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 | VOC in Patients With SCD | Patients treated for uncomplicated VOC in ICs and EDs |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sophie Lanzkron, MD, MHS, Associate Professor of Medicine and Oncology | Johns Hopkins University School of Medicine | 410-502-8642 | slanzkr@jhmi.edu |
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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 | Feb 17, 2015 | Jan 11, 2019 | Prot_SAP_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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Odds of being re-assessed for pain within 30 minutes of receiving first dose of pain medication in ED vs IC. NHLBI guidelines recommend that patients are re-assessed for adequacy of pain management 30 minutes after receiving pain medication.
| 30 minutes after administration |
| Patient Reported Satisfaction With Care Received | Survey to capture patient satisfaction with the quality of care in either the ED or IC. Validated a new tool to assess satisfaction with care in the acute care setting. The new tool was developed based on existing tools that assessed several domains: adequacy of pain management, communication with providers, interpersonal aspects of care, provider competence, involvement of family/friends, and access to care. The final 15 item validated Patient Satisfaction with Pain Management in Sickle Cell Disease (SCD) (PSPS) scale was used to compare satisfaction of care comparing ED to IC acute visits. Overall mean satisfaction scores ranged from 0-7 with higher scores signifying greater satisfaction | within 72 hours of acute visit |
| Patient Reported Perception of Risk From Visit | One question on the survey asked patients to rate the overall level of medical safety they felt during their visit to the ED or IC. Choices for responses: Excellent, Very Good, Good, Fair or Poor. Excellent and Very Good were determined as having greater feelings of overall safety while patients who chose Good, Fair or Poor were determined having lesser feelings of overall safety. | within 72 hours of acute visit |
| Cleveland |
| Ohio |
| 44106 |
| United States |
| Medical College of Wisconsin, Blood Center | Milwaukee | Wisconsin | 53201 | United States |
| 16129027 | Background | McClish DK, Penberthy LT, Bovbjerg VE, Roberts JD, Aisiku IP, Levenson JL, Roseff SD, Smith WR. Health related quality of life in sickle cell patients: the PiSCES project. Health Qual Life Outcomes. 2005 Aug 29;3:50. doi: 10.1186/1477-7525-3-50. |
| 21099066 | Background | Bediako SM. Predictors of employment status among African Americans with sickle cell disease. J Health Care Poor Underserved. 2010 Nov;21(4):1124-37. doi: 10.1353/hpu.2010.0945. |
| 25639822 | Background | Lanzkron S, Carroll CP, Hill P, David M, Paul N, Haywood C Jr. Impact of a dedicated infusion clinic for acute management of adults with sickle cell pain crisis. Am J Hematol. 2015 May;90(5):376-80. doi: 10.1002/ajh.23961. Epub 2015 Feb 25. |
| 23380119 | Background | Haywood C Jr, Tanabe P, Naik R, Beach MC, Lanzkron S. The impact of race and disease on sickle cell patient wait times in the emergency department. Am J Emerg Med. 2013 Apr;31(4):651-6. doi: 10.1016/j.ajem.2012.11.005. Epub 2013 Feb 4. |
| 20730795 | Background | Lanzkron S, Carroll CP, Haywood C Jr. The burden of emergency department use for sickle-cell disease: an analysis of the national emergency department sample database. Am J Hematol. 2010 Oct;85(10):797-9. doi: 10.1002/ajh.21807. |
| 34224261 | Derived | Lanzkron S, Little J, Wang H, Field JJ, Shows JR, Haywood C Jr, Saheed M, Proudford M, Robertson D, Kincaid A, Burgess L, Green C, Seufert R, Brooks J, Piehet A, Griffin B, Arnold N, Frymark S, Wallace M, Abu Al Hamayel N, Huang CY, Segal JB, Varadhan R. Treatment of Acute Pain in Adults With Sickle Cell Disease in an Infusion Center Versus the Emergency Department : A Multicenter Prospective Cohort Study. Ann Intern Med. 2021 Sep;174(9):1207-1213. doi: 10.7326/M20-7171. Epub 2021 Jul 6. |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | VOC in Patients With SCD Who Went to ICs | Patients treated for uncomplicated VOC in ICs |
|
|
|
| Secondary | Disposition From Acute Care Visit | Odds for admission to the hospital versus discharge to home (ED vs IC) | Not all participants enrolled in the study visited the ED or the IC for uncomplicated vaso-occlusive crisis. The total number of subjects analyzed exceeds the total number of subjects because the same subject could visit the ED or IC one or more times. | Posted | Number | number of visits | Day 1 of admission | number of visits | number of visits |
|
|
|
|
| Secondary | Pain Reassessment Within 30 Minutes of First Dose of Parenteral Pain Medication Administered | Odds of being re-assessed for pain within 30 minutes of receiving first dose of pain medication in ED vs IC. NHLBI guidelines recommend that patients are re-assessed for adequacy of pain management 30 minutes after receiving pain medication. | Not all participants enrolled in the study visited the ED or the IC for uncomplicated vaso-occlusive crisis. The total number of subjects analyzed exceeds the total number of subjects because the same subject could visit the ED or IC one or more times. | Posted | Number | number of visits | 30 minutes after administration | number of visits | number of visits |
|
|
|
|
| Secondary | Patient Reported Satisfaction With Care Received | Survey to capture patient satisfaction with the quality of care in either the ED or IC. Validated a new tool to assess satisfaction with care in the acute care setting. The new tool was developed based on existing tools that assessed several domains: adequacy of pain management, communication with providers, interpersonal aspects of care, provider competence, involvement of family/friends, and access to care. The final 15 item validated Patient Satisfaction with Pain Management in Sickle Cell Disease (SCD) (PSPS) scale was used to compare satisfaction of care comparing ED to IC acute visits. Overall mean satisfaction scores ranged from 0-7 with higher scores signifying greater satisfaction | 207 participants completed the satisfaction survey after their first visit during the study time period. | Posted | Mean | Standard Deviation | score on a scale | within 72 hours of acute visit |
|
|
|
| Secondary | Patient Reported Perception of Risk From Visit | One question on the survey asked patients to rate the overall level of medical safety they felt during their visit to the ED or IC. Choices for responses: Excellent, Very Good, Good, Fair or Poor. Excellent and Very Good were determined as having greater feelings of overall safety while patients who chose Good, Fair or Poor were determined having lesser feelings of overall safety. | Only 205 patients completed the perception of risk question at the first visit to either the ED or the IC. | Posted | Count of Participants | Participants | within 72 hours of acute visit |
|
|
|
| 10 |
| 483 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |