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Comparison of Patient Centered Outcomes for People With Sickle Cell Disease in the Acute Care Setting (ESCAPED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02411396
Recruitment Status : Completed
First Posted : April 8, 2015
Results First Posted : June 17, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

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.


Condition or disease
Sickle Cell Disease

Detailed Description:

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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Study Type : Observational
Actual Enrollment : 483 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Centered Outcomes Research Institute (PCORI) ESCAPED Study: Comparison of Patient Centered Outcomes for People With SCD in the Acute Care Setting
Actual Study Start Date : April 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Patients With SCD
Patients treated for uncomplicated VOC in ICs and EDs.



Primary Outcome Measures :
  1. Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered [ Time Frame: Within 6 hours after arrival ]
    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.


Secondary Outcome Measures :
  1. Disposition From Acute Care Visit [ Time Frame: Day 1 of admission ]
    Odds for admission to the hospital versus discharge to home (ED vs IC)

  2. Pain Reassessment Within 30 Minutes of First Dose of Parenteral Pain Medication Administered [ Time Frame: 30 minutes after administration ]
    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.

  3. Patient Reported Satisfaction With Care Received [ Time Frame: within 72 hours of acute visit ]
    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

  4. Patient Reported Perception of Risk From Visit [ Time Frame: within 72 hours of acute 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

Inclusion Criteria:

  • Confirmed Sickle Cell Disease patients who live within 60 miles of the study center or who already receive regular care at the participating centers.

Exclusion Criteria:

  • Stable patients who have been on chronic transfusion therapy and have not had a painful episode within two years of enrollment.
  • Patients who are pregnant.
  • Patients who are unwilling or unable to sign consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411396


Locations
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United States, Louisiana
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, United States, 70809
United States, Ohio
Cleveland Medical Center at University Hospitals
Cleveland, Ohio, United States, 44106
United States, Wisconsin
Medical College of Wisconsin, Blood Center
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Sophie Lanzkron, MD, MHS Johns Hopkins University, Division of Hematology
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02411396    
Other Study ID Numbers: IRB00054029
PCORI-1403-11888 ( Other Grant/Funding Number: PCORI )
First Posted: April 8, 2015    Key Record Dates
Results First Posted: June 17, 2019
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn