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

• 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: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Tracking Information

• First Submitted Date: March 30, 2015
• First Posted Date: April 8, 2015
• Results First Submitted Date: January 22, 2019
• Results First Posted Date: June 17, 2019
• Last Update Posted Date: June 27, 2019
• Actual Study Start Date: April 2015
• Actual Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 12, 2019)

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.

Original Primary Outcome Measures (submitted: April 2, 2015)

Time from arrival to first dose of parenteral pain medication [ Time Frame: Within 6 hours after arrival ]

Comparing time to medicate in the ED versus the Infusion Center

Current Secondary Outcome Measures (submitted: March 12, 2019)

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

Original Secondary Outcome Measures (submitted: April 2, 2015)

• Outcome of acute visit - admission or discharge to home [ Time Frame: First day ]
• Patient status reassessment after first dose of pain medication administered [ Time Frame: 30 minutes after administration ]
• Patient reported satisfaction and perception of risk [ Time Frame: within 72 hours of acute visit ]
  Surveys to capture patient comments

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Patient Centered Outcomes for People With Sickle Cell Disease in the Acute Care Setting
• Official Title: Patient Centered Outcomes Research Institute (PCORI) ESCAPED Study: Comparison of Patient Centered Outcomes for People With SCD in the Acute Care Setting

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.

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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).
• Condition: Sickle Cell Disease
• Intervention: Not Provided

Study Groups/Cohorts

Patients With SCD

Patients treated for uncomplicated VOC in ICs and EDs.

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Ann Intern Med. 2021 Aug 3;:

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 21, 2017): 483
• Original Estimated Enrollment (submitted: April 2, 2015): 500
• Actual Study Completion Date: June 2018
• Actual Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02411396
• Other Study ID Numbers: IRB00054029; PCORI-1403-11888 ( Other Grant/Funding Number: PCORI )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Johns Hopkins University
• Original Responsible Party: Sophie Lanzkron, MD, Johns Hopkins University, Associate Professor of Medicine & Oncology/Director of Sickle Cell Ctr
• Current Study Sponsor: Johns Hopkins University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sophie Lanzkron, MD, MHS; Johns Hopkins University, Division of Hematology

• PRS Account: Johns Hopkins University
• Verification Date: June 2019