Sickle Cell DiseaseESCAPEDNCT02411396
Comparison of Patient Centered Outcomes for People With Sickle Cell Disease in the Acute Care Setting
An observational study of Sickle Cell Disease, run by Johns Hopkins University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 483 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2015to Jun 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Confirmed Sickle Cell Disease patients who live within 60 miles of the study center or who already receive regular care at the participating centers.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, 70809
Cleveland Medical Center at University Hospitals
Cleveland, Ohio, 44106
Medical College of Wisconsin, Blood Center
Milwaukee, Wisconsin, 53201
About this study
Official title: Patient Centered Outcomes Research Institute (PCORI) ESCAPED Study: Comparison of Patient Centered Outcomes for People With SCD in the Acute Care Setting
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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients With SCD | Patients treated for uncomplicated VOC in ICs and EDs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6 hours after arrival
Secondary outcomes (4)
Disposition From Acute Care Visit
Odds for admission to the hospital versus discharge to home (ED vs IC)
Measured: Day 1 of admission
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.
Measured: 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
Measured: 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.
Measured: within 72 hours of acute visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Lanzkron, MD, MHS, Principal investigator, Johns Hopkins University, Division of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411396
- Sponsor's protocol ID
- IRB00054029
- Other IDs
- PCORI-1403-11888
- Acronym
- ESCAPED
- Status last verified
- Jun 2019
- First submitted
- 30 Mar 2015
- Last updated
- 27 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 20331952Platt 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.
PubMed 7993409McClish 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.
PubMed 16129027Bediako 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.
PubMed 21099066Lanzkron 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.
PubMed 25639822Haywood 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.
PubMed 23380119Lanzkron 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.
PubMed 20730795Lanzkron 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.
PubMed 34224261
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Outcomes Research Institute (PCORI) ESCAPED Study: Comparison of Patient Centered Outcomes for People With SCD in the Acute Care Setting
- ClinicalTrials.gov ID
- NCT02411396
- Acronym / sponsor ID
- ESCAPED / IRB00054029
- Conditions
- Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Posted 17 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With SCD | – | –Patients treated for uncomplicated VOC in ICs and EDs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Confirmed Sickle Cell Disease patients who live within 60 miles of the study center or who already receive regular care at the participating centers.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Disposition From Acute Care Visit
Time frame: Day 1 of admission
Pain Reassessment Within 30 Minutes of First Dose of Parenteral Pain Medication Administered
Time frame: 30 minutes after administration
Patient Reported Satisfaction With Care Received
Time frame: within 72 hours of acute visit
Patient Reported Perception of Risk From Visit
Time frame: within 72 hours of acute visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20331952Hassell 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.
- Background: PubMed 7993409Platt 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.
- Background: PubMed 16129027McClish 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.
- Background: PubMed 21099066Bediako 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.
- Background: PubMed 25639822Lanzkron 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.
- Background: PubMed 23380119Haywood 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.
- Background: PubMed 20730795Lanzkron 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.
- Derived from this study: PubMed 34224261Lanzkron 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Lanzkron, MD, MHS principal investigator
Johns Hopkins University, Division of Hematology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Johns Hopkins University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered (time frame: Within 6 hours after arrival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02411396, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.