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

Completed

• Conditions: Sickle Cell Disease

• Registration Number: NCT02411396
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-03-30
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-08
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Results First Submitted: 2019-01-22
• Results First Submitted QC: 2019-03-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-14
• Results First Posted: 2019-06-17
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 483

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered	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

Name	Time	Method
Disposition From Acute Care Visit	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	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	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	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.

Trial Locations

Locations (3)

Our Lady of the Lake Hospital; 🇺🇸 Baton Rouge, Louisiana, United States

Medical College of Wisconsin, Blood Center; 🇺🇸 Milwaukee, Wisconsin, United States

Cleveland Medical Center at University Hospitals; 🇺🇸 Cleveland, Ohio, United States