Trial Outcomes & Findings for Comparison of Patient Centered Outcomes for People With Sickle Cell Disease in the Acute Care Setting (NCT NCT02411396)

Last Updated: 2019-06-27

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

483 participants

Primary outcome timeframe

Within 6 hours after arrival

Results posted on

2019-06-27

Participant Flow

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

Participant milestones

Participant milestones
Measure	Vaso-Occlusive Crisis (VOC) in Patients With SCD Patients treated for uncomplicated Vaso-Occlusive Crisis (VOC) in ICs and EDs.
Overall Study STARTED	483
Overall Study COMPLETED	442
Overall Study NOT COMPLETED	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Vaso-Occlusive Crisis (VOC) in Patients With SCD Patients treated for uncomplicated Vaso-Occlusive Crisis (VOC) in ICs and EDs.
Overall Study Lost to Follow-up	31
Overall Study Death	10

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VOC in Patients With SCD n=483 Participants Patients treated for uncomplicated VOC in ICs and EDs.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	476 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	34.4 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	293 Participants n=5 Participants
Sex: Female, Male Male	190 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	477 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	471 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	483 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 6 hours after arrival

Population: 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.

Outcome measures

Outcome measures
Measure	VOC in Patients With SCD Who Went to EDs n=1558 number of visits Patients treated for uncomplicated VOC in EDs.	VOC in Patients With SCD Who Went to ICs n=1469 number of visits Patients treated for uncomplicated VOC in ICs
Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered	125.3 minutes Interval 118.3 to 131.8	61.8 minutes Interval 59.3 to 64.3

SECONDARY outcome

Timeframe: Day 1 of admission

Odds for admission to the hospital versus discharge to home (ED vs IC)

Outcome measures

Outcome measures
Measure	VOC in Patients With SCD Who Went to EDs n=1556 number of visits Patients treated for uncomplicated VOC in EDs.	VOC in Patients With SCD Who Went to ICs n=1468 number of visits Patients treated for uncomplicated VOC in ICs
Disposition From Acute Care Visit Number of visits being hospitalized	517 number of visits	128 number of visits
Disposition From Acute Care Visit Number of visits being sent home	1039 number of visits	1340 number of visits

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VOC in Patients With SCD Who Went to EDs n=1394 number of visits Patients treated for uncomplicated VOC in EDs.	VOC in Patients With SCD Who Went to ICs n=1455 number of visits Patients treated for uncomplicated VOC in ICs
Pain Reassessment Within 30 Minutes of First Dose of Parenteral Pain Medication Administered Number of visits being reassessed in 30 mins	287 number of visits	544 number of visits
Pain Reassessment Within 30 Minutes of First Dose of Parenteral Pain Medication Administered Number of visits not being reassessed in 30 mins	1107 number of visits	911 number of visits

SECONDARY outcome

Timeframe: within 72 hours of acute visit

Population: 207 participants completed the satisfaction survey after their first visit during the study time period.

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

Outcome measures

Outcome measures
Measure	VOC in Patients With SCD Who Went to EDs n=85 Participants Patients treated for uncomplicated VOC in EDs.	VOC in Patients With SCD Who Went to ICs n=122 Participants Patients treated for uncomplicated VOC in ICs
Patient Reported Satisfaction With Care Received	4.8 score on a scale Standard Deviation 1.1	5.8 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: within 72 hours of acute visit

Population: Only 205 patients completed the perception of risk question at the first visit to either the ED or the IC.

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.

Outcome measures

Outcome measures
Measure	VOC in Patients With SCD Who Went to EDs n=87 Participants Patients treated for uncomplicated VOC in EDs.	VOC in Patients With SCD Who Went to ICs n=118 Participants Patients treated for uncomplicated VOC in ICs
Patient Reported Perception of Risk From Visit Greater feelings of overall medical safety	43 Participants	98 Participants
Patient Reported Perception of Risk From Visit Lesser feelings of overall safety	44 Participants	20 Participants

Adverse Events

VOC in Patients With SCD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sophie Lanzkron, MD, MHS, Associate Professor of Medicine and Oncology

Johns Hopkins University School of Medicine

Phone: 410-502-8642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place