Sickle Cell Disease
Conditions
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.
Interventions
None listed
Sponsors
Johns Hopkins University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| VOC in Patients With SCD Patients treated for uncomplicated VOC in ICs and EDs. | 483 |
| Total | 483 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 10 |
| Overall Study | Lost to Follow-up | 31 |
Baseline characteristics
| Characteristic | VOC in Patients With SCD |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 476 Participants |
| Age, Continuous | 34.4 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 477 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 471 Participants |
| Race (NIH/OMB) More than one race | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 483 participants |
| Sex: Female, Male Female | 293 Participants |
| Sex: Female, Male Male | 190 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 10 / 483 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| VOC in Patients With SCD Who Went to EDs | Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered | 125.3 minutes |
| VOC in Patients With SCD Who Went to ICs | Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered | 61.8 minutes |
Comparison: This analysis is to compare outcome measure between ED or IC visits by using time varying propensity score method developed by our group to adjust imbalance of covariates between the two arms. Each patient can have multiple visits to the facility of choice.95% CI: [118.3, 130.9]
Secondary
Disposition From Acute Care Visit
Odds for admission to the hospital versus discharge to home (ED vs IC)
Time frame: Day 1 of admission
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VOC in Patients With SCD Who Went to EDs | Disposition From Acute Care Visit | Number of visits being hospitalized | 517 number of visits |
| VOC in Patients With SCD Who Went to EDs | Disposition From Acute Care Visit | Number of visits being sent home | 1039 number of visits |
| VOC in Patients With SCD Who Went to ICs | Disposition From Acute Care Visit | Number of visits being hospitalized | 128 number of visits |
| VOC in Patients With SCD Who Went to ICs | Disposition From Acute Care Visit | Number of visits being sent home | 1340 number of visits |
95% CI: [4.13, 6.41]
Secondary
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.
Time frame: 30 minutes after administration
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VOC in Patients With SCD Who Went to EDs | 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 |
| VOC in Patients With SCD Who Went to EDs | 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 |
| VOC in Patients With SCD Who Went to ICs | Pain Reassessment Within 30 Minutes of First Dose of Parenteral Pain Medication Administered | Number of visits being reassessed in 30 mins | 544 number of visits |
| VOC in Patients With SCD Who Went to ICs | Pain Reassessment Within 30 Minutes of First Dose of Parenteral Pain Medication Administered | Number of visits not being reassessed in 30 mins | 911 number of visits |
95% CI: [1.84, 2.72]
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VOC in Patients With SCD Who Went to EDs | Patient Reported Perception of Risk From Visit | Greater feelings of overall medical safety | 43 Participants |
| VOC in Patients With SCD Who Went to EDs | Patient Reported Perception of Risk From Visit | Lesser feelings of overall safety | 44 Participants |
| VOC in Patients With SCD Who Went to ICs | Patient Reported Perception of Risk From Visit | Greater feelings of overall medical safety | 98 Participants |
| VOC in Patients With SCD Who Went to ICs | Patient Reported Perception of Risk From Visit | Lesser feelings of overall safety | 20 Participants |
Secondary
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
Time frame: within 72 hours of acute visit
Population: 207 participants completed the satisfaction survey after their first visit during the study time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VOC in Patients With SCD Who Went to EDs | Patient Reported Satisfaction With Care Received | 4.8 score on a scale | Standard Deviation 1.1 |
| VOC in Patients With SCD Who Went to ICs | Patient Reported Satisfaction With Care Received | 5.8 score on a scale | Standard Deviation 1 |