Results Summary
What was the research about?
Sickle cell disease, or SCD, is an inherited blood disease. In SCD, blood cells have a sickle shape. They may lodge in small blood vessels, causing sudden, severe pain called an SCD crisis. An SCD crisis can happen without warning. To get relief, patients often get treatment in an emergency room, or ER. Patients having an SCD crisis can also get treatment in infusion centers. At these special clinics, doctors and nurses are trained to give care to patients with SCD.
In this study, the research team compared patients’ experiences getting treatment for an SCD crisis in ERs and infusion centers.
What were the results?
Compared with patients treated in ERs, patients treated in infusion centers
- Waited less time for pain medicine, about half as long as patients in the ER
- Were more likely to have their pain rechecked within 30 minutes of receiving the medicine
- Were less likely to be admitted to the hospital
- Were more satisfied with their care and felt safer
Who was in the study?
The study included 444 adults with SCD who were receiving care at one of four health centers in Maryland, Ohio, Wisconsin, and Louisiana. Of these, 98 percent were African American. The average age was 34, and 61 percent were women.
What did the research team do?
The research team recruited people with SCD to take part in the study during their regular clinic visits. Patients could choose to go to either an ER or an infusion center during any SCD crisis during the study.
The research team looked at patients’ health records over 18 months to compare treatment in ERs and infusion centers. Patients also filled out a survey about how satisfied they were with their care and how safe they felt when receiving care.
Patients with SCD, parents and children of patients with SCD, advocacy groups, and a representative from a health insurance company worked with the research team on the study.
What were the limits of the study?
The study looked only at care for SCD crises. Results might not apply to other types of care for SCD.
Future research could compare care at ERs and infusion centers for other SCD complications.
How can people use the results?
People with SCD can use the results when considering where to get care for an SCD crisis. Hospitals can use the results when thinking about whether to offer infusion centers for patients with SCD.
Professional Abstract
Objective
To compare pain management in emergency departments (EDs) versus infusion centers (ICs) for patients with sickle cell disease (SCD) receiving treatment for uncomplicated vaso-occlusive crises
Study Design
| Design Element | Description |
|---|---|
| Design | Observational: cohort study |
| Population | 444 adults with SCD |
| Interventions/ Comparators |
|
| Outcomes |
Primary: time to first dose of parenteral analgesia after patients with uncomplicated vaso-occlusive crises registered at an ED or IC Secondary: whether patients had pain reassessed within 30 minutes of first dose of pain medication, whether patients were admitted to the hospital or discharged to home, patient satisfaction with care, patient perception of safety at care site |
| Timeframe | Immediate follow-up for primary outcome |
This prospective observational cohort study compared pain management in EDs versus ICs for patients with SCD receiving treatment for uncomplicated vaso-occlusive crises. These crises involve sudden onset of pain when sickle cells lodge in small blood vessels, blocking blood flow.
The study included 444 adults with SCD who were receiving regular outpatient clinic care at one of four medical centers in Maryland, Ohio, Wisconsin, and Louisiana. Of these patients, 98% were African American. The mean age was 34, and 61% were female.
Patients chose whether to seek care at an ED or IC for each episode. Over 18 months, researchers reviewed health records to compare wait time for the first dose of parenteral analgesia and whether patients had their pain reassessed within 30 minutes of the first dose. Researchers also reviewed patients’ hospital admissions or discharges. Within three days of each eligible visit, patients completed questionnaires on satisfaction with care and perception of safety. Researchers used a time-varying propensity score model to compare participants with similar characteristics at both care sites.
Patients with SCD, parents and children of patients with SCD, advocacy organizations, and a representative from a health insurer helped plan and conduct the study.
Results
The mean time to first dose of parenteral pain medication was 63 minutes in ICs and 125 minutes in EDs (95% confidence interval [CI]: 54, 69).
Compared with patients treated in EDs, patients treated in ICs were significantly
- More likely to have their pain reassessed within 30 minutes of their first dose of pain medication (odds ratio [OR]=2.5%; 95% CI: 2.1, 3.0)
- Less likely to be admitted to the hospital (OR=0.17%; 95% CI: 0.137, 0.212)
- More satisfied with pain management (p<0.001) and felt safer (p<0.01)
Limitations
The study focused on uncomplicated vaso-occlusive crises; findings cannot be extrapolated to other SCD complications.
Conclusions and Relevance
In this study, patients with SCD treated in ICs had significantly better treatment experiences for uncomplicated vaso-occlusive crises than patients treated in EDs.
Future Research Needs
Future research could compare treatment for other SCD complications in ICs versus EDs.
Final Research Report
View this project's final research report.
Implementation
Related PCORI Dissemination and Implementation Project
Journal Citations
Article Highlight: Findings from this PCORI-funded study published in the Annals of Internal Medicine show promise for improving care of individuals living with sickle cell disease (SCD) in the United States, who historically have been underserved by the medical community. Researchers compared treatment for patients with uncomplicated vaso-occlusive crisis (VOC) in emergency rooms (ERs) and infusion centers. VOC is the most prevalent SCD complication and causes acute, excruciating pain that most commonly is treated in ERs. Patients receiving care in infusion centers reported waiting less time—about half as long—for pain medicine than ER patients. They also were more likely to receive care adhering to guidelines for the management of acute pain and less likely to be admitted to the hospital.
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers noted that the researchers suggest that care in emergency departments (ED) may be hampered by ED providers’ limited knowledge of individual patients. The reviewers wondered if sites participating in the study used individualized care plans, either in the ED or in the infusion centers (IC). The researchers said the treatment sites did not have individualized treatment plans for all patients but said patient-specific treatment plans are typically not available in ED settings. The researchers noted that the study did not strive to compare the use of patient-specific treatment plans in ED versus IC settings.
- The reviewers commented that the researchers did not report on length of visits and that differences in time spent in the IC or ED may have contributed to differences in hospital admission rates, perhaps because ED did not have the resources to keep patients for as long. The researchers added mean and median lengths of time subjects spent in both settings and noted that subjects spent more time in ED settings than in IC settings. The researchers said a more detailed evaluation of how time spent in care sites affected outcomes will be done in the future.
- The reviewers noted that the researchers did not collect data for multiple visits within the same month, which probably led to an underestimate of ongoing crises, a major reason for returning ED patients and readmission. The researchers added this consideration to their study limitations, but also noted that their sensitivity analyses did not find significant differences in outcomes for the high utilizer population, or the individuals most likely to experience multiple ED visits or readmissions in one month.
- The reviewers asked for more detail on the study’s reported use of the last-observation-carried-forward analysis technique to account for missing data. The researchers explained that they only used this method of imputing missing values for information on whether there was a change in medical history between acute care visits. For their primary and secondary outcomes, which had very low missing data rates, the researchers used complete case analysis rather than imputing outcomes.