PCORI funds implementation projects to promote the use of findings from PCORI-funded studies. This project focuses on implementing findings from the completed PCORI-funded research project: Comparing Pain Management for Sickle Cell Disease Crises in Emergency Rooms and Infusion Centers
1. What were the results from the original PCORI-funded research study?
In the PCORI-funded ESCAPED trial, the project team enrolled participants with sickle cell disease (SCD) from four different care centers across the United States to evaluate the care of uncomplicated vaso-occlusive pain episodes in infusion centers (IC) compared to emergency departments (ED) in four sites across the United States. The team assessed efficacy of the IC compared to ED-based care by examining several important outcomes for patients: the primary outcome was time to first dose of analgesia after arrival to site of care and secondary outcomes included whether participants had their pain reassessed 30 minutes after their first dose of pain medication and whether the acute visit resulted in hospital admission or discharge home.
There were 483 subjects enrolled in the trial. Over the study period within the four sites, there were 3,027 acute visits, 1,558 visits to an ED, and 1,469 visits to an IC. In the adjusted analyses, the mean time to first dose of parenteral pain medications was 125 minutes in an ED setting and 63 minutes in an IC setting; the mean difference between time to first dose was 62 minutes (95 percent CI, 54-69). Patients seen in an IC were significantly more likely to have their pain reassessed 30 minutes after their first dose of pain medication than patients treated in an ED (OR, 2.5; 95 percent CI, 2.1-3.0) and visits to the ED were significantly more likely to end in the patient being admitted to the hospital than visits to the IC (OR, 5.9; 95 percent CI, 4.7-7.3).
In addition, for patients who received care at an IC, the overall mean satisfaction score as measured by the validated patient satisfaction with pain management survey tool was 5.8 (SD, 1.0) whereas for patients who received care at an ED, the overall mean satisfaction score was 4.8 (SD, 1.1).
2. Why is this research finding important?
The best-known burden of SCD is the vaso-occlusive crisis (VOC). These acute, excruciatingly painful events are the leading cause of hospital and ED utilization. The ED has been the standard location where patients with SCD seek care for the treatment of acute painful events. Studies show that patients and healthcare providers are dissatisfied with the quality of SCD pain management, which is currently centered in the ED. ED care for SCD is marked by long delays, lack of efficacy, and conflict. Nationally, 40 percent of ED visits for SCD pain are concluded by hospital admissions. SCD patients report that they do not have enough involvement in decisions about their own care and that providers do not demonstrate respect, trust, and compassion. Numerous studies have demonstrated that providers hold highly negative attitudes toward SCD patients and are strongly predisposed to suspect addiction in patients presenting for VOC care.
Patients with SCD often face both structural and interpersonal racism, presenting to EDs with severe pain only to be met with racist attitudes expressed by those in healthcare and receiving inadequate care. Prior to the ESCAPED study there had not been a direct, prospective comparison between ICs and the ED for pain management in SCD. The results demonstrate that care in an IC results in better patient-centered outcomes than care in an ED.
3. What is the goal of this project?
The goal is to launch and evaluate an infusion clinic implementation toolkit and facilitation network to accelerate the implementation of infusion clinic in communities who serve individuals with SCD. Aim 1 is to deploy and evaluate the implementation facilitation program and toolkit on implementation success of infusion clinics in 10 sites using the RE-AIM framework. Aim 2 is to evaluate the impact of implementation of infusion clinics on secondary patient outcomes including time to first dose of parenteral pain medications, risk of hospitalizations, and patient satisfaction with pain management.
4. What is the project team doing?
The tailored implementation strategy includes key components: (1) ECHO telementoring model to provide implementation facilitation and clinical consultation and education; (2) resource toolkit with templates, manuals, and IC policies and procedures; (3) audit and feedback of implementation and health outcomes to monitor success and identify gaps in care; and (4) stakeholder engagement to promote implementation across health systems, communities, and patients.
This project will have broad reach as there will be nine participating centers across the United States. The project team will also implement the IC model in both academic and community settings. The sites involved are in Maryland, Virginia, Indiana, Minnesota, Pennsylvania, Massachusetts, Kansas, North Carolina, and Delaware. The team anticipates that this project will reach 10 percent of the adult population with SCD in the United States.
5. How is the team evaluating this project?
Our evaluation will use RE-AIM, a well-established framework in implementation science for study planning and evaluation of public health impact in implementation science. Quality metric goals that will be monitored are the following:
- Discharge rate at IC will be 80 percent.
- Time to first dose will be less than or equal to 60 minutes.
- Average rating of patient satisfaction tool will be at least 5.5 to match results from the ESCAPED trial.
The project team will also target to achieve 75 percent of providers who rate the implementation strategies feasible and accessible, and target 75 percent of responses above average for usability and satisfaction of the developed toolkit resources using the system usability scale stated above.
6. How is the team involving patients and others in making sure the findings reach people who can use them?
There are a number of stakeholders that are essential to the success of this project. The project team will include a consultant who is a nurse and a person living with SCD. She was instrumental in the development of the toolkit and will bring her experience both as a clinician and a person living with SCD to the centers involved. In addition, each site will be identifying a person living with SCD or a family member who will participate in our advisory board and annual meetings to provide feedback on the project.
Finally, the president of the Maryland Sickle Cell Disease Association will be a liaison with the patient and caretaker communities. The project team will also partner with the National Alliance for Sickle Cell Centers (NASCC), whose mission is to support sickle cell disease centers in delivering high-quality comprehensive care. Work with this organization will help support funding in the future for sustainability of the ICs created during this project.
7. How will this project help ensure future uptake and use of findings from patient-centered outcomes research?
Once the utility of the toolkit has been established the project team will make it freely available to any site that wishes to open an IC. The data collected during this project will be used to demonstrate the benefits of the IC model over the ED and will be shared broadly.
Initial PCORI-Funded Research Study
This implementation project focuses on putting findings into practice from this completed PCORI-funded research study: Comparing Pain Management for Sickle Cell Disease Crises in Emergency Rooms and Infusion Centers
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.