Project Summary
PCORI has identified the need for large studies that look at real-life questions faced by diverse patients, caregivers, and clinicians. To address this need, PCORI launched the Pragmatic Clinical Studies initiative in 2014. Pragmatic clinical studies allow for larger-scale studies with longer timelines to compare the benefits and harms of two or more approaches known to be effective for preventing, diagnosing, treating, or managing a disease or symptom. They focus on everyday care for a wide range of patients. This research project is one of the studies PCORI awarded as part of this program.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Some patients who get chemotherapy come down with a serious health problem called febrile neutropenia, which involves having a fever and a low number of a type of white blood cells. Having a low number of white blood cells puts patients at risk for infection. Different types of chemotherapy put patients at different levels of risk for febrile neutropenia. When patients get chemotherapy that creates a high risk of febrile neutropenia, a type of medicine called colony-stimulating factor can help prevent it. When patients get chemotherapy that creates a low risk of this health problem, they do not need this medicine. It’s unclear whether the medicine helps patients who get chemotherapy that creates a medium risk of this health problem.
In this study, researchers are testing ways of giving doctors information to help them prescribe colony-stimulating factor medicine to the right patients.
Many doctors use computer systems to order prescriptions. The researchers want to know whether doctors follow national guidelines about when to prescribe colony-stimulating factor if their prescription order system automatically recommends it for patients who get chemotherapy that creates increased risk. They also want to find out how effective the medicine is for patients according to the risk level that their chemotherapy creates.
Who can this research help?
Results from this study can help doctors decide whether to prescribe colony-stimulating factor medicine for patients getting chemotherapy that creates a medium risk of febrile neutropenia. Results can also help healthcare leaders decide whether changing their prescription order system to make it easier for doctors to follow national guidelines will help chemotherapy patients get medicine that will help them, and spare patients who don’t need it the costs and potential side effects.
What is the research team doing?
The research team is recruiting 3,960 patients at 45 cancer clinics. They are assigning each clinic to one of four groups:
- Group 1 includes clinics that already use a prescription order system to help doctors prescribe colony-stimulating factor medicine according to guidelines. The doctors use the system to order medicine as they usually would. Clinics that do not already use this type of order system are being assigned to group 2, 3, or 4 by chance.
- In group 2 clinics, doctors order medicine as they usually would, without use of a prescription order system.
- In group 3 clinics, when doctors order high- or medium-risk chemotherapy, a study-provided prescription order system recommends that patients get the medicine.
- In group 4 clinics, doctors use the study-provided prescription order system, but it recommends the medicine only for patients getting high-risk chemotherapy, not for patients getting medium-risk chemotherapy.
This study includes adults aged 18 and older with breast, lung, or colorectal cancer who are getting chemotherapy at one of the 45 study clinics and who speak English or Spanish. Patients complete surveys about their quality of life, the cost of treatment, and what they know about the risks and benefits of colony-stimulating factor medicine. Patients complete the surveys when they enroll in the study, after their first cycle of chemotherapy, and six months later.
Researchers are looking at how often doctors follow recommendations from the prescription order systems for prescribing colony-stimulating factor medicine. The researchers are also looking at patient experiences, including how often patients develop fever and a low number of white blood cells, whether they use antibiotics, whether they take the medicine as prescribed by their doctor, whether they go to the emergency room, how often they go to the hospital, whether they finish their planned chemotherapy, and whether they die from any cause. .
Patients, cancer doctors and nurses, pharmacists, insurance-plan leaders, policy makers, and clinic leaders are involved in this study. They are offering input on research questions, the study design, ways to enroll patients in the study, and sharing information about the study with the public.
Research methods at a glance
| Design Element | Description |
|---|---|
| Study Design | Randomized controlled trial |
| Population | Adults aged 18 and older with breast, non-small cell lung, or colorectal cancer who are receiving chemotherapy at 1 of the participating clinics and speak English or Spanish |
| Interventions/ Comparators |
|
| Outcomes |
Use of prophylactic colony-stimulating factor medicine that is consistent with guidelines, rate of febrile neutropenia, prophylactic and febrile neutropenia-related antibiotic use, emergency room visits and hospitalizations related to febrile neutropenia, mortality, health-related quality of life, out-of-pocket costs, knowledge of risks, benefits, and costs of prophylactic colony-stimulating factor medicine |
 |
12-month follow-up for study outcomes |
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