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
  • Standardized prescription order system already in use for prescribing prophylactic colony-stimulating factor (group 1, observational cohort)
  • No standardized prescription order system. Patients receive medicine based on clinic’s existing clinical practice guidelines (group 2, primary randomization)
  • Standardized prescription order system; National Comprehensive Cancer Network guideline-based prophylactic colony-stimulating factor (medicine to prevent febrile neutropenia) orders and recommendations for patients undergoing chemotherapy that creates high or low risk of febrile neutropenia (groups 3 and 4, primary randomization)
  • Prophylactic colony-stimulating factor medicine recommendation for patients undergoing chemotherapy that creates medium risk of febrile neutropenia (group 3, secondary randomization)
  • No prophylactic colony-stimulating factor medicine for patients undergoing chemotherapy that creates medium risk of febrile neutropenia (group 4, secondary randomization)
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

Timeframe 12-month follow-up for study outcomes

More on This Project

Project Information

Scott D. Ramsey, MD, PhD
Fred Hutchinson Cancer Research Center
$7,817,799
A Pragmatic Trial to Improve Colony Stimulating Factor Use in Cancer

Key Dates

February 2015
April 2022
2015

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
Research Priority Area
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 14, 2022