Point of Care Research
Point of Care Research (POC-R) is a new approach to clinical study design that embeds trials into regular medical care. It's uniquely positioned to compare two or more approved treatments or diagnostic techniques that are considered to be equivalent. More about Point of Care research.
CSP #597: The Diuretic Comparison Project is an example of POC-R taking place within CSP.
For Potential Participants
What is Point of Care Research?
VA is introducing a new approach to research that combines research studies with routine medical care. This will help us learn how to best treat and improve the lives of Veterans. Point of Care Research (POC-R) provides a new way to compare commonly used treatments to find out if one is more effective than another.
How does POC-R differ from other medical research studies like a clinical trial?
In a clinical trial, researchers study new drugs, medical devices, diagnostic tests, or treatments. Participants have scheduled visits with the researchers in addition to their usual health care provider and often undergo extra tests or procedures for the purpose of the research study. A POC-R study will only compare options that are already approved and are being used every day in medical care. Veterans continue to receive their medical care provided in the usual way at their VA. No separate visits for research are required because researchers will learn about the results of treatment from the usual information entered into the medical record.
How will POC-R help Veterans?
By integrating research into routine medical care, POC-R will help VA answer questions faster, and for less money. Results will let doctors know which treatment works best for their patients and guide them in making decisions to ultimately deliver the best care to Veterans.
Haven’t drugs already been tested before you start using them? What information do you need?
Before a new medication is used in everyday health care, drug companies are required to prove that it works and that it is safe. They are not always required to compare their drug to others on the market to determine which is more effective. As a result, doctors may have several treatment options available. When there is no clear answer as to which drug is more effective, VA researchers can use POC-R to learn more and ultimately provide better care to Veterans.
How does POC-R work?
You may have a chance to participate in POC-R while being seen in a clinic or during a hospitalization. This can happen if there are several treatment options available and your doctor does not have a strong preference for one over another. For example, two commonly used medications to treat high blood pressure may be studied to find out which one works best. In this case, if you are willing to participate, you will randomly be assigned to receive one or the other. This helps us make sure that we can compare the two drugs fairly. Your doctor will still be responsible for making decisions about your medical care, and may even change your medicine if necessary. Researchers will collect information from your electronic medical record (EMR) and compare the results of the two treatments to identify which works better. After you agree to participate, there are no other study related requirements.
What does participation involve?
Each POC-R study will be different. However, similar to any research study, you will be provided with detailed information on what the study entails, including potential risks. If you agree to participate, there will be no additional appointments or tests outside of your routine medical care. Researchers will receive information on your treatment and how it is working from your VA EMR. Although research results may be published or shared with other scientists, your name and identity will never be revealed to anyone outside of VA.
I trust my doctor. Will he or she still take care of me if I am in a POC-R study?
Yes, your primary care doctor and any specialists you see for care will be responsible for your individual medical needs, whether or not you participate in POC-R.
Will a computer be making decisions about my medical care?
Your doctor will consider the various treatment options available and decide if one is best for you. You will only participate in POC-R when your doctor has no preference for one treatment over all of the others. In that specific case, the study will randomly assign you to one treatment option. The computer isn’t taking the place of doctors; it is just “flipping the coin” for them. Your doctor will still be responsible for making decisions about your medical care.
For Investigators: Starting a POC-R Study
Eligible VA investigators who wish to start a POC-R study must submit a Letter of Intent (LOI). This serves as a request for planning and includes:
- Study objectives
- Importance of the research to VA and its patients
- Feasibility of conducting the research as a POC-R study
- Summary of preliminary research and data to support further investigation
- Please refer to the CSP Investigator Guidelines for further instructions on submitting an LOI. Be aware that, although these guidelines do not provide specific information for POC-R feasibility, this information should be included in a POC-R LOI.
