How is APPRAISE different from other studies?

Normally, researchers get permission (consent) before a person can be included in a study. A person with a major trauma injury may not be able to give consent at the time of injury. Also, since major trauma patients must be treated quickly, there might not be enough time to locate and talk to the person’s family or legal representative about the study. The software system being studied is designed for use during the first 30 minutes after arrival to the hospital. When consent during this time is not possible, a person might be enrolled in this study without consent. This is called “Exception from Informed Consent” (EFIC).

In cases when we begin the study without consent (because the patient is unable to provide consent) we will locate a family member or legal representative as soon as we are able, to ask whether they want the patient to continue to participate in this study.

What is EFIC?

Exception from informed consent (EFIC) for emergency research refers to a special set of rules established by US Federal law to regulate studies when research participants cannot tell researchers their desires in a medical emergency. These special rules allow research studies in certain emergency situations to be conducted without consent.

EFIC can only be used when:

• The person’s life is at risk; AND
• The best treatment is not known; AND
• The study might help the person; AND
• It is not possible to get permission from the person (because of his or her medical condition); AND
• It is not possible to get permission from the person’s family or legal representative (because there is a very short amount of time required to treat the medical problem, or the representative is not available).

Who will be included?

Adult (≥ 18 years) trauma patients treated at MGH may be enrolled in this study (Trauma is any accident or physical event with the potential to cause major physical injuries including death or long-term disability, such as car crashes, falls, and serious knife wounds). However, we will not enroll patients if they are known to be pregnant, or if they have opted out.

What are the benefits?

Trauma patient care is complicated, because the condition of a trauma patient is often rapidly changing through time and it can be challenging for doctors and nurses to keep track of all the necessary and appropriate tasks at any given time. Multiple studies from hospitals all over the country have shown that doctors and nurses often overlook important tasks during the early management of trauma patients.

To help trauma patients get the very best care each and every time, the research team at MGH has developed a software system, which is named APPRAISE, that keeps track of the state of the patient and displays management recommendations intended to reduce or eliminate delays or mistakes in caring for trauma patients.

For trauma patients, the potential benefit of being in this study would be improved medical care. The APPRAISE software system may help doctors and nurses give important life-saving interventions faster than usual, with reduced delays and mistakes. This improved management may lead to reduced critical illness and improved trauma patient outcomes.

What are the risks?

The APPRAISE software system might distract, confuse, or mislead clinicians, which could then cause a delay in time-sensitive interventions. Or the software could confuse or mislead clinicians to perform an intervention that is not appropriate and harmful to the patient.

To minimize these risks, the APPRAISE software has undergone extensive testing and evaluation prior to this research study. There are many fail safe features of the software and the testing protocol. As well, the APPRAISE software will be used only as a secondary supplement to the routine practices for trauma patient management at the hospital. However, there is always some risk whenever anything new and unproven is tested for the first time.

This research study has been approved by the US FDA.

What do I do if I do not want to be included in the study?

If you decide you don’t want to be included in this study in the event that you suffer a future major injury, contact us to “opt out” of this study. If you would like to opt out, we will mail you a medical alert bracelet to wear with the words “EFIC Opt Out.” Wearing this medical alert bracelet at all times throughout the study period (about five years) is the best way of communicating your wishes that you do not want to be included in this study in case you suffer a major injury and are unconscious. We will also mail you “opt out” stickers to place on the back of your cellphone, or to place on your wallet ID, to identify you as someone who should not be included in the APPRAISE study. Lastly, we will add a note to your Mass General medical record that you have opted-out of this study.

If you choose to not participate in this study, you will receive the standard medical treatment provided for trauma at the hospital in your community.