About the Study
What is the goal of the APEX study?
We are doing a study to learn more about how adolescents feel after they have surgery and take medicine for pain. We want to know how their lives are before and after the surgery and how it affects the pain and medicine they need. We will use this information to help doctors take care of adolescents who have surgery in the future.
Who can participate?
Adolescents and their parents are invited to participate in this research study if the adolescent is between 12-17 and scheduled for eligible surgery at a participating hospital. Study staff will ask potential participants a few questions to see if they are eligible to participate. About 10,000 adolescents and their parent/caregiver from these hospitals will participate in this study (20,000 people total).
Why should I participate the APEX study?
Results from this study will help young people undergoing surgery in the future by improving decision-making about pain management and recovery following surgery. Being in this research study may not help participants right now. When we finish the research, we hope that we will know more about pain management in adolescent surgical patients. This may help other young people in the future. Adolescents will receive electronic gift cards for participating in the study.
How is this program funded?
A grant from the National Institute on Drug Abuse (NIDA) will provide funding for this study. It is a multi-center study conducted at Boston Children’s Hospital. A total of 5 hospitals will participate nationwide. Dr. Sharon Levy and Dr. Joseph Cravero are the Co-Lead Investigators.
Participation
What will be expected of me if I participate in the APEX study?
Potentially eligible patients and families will be contacted by study staff. They will receive information about the study and, if interested, complete an anonymous eligibility screener. If eligible, adolescents and caregivers will complete a consent and assent session with a staff member to officially enroll in the study. Once enrolled, the adolescent and a parent/caregiver will be asked to complete surveys before the surgery, and then 4 weeks, 3 months, 6 months, and about one year after surgery. Each of these surveys takes 10-20 minutes. We will also ask adolescents 2-3 daily brief questions about pain and medication use for the first 10 days after surgery.
We will also gather details about the surgery, how the adolescent felt after the surgery, and if they had to go back to the hospital within 1 year after surgery from the adolescent’s electronic medical record (EMR).
What’s the total time commitment?
The first steps to participate in this study is an informational call, eligibility screen, and assent and consent session. This will take 20-30 minutes.
If participants decide to enroll in the study, they will participate for up to 14 months, completing electronic surveys at various timepoints. We anticipate the first and last surveys will take about 20 minutes while the others will take about 10 minutes. For the first ten days after surgery, adolescents will be asked to answer two or three brief questions each day, which will take about two minutes. The estimated total time to complete surveys is seventy minutes over 14 months.
I’m traveling to another hospital for my surgery. Can I still participate?
Adolescents who are undergoing eligible surgery at a participating hospital are potentially eligible for this study. Even if this hospital is not the family’s regular hospital and they are traveling to receive the surgery, they can participate in the study.
Do I need a computer?
Most participants will complete the electronic surveys on a computer or smartphone. If your family does not have access to this technology, each survey can be completed during a phone call with a study staff member. The informed consent and assent process can be completed over the phone, video call, or in-person. If technology poses a challenge for participating in this study, families are encouraged to let the study staff know.
Will my health information be secure? How will you ensure privacy?
The information we collect for this study may include personal information, such as name, address, birth date, and information from the adolescent’s medical record. Participants’ health information is protected by a law called the Health Information Portability and Accountability act (HIPAA). In general, anyone who is involved in this research, including those funding and regulating the study, may see the data, including information about you. The results of this research may be published in a medical book or journal or be used for teaching purposes. However, only aggregate data will be published no names or identifying information will be used without specific permission from the participants.
Will my doctor see my answers?
Adolescents’ physicians will not see their survey answers. If during participation in this research there is reason to believe that the adolescent is at risk of hurting themselves or others, the research team is required by law and Boston Children’s Hospital policy to act on this suspicion. This may include notifying physicians at the hospital. In these cases, confidentiality may not be ensured.
Who can I contact if I have more questions?
Visit the contact us page to find the contact information about your site. For general information about this research, contact the Boston Children’s Hospital APEX team.