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Judy Martin, MD, demonstrates how to initiate the recruitment process with a parent in an unbiased way that respects the parent’s decision-making process.
When watching this video, note the six important points below, which are covered at the time intervals noted.
For an even greater understanding on what goes on in the recruitment call, a complete script follows with notations in blue how the research team member should present the information to the parent.
It’s important to identify yourself and where you are calling from to provide context. Assess the readiness and availability of the person called to listen.
Judy Martin, MD: Hi, I am Dr. Judy Martin, I am calling from the UTI Center of Children’s Hospital. I would like to speak with one of Sarah’s parents if they are available.
Parent: This is Sarah’s mom, Vicki.
Martin: Hello Vicki, this is Dr. Martin, is now a good time to talk?
Parent: Yes, I have a few minutes.
Mentioning that you talked to the child’s doctor will also make them feel comfortable. Let them know their usual clinician is aware and gave permission for the researcher to contact the family. Show interest in child’s health but do not over empathize – stay focused on purpose of call.
Martin: Great! I am a physician and researcher from the UTI Center at Children’s Hospital and I am calling because Sarah was recently seen in the Emergency Department for a urinary tract infection. I spoke with Sarah’s doctor, Dr. Smith, who asked me to contact you. I am calling to follow up on how she is doing. How is she doing?
Parent: She’s doing much better now, thank you.
Martin: Has she had a urinary tract infection before?
Parent: Yes, this was her third time in the ER for this.
Martin: I am sorry to hear that.
Assess and enhance parent understanding of general aspects of the child’s condition cause, management, prevention, offer resources if appropriate.
Start with a conversation about the child’s medical condition. Take your time and answer their questions. Foreshadow discussion about research studies. After this part of the discussion, then begin conversation about the study.
Martin: As part of what we do with the UTI – or Urinary Tract Infection Center – at CHP is to help families find possible reasons why their child got a urinary tract infection and see if there are ways to try to prevent another one. We also have a number of UTI research studies that you may be interested in participating in with your child.
Establish what the family already knows about the condition so that you have a starting point to begin the discussion.
Martin: First, let’s talk a little bit about her urinary tract infections. What do you know about urinary tract infections?
Parent: Dr. Smith told us that it might be because she is constipated all the time.
Provide information regarding the underlying medical problem.
Martin: Yes, that is certainly one of the reasons that children get urinary tract infections. It is clear that these two things often go together. It is very easy for bacteria to get into the bladder in girls. It is the fact that we constantly drink and constantly urinate that helps to flush out any bacteria that get into the bladder. It is when children don’t pee as frequently or don’t completely empty their bladders when they pee that some bacteria remain in the bladder and they are more likely to get a urinary tract infection.
Sometimes we see UTIs after a child has an illness like a stomach virus when they are drinking and peeing less than normal. Sometimes we see UTIs in children who have problems with constipation. They may not be completely emptying their bladders when they pee. Often children do not take the time to completely empty their bladders. They are in a hurry to get back to playing and leave some urine in their bladders. Does this sound like what might be happening with Sarah?
Parent: Yes, she won’t use the bathroom at school and she is always constipated. We have tried getting her to drink more water but it does not seem to be helping.
You are not the clinician so avoid giving specific clinical advice. In this case, the researcher indicates that the UTI Center can be a resource.
Martin: This is a very common problem and we [the UTI Center] have some suggestions that might help improve this and hopefully then she will have fewer urinary tract infections.
Parent: Thank you. That would be great.
Martin: Have I answered all of your questions about things that you can do to try to help?
Pause, check to assure they are listening and to assess if they have questions.
Parent: Yes, thank you so much for your advice.
Transition from discussion about medical issue, standard care and treatment to a conversation about the research study.
Make certain to use the term “research study” and not “study” alone. Ask for permission to transition to research study discussion.
Martin: Now, can I talk to you now about one of our UTI research studies?
Parent: Yes, I would like to hear more.
Describe why we are doing the study, what we know and what we don’t know. Describe any risks or benefits of participation. Share what previous research studies tell us and what we still need to learn.
Martin: What we know about urinary tract infections in young children is that the antibiotic medicine is used to treat the infection and help children to feel better quickly. We also know that antibiotic medicines can also give children side effects such as diarrhea and rashes. We are worried about overusing antibiotics because of these side effects and because we know that if we use them too much, the germs or bacteria can become resistant to those medicines and they won’t be able to kill the bacteria and then the medicine will no longer work. Right now, what we usually do is ask that Sarah and other children with urinary tract infections take their medicine for 10 days.
There have been research studies done in adult women that show that they only need one to three days of antibiotics to treat their infections. However, these studies have not been done to prove that a fewer days of antibiotic treatment is OK in children like Sarah. Most children are better after several days of medication, but we don’t know if five days is enough or if 10 days is what the children really need.
Clearly state the purpose of the research study. Use everyday language whenever possible.
Martin: The purpose of this research study is to see if fewer days of antibiotic medicine may be enough to treat the infection and to see if there are fewer side effects and less bacterial resistance in the children taking less medicine.
We are not testing any new medications, just the same antibiotics that your child is already taking. We are just comparing five days of medicine with 10 days of medicine. We have been working with Dr. Smith for several years and I talked with him and he is OK with Sarah participating in this study.
Pause to check in with the parent.
Martin: Does this sound like something that you and Sarah might be interested in?
Parent: Yes, I am interested, but what would it mean for me and my child?
Describe the research study procedures. Anticipate, listen for and respond to parental concerns. Discuss key points. Always make it clear that the study is voluntary and that confidentiality is protected.
Martin: This study is voluntary. You do not have to participate. Your information will be kept confidential. If you are interested in the study then Sarah would take five days of the antibiotic that she is already taking. If she is still sick after five days, then she will just take the rest of her bottle of medicine and not be in the study. But if she is completely 100 percent back to normal after five days of medicine then she will be placed into one of two groups. Sarah would either continue to get the same antibiotic the doctor gave her for the next five days, or she would take a placebo or a suspension that looks like her medicine, for the next five days.
Define or explain terms like randomization and placebo.
Martin: This placebo looks and tastes like the antibiotic but does not have any medicine in it. We will not know which group she is in. It will be random, like flipping a coin which group she will be in. Later, we can see if there are any differences in the children who received 10 days of medicine and the children who received five days of medicine.
Pause to check in again.
Martin: Do you have any questions about that part?
Parent: Will I know which group she is in?
Martin: No, the doctors and the study staff will not know which group Sarah is in and you won’t know which group either. We call this being “blinded.” After the study is all over and we start to look at the results, then we will learn who is in which group.
Parent: OK, what else do I need to know?
Explain the time commitment and expectations of the research study.
Martin: There are a total of three research study visits; you and Sarah would have to be seen by the research study staff three times. The first visit will be when she finishes five days of her medicine. We want to make sure that Sarah is perfectly well and has no problems before making any changes in her medicine. If she is well, then we will give you a bottle to take for the next five days. Then the second visit will be when she finishes the study product. This time, we will test her urine (we will ask her to pee into a cup) to make sure that the infection is gone and to make sure that she is still doing well. Then, there is a third and final visit one month after the emergency room visit to again make sure that she is well.
Emphasize that her daughter’s safety and medical care come first before the research. Emphasize availability of study investigators if there are any questions or problems.
Martin: For all of this time, we will pay close attention to how she is doing, to make sure that she is OK and safe. You and her doctor can call us with any questions any time of the day or night. Does that make sense?
Parent: Who would I call if I have a question later?
Martin: You can call the study staff at 412-692-UTIS. We will work with you and pay careful attention to make sure that she is doing OK and we will address any problems. We will be available by phone, 24 hours a day. If you are worried or have any questions at all, you can just call us. Are you interested in participating?
Parent: I would like to talk to my daughter when she gets home from school and get back to you.
Provide time for the family to consider the study and get back to you with questions and with an answer regarding potential participation. Offer or indicate that you will call back and check in after they have had time to think about this.
Martin: Perfect! Thank you for your time. Please call me, Dr. Martin, if you have any additional questions. You can also find more information about this study on our website.
Return to “Recruitment”
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