CHOP Pediatric Critical Care Medicine 2015 Obtaining Informed Consent
CASE SUMMARY
Author(s): Christine Bailey, Vinay Nadkarni, Vijay Srinivasan, Martha Sisko, Denise LaMarra Case focus: Obtaining Informed Consent and Addressing Parent’s Concerns
1. Major purpose of case: The purpose of this case is for the Pediatric Intensive Care Research Coordinators (“participants” in this simulation exercise) to approach the parent and obtain consent for the HALF-PINT study and address the parent’s concerns in a professional and supportive manner. In the first scenario, the participant will approach the parent and introduce the research study. In the subsequent scenarios, the participant will address specific concerns expressed by the parent.
2. Each session will begin with the participant practicing approaching parent for consent. The parent will be crying and too stressed to be able to consider participating (First encounter). This conversation will last for approximately 5 -10 minutes depending on Participant comfort and/or need for time-outs, and then the Simulation will pause; next the Facilitator will debrief with the participants on how the approach went. The scenario may be replayed with a more successful outcome, or another scenario will play out, at the discretion of the Facilitator. Feedback will be given by the SP and other facilitators after each “pause”.
The simulation will resume with 1 of the following scenarios below playing out:
a. Parent will raise concerns about the risks (worried/concerned parent, question of medical literacy) (Second encounter).
b. Parent will insist his/her child be randomized to one control group vs. the other (parent is knowledgeable and adamant; however with appropriate explanation will change mind and agree) (Third encounter).
c. Parent will be concerned that the computer is making decisions for her daughter and that it is too much of a burden for the nurses (Fourth encounter).
You are Michelle Waverly, a 35-year-old accountant, waiting to hear an update from the doctor about your daughter, Maxine’s, condition.
Your child is a 12-month-old previously healthy female infant who you found unresponsive at home. She required 3 minutes of CPR. Maxine was taken via ambulance to CHOP and admitted to the PICU. Maxine is intubated on a ventilator, has an arterial line, a central line, and is receiving continuous medication infusions to support her blood pressure and perfusion. You have been in the PICU for approximately 10 hours.
You are tired and overwhelmed with your child’s diagnosis. You have a basic understanding of how sick your child is and what all the IV’s, monitors, ventilator, and medications are. Your main concern is your child’s recovery and wanting the best outcome possible for your child. You have heard about research studies before.
Definitions:
Intubated = the insertion of a tube in mouth or nose to deliver oxygen directly into the airway
Cardiovascular Failure=heart failure, low blood pressure, requiring medications to improve heart rate and blood pressure
Respiratory Failure= child has a breathing tube and a ventilator Hyperglycemia= high blood sugar
Intubated Baby
Dress: Wear comfortable clothes such as sweat pants/sweatshirt or jeans.
Affect:
When the Research Coordinator enters the room you are sitting by your baby’s bed. You want to work with the team to get the best care for your daughter.
You are worried. So much has happened in the past 24 hours.
You are exhausted.
You are not familiar with medical terminology. But when information is explained clearly to you, you understand.
Your reaction: You are unsure if you would like to participate in the research study and need to feel that the Coordinator is acknowledging your concerns and establishing a therapeutic, professional relationship with you.
TIMELINE OF EVENTS
48 hours ago Maxine, a happy and healthy 12 month old
child, had a cold, with fever, and runny nose.
You had called the pediatrician’s office, and they told you to treat the fever with baby Tylenol. The fever went as high as 101 °F but the Tylenol seemed to be working – it went down to 100 °F and was fluctuating between 99 °F and 100 °F yesterday.
24 hours ago You put Maxine to bed. She still was
congested and hadn’t been eating well
16 hours ago When you checked on Maxine you could not
arouse her. She was unconscious and barely breathing. You called 911. EMS arrived and started CPR. After 3 minutes of CPR,
Maxine had a pulse but was still unconscious. She was transported via ambulance to CHOP and admitted to the PICU. You rode in the ambulance with her and your husband drove separately.
10 hours ago You arrived in the PICU. The doctors and
nurses have been very supportive and explained the care your child is receiving.
NOW You have just spoken with the healthcare
team and are processing all of the
information, when the Research Coordinator arrives at the bedside.
If asked about your current understanding of Maxine’s condition, you understand that that she is really sick and just survived CPR. You understand that she will be in the ICU for at least a week. She needs a breathing tube and ventilator to support her lungs. She needs medications to support her blood pressure.
Past Medical History and Prognosis:
This has been a shocking nightmare—Maxine has not had any problems ever. She is the most vibrant, happy, and healthy baby. This unfolded so quickly. The past 24 hours have been a roller coaster. You get news that sounds devastating (a breathing tube!?) and then the next report sounds promising (“her heart rate is great”). It’s been one step up, two steps back, then one step back, two steps forward. At the start of the encounter, you are on edge. You eagerly await any information from anyone who walks into the room. Will this be good news or bad news?
Social / Lifestyle Information:
You are an accountant for a CPA firm. Your spouse is a project manager at the same firm (different department). He went downstairs to make some calls to work and family to give them an update.
You have been married for 5 years. This is your first child and only child. You enjoy your life together.
Maxine is absolutely the love of your lives. You are close with your extended families and friends.
The participant who will be speaking to you today is a Research Coordinator working at the hospital.
The Coordinator is not part of your child’s healthcare team. This Coordinator is part of the Research Team and is trying to enroll your child in a research study about glucose control.
SP Instructions on Reacting to Approaching for Consent:
You begin the first encounter interested and concerned. You think this Coordinator might be here to give you an update on your daughter’s condition.
Opening Line: “Is everything alright?”
Maintain good eye contact but look away frequently at your child. Listen carefully to what you are being told. Be careful not to anticipate what you are going to hear.
You express the following: you are too overwhelmed with everything that is going on right now to consider participating in a research study. She’s just too sick. (sobbing, stressed parent) There is so much going on right now; you just don’t want to add something that will makes things even more complicated.
If the Coordinator does not approach you and discuss the purpose of the study appropriately, act disinterested and worried.
If the Coordinator demonstrates supportive and professional behaviors, act interested and agree to hear more information.
Second Encounter:
You are unsure what caused your child to have hyperglycemia. You are unsure how being on an insulin infusion will affect your child long term. You are worried about long term risks. You are skeptical.
Opening Line: “I’m afraid this is going to give her diabetes.”
The Coordinator should assess your understanding of insulin and clarify what is concerning to you - you are worried about long term consequences.
Some supportive behaviors may include:
Provide pen and paper
Provide fast FAQs handout/abbreviated “need to know” information
“Show and Tell”- demo the equipment/supplies
Stop and Ask if parent has questions- tell them it is ok if they have questions
Repeat information
Other suggestions to improve comprehension: medical literacy assessment, have parent repeat their understanding
Allow parent time to independently review consent form
Encounter Three:
Insist that your child be randomized to one control group vs. the other. You are adamant that your child must be in the lower glucose control group. You are knowledgeable and adamant; however with appropriate explanation of why you cannot choose which arm of the study you are randomized to, you will change your mind and agree.
Opening Line: “I might be okay with this but she would have to be in the low blood sugar group.”
Another concern: If she is in the “high” group, will the research team drive her blood sugar up to 150- 180 artificially?
An appropriate Coordinator response may be: That is a common request, unfortunately that is not possible in this study. To participate in the study, we have to “randomize” (allow chance, like the flip of a coin) to determine which arm your child is in, otherwise we might influence the results of the study. In fact, your doctors and nurses do not even know which arm of the study is better, which is why we are doing the study in the first place. The two ranges of blood sugars, 80-110 mg/dL and 150-180 mg/dL, are within our usual standard of care. Either way your child will receive the best and safest care. …I want to be sure you have all the
information you need while you make this decision… It sounds like you are worried about the study…Can you tell me what you are concerned about? ...and why you think one arm of the study is better for your child?
Suggestions to decrease parent distraction and feeling of being overwhelmed:
Acknowledging parent’s state of mind and the gravity of the situation.
Demonstrating empathy and concern.
Suggest having nurse join the discussion to reassure parents of the workload
Timing of Communications
Check with healthcare team to verify when is a good time to approach the family
Check with the family - allow them control/choices for the best time
Location
Invite parent to move to a consult room where there are less distractions - offer them the opportunity to remain at the bedside or relocate
Encounter Four:
You are not comfortable with the idea that a computer will be adjusting the insulin levels of your child.
It is very important to you that the medical team oversee Maxine’s care and that the team – and not a computer - makes all of the important medical decisions.
Opening Line: “Are you telling me the computer is making the decisions and not the doctor?”
You are worried that over-reliance on a computer would mean that no one would be paying attention to your child’s blood glucose levels. What if the computer makes a mistake or was programmed wrong, would anybody notice? I overheard some nurses talking about how the computer adds to her
workload" "I don't want my daughter to be perceived as a problem..."
You may be told that the insulin level is monitored via computer for the blood sugar management - and titrating/adjusting the insulin. You are not familiar with the word “titrate /titrating” and if you hear this you will frown and shake your head. If the Coordinator checks your understanding or asks if you have concerns, ask for clarification of this word.
If the Coordinator uses the word “algorithm” to explain how the glucose level is monitored you will become flustered. You have heard the word before and have a general idea what it means but you don’t understand it in this context at all.
In general with jargon: If jargon is used and then explained in a way that is clear and simple for you, you will be appreciative and indicate that you do understand. If it is not explained, or explained in a way that sounds complicated you will look worried and become less and less engaged in the
conversation.
Your responses will depend on the Coordinator’s approach. You will essentially reward Coordinators who handle the situation well by remaining engaged in the conversation
In general, for all parts, some positive behaviors on the student’s part might include:
Referring to Maxine by her name
Giving you time to absorb and to speak (looking at you, not rushing to fill any silence.)
Showing empathy (e.g., “I am so sorry that this happened to Maxine; I can only imagine how you must be feeling right now.”)
Compassionate listening (nodding, allowing you to speak, maintaining warm eye contact)
Remaining patient, allowing you to interrupt; answering the questions that you interjected.
Offering some kind of help - to get you more information, make calls for you, set up a time for the two of you to meet with the resident (if you have made that request).
If a Coordinator demonstrates consistently negative behaviors, you will tell them you are still not sure about participating, and remain focused on the concern you started with.
In general, for all parts: Some negative behaviors that would make you remain overwhelmed or unsure of participating
Patronizing you or talking down to you (“There are medical reasons behind what we had to do, which you wouldn’t understand.”)
Blaming the patient
Minimizing your concerns
Using jargon
Re-directing the discussion/changing the subject
Becoming aggressive/coercive
Being indifferent/going through the motions/ looking at watch.
