Emergency Medicine

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Community Consultation Information

Community consultation involves the identification of a surrogate community that represents the population from which potential research candidates would be drawn. This community must be actively informed of the research activity and understand the nature of the research project, its goals and objectives and the protocols involved. The community must have the opportunity to ask questions and raise concerns about the project itself. Hospital style ID bracelets will be made available to persons who do not want to be enrolled in the study, but would rather opt-out.  Prehospital personnel will be trained to check for these bracelets prior to enrolling any patients.

Community Consultation was successfully done in June 2012 using a proportionate population survey of the medical treatment area through a random, structured telephone survey to elicit feedback in. The results of the survey showed overwhelming support for the study.

For those who want an opt-out study bracelet, please call 414-805-6493.

Medical College of Wisconsin / Froedtert Hospital

Resuscitation Outcomes Consortium (ROC)

Cardiac Community Consultation Survey

Random Digit Dialing

 

Hello, my name is ________________________.  I am calling on behalf of the Medical College of Wisconsin/Froedtert Hospital about a medical research study that may be conducted in your community. 

 

[IF SPEAKING TO A CHILD] May I speak to someone in your household who is at least 18 years of age?  Thank you.

This call does not involve sales or fundraising of any kind.

 

The Medical College of Wisconsin/Froedtert Hospital and several other universities across the United States and Canada are planning on conducting two medical research studies in your community that may affect you or someone you know.  We need to find out ahead of time what residents think about these studies which are trying to find better ways to keep victims of cardiac arrest alive. 

 

I would like to tell you a little bit about this research and ask you a few questions about it. Would that be okay?

 

A cardiac arrest is a life-threatening medical emergency where the heart stops beating.  Individuals experiencing a cardiac arrest lose blood flow to the brain and become unconscious.  Without treatments such as cardiopulmonary resuscitation(or CPR) and an electric shock to restore the heartbeat, death can occur in 4-6 minutes. CPR consists of pushing on the chest with the heel of the hands to help the blood move, and helping a person breathe. It is estimated that more than 95% of cardiac arrest victims die before reaching a hospital.  Because survival is so poor, doctors are trying to find better treatments to save more lives.  The two studies I will be describing to you are part of this effort to find better treatments..

Study 1

In the first research study, patients who experience a cardiac arrest will first receive the standard treatment from emergency staff.  This includes CPR and an electric shock to restart the heart. Each of these patients will be randomly assigned to one of three groups (like a flip of a coin).  Patients in the first group will receive a heart medication called amiodarone. Patients in the second group will receive a different medication called lidocaine.  Both of these medications are approved for use by the United States Food and Drug Administration and are regularly prescribed by physicians throughout the United States , but neither has ever been proven to save lives from cardiac arrest.  In order to determine if either of these medications is helpful, patients in the third group of patients will receive neither medication, that is, what is called a placebo (an inactive water solution). Thus, these patients will not get either medication. By making such comparisons, it is hoped we will be able to determine whether such drugs are useful at all for saving lives after cardiac arrest, and if so, which of the two may be better.  “Better” in this study means increasing the chances of a person surviving cardiac arrest and being discharged alive from the hospital. Treatment is otherwise unchanged.  That is, all patients will either receive the standard of care or the standard of care plus the study intervention. 

 

For patients to participate in a medical study, researchers usually must receive patients’ consent before enrolling them.  In the case of cardiac arrest, however, it is not possible for patients to give consent because they are unconscious or otherwise unable to communicate.  Also, family members may not be available to speak for them.  Even if they were, treatment of cardiac arrest must begin without delay because such patients have no pulse and will die within a few short minutes so it would not be possible to get consent from them. Therefore, this study must be conducted without first receiving the patient’s consent or the consent of a family member.  Once patients regain consciousness, researchers will describe the research to them, and provide an opportunity for them to withdraw from any further involvement with it if they wish.

 

The United States Food and Drug Administration permits research studies without consent to take place under certain conditions.  First, patients must have a high risk of dying without treatment.  Second, patients or family members must be unable to give consent because of the severity of the illness or the circumstances do not afford time to obtain such consent before treatment must be started.  Finally, available treatments must be  unsatisfactory and the research treatments must offer hope of benefit to the patient. This study meets these conditions.  In addition, a research ethics boards also monitor and review the study in depth before and during its conduct in order to keep it as safe as possible.  Part of the ethics board review is to receive input from community members like you to see how you feel about the study.  The board will use your feedback to help determine whether the study will be done.

 

The medications being tested in this study are regularly prescribed by doctors, but they have not been proven to save lives from cardiac arrest.  This is why it is so important to compare their use against not using them in cardiac arrest.  As with any treatment, there is always a risk of unexpected side effects.  While the doctors conducting this research believe the medications may help improve survival from cardiac arrest, it is equally possible that this is not the case.  The only way to save future lives is to make such a determination. 

 

Now I would like to ask you a few questions about this study.

1.  Based on the information I just read to you, do you understand what this study is about?

            1.  Yes  [SKIP TO Q3]

            2.  No

            3.  Refused/Don’t know

 

Cardiac arrest is a life threatening emergency in which approximately 95% of patients die before reaching a hospital.  Doctors are trying to find new ways to keep people alive long enough to reach the hospital where they can receive appropriate care.  When a patient has a cardiac arrest, emergency medical staff will arrive on the scene and administer CPR and an electric shock to the heart to restore the heartbeat.  If the patient is unconscious and no family members are present, the patient will be enrolled in the study even though the patient is not able to provide consent. Because none of the medicines in this study have been shown to save lives in cardiac arrest, the patient will be given one of three possible treatments.  The patient will receive one of two heart medications currently prescribed by doctors across the United States or neither, that is a placebo, (an inactive water solution). Patients who get the placebo will not get either of the other medications. Later, when the patient is conscious, the physicians conducting the study will describe the research and provide an opportunity for them to withdraw from any further involvement with it if they wish.

 

2. Based on this information, do you understand what this study is about?

            1.  Yes

            2.  No 

            3.  Refused/Don’t know

 

3. Let’s say you were going to the grocery store and had a cardiac arrest and are unconscious.  No family members are with you.  Emergency medical staff arrive within a few minutes and administer the standard treatment which includes CPR and an electric shock to restart your heart.  You also are enrolled in this study and receive one of the three study solutions.  Is it acceptable to you to be enrolled on this study even though you could not provide consent?

            1. Yes  [SKIP TO Q5]

            2. No

            3. Refused/Don’t know

 

4.  What is the reason for your concern? 

1. Fear about possible side effects

2. Research should never be done without consent

3. Other

4. Refused/Don’t know

 

GO TO Q6

 

5. Why do you think it is acceptable to be enrolled in the study? 

 

6. Are you in favor of or opposed to the researchers carrying out this study in your community?

            1.  Yes

            2.  No

            3.  Not sure, Uncertain

            4.  Refused/Don’t know

 

Study 2

The doctors will also be conducting a different research study with a different group of cardiac arrest patients.  The patients in this second study will also be unconscious.  They may also be enrolled in this study without providing consent or without consent from a family member.  Here is what this second study is about.

 

Emergency medical staff usually treat cardiac arrest patients using CPR and giving an electric shock to restart the patient’s heart.  As you may know, CPR involves pushing on the patient’s chest with the heel of the hands to circulate blood throughout the body.  After pushing the chest down 30 times, the rescuer stops and blows air into the patient’s mouth to deliver oxygen to the patient’s lungs. 

 

Researchers know that when chest compressions are stopped so rescuers can blow air into the patient’s mouth, the blood stops circulating in the body.  This is the current practice for attempting to resuscitate someone with cardiac arrest.  In this study, CPR will be provided in two different ways.  One group will receive the current practice of providing 30 compressions, then stopping compressions and providing two breaths, and then re-starting compressions.  The second group will receive continuous chest compressions without interruption.  Breaths will be provided by squeezing a rescue bag attached to a mask placed  over the patient’s mouth during continuous chest compressions.  Treatment is otherwise unchanged.  That is, during the first 6 minutes of rescue effort, one group of patients will receive standard CPR where chest compressions are stopped to deliver breaths and the other group will receive continuous chest compressions where breaths are delivered by squeezing a rescue bag placed over the patient’s mouth without stopping chest compressions.. The purpose of this research study is to determine if giving continuous compressions during the first six minutes of CPR will help more patients survive cardiac arrest and be discharged alive from the hospital. 

 

7.  Based on the information I just read to you, do you understand what this study is about?

            1.  Yes  [SKIP TO Q9]

            2.  No

            3.  Refused/Don’t know

 

 

When a person has a cardiac arrest, CPR and an electric shock to the heart must be given to keep them alive.  CPR forces blood to circulate throughout the body.  Normally, emergency personnel stop pushing down on the chest in order to blow air into the patient’s mouth and lungs to give them oxygen.  In this study, one group will receive the current practice of providing 30 compressions, then stopping compressions and providing two breaths, and then re-starting compressions.  The second group will receive continuous chest compressions without interruption.  Air will be provided by squeezing a rescue bag placed over the patient’s mouth without stopping chest compressions. The purpose of the study is to see if continuous chest compressions for the first 6 minutes of CPR will help more people stay alive.

 

8. Based on this information, do you understand what this study is about?

            1.  Yes

            2.  No

            3.  Refused/Don’t know

  

 

9. Let’s say you had a cardiac arrest and are unconscious, and you are admitted to this second study without providing your consent.  You receive CPR and electric shock to restart your heart. The CPR you receive is the new approach being tested which is continuous chest compressions with oxygen being provided by squeezing a rescue bag placed over the mouth without stopping chest compressions for the first six minutes. Is it acceptable to you to be enrolled this study even though you could not provide consent?

            1. Yes  [SKIP TO Q11]

            2. No

            3. Refused/Don’t know

 

10.  What is the reason for your concern?

1. Fear about possible side effects

2. Research should never be done without consent

3. Other

4. Refused/Don’t know

 

GO TO Q12

 

11. Why do you think it is acceptable to be enrolled in the study? 

 

12.  Are you in favor of or opposed to the researchers carrying out this study in your community?

            1.  Yes

            2.  No

            3.  Not sure

            4.  Refused

 

13. If a member of your immediate family suffered a cardiac arrest and was unable to communicate, would you be willing to give consent for this individual to be enrolled in this study? 

1. Yes

2. No

3. Refused/Don’t know

4. Other

 

IF Q13 = 4 SKIP TO Q15

 

14. What is the reason for your answer? 

 

15. Do you have any additional comments for the researchers regarding either of these studies? 

 

DEMOGRAPHIC CHARACTERISTICS

 

The following questions will help us make sure that we have a representative sampling of your community’s opinions. Your answers will be kept anonymous.

 

16. What is your age?

 

17. Are you Hispanic or Latino?

            1.  Yes

            2.  No

            3.  Not Sure/Don’t Know

            4.  Refused

 

18. What is your race?

1. White

2. Black or African American

3. Alaskan Native or American Indian

4. Asian

5. Native Hawaiian or other Pacific Islander

6. Some other race

7 Not Sure/Don’t Know

8. Refused

 

19. What is the highest level of education you have completed?

1.  Less than 9th grade

2.  9th to 12th grade, no diploma

3.  High school graduate (including equivalency)

4.  Some college credit up to one or more years of college, no degree

5.  Associate, Technical or Vocational degree (2-year)

6.  Bachelor's degree

7.  Graduate or professional degree

8.  Refused/Don’t Know

 

If you would like more information regarding the study, I can give you the name and toll free phone number of the Study Coordinator or the study’s website address.  Would you like any of this information?

Study Coordinator:  Joe Brandt

Phone number:  414-805-6493

Website:   www.mcw.edu/rocccc

 

THAT CONCLUDES OUR SURVEY.  THANK YOU VERY MUCH FOR YOUR TIME AND COOPERATION.

 

POSTCODE GENDER:

1. MALE                                                         

2. FEMALE

 

 

 

 

 

 

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Page Updated 03/11/2014