Download evaluation consent for heart transplant

Heart Transplant Program
EVALUATION CONSENT FOR HEART TRANSPLANT
CONSENT FORM
The following information is provided in order to help inform you of the heart transplant evaluation procedure
including the purpose, treatment course, and potential risks and benefits. If you have any questions, please do
not hesitate to ask. You are ready to be evaluated to see if you are a candidate for heart transplantation. In order
to decide whether or not you should agree to this treatment plan, you should understand enough about its risks
and benefits to make an informed judgment. This consent form gives detailed information about the evaluation,
some of which the transplant team has already discussed with you or will be discussed during your evaluation.
Please be aware that you have the right to review with your transplant team any part of this consent that you do
not understand. Once you have read this consent and have had all your questions answered, you will be asked
to sign this form at the time of the evaluation if you wish to proceed. You will be given a signed copy of this
consent form for your records.
PURPOSE
Because you have been diagnosed as having end stage cardiac disease, a heart transplant evaluation has been
recommended to see if heart transplantation is the best treatment option for you. The purpose of heart
transplantation is to restore a meaningful quality of life to you, as well as extend your life.
SELECTION CRITERIA
Inclusion criteria include:
 End-stage cardiac disease defined by New York Heart Association Class III/IV with limited expected survival
of less than 1 year.
 Age generally less than age 65.
 Absence of systemic disease or infection.
 Psychosocial stability and supportive family/social structure as defined by social assessments.
 No expectation of improvement with alternative medical or surgical treatment.
Exclusion criteria include:
 Sepsis or active infection
 Irreversible renal or hepatic dysfunction – consider dual organ transplant for renal failure.
 History of chronic noncompliance
 Recent pulmonary infarction – delay activation
 Extensive peripheral vascular disease
 Evidence of end organ damage due to diabetes (retinopathy, nephropathy, neuropathy).
 Severe Chronic Obstructive Pulmonary Disease
 Active mental illness or psychosocial instability
 Evidence of drug, tobacco or alcohol abuse currently or within the past six months.
 Obesity (>150% IBW or BMI > 42)
 Severe pulmonary hypertension as evidenced by a fixed pulmonary vascular resistance of greater than 4
Wood units.
 Malignancy – varies by type and date of diagnosis
Patient Initials
Patient Label:
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.MDP.05.103 (Rev. 04/19/10)
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Heart Transplant Program
EVALUATION CONSENT FOR HEART TRANSPLANT
EVALUATION
The evaluation consists of a series of examinations and tests conducted to determine that you are otherwise
healthy and free of other serious problems which would limit the success of a transplant. Part of this evaluation
includes assessing your personal support system and your previous medical compliance, as well as providing you
information about your financial obligations.
The evaluation may reveal certain conditions which need to be corrected before transplant surgery. It could also
reveal certain conditions which would make the transplant surgery a poor choice. We understand that you will be
undergoing many unpleasant and frustrating tests. We understand that, but will be concerned if you show a lack
of cooperation or lack of commitment to the process. We are looking for you to be willing to take an active role in
your health care. This will play a major role in recovery after surgery.
Most evaluations are done while you are in the hospital, although part may require you to see some physicians or
have some tests after you have been discharged. During the evaluation, you will see many different people who
function as part of the heart transplant team.
The transplant nurse coordinator will provide you and your family with a patient education manual with information
about heart transplantation and the evaluation process. Along with the physicians, she will keep you informed
about the results of the tests and procedures.
The transplant cardiologist will oversee your care. This doctor may be different from the cardiologist who is taking
care of you during your stay. The transplant cardiologist has special knowledge, training, and interest in heart
transplantation.
The transplant surgeon is the doctor who will perform the operation. We have several surgeons who perform
heart transplants and you will meet one of them during this evaluation.
The transplant social worker will assist you in your social and financial concerns of living with a new heart. She
will talk with you and your family about home health needs, family support, insurance concerns, and financial
obligations and needs.
The psychiatrist, psychologist, or psychiatric nurse practitioner will talk with you about any emotional or
psychological concerns that you may have now or have had in the past and potential stresses that you may incur
related to the evaluation and possible transplant. Psychological concerns about the waiting period, operation and
follow up care may be discussed at this time.
The pulmonologist, or lung doctor, will examine your lungs to ensure that they are healthy, since healthy lungs are
required for a new heart to function.
One of the infectious diseases physicians will visit you. This doctor will talk with you about your childhood and
adult diseases, any serious infections that you may have had, travel, pets, and your environment.
You will need to see the oral surgeon or your dentist. Oral hygiene is important since infections in the teeth and
gums can travel to the heart. If you have dental problems which cannot be repaired, the dentist or oral surgeon
may recommend that all of your teeth be pulled. This would need to be done before transplantation.
Patient Initials
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EVALUATION CONSENT FOR HEART TRANSPLANT
An up to date Pap smear and mammogram are necessary for our female patients. If these have recently been
done, you may have the reports sent to us. If not, we can arrange to have them done here.
Our male patients need to have a recent PSA (prostate screening test) and a recent prostate exam. If these have
been recently done, you may have the reports sent to us. If not, we can arrange to have them done here.
Depending upon your previous medical history, there are other physicians you may need to see. Some of the
possibilities are listed below:
 The endocrinologist specializes in the care of diabetic patients. If you are diabetic, you will see the
endocrinologist.
 If you are diabetic, you will also see an ophthalmologist (eye doctor) who will examine your eyes for symptoms
of advanced diabetes.
 If you are diabetic, or have had previous kidney problems, you may be seen by the nephrologist (kidney
specialist).
 If you have had ulcers, stomach, or bowel problems, or are over the age of 50, you will be examined by the
gastroenterologist, who is a specialist in the care of esophagus, stomach, and intestinal problems.
 The neurologist specializes in diseases of the brain. If you have had seizures, stroke, or difficulties involving
the brain, you may see this doctor.
EVALUATION TESTS AND PROCEDURES
Many tubes of blood will be drawn at the time of the evaluation. These include testing for blood type, tissue type,
hepatitis, kidney function, liver function, syphilis, and chickenpox.
You may have a drug or tobacco screen done.
You will also have an HIV or AIDS blood test.
 AIDS, or Acquired Immune Deficiency Syndrome, is a disease that causes the body to lose its natural immunity to
certain infections.
 AIDS is caused by the HIV virus. The HIV virus can be transmitted from person to person through sexual contact,
exposure to or sharing of contaminated intravenous needles and through exposure to infected blood or its
components. Certain behaviors, including sharing drug needles, practicing unprotected sex (without a condom) or
any exchange of infected blood, semen or vaginal fluids, increases a person’s risk of acquiring HIV.
 When infected by a virus, the body produces substances called antibodies to fight off the infection. The blood test
shows if you have antibodies to HIV, the virus that causes AIDS.
 A screening test (called the ELISA test) will be performed on a sample of your blood. If that test shows that you
have HIV antibodies, an additional confirmation test (called the Western Blot) will be done on the same blood
sample to make sure the first test was correct.
 The accuracy and reliability of the HIV test is uncertain. (HIV antibody testing is considered to be quite accurate but
not 100%). A negative test means that you are probably not infected with the virus, but does not conclusively
exclude the possibility of infection with the virus. A positive test usually means that you have been exposed to the
virus but does not mean that you have AIDS or will develop AIDS in the future. In addition, false positives may
occur. Your physician or designee will notify and explain the results to you.
 State law requires positive HIV test results to be reported to the state Department of Health. XXX, to the best of
its ability, will not disclose the results of these tests to others except to the extent required by law.
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EVALUATION CONSENT FOR HEART TRANSPLANT
You will receive two skin tests - one on each forearm - one is for mumps and the other is for tuberculosis. These
will need to be checked 24 and 48 hours after they are given. If you will be discharged from the hospital before
that time, you will need to make arrangements with your family doctor to check your arm and send us the results
of the test.
If you have not had a flu shot for this year, nor a pneumonia vaccination in the past six years, you will receive
those.
Pulmonary function tests which measure your lung capacity will be done. You will go to another department in the
hospital to have these done.
Your urine will be saved for 24 hours to do a special test of kidney function. The nurse will place a jug in a pan of
ice in your bathroom. Every time you urinate the specimen must be put into the jug. If any is discarded, the test
must be started over.
You will be sent to the radiology department for a chest x-ray and a panorex (teeth and jaw x-ray). An abdominal
sonogram will be done - it is a sound wave test which will look at your gallbladder, kidneys, liver, and abdominal
aorta.
You may go to the vascular laboratory to have a sound wave test of the arteries in your neck and the ones in your
legs. These tests are called carotid duplex and peripheral vascular doppler studies. This test is not painful.
The gastrointestinal doctor may decide that you need tests to look at your stomach or your colon. These tests will
be done in another department called the GI laboratory. Preparation for these tests includes cleansing the bowel
and not being able to eat or drink for several hours. The preparation can be frustrating and uncomfortable. You
will be sedated for the actual procedure.
Last, but not least, you will need some studies of your heart. You may have recently had some of them done, and
not every patient needs every one of these tests.
 Electrocardiogram (ECG)
 Right heart catheterization to measure the pressure in the right side of your heart. This is different from the
cardiac cath you may have had which looks at your coronary arteries for blockages. Preparation for a right
heart catheterization involves not being able to eat or drink for several hours. After local anesthesia, the
cardiologist places a tube into a vein in either the neck or groin and then will insert a measuring type catheter
into the tube. Depending upon the results of the test, this catheter may be removed or it may be left in for
additional measurements. When the test is finished, a dressing will be placed over the site. If the tube is
removed, you will be returned to your room. If it is left in, you will be moved to the intensive care unit (ICU).
Possible complications of the right heart catheterization include, but are not limited to, bleeding and change in
heart rhythm.
 Echocardiogram (Echo). This is a sound wave test of your heart.
A test of your oxygen consumption may be scheduled either while you are in the hospital or shortly after you
leave. It is called a MVO2 test. This is done in the pulmonary lab and takes about an hour. You will either walk
on a treadmill or ride a bicycle and breathe into a machine. This test measures your exercise capacity.
Patient Initials
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EVALUATION CONSENT FOR HEART TRANSPLANT
While these tests and procedures are in progress, the nurse coordinator will visit you regularly to keep you
informed of the results. After the tests are completed, you may be discharged from the hospital before all of the
results are available. The decision about your suitability for transplantation is made by the transplant team after
all of the results of the tests are gathered. Each case is examined individually and many factors are weighed
before a final decision is made. The nurse coordinator or the cardiologist will notify you after a decision is made.
The cardiologist will also correspond with your primary care physician.
If you do not have a primary care physician, this is a good time to get one. You will need to check with your
insurance company for a list of physicians. If you need help in choosing, please talk with the social worker or the
nurse coordinator.
RISKS
Blood Draws - When you have your vein stuck directly with a needle to draw blood, you may feel slight discomfort
and have a small amount of bleeding or bruising at the site where the needle is inserted. A small risk that you
could get an infection or clot in the vein exists with any blood collection.
Infection – You could experience an infection from being in the hospital, having blood draws, having a right heart
catheterization, or at an IV site.
BENEFIT
The benefit to having a heart transplant evaluation is to know whether or not heart transplantation is an option for
you.
ALTERNATIVES
If you choose not to proceed with the evaluation, you may continue to have the current medical treatment that you
have now. You may also choose to receive no treatment for your disease, in which case your doctor will continue
to provide care to you.
CONFIDENTIALITY
We are required by law to maintain the privacy/confidentiality of your health information. All information that is
obtained in connection with this procedure, which can be linked to you, will remain as confidential as possible
within the requirements of state and federal law. The results of this procedure will be reviewed and may be
published in a scientific journal or book without identifying you by name. If the data is used for publication in the
medical literature or for teaching purposes, your name will not be used. Records will be kept regarding this
procedure and will be made available for required reviews/audit by representatives of the Food and Drug
Administration (FDA), members of the XXX heart transplant program, members of the Cardiac Transplant
Research Database (CTRD) and Heartmate/Thoratec Register, and representatives of United Network for
Organ Sharing (UNOS) under the guidelines established by the Federal Privacy Act. Federal and State
reviewers/auditors may also have access to your medical records, which contain your identity however they are
required to maintain confidentiality. Your insurance company may also review your record.
Patient Initials
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Heart Transplant Program
EVALUATION CONSENT FOR HEART TRANSPLANT
LIABILITY AND COMPENSATION
Adverse complications and outcomes are possible in any procedure despite the use of high standards.
Complications and outcomes that we are aware of are described in this consent form. However, we are unable to
predict all complications that may occur and could require care. Sometimes, despite all the best efforts by both
you and the heart transplant team, unexpected complications or outcomes occur. If you become sick or hurt
because you received a transplant evaluation, the hospital and doctors will treat you. The hospital and doctors
will also send the bill to you or your insurance company. You do not give up any of your legal rights by signing
this form. By signing this form, you indicate that members of the transplant team have informed you about this
procedure, your questions have been answered sufficiently, and that you agree to proceed.
You can obtain further information by calling the Heart Transplant Office at 816-932-3264.
VOLUNTARY PARTICIPATION
Your participation is voluntary, and you may choose to not participate or may withdraw – not start or stop in the
middle of the evaluation - at any time without adversely affecting your relationship with your doctors and nurses.
The treatment plan you receive from your doctors and nurses is based upon their experience plus ongoing review
of the scientific literature related to care of heart transplant patients.
MULTIPLE LISTING
According to UNOS regulations, you have the right to be on multiple waiting lists. There is the option of
transferring primary waiting time, as well as the option to transfer your care to a different transplant center without
the loss of accrued waiting time. Our program’s philosophy is that the relationship between a transplant program
and a transplant candidate is based on mutual trust and commitment. Because we believe that only one center
should manage the multitude of issues associated with transplant preparation, our center does not accept multiple
listed candidates. Although UNOS policy requires that we inform you of your right for multiple listing, UNOS does
not require a center to accept those patients. For more information, please discuss this further with your
transplant coordinator.
CMS INFORMATION
Specific outcome requirements need to be met by transplant centers and we are required to notify you if we do
not meet those requirements. Currently, XXX meets all Center of Medicare & Medicaid Services (CMS)
requirements and is an approved Medicare heart and kidney transplant center. If you are accepted for a heart
transplant, and the hospital does not meet CMS criteria at some point during the time you are waiting for a heart
transplant, we will notify you in writing. If you receive a transplant at a non-Medicare- approved transplant
center, it could affect your ability to have your immunosuppressive drugs paid for under Medicare Part B.
Patient Initials
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Heart Transplant Program
EVALUATION CONSENT FOR HEART TRANSPLANT
AUTHORIZATION
Your signature certifies that you have decided to proceed, having read the information contained in the consent
form, having received the patient educational manual provided to you at this time, and having had the risks and
benefits explained to you, either today or previously. Upon signing this form, you will receive a copy.
Patient Signature
Date
Time
Transplant Team Physician Signature
Date
Time
Transplant Coordinator or Nurse Practitioner Signature
Date
Time
Patient Label:
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MDP.09.105 (Rev. 04/19/10)