INFORMED CONSENT PACKAGE FOR ELECTROCONVULSIVE THERAPY (ECT)

DDMHS

INFORMED CONSENT PACKAGE FOR ELECTROCONVULSIVE THERAPY (ECT)

PART A

INFORMATION ABOUT ECT

ECT involves a series of treatments. Before patients begin to receive these treatments, they have various testing done in order to evaluate their overall physical health. Testing will also establish how they are doing in various psychological areas before ECT.

To receive each treatment, patients are brought to a specially equipped area in this hospital. Because the treatments involve general anesthesia, there can be nothing to eat or drink for at least eight hours before each treatment, apart from any medication ordered by the doctor.

After being placed on a stretcher in the ECT area, the patient has a medical needle placed in the vein so that medication can be given through an intravenous (IV) catheter.

Then the patient is prepared for treatment. Monitoring sensors are placed on the head and other parts of the body, in order to keep track of brain waves, heart, and the oxygen being taken in. A blood pressure cuff is placed on an arm or leg to measure blood pressure. These monitors are not painful or uncomfortable. When the patient is ready, a medicine is given that quickly puts him or her to sleep. A second drug is given to rlax the patient's muscles, including the muscles that help the patient breath. Throughout the procedure, the patient receives oxygen through a mask. Breathing is assisted until the patient resumes breathing on his or her own. Because the person is asleep, he or she does not feel pain and is not uncomfortable during the ECT.

After the patient is asleep, a small, carefully controlled amount of electricity is passed between two electrodes that have been placed on the head. When the current is passed through the brain, a generalized seizure occurs. This is also called a convulsion or an epileptic fit. Because of the medication received to relax the muscles, the movements in the body that would ordinarily come with this reaction are very much softened. The seizure lasts for about one minute. The amount of electricity used is adjusted to individual needs, based on the judgment of the ECT physician. In one method, during the first treatment, more than one electrical stimulation may be applied to establish the level needed to produce a seizure. After that usually only one stimulation will be applied in each treatment session.

Within a few minutes, the medication for sleep wears off and the patient wakes up. He or she is then brought to a recovery room, and is watched over until it is time to leave the ECT area.

The potential benefit of ECT is that it may lead to improvement in an individual's condition. ECT has been shown to be a treatment that works very well for a number of conditions. As with many kinds of medical treatment, some patients recover quickly, some recover only to relapse again and need more treatments; while some are not helped at all. The chances of being helped are less good in some people than others. People less likely to be helped include those who haven't been helped in the past by medications or ECT.

Like other medical treatments, ECT has risks and side effects. To reduce the risk of problems, patients receive a full medical review before starting ECT. The medications a person has been taking may be changed. Even with precautions, it is possible that a medical problem will result from the ECT. As with any procedure putting someone to sleep, there is a remote possibility of death. The risk of death from ECT is very low, about one in 10,000 patients. This rate may be higher in patients with serious medical problems.

ECT very rarely results in serious medical problems, such as heart attack, stroke, breathing problems, or continuous seizures. More often, ECT results in heartbeat problems. These problems are usually mild and short lasting, but in some instances can be life threatening. With modern ECT methods, problems with teeth are not frequent. Bones being broken or moving out of joint are very rare. If serious side effects happen, the medical care that is needed will be given.

Uncommonly, as with other antidepressant treatments, ECT may bring on mania or hypo-mania in bipolar disorder which may or may not have been previously diagnosed.

The minor side effects that are common include headache, muscle soreness and nausea. These side effects usually get better with simple treatment.

When a person wakes up after each treatment, he or she may be confused. This confusion usually goes away within an hour.

Common side effects of ECT are changes in memory. The memory problems with ECT have the following pattern: Shortly after a treatment, the problems with memory are the greatest. As time from treatment increases, these memory problems lessen. Shortly after the course of ECT, a person may have problems remembering events that happened before and while receiving ECT. This spottiness in memory for past events may go back to several months before receiving ECT, and in some people , to one, two , or more years. Many of these memories should return during the first few months after the ECT course. However, individuals may be left with some permanent gaps in memory, particularly for events that happened close in time to the ECT.

Also, for a short time period following ECT, there may be difficulty in aspects of thinking such as learning and remembering new events. This problem with making new memories should be short term and will most likely be gone within several weeks following the ECT course.

People differ greatly in their experience of the confusion and memory problems during and shortly following ECT. However, some mental conditions themselves cause problems in learning and memory. In part because of this, some patients report that their learning and memory is improved after ECT. Testing shows that many parts of thinking are improved following ECT.

However, there are reports of some people who have memory problems that are much more serious, long lasting or permanent. In addition, some people report difficulties with thinking and problem solving. There is not enough research to predict which person will experience improved thinking and memory, have temporary problems or have more severe difficulties.

The memory problems that a person may have are partly related to the number and type of treatments the person gets. A smaller number of treatments is likely to cause fewer memory problems than a larger number of treatments. The type of treatment which is given on only one side of the brain, called unilateral ECT, is likely to cause fewer memory problems than the kind which is applied to both sides, called bilateral ECT.

PART B

PATIENT PREPARATIONS FOR POSSIBLE MEMORY LOSS

AND FOLLOW-UP

ECT may cause you to forget information that you learned before the treatment. While receiving ECT, you may wish to review some of this information again. Some patients take notes, tape or even videotape some of the information being discussed. You can also have a family member or a personal friend present. Additional educational materials are available. If you have questions about information you receive from any source, feel free to bring it in and ask your doctor about it.

You may want to consider asking for the support of family or friends ahead of time to help in recovering from the possible memory problems. They could help by coaching you after ECT to help remember events. They could also help you to prepare summaries of important events from the recent past, or to develop lists of things you may need to remember.

Because of the possible problems with confusion and memory, you should not make any important personal or business decisions during or immediately after the ECT course. This may mean postponing decisions about financial or family matters. After ECT treatment you should not drive, do business or do other activities where having memory problems could interfere, until you have talked it over with your doctor.

Before your discharge from ECT treatment, you will be given the name and phone number in writing of a person you will be referred to work with for follow-up care, if it is different from your current doctor. You should inform this person promptly if there are any unexpected changes in your condition at any time, including whether you feel your memory problems are worse than you expected. In the event of memory problems which do last beyond the anticipated, temporary effects as described in the information attachment, you should receive follow-up plans from your ongoing treatment provider; if you need assistance in getting this or other follow-up help, you can contact:

____________________________________(Name and number of ECT provider)

PART C

CONSENT FOR ELECTROCONVULSIVE THERAPY

ACUTE PHASE/INDEX TREATMENT

My doctor, ________________________________, M.D., has recommended that I receive treatment with electroconvulsive therapy (ECT). Information was given to me so that I understand this treatment, in order to give my informed consent to this procedure.

I will receive ECT to treat my psychiatric condition. Whether ECT or an alternative treatment, such as medication or psychotherapy, is more appropriate for me depends on my prior experience with these treatments, the nature of my psychiatric condition and other considerations. ECT has been recommended for my specific case because:

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

My doctor has explained to me if I have medical conditions that may potentially increase my risk for complications during ECT treatment. They are:

We have discussed what steps can be taken to address these risks.

The option of receiving no treatment, and its potential consequences, have been explained to me by my doctor.

Like other medical treatments, ECT has risks and side effects.

Serious risks include:

· Complications from anesthesia including death

· Heart attack

· Stroke

· Breathing problems

· Continuous seizures

· Life threatening heart beat irregularities

· Rarely broken bones or bones out of joint

· Mania or hypo-mania in people with bipolar illness

Minor risks include:

· Headaches

· Muscle soreness

· Nausea

Memory problems are more common, especially shortly after each treatment. As time from treatment increase, these memory problems generally lessen. Shortly after a course of ECT, a person may have problems remembering events that happened before and while receiving ECT, and may go back to several months before receiving ECT. Many of these memories return during the first few months after the ECT course. Permanent gaps in memory may occur for some, especially events close in time to the ECT. There may also be difficulty in aspects of thinking such as learning and remembering new events and problem solving. There is not enough research to predict which person will experience improved thinking and memory, have temporary problems or have more severe difficulties.

I may receive either bilateral ECT or unilateral ECT. My doctor has carefully considered which is best for me, discussed that choice with me, recommended the best treatment for me, and has told me which type, bilateral or unilateral, I am to receive. I have been informed of the potential risks associated with bilateral ECT, and particularly with the increased risk of memory side effects. If there is a change from unilateral ECT to bilateral ECT during the treatment course, the reasons for this change and the risks of bilateral ECT will be reviewed with me, and my consent will be necessary for this change.

The number of treatments that I receive cannot be predicted ahead of time. This will depend on my condition, how quickly I respond to the treatment, and the medical judgment and advice of my psychiatrist. I agree to up to 12 ECT treatments in this episode. If I need more than twelve ECT treatments I will have the opportunity to review this consent information again and agree or not agree to further treatments.

Treatments are usually given three times a week, but the frequency may be fewer depending on my needs.

I understand that ECT is not a cure, and I understand the risk that I may not stay well, even if ECT helps me. I know that I will need to follow an ongoing treatment plan after ECT in order to stay well.

I understand that another consent form is needed if my follow-up treatment recommends more ECT treatments.

I have read and someone has reviewed with me the more detailed explanations on the information attachment. I have had the opportunity to ask my doctor all my questions about ECT.

I understand that I should feel free to ask questions about ECT at this time or at any time during and following the ECT course. I also understand that my decision to agree to ECT is being made on a voluntary basis, and that I may withdraw my consent for this treatment at any time. I have been given a copy of this consent and information form to keep.

The nature of ECT, including the risks and benefits that I may experience has been fully described to me and I give my consent to be treated with ECT.

Patient's signature__________________________________________Date_________________

Name of doctor reviewing with the patient (print):

__________________________________________, M.D.

Others present:_______________________________Relationship__________________

_______________________________Relationship__________________