Ed Zabrek's Technology Report - Cover Your Assets: ACOG's PACE™: The Ultimate Informed Consent Solution

Your CPA, your attorney, and your malpractice carrier all agree that you can never have too much coverage when it comes to patient “informed consent.” ACOG’s PACE program is just the ticket (www.acogpace.com). PACE is an acronym for Patient Advise and Consent Encounter. The system is currently designed to give your patient, graphically detailed essential information on a large variety of subjects and procedures. The interactive CD-ROM works with your patient at her own pace (literally, no pun intended), and requires her to be alert and attentive during the entire process. (If she is not, the computer will inform the healthcare provider in the final printoutread more on this below.) The result is entertaining, complete, and protective for both you and your patient. The fact that it is ACOG sponsored and sanctioned adds that extra security to that legal document known as your “patient’s chart.“

Over the past 15 years, I have always required my patients to view informed consent videotape. In fact, several years ago, an informed consent video got me “non-suited” in a frivolous lawsuit. The patient claimed that she was not ever informed of the risks of the procedure. In spite of a simple signed informed consent document in the chart, she found a lawyer to take her case. My attorney requested that I provide him a copy of the video the patient saw. That done, he brought it to the judge, and after viewing it, she threw the case out. Ever since that time, I have been as insistent that my patients watch an informed consent video as I am that they have pre-op H&H. Without this, I will not perform the procedure.

Materials and Methods

I received the PACE™. programs several weeks ago. My office was not set up for it at that time, and I sought the perfect hardware solution for my media room. You may have seen the PACE™. program, when it was introduced several years ago. At that time it included both hardware and software (a CPU with a touchscreen monitor) and sold for around $10,000. The system now is sold as “software only”. The purchaser can use any computer (desktop or laptop) with a minimum of 200mhz with MMX, 20X CDROM, a Soundblaster compatible soundcard and speakers, and a videocard with 800x600 SVGA resolution. With computer prices experiencing a pricing freefall over the past 6 months, this can all be accomplished for around $1000.00 in the U.S. (Note: the expensive touchscreen, while an option, is not a requirement easily replaced by a standard mouse or pointing device.)

Though most of my patients are computer literate, I felt that the “normal” computer might be too intimidating for some. I also believe that the lesser-educated patient may find it more difficult to synthesize the informed consent information. I wanted to make the experience more like an “interactive standard videotape.” For that reason, I opted to set up my system with a standard 27” television monitor ($300.00) instead of a standard computer monitor. This is easily accomplished with ATI’s TV-video card ($60.00). I also opted for a 266mhz Pentium II CPU with a 24x CDROM and 3 ½ “ standard floppy drive (custom built at my local dependable computer store for $600.00). A laser quality printer is also essential to generate the documents. The finishing touch came with a cordless pointing device from Logitech™. The Surfman™ ($100.00). This is Logitech’s “presentation” pointing device. It is simple to use and works very well with this setup. I set all of the hardware in my media room, and began to try it out on patients. I explained the system to my patients and would sit down and watch how they interacted with it. I was pleased and amazed at the results. The information was well received, and positive feedback has been the consistent response from all. All of the interactions with the computer are recorded (even if they pause too long before going to the next section). A handout (containing all of the details of the encounter) is generated both for the patient and her chart. She is instructed to initial each page, and sign the last page, indicated that she has read the entire document. A “Doctor’s Alert” page is also generated for you which will target patient responses. This page highlights areas that the patient has indicated she may have further questions or areas of concern. You can then address the specifics with the patient. Additionally, a “Patient’s Discussion List” is generated for further talking points of clarification she requires for even more thorough informed consent. Interactivity occurs based on the patient’s input, including her age. For example, the program for a pregnant teenager will be geared for her, while the older pregnant women will be directed towards more appropriate information. Computer generated diagrams and animations are available for patients who desire to view them.

Recently, I was scheduled to operate on a patient who lived 300 miles from my office. She drove into town the night before her surgery. I actually met her my office at 11:00 p.m. the night before her 7:30 a.m. surgery and set up the PACE “Laparoscopy” CD. We finished up at midnight, but I slept much better having those forms signed.

Tech support for the PACE™. system is excellent! The staff is extremely knowledgeable and helpful.

Currently, the obgyn section at my hospital requires that all VBAC patients view the now requires all patients view the PACE™. VBAC program. They have setup a computer in the hospital library and patients schedule appointments to view it.

There are several currently available on the market today. I have previewed many of them, and while all can get the job done, none to date are as complete, helpful and provide the protection that the PACE™ system gives you. I am hopeful that as new titles are added, some holes in the current program lineup will be filled. I would love to see modules on Laparotomy, Infertility, Tubal Reversal, and Hysteroscopy. There are more modules on the way, though exact dates are not known at this time.

The cost for the entire PACE™ software system is $3500.00 (a small price to pay compared to a multimillion dollar lawsuit). Individual modules can be purchased separately. You can call Cathy Patterson at (888) 536-6332 for further pricing and information. Below you will find a list of all of the currently available PACE™ modules, along with a handout from ACOG describing the system in additional detail. A sample of the VBAC encounter is also included for your perusal. Over the coming weeks I will be providing other program modules descriptions and sample encounters. I hope that you will this information both useful and helpful in deciding if the ACOG PACE™. is an appropriate addition for your practice.

Ed Zabrek, M.D.
Technology Correspondent
OBGYN.net

ACOG PACE(TM ) AVAILABLE PROGRAMS

OBSTETRICS:


GYNECOLOGY Modules


Each program provides three printouts:

  1. Two copies of what the patient was told and her responses to key questions. The patient signs one copy for her record.
  2. One copy of a Doctor's Alert targeting patient responses the doctor needs to know.
  3. One copy of a Patient's Discussion list of questions to ask her doctor.


"Software Only" Version: $3,500

CD-ROM titles are now available in a "software only" format. They are designed to run on multimedia PCs that meet certain specifications*. They also come with a full 30-day money back guarantee.

Complete set of 16 modules for $3,500 or purchase the Ob or Gyn set of 8 modules for $1,800. (Non-members add 10%)

For detailed information on any of these topics please call.

* Minimum System Requirements:

What is ACOG PACE™ ?
ACOG PACE™ (ACOG's Patient Advise and Consent Encounter) is a computer-based multimedia system on CD-ROM, which helps obstetricians and gynecologists communicate clear, consistent informed consent information to their patients while still keeping to a busy schedule.

Patients learn about material benefits and risks of procedures and treatments in a user-friendly way. With the touch of a finger or click of a mouse button the patient is led through a presentation with full screen video, simple but accurate animations of procedures, comprehensible audio, and supportive text and graphics.

ACOG PACE™ provides your patient with the information she needs to know for you to comply with informed consent requirements, and allows you to concentrate on her individual circumstances. After viewing an ACOG PACE™ program, you and your patient can focus on those issues which require further explanation. Because your patient has been informed at length you will save time and still be assured that all pertinent information has been provided. You will have a detailed printout of the patient's interaction with the computer, a printed "Doctor's Alert" which draws your attention to responses which might be clinically relevant, and the patient will have a printout reminding her of things she wishes to discuss with you.

Effective, documented communication is a powerful way to reduce your exposure to "lack of informed consent" challenges, which are usually the way that medical malpractice claims are initiated by an unhappy patient. ACOG PACE™ reduces the risk of unrealistic patient expectations by helping each patient understand her treatment options, the risks involved, and the possible outcomes.

ACOG PACE™ maximizes office time while improving patient communication. The broad information and documented interactive responses provided by ACOG PACE™ free you to focus more efficiently on your patient's problem areas.

Unique Benefits of ACOG PACE™

1. Explains procedures and treatments step-by-step:

Simply by touching the monitor or clicking the mouse, your patients will learn what they need to know about a specific procedure or treatment in a user-friendly, interesting and enjoyable interactive presentation. The patient is involved in the program and interacts with the computer program. This is quite different from a videotaped presentation in which the patient simply watches what she is being told.

2. Documents what your patient has been told:

ACOG PACE™ not only leads your patient through a description of the material risks and benefits of a procedure, but records what your patient has been told. At various points in each program the patient is quizzed, and her answer is recorded. After the program is finished, a printout documents everything the patient was told, what she was shown, and her answers to the questions posed. Two copies are printed, one which is signed and put in her medical record, and the other which she keeps. If there is ever a challenge to what she was told, you have a printedsigned record of her having been informed.

3. Reduces the risk of unrealistic patient expectations:

Studies have shown that people comprehend and retain more information from interactive multimedia presentations than from spoken or written materials. ACOG PACE™ empowers your patients by helping them understand their condition, their treatment options, risks, and possible outcomes. They can become active partners in choosing options rather than passive listeners.

Assisting in this process of truly informed consent are three different printouts:

4. Delivers consistent reliable information:

ACOG PACE™ provides the same information, the same way, to every patient. Each program was designed and reviewed by a special ACOG Task Force including representatives from ACOG's Professional Liability, Quality Assessment, Clinical Practice, and Education committees, with input from major malpractice insurance companies, and malpractice defense attorneys.

Sample Patient Printout

Vaginal Birth After Cesarean vl.0 PACE Patient Response Sheet

Thank you for viewing "Vaginal Birth after Cesarean." This is a summary of what you heard and saw when you viewed the program on 5/2/98 at 1:22 PM.

You gave your name as Jane Doe. You gave your age as 33. You were told that currently many women who have had cesareans are able to have successful vaginal births after a previous cesarean birth. This is called VBAC.

You were told that there are certain risks associated with vaginal birth after a cesarean. You were told that for some women, these risks make vaginal birth too dangerous to attempt. You were told that for most women, attempting a vaginal birth after a cesarean is a reasonable option.

You were told about the following benefits of attempting a vaginal birth after a cesarean birth: You will be more involved in the birth process with a vaginal delivery.

You are likely to have a shorter recovery time, less discomfort, and have lower hospital costs.

You will avoid the risks of major surgery, including anesthesia, infection, bleeding, and blood transfusions.

You were told that there are two incisions, one into your skin and abdominal wall, and the other into your uterus.

You were told about the different incisions and how each will influence the decision to attempt a vaginal delivery with this pregnancy.

You were told that it is not possible to tell the type of uterine incision by looking at the skin incision.

You were told that the direction and location of the incision into your uterus from your previous delivery are central factors determining the possibility of your having a vaginal delivery.

You indicated that you had a transverse incision in your previous cesarean.

You were told that the main risk in having a vaginal birth after a cesarean delivery is that the old incision will rupture or separate during labor or delivery.

You indicated that you have had 1 previous cesarean delivery.

You indicated that you had a previous cesarean delivery because the baby was in the wrong birth position.

Initials: Jane Doe 5/2/98 1:22 PM

Page # 1 of 3


Sample Patient Printout

Vaginal Birth After Cesarean vl.0

PACE Patient Response Sheet

You indicated that you know you are going to have more than one baby with this pregnancy.

You were told that there were other reasons a vaginal birth may not be suitable, and that you may not know about these until the time of delivery.

You were told that it is difficult to determine if the baby has become too large for your pelvis until after you have tried a vaginal delivery.

You were told that the baby may move into an abnormal presentation during labor, and you may require a cesarean section as a result.

You were told that even if you are a good candidate for a trial of vaginal birth, you may suffer a sudden separation or rupture of the uterine scar.

You were told that such separations are rarely or ever predictable.

You were told that such separations may, in some instances, lead to brain damage or death of the baby despite the best medical attention.

You were told that a uterine rupture can result in severe bleeding which may make emergency major abdominal surgery necessary.

You were told that blood transfusions may be necessary.

You were told that occasionally an emergency hysterectomy might have to be performed.

You were reminded that neither a cesarean delivery nor a vaginal birth are risk-free procedures for mother and baby. Because of that, a trial of a vaginal birth should occur in a hospital setting.

You were told that you and your doctor should discuss all the details of your individual situation as you make the decision whether to try vaginal birth.

You indicated that you wished to talk to your doctor to clear up questions.

You were reminded that your doctor has further information, including pamphlets, if you are interested.

Thank you for watching this program. Please sign one copy of this printout to be kept with your medical records. You will receive another copy to keep.

This is a true record of what I saw and heard in the program called "Vaginal Birth at~er Cesarean".

Initials: Jane Doe 5/2/98 1:22 PM

Page # 2 of 3

Sample Patient Printout

Vaginal Birth After Cesarean vl.0 PACE Patient Response Sheet

ACOG PACE was developed by the American College of Obstetricians and Gynecologists to assist practitioners in informing patients of the material risks and benefits of specific procedures and treatments. The information and recommendations in this program reflect scientific and clinical knowledge as of the release date and may change. In addition, variations of practice, taking into account the needs of the individual patient, resources, and limitations unique to the institutions or types of practice, may warrant alternative treatment or procedures to the recommendations outlined in this program. Therefore, this program should not be construed as dictating an exclusive course of treatment or procedure

Name (please print)

Date

Patient's Signature

DO NOT DESTROY. FILE IN PATIENTS' MEDICAL RECORD

Initials: Jane Doe 5/2/98 1:22 PM
Page # 3 of 3

Patient: Jane Doe
Date: 5/2/98
Time: 1:22 PM

Sample Patient Discussion Sheet

Vaginal Birth after Cesarean vl.0 PACE Patient Discussion Sheet

You should be sure your doctor knows that you had a transverse incision in your previous cesarean.

You should be sure that the doctor knows you have had 1 previous cesarean delivery.

You should be sure the doctor knows the reason for your previous cesarean delivery.

You should be sure that your doctor knows you are pregnant with more than one baby.

You indicated that you had questions to discuss with the doctor.

You may wish to ask your doctor for further information, including pamphlets.

My doctor and I have discussed my questions and concerns regarding "Vaginal Birth After Cesarean".

Jane Doe 5/2/98 \ 1:22 PM
Page 1 of 1


Sample Doctor Alert Sheet

Vaginal Birth after Cesarean vl.0 PACE Doctor Alert Sheet

ACOG PACE IS DESIGNED TO INFORM A PATIENT ABOUT A SPECIFIC TOPIC. IT IS NOT INTENDED TO BE A SUBSTITUTE FOR A DISCUSSION BETWEEN THE PATIENT AND PHYSICIAN. SPECIFC STATE AND FEDERAL INFORMED CONSENT LAWS AND REGULATIONS MAY APPLY TO THE TREATMENTS OR PROCEDURES DISCUSSED IN THIS PROGRAM. YOU NEED TO COMPLY WITH THESE. THIS MAY INCLUDE INFORMING PATIENTS OF RISKS AND BENEFITS CONTAINED IN THESE LAWS AND OBTAINING A PATIENTS SIGNATURE ON AN APPROVED CONSENT FORM. CONTACT YOUR STATE MEDICAL SOCIETY OR YOUR PROFESSIONAL LIABILITY INSURANCE CARRIER FOR MORE INFORMATION.

IF YOUR PATIENT INDICATED SHE IS UNDER 21 YEARS OF AGE, SPECIFIC INFORMED CONSENT REQUIREMENTS MAY APPLY TO HER IN YOUR STATE. YOU NEED TO COMPLY WITH ALL STATE AND FEDERAL LAWS AND REGULATIONS REGARDING THE ABILITY OF A MINOR TO CONSENT AND/OR THE NEED FOR PARENTS OR GUARDIANS TO BE NOTIFIED OF OR CONSENT TO THE TREATMENTS OR PROCEDURES DISCUSSED IN THIS PROGRAM. CONTACT YOUR STATE MEDICAL SOCIETY OR YOUR PROFESSIONAL LIABILITY INSURANCE CARRIER FOR MORE INFORMATION.

Your patient may have indicated that she has questions or topics for discussion. If so, these will be listed on a separate printout.

Patient: Jane Doe
Date: 5/2/98
Time: 1:22 PM

The patient indicated that she had a transverse incision in her previous cesarean.

The patient indicated that she has had 1 previous cesarean delivery.

The patient indicated that she had her previous cesarean delivery because the baby was in the wrong birth position.

The patient indicated that she is going to have more than one baby with this pregnancy.

The patient indicated that she has questions she needs to discuss with the doctor.

We have provided you with a printed transaction report called a Patient Response for each PACE encounter. This printed transaction allows the reconstruction of a patient's actual progress through the program. If you have opted to maintain the patient's record on a floppy disk, please be aware that as with all magnetic media, floppy disks can fail for a number of reasons.

Jane Doe 5/2/98 \ 1:22 PM
Page 1 of 1

For More Information Please Call 1-800-430-8271 or Visit Our Website at www.acogpace.com