Attachment H - Consent Form

Attachment G: Consent Form for Consumer Testing

Improving EHR Patient Education Materials – Development of the Health Information Rating System (HIRS)

Consumer Consent Form

We are asking you to be in a research study.

You do not have to be in the study.

If you say yes, you can quit the study at any time.

Please take as much time as you need to make your choice.

What is the study about?

We are doing this study to improve the information that doctors and nurses give to patients about their health. Abt Associates, a research company, is doing the study for the Agency for Healthcare Research and Quality (AHRQ), which is part of the US government. As part of the study, we made a rating system to judge how easy it is to understand and act on health information. Now we are asking people like you to help us see how well our rating system works. A total of 48 people will be in this study.

What happens if I say yes, I want to be in the study?

If you say yes, we will:

• Ask you to look at two pieces of health information,

• Ask you to answer some questions about each of them, which will be tape recorded

• Pay you $75 for being in the study.

The questions are to see how much you learned from the materials, and if you know what actions to take after looking at them. Your answers will help us judge if the rating system is good and can be trusted.

How long will the study take?

The study will take about one hour and twelve minutes of your time.

What happens if I say no, I do not want to be in the study?

No one will treat you differently. You will not be penalized. While you will not get paid for being in the study if you say no, you will not lose any other benefits. The care you get from your doctor will not change. Even if you agree to participate, you do not have to look at all the materials or answer all the questions.

What happens if I say yes, but change my mind later?

You can stop being in the study at any time. You will not be penalized. You will still be paid $75 for being in the study if you begin the study, but change your mind later. You will not lose any other benefits.

Who will see my answers?

The only people allowed to see your answers will be the people who work on the study and people who make sure we run our study the right way. Your answers and the tape recording, and a copy of this document will be locked in our files, and will be saved on a computer that is protected by a password.

When we share the results of the study, we will not include your name. We will do our best to make sure no one outside the study will know you are a part of the study.

Will it cost me anything to be in the study?

No.

Will being in this study help me in any way?

Being in the study will not help you right now. The study will help to improve the information given to patients about their health. This means that in the future, the information that your doctor or nurse gives to you about your health could be easier to understand.

Will I be paid for my time?

Yes. We will give you $75 to pay you for your time. You will get this money at the end of your time with us today even if you decide to skip some of the questions.

Is there a way being in this study could be bad for me?

There is a chance that the information we ask you to review will be difficult to understand. You might not know the answers to all of the questions we ask you. This could be hard for you.

What if I have questions?

Please call the head of the study, Sarah Shoemaker (617-349-2472), if you:

• Have any questions about the study.

• Have any questions about your rights.

• Feel you have been hurt in any way by being in this study.

You can also call Teresa Doksum, who is in charge of research at Abt Associates, at 617-349-2896 to ask questions about the study. These are not toll-free numbers.

Do I have to sign this document?

No. You only sign this document if you want to be in the study.

What should I do if I want to be in the study?

To be in the study, sign this document. We will give you a copy of the document to keep.

By signing this document, you are saying:

• You agree to be in the study.

• We talked with you about the information in this document and answered all your questions.

You know that:

• You can skip questions you do not want to answer.

• You can stop answering our questions at any time and nothing will happen to you.

• You can call the office in charge of research at 617-349-2896 if you have any questions about the study or about your rights.

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Your name (please print)

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Your signature Date