We would like to invite you to participate in a one-day nutritional evaluation project, which will be performed on the same day in many different hospitals globally and around the United States. We are hoping to recruit several thousand participants. “nutritionDay” in the U. S. is a part of an international project that is coordinated in Austria.
The purpose of the nutritional evaluation is to assess, on one single day, how nutritional care is managed in hospitals. The information that is collected will help hospitals improve the nutritional care of their patients and it will also be used to develop independent quality control projects. There may be no direct benefit to you for participating in this project.
If you agree to participate, the following will occur:
- You will be asked to complete a 2-page questionnaire on “nutritionDay”. The first page will ask questions about your weight over the last 3-6 months, what you ate during the last week before hospital admission, your diet while in the hospital, and your activity level. The second page will tell us how much you eat and drink during “nutritionDay,” as well as any reasons for eating less than you were offered. The best way to do this is to fill in each part of the questionnaire after each meal or snack. If you feel that you need any additional information, please ask ______________________________ to help you. If writing is difficult for you, please ask for help to complete the questionnaire. If you are in an Intensive Care Unit and able to answer, instead of a completing a questionnaire, we will ask you a few questions about how you are feeling, record if you are receiving no nutrition, or document any artificial nutrition or nutrition support that you might receive that day.
- On the same day that you are completing your questionnaire, we will also be collecting some basic information from your medical chart about your diagnosis and treatment.
- At approximately 30 or 60 days after “nutritionDay,” we will collect some final information about you from your medical chart, such as when you were discharged from the hospital, whether you went home, or were transferred to another facility, etc.
There are minimal risks to participation. Risks may include the loss of confidentiality, but the researchers have taken precautions to prevent this.
All questionnaires will be completed anonymously, as no identifying information will be included on the forms. It is important that your anonymity is ensured at all stages of this nutritional evaluation and only the clinical staff looking after you have access to information where your name is documented. Completed questionnaires and consent forms will be secured in a locked file cabinet in ______________ office. Data will be kept until November 5, 2017. After this date, no forms will be kept in which any person can be identified. Any forms that may identify you will be placed in (facility name) _______________ confidential trash containers and shredded.
The anonymous information that is collected about you will be sent to the “nutritionDay“ Coordinating Centre in Austria for statistical analysis. No reference to your name will be available during this analysis. Your name will not appear in the planned publication.
Your participation in this project is voluntary and you can withdraw at any time without penalty. Your decision to participate or not will not affect your care.
If you have any questions about this project, you can contact (project leader) _______________ at (project leader’s phone number) ______________. If you have questions or concerns about the treatment of participants in this project, you may contact the Institutional Review Board (IRB) at (facility name) _________________. This nutritional evaluation has been reviewed by the (facility name) _________________ IRB.
If you do not want to take part in the nutritional review, draw a line through the questionnaire, sign, and return to __________________.
I have read this consent and I agree / do not agree to take part in this project
Signature: ____________________________________ Date: __________
Person Obtaining Consent: __________________________
If the participant is unable to provide consent:
Signature of Legal Representative: __________________________ Date: __________
If the participant is unable to read or sign their name:
Signature of Witness to Subject Mark or Consent:
Signature: ____________________________________ Date: ____________