Informed Consent to Participants in Maryland's National Diabetes Prevention Program Grant - 5/16/17
As a member of either the Amerigroup, MedStar Family Choice, Jai Medical Systems, or Priority Partners Medicaid managed care organization (MCO), you are invited to take part in a diabetes prevention program. This diabetes prevention program is supported by a grant received by the Maryland Department of Health. You (i.e. the member) are invited to ask questions and to take part in this diabetes prevention program and its evaluation at no cost to you.
By taking part in this diabetes prevention program, you are choosing to receive diabetes prevention services, which involve attending weekly group sessions to start, and later monthly sessions, led by lifestyle coaches. Your weight will be checked regularly by your diabetes prevention program lifestyle coach, and your blood pressure and blood sugar may be checked from time to time by your health care provider. By taking part in this program, you will also be participating in an evaluation of the program and may be asked to complete two surveys. If you choose not to be part of this program, you will still be offered needed health services, as before.
As a volunteer participant in this Program, your MCO will receive and look at information about you collected during your involvement in the diabetes prevention program, as well as insurance claims and other information about past use of health services.
Your MCO will share information collected about you during your participation in this program, with a professional evaluation team. This information includes the number of sessions you attended, your starting and ending height and weight, the number of physical activity minutes you have completed, along with your age, race, and gender. This team is contracted to look at the benefits and costs of this diabetes prevention program. Your information will be shared in a confidential way so that no one outside the team will be able to know that it is your personal health information, and your privacy will be protected. The information collected during your participation in this program will not be integrated into your health record maintained by your MCO.
At the beginning and at the end of your participation in the diabetes prevention program, a member of this evaluation team may contact you by phone to ask how you feel about it. Therefore, your name, phone number, and address will be collected and shared with this evaluation team. Before the first call, the evaluation team may send you a letter with $2 to encourage your participation in the upcoming phone survey. This letter will also include a phone number to call if you wish to contact them before they call you. If you are selected to participate, you will receive a $30 VISA prepaid gift card each time if you complete a phone survey, for a maximum of $60.
If you choose to take part in the diabetes prevention program, you may stop participating at any time, you will not lose any of your health benefits, and you will continue to receive your routine health care. By taking part in this diabetes prevention program, you may or may not achieve weight loss, better health and lower risk for diabetes.
If you become pregnant or are diagnosed with diabetes during this program, you may no longer be eligible to participate in this program; please talk with your diabetes prevention program lifestyle coach about your options. If you change Maryland HealthChoice MCO plans or no longer qualify for Medicaid coverage during this program, you may no longer be eligible to participate in the diabetes prevention program through this demonstration program. If you have made such a change, and are unsure of your eligibility to continue, please talk with your diabetes prevention program lifestyle coach.
If you have questions regarding the surveys, or would like to remove your information from the study, please contact the evaluator, Dr. Deborah Porterfield at RTI International, at 919-630-0532 or [email protected]. If you have questions regarding your rights as a participant, contact Gay Hutchen, MDH Institutional Review Board Administrator, at 410-767-8448 or [email protected].