Study Title: The MS SUPPORT Study
One of the patients with MS you saw in clinic on [data] is participating in the MS-SUPPORT Study. We developed an online doctor-patient tool (MS-SUPPORT) to improve decisions about MS and DMTs. We want to know if the tool affects the use of DMTs, patient-provider communication, quality of care, and quality of life.
What should I know about this research?
- Adults with a relapsing form of MS are randomized to the intervention group (to view the online MS-SUPPORT before their clinic appointment) or to the control group (no access to MS SUPPORT).
- MS-SUPPORT asks patients questions about how they manage their MS, how MS affects their life, and what matters to them. It provides tailored feedback and generates a short summary that includes their treatment goals and preferences, and adherence-related behaviors. The patient may or may not have shared the summary page with you at their recent clinical visit.
- Your patient shared your name with us when he or she volunteered to participate in this study.
- If you agree to participate, we ask you to evaluate the clinic visit, whether or not your patient received or shared the summary with you.
- You may not know whether the patient is in the intervention or the control group.
- The brief online evaluation will take approximately [2-5] minutes to complete. We will email you an online Amazon gift card ($75) upon completion for your time.
- The study has been approved by a Central IRB and all participants have consented.
- The study is sponsored by an independent contract research company (Shared Decision Making Resources) under a Scientific Research Agreement with EMD Serono in partnership with the Multiple Sclerosis Association of America (MSAA).
- In pilot testing, MS- SUPPORT improved patient-provider communication and the efficiency of the visit.
How long will I be in this research?
Your participation in this research will last for the 2-5 minutes it takes to complete this evaluation.
What happens to me if I agree to take part in this research?
During this study, you will be asked a few questions about yourself and the clinic visit with the patient in the MS-SUPPORT study.
Could being in this research hurt me or pose a risk?
We believe there are no known risks associated with this research study; however, as with any online related activity, the risk of a breach of confidentiality is always possible. To the best of our ability, your answers in this study will remain confidential. We will minimize any risks by encrypting data, using the most secure software, removing personal identifiers from stored data, restricting access to the data to only the study investigators, and keeping a list mapping study ID to consented patients in a locked file, separate from the rest of the study data.
Who will have access to my study information?
Records of your participation in this study will be held confidential so far as permitted by law. However, the study principal investigator and study coordinators and, under certain circumstances, the Department of Health and Human Services, the Food and Drug Administration and New England Independent Review Board (IRB) will be able to inspect and have access to confidential data that identifies you by name. Any publication or presentation of the data will not identify you.
Will being in this research benefit me?
There are no direct benefits to participants. However, your participation will help us test a decision tool that may improve decision-making about MS treatments.
What other options are available?
You may choose to not participate in this study without penalty.
Will I be paid for being in this study?
As compensation for your participation, you will be emailed an Amazon gift card worth $75.
Who do I contact if I have questions about the study?
If you have questions, complaints or concerns about this study, you may contact Dr. Nananda Col, Principal Investigator, at (207) 272-9829 or via email at MSstudy@SDMR.US. If you have questions about your rights as a research subject, or other complaints or concerns about this research, you can contact the New England Independent Review Board at 1-800-232-9570 or at info@neirb.com.
I have read the above consent form and agree to participate in this study.