...
Way to Health (W2H) is a cloud-based platform that blends behavioral science with scaleable scalable digital technology. To learn more, please visit our website at https://www.waytohealth.org/.
STEP 1: Is W2H the right resource for your project?
If you are interested in using W2H, but still have some questions, feel free to please contact our team at waytohealth@pennmedicine.upenn.edu
We like to have have these conversations upfront to make sure that W2H is a good fit and to also understand what other things (integrations to devices, Epic etc. etc.) you might have in mind. If you have worked with us before, feel free to drop a note to that person and just to make sure it doesn't fall through the cracks, please also CC the email address above.
STEP 2: I'm ready to get started
If you are submitting a grant proposal or already have funding secured, you can Request a Quote for servicesOnce we've had a conversation with you and confirmed that we can indeed support the program you have in mind, please visit our website and send in a Quote Request. You can expect your quote in 1-2 weeks, however if expediting is necessary. If you need it sooner, , please specify in your submissionthat in the form and we'll do our best to accommodate it. You may also wish to submit some information about W2H to the funder. Please feel free to use content from this document in your funding application: W2H Structure.docx. This information continues to evolve and we will update the document the best that we can.
STEP 3: I have a W2H quote and funding secured: What's next?
Contact us
Let us know that your project has been funded and that you are ready to get started by sending an email to waytohealth@pennmedicine.upenn.edu
Send us the most updated study protocol since notice of award. We will likely have some feedback. Please note: if the protocol changes after any kind of build has started, additional costs will be incurred.
Schedule an introductory meeting with our team so you can get to know the analyst assigned to you.
STEP 3a: If you are a university or health system
OUTSIDE of University of Pennsylvania/Penn Medicine
Please recognize there are overheads involved.
If additional security reviews or integrations are required,
there might be additional costs, assuming we haven't talked about them before.
Legal agreements can take time. We prefer and almost require, the use of our standard legal documents which you can access here.
Provide updated financial information to get your account setup by
completing this Project Intake Form.giving us some basic information such as BEN/AU number/BA person and email so that we can figure out how and where to send invoices to. We’ll provide a form shortly to use so we can standardize that.
STEP 4: Submit regulatory documentation
Research studies
- Include
If relevant, include W2H IRB Documentation in your IRB Submission
. https://www.
waytohealth.org/irbdocs. Register your study on www.clinicaltrials.gov. This is essential. We have no way to monitor this so please do so.
Clinical pilots and deployments at Penn Medicine
If you are using a text-based intervention,
you might consider using the Texting_consent_form_sample.pdf.please follow the guidance provided here.
STEP 5: Preparing for your W2H build
While you are preparing your submission to the IRB, you may find that you need additional guidance on exactly how your protocol will translate into the platform. For example: How will you enroll participants? What surveys will you be sending out and when? What devices will be collecting data?
Your implementation lead will go over the details of your protocol and help you develop a unique enrollment flow and arm schedules based on your design. These templates will guide you in building the enrollment flow and each arm of your intervention:
...
, please follow the guidance provided here.
Ordering devices
If your intervention is leveraging any devices from our ecosystem, you should plan on ordering those directly through the device vendor. For a list of connected devices, visit our website: https://www.waytohealth.org/integrations. Some discounts may apply for Penn researchers. Contact the W2H team to ask about negotiated rates with our preferred vendors.
We have a variety of devices we have integrations built to already such as Fitbit, Omron BP cuffs, Withings Weight Scales, medication adherence devices and many more. Website constraints prevent us from displaying them all. Please tell us during the initial contact what devices you have in mind and we can guide you appropriately. Some device vendors have preferred rates for research and we can guide you as well. To be clear, vendor policies change so we cannot guarantee those.
STEP 6: Building and testing
Building on the platform
Once you have clearly mapped out your enrollment and arm schedules, your implementation lead will work with you on building the intervention in W2H. Each project is unique, so the time to build may vary based on the interventions complexity of the intervention(s). A typical build timeline looks like this:
- Implementation lead reviews enrollment and arm schedules submitted by you (Week 1).
- Implementation lead creates a W2H account for you and your study. They will set up some basic configurations such as study phone number and devices that you plan on using (Week 1).
- Implementation lead hosts a training to review basic features that apply to your study design (Week 2).
- You take what you've learned and begin building on the platform (Week 2).
- You have a second meeting/training session to review questions that came up while building on the platform (Week 2 or 3).
- You and your implementation lead schedule any follow up meetings or phone calls as needed (Week 3 or 4).
- Testing (see below). (Week 4+)
Testing your intervention(s)
Once the design is finalized you will begin the testing phase. For experienced builders, you may do this in partnership with building and test as you go. Talk to your implementation lead about the best approach for your project.
Testing is a necessary step prior to launch, even if you are using an existing study design. You will want to test a variety of different scenarios to make sure that all use cases are thought through prior to launch. Here are some helpful resources to aid you in developing and carrying out a testing plan:
- Testing Guides
- Enrollment Testing
- Randomization Testing
- Study Arms Testing
- W2H Environments: Learn the difference between production, staging and shadow studies
...
Design and protocol finalization: 30 days. If there is a text based intervention, W2H will initiate the procurement of the phone number as well as submission of the campaign to all the carriers (via Twilio) for approval.
Building: Depending on whether W2H personnel are building this and their availability, this could take anywhere from 30-90 days
Testing and iteration: This is usually where the rubber meets the road. Program teams often realize that the length of the messages, the frequency etc. need to be changed. Depending on the number and extent of changes, this step can take anywhere from 30-60 days. We have guides to hep you with this. Your assigned analyst can help with this as well.
Launch: This is quick. We will wipe out the testing data and launch the program. PLEASE do not launch the program without letting us know.
Guides for managing your study
Once the program launches, you will need to know how to access information and what you need to pay attention to. A lot of this will be set up for you during the design and build phase so nothing should be a surprise.
The W2H User Guide is a great resource for study teams, however, it does not include information on how your unique intervention will work. It is highly recommended that you create a series of Standard Operating Procedures (SOPs) specific to your intervention. These documents should define exactly how to manage the intervention after launch. An SOP will include detailed documentation on how to enroll patients, how to set up devices for participants, how to approve transactions, etc.
STEP 7: Launching your study
Once you have completed all necessary tests, and have confirmed W2H is working as expected, you are almost ready to enroll your first participant! Simply ask your implementation lead to clear out the test participant data and reset your study.
After enrolling your first participant, you will officially be in study maintenance mode. Moving forward you can direct how-to questions and troubleshooting directly to our Help Desk: www.support.waytohealth.org.
or sending an email to w2hsupport@pennmedicine.upenn.edu