Mapping Out W2H Enrollment

In this guide, you will learn how to plan out enrollment in Way to Health. This should be done prior to building on the platform so it can be configured quickly and efficiently. It is also a great way to get started on your individual study's standard operating procedures so it is clear to all staff how the platform is set up.

An example template is here for you to use as a starting place: Enrollment Planning Form.docx. You can submit this to your W2H implementation lead when it is ready for review.

Way to Health can enroll participants via three interfaces:

• Participant Portal (recommended): Participant or project staff walk step-by-step through the enrollment process.
  
  
• Administrative Portal: Project staff add participant records through the Manage Participants view and walk through the enrollment flow via the participant record.
  
  
• Epic / PennChart: Clinicians or schedulers enroll patients during through the patient’s electronic health record. PennChart is Penn Medicine’s instance of Epic.

Way to Health Standard Enrollment Steps

For a new study, Way to Health has a basic enrollment process already setup. The core steps are listed and defined below.

*Don't see Informed Consent? That is because Informed Consent can be added by Administering a Survey. 

Account Creation (Participant Portal and Epic / PennChart Only)

After being directed to your study's URL, participants will click an "Enroll" button and be asked to complete the following fields that you configure to be required or optional:

• First name (required)
• Last name (required)
• Password (required)
• Email address
• Username
• Date of birth
• Cell phone
• Home phone
• Work phone
• Address
• Time zone
• External ID
• Notification preferences (Email, Text, Phone Call - administered via Interactive Voice Recording)

After entering in this information, participant will click the "Complete" button and move on to the next step in the enrollment flow.

Contact Verification (Participant Portal Only)

You can choose to allow participants to verify their contact information through email address or cell phone. After signing up, participants will either receive a 6-digit code to verify or select a button to confirm their contact information depending on how you configure your study.

Randomization

This step is not visible to the participant via the Participant Portal enrollment flow. They will be take to the next step in the enrollment process, which will be an arm-specific step now that they've been randomized and assigned an arm.

Arm-specific steps

These are steps prior to starting in the study for each arm.

Study start

This is invisible to the participant in the Participant Portal enrollment flow. It will take them to the study dashboard upon completion of the prior step.

Additional Enrollment Steps to Customize Your Unique Enrollment Flow

Profile (Participant Portal Only)

You can collect the same information in the profile step as the account creation step: 

• First name (required)
• Last name (required)
• Email address
• Username
• Date of birth
• Cell phone
• Home phone
• Work phone
• Address
• Time zone
• External ID
• Notification preferences (Email, Text, Phone Call - administered via Interactive Voice Recording)

If enrolling via the Admin Portal, this information can be completed upon initial creation of participant record. 

W9

If you plan to pay your participants via checks through Way to Health, you should consider adding the W-9 enrollment step. This asks for participants SSN number. For studies a University of Pennsylvania, please refer to Penn's Manual for Clinical Research: https://www.med.upenn.edu/pennmanual/secure/subject-payment-procedures.html

Administer a Survey

This enrollment step can be used to administer surveys during the enrollment process. You can build surveys through our Survey Builder. For example: screening survey, eligibility survey, demographic survey, informed consent.

Pause Enrollment

This feature is used to pause participants during their enrollment process and block them from moving forward. To continue the enrollment process, study staff will go into the backend to allow these participants to continue through enrollment

The Pause Enrollment Step is useful for:

• • Blocking some time during enrollment for device set-up or any other study instructions
  • Changing from participants enrolling on the frontend to coordinators/PMs continuing enrollment on the backend

Device Authorization

If using a device in your study that requires a participant to authorize the data to flow from their account into W2H, you will need a device authorization step. The most common devices that require this step include Fitbit, Withings, Misfit, Been and iHealth products.

For a full list of integrations, visit https://www.waytohealth.org/integrations.

Data Upload

This step is used when a study is using integrated devices. It verifies that Way to Health is receiving data from the device before continuing enrollment. This step is most useful for devices that do not have participant authorization. Examples include Adheretech and Wisepill medication adherence bottles and the HidrateSpark smart water bottle.

You can also pair this with a device that requires authorization, but it is not required. Participants will not be able to move to the next step until data is retrieved by the platform.

For a full list of integrations, visit https://www.waytohealth.org/integrations.

Enrollment Block

This feature allows you to administer the same types of events that you would during the intervention period. The most common use of an Enrollment Block is to collect baseline data from a device, such as baseline step counts with a Fitbit.

The events that can be added in the enrollment block include:

• • Send Message
  • Send a Conditional Message
  • Administer a Survey
  • Add Logic

This is useful for:

• • Adding additional events in the enrollment process
  • Collecting data before starting the study to verify device is working

Arm Specific Enrollment Steps

These are the same steps but under the Arm-level and not Study-wide. As an example, you might include an arm-specific device authorization step because the control arm will not be receiving a device as a part of the intervention.

Randomization

Questions about randomization schemes? See Randomization.

• Are you randomizing participants to different arms? If so,
  • Number of study arms?
  • What type of randomization scheme are you using?
    • Basic randomization
    • Block randomization 
      
      • What are the block sizes?
    • Block, stratified randomization 
      • What are the strata? e.g. gender, age range, hospital site, etc. 

Study case example: 

Once you have mapped out enrollment you can begin building it on the platform. See Old Enrollment Process and Enrollment Youtube Video.