In this playbook, we will discuss frequently asked questions from client teams and observed best practices as they prepare to configure a project in RKStudio based on their project protocol.
User guide articles in this knowledge base are tactical and describe precisely how to accomplish a task in RKStudio. A playbook is a workflow and RKStudio project configuration document guide to help you make a set of project configuration decisions and optimize your overall project workflow.
Project Intake / Protocol Design Questionnaire
The project team lead (e.g., Research Coordinator, Project Manager) will typically have a set of questions to answer before configuration in RKStudio can begin. Many clients find it useful to first meet internally and discuss the questions below as part of their protocol finalization process. RKStudio's patient engagement platform will provide you with new and innovative participant data lakes and it is recommended you thoroughly plan your digital study before you begin the configuration process in RKStudio.
Enrollment (e.g., MyDataHelps Registration)
How will I invite participants to my study in RKStudio?
- This can be done via email invitation in RKStudio. Or you may choose to pre-load email addresses for participants into RKStudio, and send the invitations using a 3rd party email application.
- If you do not have email addresses for participants, you may wish to post a study specific QR code in a public place for open enrollment.
- If participants are not able to access a phone or computer during enrollment (e.g., in the surgical room), you may wish to use an iPad to enroll them using RKStudio's shared device mode.
Do you have an existing participant identifier for each participant or should RKStudio autogenerate?
- As a default, RKStudio will assign a participant identifier to each new participant invited via the RKStudio invitation module. However, you may wish to include your own participant identifier as a primary or secondary identifier. This can be done in the RKStudio invitation module.
Will there be only one invitation or will subsequent communications take place to nudge participants to enroll?
- After sending the initial invitation, you may decide to send a series of emails to "nudge" the participants to join your study. You can do this in the notifications module.
Consent (First Step After App Registration)
Will the consent be paper based or electronically submitted (e.g., using the MyDataHelps participant facing app)?
- RKStudio allows you to enroll participants electronically using our eConsent form. You may decide to include an electronic signature as part of this process.
Should this consent form be one big long form to scroll down or should it be presented step by step in smaller chunks?
- You may choose to display a consent form as one long scrollable "step" (Consent Review Step) or delivered one section at a time (Visual Consent Step). You may also choose to first deliver each section individually using the Visual Consent Step and then summarize the consent with one Consent Review Step.
Will there be eligibility criteria to participate in the study (e.g., participant must be over 18 years old)?
- If you want to include eligibility criteria in your survey, you may add a Text Choice step and validation logic. Optionally, you may visit the RKStudio Survey Store and import the Sample Consent form into your surveys to view a sample eligibility criteria.
Setting Initial Surveys and Active Tasks
What surveys will you design and send to participants?
- RKStudio supports a wide range of step (i.e. question) types allowing great flexibility in creating any survey or instrument needed for your project/study. Optionally, you may visit the RKStudio Survey Store and import many sample surveys or surveys submitted by previous clients (e.g., PHQ-9).
What frequency or cadence will you send these surveys (using the RKS schedule interface)?
- Once you have decided on a frequency and cadence for your survey delivery, you will configure your survey schedule using the RKStudio scheduler module.
Wearable Devices (Sensor) and EHR Data
Which devices (brand and model) will your participants be wearing in this project?
- RKStudio supports Fitbit devices and those devices compatible with Apple Health and Google Fit. Note that RKStudio is at the mercy of what data the device manufacturer will share with Apple Health / Google Fit, and what data Apple Health / Google Fit will share with RKStudio. Visit your device manufacturer's website or the Apple Health / Google Fit documentation to understand compatibility.
Will you be capturing wearable device sensor data (e.g., Fitbit sleep, Apple Watch HR, Google Fit steps) as part of this project?
- In RKStudio project settings, you may set which sensor / device data you wish to collect from Apple Health, Google Fit, and Fitbit. For specific Fitbit data elements, you will need to reach out to your CareEvolution project lead for further configuration. For Apple Health and GoogleFit, you may select your specific device data to be collected.
Will you be allowing participants to access their EHR data as part of this project?
- Certain projects require the ability for participants to link to their Electronic Health Record (EHR) accounts (using RKStudio FHIR connectivity standards). If this is the case for your project, please reach out to your CareEvolution project lead.
Participant Dashboard, Goal Setting, and Incentives
Do you plan to include a participant facing dashboard as part of this project? For example, device data graphs such as steps, HR, or sleep; survey answers, individual vs. population comparisons; ancestry report (generated by your team).
- RKStudio offers the ability to display results and data (e.g., device/sensor/wearable data, survey, etc) back to the participants. An example of this is a mental health study where the project team wishes to deliver a table showing the correlation of daily mood vs. nightly sleep. If you are interested in a participant facing dashboard, please reach out to your CareEvolution project lead to understand what is configurable.
Participant Notifications (e.g., Just In time Adaptive Interventions)
What participant notifications will this project require?
- You may wish to send information, nudges, or Just In Time Adaptive Interventions (JITAIs) to your participants. RKStudio currently supports email, push, and SMS notifications.
What will trigger these notifications? What frequency should they be sent at?
- Once you know your notification triggers, information, and frequency, you can configure the notifications by following the instructions in this user guide article and following up with your CareEvolution project lead as described to complete configuration.
Next Steps: Begin RKStudio Project Configuration
After a project protocol has been finalized and approved by the project team, the next step is for your research team to setup an RKStudio account and either join or create an organization. You should then follow the Getting Started user guide articles to begin to configure and design your RKStudio project including consent, surveys, survey schedulers, device data, and notifications.
Best Practices on Your Team's RKStudio Configuration vs. CE Team Configurations
The RKStudio patient engagement platform was designed to enable project teams to configure and manage their own content (e.g., consent and surveys) and projects settings (e.g., which device data to collect?) over the duration of the project. However, there are certain advanced project elements that only CareEvolution can implement (described in detail in each user guide article for each topic). This includes but is not limited to participant facing dashboards, EHR data setup, and setting the triggers you defined for notifications. After your team internally discusses the above set of questions, it is helpful to email the CareEvolution team to ensure we have your project protocol and understand any specific project component that need to be implemented by our team.