Methodology
This section contains methodological information for the study.
PRELAUNCH STATUS
TO DO:
- Update CT.Gov office DONE
- Set up Participant Payments
- Recruitment plan
- SOP for fully putting someone on study using STAR
- final review of all implementations below
Decisions
- Raw data storage will be at both the subid level and aggregate
- both located on R drive
- Processed data on S drive
Data Pipeline Overview
Data collection tools:
- Qualtrics forms
- NDA GUID tool
- FollowMee
- PRISM (by running scripts)
Staff data manipulation for running the study:
Susan: Update this section with path/input/output like on prism page
- create_bulk_guid.qmd: creates identity file from Qualtrics onboarding script for NDA GUID creation tool
- format_nda_data.qmd: Creates the formatted template files for uploading data to NDA
- NEED SCRIPT.R: update_participants.R AND/OR qmd. (Might need both)
- Updates a PRISM participant list on the R drive automatically so we have a running record of participants (PRISM list will only have on-study?)
- Also needs to be run by an RA manually after consent/interview to update when someone is added to or taken off study.
- NEED SCRIPT: check_adherence.qmd (start from Risk2 script)
- NEED SCRIPT: make_payment.qmd (start from Risk2 script)
- NEED SCRIPT: enrollment_rppr.qmd (creates updated RPPR enrollment csv)
Data analysis:
- TBD
Qualtrics forms
Participant facing
- Screening
- 2026_0422 TB confirmed qualtrics implementation as definitive, other docs updated to match
- needs lab review
- use responseID as screen_id which can be carried forward to consent (inserted in URL by RA)
- Consent
- needs lab review
- will need to be updated post-IRB change approval
- DONE needs forwarding to onboard survey
- Onboard
- needs lab review
- collects phone number and address for EMA & payment
- may change per new participant payment regulations
- DONE needs forwarding to birth data survey
- Birth data
- needs lab review
- subid assigned here, unless decided otherwise
- Baseline measures
- SW final review to match 2026_0309
- keep 2 optional questions on flourishing?
- inclusion and placement of STAR questions on trust_id?
- needs lab review
- DONE add subid as embedded data
- SW final review to match 2026_0309
- Mid/end repeated measures
- 2026_0422 TB confirmed matches qmd measures except:
- message_usefulness has a five-point scale, but message.qmd says it should have a seven-point scale - do we alter?
- needs lab review
- add subid as embedded data
- 2026_0422 TB confirmed matches qmd measures except:
- Daily EMA
- Finalized
- Location context (part of EMA after day 7)
- Finalized
The following are not finalized in qualtrics as significant revision is happening:
- Daily Feedback
- needs update when we get final models
- modify for the survey to be rebuilt from data daily by script, rather than have qualtrics pull from PRISM
RA facing:
- RA session form
- collects daily EMA times
- Date log form
- WOG
- TLFB (gathered by interview)
- Needs calendar added and finalization of what is to be collected (only n drinks, also hours drinking, etc)
- Exit Interview (gathered by interview)
FollowMee
Input:
- Installed with token on participant phones
- Administration done from web dashboard
Output:
- 3-14 days of data.
- There will be 24x daily automated data pulls by script, saved as daily and study-longaggregate csv files (subid level vs all aggregate?).
Scripts
These live in the proj_optimize repo where they will be called by PRISM. More will be added as they are completed
automation:
- task_scheduler_opt.R - schedules R scripts to run
- daily_download_opt.R - downloads GPS
- mak_daily_qualtrics.R - downloads survey data from qualtrics including EMA
- part of it will download EMA times from the RA session survey to be used by PRISM
scripts_staff:
- create_bulk_guid.qmd - formats a dataframe downloaded from qualtrics to be used in the NDA GUID tool
- format_nda_data.qmd - formats qualtrics data for NDA upload
- format_nda_templates.R (helper script for above)
scripts_prism:
- find_new_locations_opt.R - pulls user GPS data and finds new locations to query in EMA location context questions
NEED TO ADD:
- John’s model script
- recommendation script
- mak_payments
- chk_adherence
PRISM
Input:
- See csv files listed here - NB these can be updated from script OR manually
Output:
- EMA messages linked to a qualtrics survey with location questions
- See csv files listed here
NDA GUID tool
Input: RA batch loads CSV file pulled from Birth Data qualtrics form (Currently only Susan can do this) Output: CSV file with GUID added for use in NDA
OnCore
Input:
- Participant ID information (batch upload or manual?)
- Participant eligibility information
- Participant visit information
Output: Whatever the CT oversight group needs - Not for study data collection, although it will provide visit information
SOPS
See SOPs
Recruitment
Soft Launch
- Craiglist ads in Madison/Milwaukee/Chicago
- Possibly bulk email to UW staff & students?
Advertising
- Craigslist
- Clinic partnerships, if we can find them