Clincosm LogoSign in Get a demo

Precision Nudging Drives Wellness Visit Attendance at Scale

Sponsor
Lirio (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05509049
Collaborator
Rochester Regional Health (Other)
30,000
Enrollment
2
Arms
17
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of the present randomized controlled trial is to explore the effectiveness of a 12-month well woman digital health intervention leveraging Precision Nudging - the application of behavioral science and reinforcement learning to create individualized, tailored health messaging at scale that matches the right message to the right person at the right time - in promoting behavior change. Specifically, it is hypothesized that scaling behavioral science through reinforcement learning will be more effective at motivating participants to engage with well woman messages and to schedule and to attend a well woman visit compared to a standard of care message.

Condition or Disease Intervention/Treatment Phase
  • Other: Precision nudging
  • Other: Standard of care
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is designed as a prospective, parallel, large simple superiority randomized controlled trial using simple randomization (no blocking, no stratification).This study is designed as a prospective, parallel, large simple superiority randomized controlled trial using simple randomization (no blocking, no stratification).
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
Employing Machine Learning and Behavioral Science Solutions to Increase Women's Wellness Scheduling and Attendance: A Randomized Controlled Trial
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Behavioral science and reinforcement learning-driven hyper-personalized messages

Other: Precision nudging
Precision nudging (i.e., the application of behavioral science and reinforcement learning to create individualized, tailored health messaging at scale that matches the right message to the right person at the right time)
Active Comparator: Control

Standard of care message

Other: Standard of care
Standard of care communication (e.g., personalized letters and patient portal notices)

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants who attended a well woman visit [3 months]

  2. Proportion of participants who attended a well woman visit [6 months]

  3. Proportion of participants who attended a well woman visit [9 months]

  4. Proportion of participants who attended a well woman visit [12 months]

  5. Proportion of participants who scheduled a well woman visit [3 months]

  6. Proportion of participants who scheduled a well woman visit [6 months]

  7. Proportion of participants who scheduled a well woman visit [9 months]

  8. Proportion of participants who scheduled a well woman visit [12 months]

  9. Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule) [3 months]

  10. Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule) [6 months]

  11. Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule) [9 months]

  12. Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule) [12 months]

Secondary Outcome Measures

  1. Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s) [3 months]

  2. Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s) [6 months]

  3. Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s) [9 months]

  4. Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s) [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Patient of health care system.

  • Visit with OBGYN office in the last 36 months.

  • OBGYN office provider is a Women's Wellness group approved provider.

Exclusion Criteria:

  • Completed a women's wellness within the last 366 days.

  • Upcoming women's wellness appointment.

  • Had a childbirth episode (e.g., C-section vaginal delivery, or other event, including stillbirth) within the last 3 months or has a pregnancy due date in the future.

  • Unsubscribed.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Lirio
  • Rochester Regional Health

Investigators

  • Principal Investigator: Meghan Aldrich, DNP, CPNP, Rochester Regional Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lirio
ClinicalTrials.gov Identifier:
NCT05509049
Other Study ID Numbers:
  • LRRHWWRCT
  • IRB 2129
First Posted:
Aug 19, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lirio
Digital Health Intervention
Behavior Change
Reinforcement Learning
Artificial Intelligence

Study Results

No Results Posted as of Aug 23, 2022