Clinical trial NCT05509049: Precision Nudging Drives Wellness Visit Attendance at Scale
Official title: Employing Machine Learning and Behavioral Science Solutions to Increase Women's Wellness Scheduling and Attendance: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women's Health
Annual Visit
Well Visit
Health Behavior
Prevention
Keywords: Digital Health Intervention
Behavior Change
Reinforcement Learning
Artificial Intelligence
Lead sponsor: Lirio
Sponsor class: INDUSTRY
Collaborators: name: Rochester Regional Health
First posted: 2022-08-19
Enrollment: 30068
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as a prospective, parallel, large simple superiority randomized controlled trial using simple randomization (no blocking, no stratification).
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants who attended a well woman visit
timeFrame: 3 months
measure: Proportion of participants who attended a well woman visit
timeFrame: 6 months
measure: Proportion of participants who attended a well woman visit
timeFrame: 9 months
measure: Proportion of participants who attended a well woman visit
timeFrame: 12 months
measure: Proportion of participants who scheduled a well woman visit
timeFrame: 3 months
measure: Proportion of participants who scheduled a well woman visit
timeFrame: 6 months
measure: Proportion of participants who scheduled a well woman visit
timeFrame: 9 months
measure: Proportion of participants who scheduled a well woman visit
timeFrame: 12 months
measure: Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
timeFrame: 3 months
measure: Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
timeFrame: 6 months
measure: Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
timeFrame: 9 months
measure: Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
timeFrame: 3 months
measure: Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
timeFrame: 6 months
measure: Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
timeFrame: 9 months
measure: Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Rochester Regional Health
state: New York
Study officials:
affiliation: Rochester Regional Health
name: Laurie Ernest, DNP, BSN, MS, WHNP-C
role: PRINCIPAL_INVESTIGATOR
References: