Precision Nudging Drives Wellness Visit Attendance at Scale

Study Overview
=================
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.

Official Title
-----------------
Employing Machine Learning and Behavioral Science Solutions to Increase Women's Wellness Scheduling and Attendance: A Randomized Controlled Trial

Conditions
-----------------
Women's Health, Annual Visit, Well Visit, Health Behavior, Prevention

Intervention / Treatment
-----------------
* Other: Precision nudging
* Other: Standard of care


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is designed as a prospective, parallel, large simple superiority randomized controlled trial using simple randomization (no blocking, no stratification).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Behavioral science and reinforcement learning-driven hyper-personalized messages | Other: Precision nudging<br>* 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)<br>|
| Active Comparator: Control<br>Standard of care message | Other: Standard of care<br>* Standard of care communication (e.g., personalized letters and patient portal notices)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who attended a well woman visit |  | 3 months | 
| Proportion of participants who attended a well woman visit |  | 6 months | 
| Proportion of participants who attended a well woman visit |  | 9 months | 
| Proportion of participants who attended a well woman visit |  | 12 months | 
| Proportion of participants who scheduled a well woman visit |  | 3 months | 
| Proportion of participants who scheduled a well woman visit |  | 6 months | 
| Proportion of participants who scheduled a well woman visit |  | 9 months | 
| Proportion of participants who scheduled a well woman visit |  | 12 months | 
| Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule) |  | 3 months | 
| Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule) |  | 6 months | 
| Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule) |  | 9 months | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s) |  | 3 months | 
| Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s) |  | 6 months | 
| Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s) |  | 9 months | 
| Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s) |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digital Health Intervention, Behavior Change, Reinforcement Learning, Artificial Intelligence