- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05509049
Precision Nudging Drives Wellness Visit Attendance at Scale
January 16, 2024 updated by: Lirio
Employing Machine Learning and Behavioral Science Solutions to Increase Women's Wellness Scheduling and Attendance: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30068
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 14617
- Rochester Regional Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
Behavioral science and reinforcement learning-driven hyper-personalized messages
|
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
|
Standard of care communication (e.g., personalized letters and patient portal notices)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of participants who attended a well woman visit
Time Frame: 3 months
|
3 months
|
|
Proportion of participants who attended a well woman visit
Time Frame: 6 months
|
6 months
|
|
Proportion of participants who attended a well woman visit
Time Frame: 9 months
|
9 months
|
|
Proportion of participants who attended a well woman visit
Time Frame: 12 months
|
12 months
|
|
Proportion of participants who scheduled a well woman visit
Time Frame: 3 months
|
3 months
|
|
Proportion of participants who scheduled a well woman visit
Time Frame: 6 months
|
6 months
|
|
Proportion of participants who scheduled a well woman visit
Time Frame: 9 months
|
9 months
|
|
Proportion of participants who scheduled a well woman visit
Time Frame: 12 months
|
12 months
|
|
Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
Time Frame: 3 months
|
3 months
|
|
Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
Time Frame: 6 months
|
6 months
|
|
Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
Time Frame: 9 months
|
9 months
|
|
Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
Time Frame: 3 months
|
3 months
|
|
Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
Time Frame: 6 months
|
6 months
|
|
Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
Time Frame: 9 months
|
9 months
|
|
Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Laurie Ernest, DNP, BSN, MS, WHNP-C, Rochester Regional Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2022
Primary Completion (Actual)
January 9, 2024
Study Completion (Actual)
January 9, 2024
Study Registration Dates
First Submitted
August 17, 2022
First Submitted That Met QC Criteria
August 17, 2022
First Posted (Actual)
August 19, 2022
Study Record Updates
Last Update Posted (Estimated)
January 17, 2024
Last Update Submitted That Met QC Criteria
January 16, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- LRRHWWRCT
- IRB 2129 (Other Identifier: Rochester Regional Health Institutional Review Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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