Precision Nudging Drives Wellness Visit Attendance at Scale

NCT05509049 | Completed

• 2 other identifiers: LRRHWWRCTIRB 2129
• Study Type: interventional
• Target: 30,068
• Locations: 1 country
• Sites: 1

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.

Conditions

Women's Health; Annual Visit; Well Visit; Health Behavior; Prevention

Keywords

Digital Health Intervention; Behavior Change; Reinforcement Learning; Artificial Intelligence

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (4)

• 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

Study Arms (2)

Treatment

EXPERIMENTAL

Behavioral science and reinforcement learning-driven hyper-personalized messages

Other: Precision nudging

Control

ACTIVE COMPARATOR

Standard of care message

Other: Standard of care

Interventions

Precision nudging OTHER

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)

Treatment

Standard of care OTHER

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

Control

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lirio: lead
• Rochester Regional Health: collaborator

Study Sites (1)

Rochester Regional Health

New York, New York, 14617, United States

Location

MeSH Terms

Conditions

Health Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Laurie Ernest, DNP, BSN, MS, WHNP-C

  Rochester Regional Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is designed as a prospective, parallel, large simple superiority randomized controlled trial using simple randomization (no blocking, no stratification).

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 19, 2022
• Study Start: September 7, 2022
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)