Visual Aids for Induction of Labor RCT

Study Overview
=================
Brief Summary
-----------------
This study aims to develop a visual aid tool for induction education informed by the experiences and needs of historically marginalized pregnant women, as well as determine the impact of the patient-informed visual aid on patient knowledge, satisfaction, and trust in physicians regarding induction methods.

Detailed Description
-----------------
This is a multi-phased study of patients undergoing IOL. Only the second phase of the study will be detailed in this protocol, as this will be the RCT portion of the study's design. We will test the efficacy of the visual aid by conducting a randomized trial of routine counseling versus counseling with the use of a visual aid (informed by patient interviews in the first phase) at the time of admission for IOL and studying the effect of the visual aid on patient knowledge, trust in providers, and satisfaction.

Official Title
-----------------
Visual Aids for Induction of Labor (IOL): A Randomized Controlled Trial for Assessment of Patient IOL Knowledge

Conditions
-----------------
Induced; Birth

Intervention / Treatment
-----------------
* Other: Visual aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for or admitted for induction of labor and who can speak, read, and write in the English language. Exclusion Criteria: Patients undergoing induction termination or with a history of prior cesarean section, major fetal anomaly, known chromosomal anomaly, or fetal growth restriction with doppler abnormalities. Patients whose induction has already commenced will also be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Single Group Assignment
Interventional Model Description: Using a web-based randomization sequence on REDCap, patients will be randomized in 1:1 ratio to standard counseling or counseling with a visual aid immediately prior to initiation of their IOL.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard counseling<br>Standard induction of labor counseling | |
| Experimental: Visual aid counseling<br>Counseling on induction of labor with either a video or a handout | Other: Visual aid<br>* Handout and video describing different types of induction of labor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction of labor knowledge | Multiple choice questions | 10 minutes (during completion of survey) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Likert scale (1-10) | 10 minutes (during completion of survey) | 
| Patient trust in providers survey |  | 10 minutes (during completion of survey) |