Labor, Induced, Patient Preference
Conditions
Keywords
Shared Decision Making
Brief summary
The goal of the proposed study is to perform a pilot test of a patient-centered decision support tool to help pregnant people and providers work together in making informed, shared decisions regarding whether or not to opt for elective IOL at 39 weeks gestation
Detailed description
60 nulliparous pregnant people with singleton, vertex pregnancies at 36-38 weeks who do not have an indication for induction of labor (IOL) will be enrolled and will view a decision support tool (DST) regarding induction without medical indication. During the enrollment face-to-face interview, participants will interact with the DST and complete pre- and post-DST viewing questionnaires. The investigators will conduct telephone interviews a few days later but before 39+0 weeks, and again 2-4 weeks postpartum and will review the medical record for delivery events and outcomes.
Interventions
BEHAVIORALElective Induction of Labor Decision Support Tool
Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor
Sponsors
Ohio State University
University of California, San Francisco
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of South Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant person * Nulliparous * Planned vaginal delivery * No medical indication for induction of labor
Exclusion criteria
* Contraindication to vaginal delivery * Prior delivery (vaginal or cesarean) * Medical indication for induction of labor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | 32-38 weeks gestation | Recruitment rate, defined as the number of people who agree to participate out of those who are approached for the study |
| Proportion of People Completely Viewing the Decision Support Tool | 36-38 weeks gestation | The proportion of participants who view all of the pages of the decision support tool will be calculated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With the Decision Support Tool | 36-38 weeks gestation | 4 item scale. Range of 0-20, with higher scores indicating higher satisfaction. |
| Impact of App on Decision Making | 2-4 weeks Postpartum | 5 point scale (Strongly disagree to Strongly agree, 5=Strongly agree) Viewing the App affected my decision making |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Decision Support Tool Participants will interact with the decision support tool prior to making their decision regarding whether to have an induction of labor without a medical indication
Elective Induction of Labor Decision Support Tool: Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor | 66 |
| Total | 66 |
Baseline characteristics
| Characteristic | Decision Support Tool |
|---|---|
| Age, Continuous | 29.2 years STANDARD_DEVIATION 3.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Region of Enrollment United States | 66 participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 66 |
| other Total, other adverse events | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 |
Outcome results
Primary
Proportion of People Completely Viewing the Decision Support Tool
The proportion of participants who view all of the pages of the decision support tool will be calculated
Time frame: 36-38 weeks gestation
Population: All participants interacting with the decision support tool
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Decision Support Tool | Proportion of People Completely Viewing the Decision Support Tool | 52 Participants |
Primary
Recruitment Rate
Recruitment rate, defined as the number of people who agree to participate out of those who are approached for the study
Time frame: 32-38 weeks gestation
Population: Recruitment rate will be calculated based on the number of people approached who were eligible and agreed to participate in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Decision Support Tool | Recruitment Rate | 66 Participants |
Secondary
Impact of App on Decision Making
5 point scale (Strongly disagree to Strongly agree, 5=Strongly agree) Viewing the App affected my decision making
Time frame: 2-4 weeks Postpartum
Population: Participants completing follow up questionnaire at 2-4 weeks postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Support Tool | Impact of App on Decision Making | 2.8 units on a scale | Standard Deviation 1.1 |
Secondary
Satisfaction With the Decision Support Tool
4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.
Time frame: 36-38 weeks gestation
Population: Participants completing questionnaire after interacting with the decision support tool
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Support Tool | Satisfaction With the Decision Support Tool | 17.4 score on a scale | Standard Deviation 2.7 |
Secondary
Satisfaction With the Decision Support Tool
4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.
Time frame: 38-39 weeks gestation, prior to delivery
Population: Participants completing follow up questionnaire at 38-39 weeks gestation, prior to delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Support Tool | Satisfaction With the Decision Support Tool | 17.0 score on a scale | Standard Deviation 3 |