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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD098496 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Ohio State University | OTHER |
| University of California, San Francisco | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision Support Tool | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elective Induction of Labor Decision Support Tool | Behavioral | Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Recruitment rate, defined as the number of people who agree to participate out of those who are approached for the study | 32-38 weeks gestation |
| 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 | 36-38 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction With the Decision Support Tool | 4 item scale. Range of 0-20, with higher scores indicating higher satisfaction. | 36-38 weeks gestation |
| Satisfaction With the Decision Support Tool |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33606 | United States | ||
| The Ohio State University |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Rate | Recruitment rate, defined as the number of people who agree to participate out of those who are approached for the study | Recruitment rate will be calculated based on the number of people approached who were eligible and agreed to participate in the study | Posted | Count of Participants | Participants | 32-38 weeks gestation |
|
From study start through completion of the last chart review (30 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anjali Kaimal, MD, MAS | University of South Florida Morsani College of Medicine, Department of Obstetrics and Gynecology | (813) 259-8680 | akaimal@usf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2023 | Dec 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.
| 38-39 weeks gestation, prior to delivery |
| Impact of App on Decision Making | 5 point scale (Strongly disagree to Strongly agree, 5=Strongly agree) "Viewing the App affected my decision making" | 2-4 weeks Postpartum |
| Columbus |
| Ohio |
| 43210 |
| United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| 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 | All participants interacting with the decision support tool | Posted | Count of Participants | Participants | 36-38 weeks gestation |
|
|
|
| Secondary | Satisfaction With the Decision Support Tool | 4 item scale. Range of 0-20, with higher scores indicating higher satisfaction. | Participants completing questionnaire after interacting with the decision support tool | Posted | Mean | Standard Deviation | score on a scale | 36-38 weeks gestation |
|
|
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| Secondary | Satisfaction With the Decision Support Tool | 4 item scale. Range of 0-20, with higher scores indicating higher satisfaction. | Participants completing follow up questionnaire at 38-39 weeks gestation, prior to delivery | Posted | Mean | Standard Deviation | score on a scale | 38-39 weeks gestation, prior to delivery |
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| 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" | Participants completing follow up questionnaire at 2-4 weeks postpartum | Posted | Mean | Standard Deviation | units on a scale | 2-4 weeks Postpartum |
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| 0 |
| 66 |
| 0 |
| 66 |
| 0 |
| 66 |
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