Effect of a Patient-Centered Decision App on TOLAC

Study Overview
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Brief Summary
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Cesarean delivery (CD) is the most common inpatient surgery in the US, accounting for nearly one third of births annually. In the last decade, the CD rate has increased by approximately 50%, with almost 1.3 million procedures performed in 2012 (Hamilton 2013). CDs have been associated with an increase in major maternal morbidity (Silver 2010), with corresponding increases in length of inpatient care following delivery and frequency of hospital readmission (Lydon-Rochelle 2000). Organizations including Healthy People, the American College of Obstetricians and Gynecologists (ACOG), and the American College of Nurse Midwives have targeted reducing the CD rate as an important public health goal for more than a decade; however, identifying interventions to achieve this goal has proven challenging. Repeat CDs are a significant contributor to the increased cesarean rate, resulting from the combination of a rising rate of primary CD and a decreasing rate of vaginal birth after cesarean (VBAC), which declined from a high of 28.3% in 1996 (Guide 2010) to 9.2% in 2010 (Hamilton 2011). Why the VBAC rate has decreased so dramatically remains a subject of debate; the extent to which these changes are driven by patient preferences is not known. An NIH consensus conference statement noted that the informed consent process for TOLAC and Elective Repeat Cesarean Delivery (ERCD) should be evidence-based, minimize bias, and incorporate a strong emphasis on the values and preferences of pregnant women, and recommended interprofessional collaboration to refine, validate, and implement decision-making and risk assessment tools to accomplish that goal (Cunningham 2010). Our group recently created a decision tool, which we refer to as the Prior CD App (PCDA), to help English- or Spanish-speaking TOLAC-eligible women delivering at hospitals that offer TOLAC consider individualized risk assessments, incorporate their values and preferences, and participate in a shared decision making process with their providers to make informed decisions about delivery approach. We are now conducting a randomized study of the effect of a Prior CD App on TOLAC and VBAC rates, as well as a number of aspects of decision quality.

Official Title
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Effect of a Patient-Centered Decision App on TOLAC: An RCT

Conditions
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Pregnancy, Repeat Cesarean Section, Vaginal Births After Cesarean

Intervention / Treatment
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* Behavioral: Prior CD Decision App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with exactly one prior Cesarean Delivery. Current singleton pregnancy. Gestational age, 12-24 weeks. English or Spanish speaker. Must be receiving prenatal care at one of the participating centers. Exclusion Criteria: Contraindications to vaginal delivery (e.g., placenta previa, prior classical cesarean, previous uterine rupture). Prior VBAC.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prior CD Decision App (PCDDA)<br>Women who are randomized to PCDDA will be provided access to a tablet which they can use to view the Prior CD Decision App at their own pace. The research assistant will print a summary of the participant's predicted likelihood of a vaginal delivery (VBAC) if she undergoes a trial of labor (TOLAC), as well as her answers to the values clarification exercises, that she can review and share with whomever she chooses, including her provider. | Behavioral: Prior CD Decision App<br>* The Prior CD Decision App begins with an explanation that its goal is to help the user better understand the two approaches to delivery she is eligible for (trial of labor after cesarean (TOLAC) and elective repeat cesarean delivery (ERCD)), and that its goal is to help her engage with her provide in making an informed, shared decision regarding which approach to undergo. It includes four sections: a calculator to estimate the likelihood of having a vaginal delivery if she undergoes TOLAC, a series of information pages that include graphical presentations of the chances of various potential outcomes of the two options, a series of values clarification exercises to help the user think through what's important to her, and a summary print out for her to keep.<br>|
| No Intervention: Usual Care - No App<br>Women randomized to the Usual Care - No App group will simply continue with usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery | Number of participants who underwent a trial of labor after cesarean (TOLAC) delivery, as noted in the medical record. | 0-8 weeks after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC) | Number of participants who underwent vaginal birth after cesarean (VBAC), as noted in the medical record. | 0 to 8 weeks after delivery | 
| Knowledge About TOLAC and ERCD | 8-item knowledge scale, administered during telephone interview. Scores ranged from 0 to 8 with higher scored indicating greater knowledge. | Approx 34-37 weeks gestation | 
| Decisional Conflict | 16-item Decisional Conflict Scale with 5 response categories, administered during telephone interview. Scoring: total scale-0 (no decisional conflict) to 100 (extreme decisional conflict) lower values indicate lower decisional conflict. | Approx 34-37 weeks gestation | 
| Shared Decision Making | 9-item Shared Decision Making Scale, administered during telephone interview. Shared decision-making was measured using the 9-item Shared Decision Making Questionnaire (SDM-Q-9), a psychometrically evaluated tool. The core instrument consists of nine statements, which can be rated on a six-point scale from completely disagree (0) to completely agree (5). The Shared Decision Score can range from 0 to 100, with higher scores indicating more shared decision-making. | Approx 34-37 weeks gestation | 
| Decision Self-Efficacy | 11-item Decisional Self-Efficacy Scale, administered during telephone interview. The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (not confident) to 100 (extremely confident). | Approx 34-37 weeks gestation | 
| Decision Satisfaction | 6-item Satisfaction with Decision Scale, administered during telephone interview. Satisfaction With Decision Scale scores range from 0 to 5, with higher scores indicating more satisfaction. | Approx 34-37 weeks gestation | 
| Maternal Major Morbidity | Defined as any of: uterine rupture, hysterectomy, surgical injury (bowel, bladder/ureter, or other), maternal death, as noted in the medical record for her delivery. | Collected 0 to 8 weeks after delivery. | 
| Maternal Minor Morbidity | Defined as any of: blood transfusion, postpartum febrile morbidity (endometritis, cellulitis, urinary tract infection, or other infection), as noted in the medical record for her delivery. | Collected 0 to 8 weeks after delivery. | 
| 3rd or 4th Degree Lacerations | 3rd or 4th degree lacerations, as noted in the medical record for her delivery. | Collected 0 to 8 weeks after delivery. | 
| Perinatal Death or Hypoxic-ischemic Encephalopathy | Stillbirth/fetal demise (antepartum or intrapartum), neonatal death, HIE, as noted in the medical record for her delivery. | Collected 0 to 8 weeks after delivery. | 
| Neonatal Respiratory Morbidity | Respiratory morbidity requiring CPAP or intubation, as noted in the medical record for her delivery. | Collected 0 to 8 weeks after delivery. | 
| Neonatal Intensive Care Unit (NICU) Admission | Neonatal intensive care unit (NICU) admission, as noted in the medical record for her delivery. | Collected 0 to 8 weeks after delivery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trial of labor after cesarean, Elective repeat cesarean delivery, Decision tool, Shared decision making