Effect of a Patient-Centered Decision App on TOLAC (PROCEED)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Repeat Cesarean Section; Vaginal Births After Cesarean; Pregnancy

Treatments: Behavioral: Prior CD Decision App

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02646423

1R01HD078748 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,485 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women with exactly one prior Cesarean Delivery.
2. Current singleton pregnancy.
3. Gestational age, 12-24 weeks.
4. English or Spanish speaker.
5. Must be receiving prenatal care at one of the participating centers.

Exclusion criteria

1. Contraindications to vaginal delivery (e.g., placenta previa, prior classical cesarean, previous uterine rupture).
2. Prior VBAC.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,485 participants in 2 patient groups

Prior CD Decision App (PCDDA)

Experimental group

Description:

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.

Treatment:

Behavioral: Prior CD Decision App

Usual Care - No App

No Intervention group

Description:

Women randomized to the Usual Care - No App group will simply continue with usual care.