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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Repeat Cesarean Section; Vaginal Births After Cesarean
• Intervention / Treatment: Behavioral: Prior CD Decision App

• Study Type: Interventional
• Enrollment (Actual): 1485
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF
    • San Francisco, California, United States, 94110
      • Sutter Health, California Pacific Medical Center, St. Luke's Campus
    • San Rafael, California, United States, 94901
      • Marin Community Clinic
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prior CD Decision App (PCDDA); 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; 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.
No Intervention: Usual Care - No App; Women randomized to the Usual Care - No App group will simply continue with usual care.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Massachusetts General Hospital; Northwestern Memorial Hospital; Sutter Health; Marin Community Clinics
• Investigators: Principal Investigator: Miriam Kupperman, PhD, MPH, University of California, San Francisco

Publications and helpful links

General Publications

• Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi: 10.1177/0272989X9601600114.
• Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
• O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
• Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Kirmeyer S, Mathews TJ, Wilson EC. Births: final data for 2009. Natl Vital Stat Rep. 2011 Nov 3;60(1):1-70.
• Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2012. Natl Vital Stat Rep. 2013 Sep;62(3):1-20.
• Bernstein SN, Matalon-Grazi S, Rosenn BM. Trial of labor versus repeat cesarean: are patients making an informed decision? Am J Obstet Gynecol. 2012 Sep;207(3):204.e1-6. doi: 10.1016/j.ajog.2012.06.057. Epub 2012 Jul 4.
• Farnworth A, Robson SC, Thomson RG, Watson DB, Murtagh MJ. Decision support for women choosing mode of delivery after a previous caesarean section: a developmental study. Patient Educ Couns. 2008 Apr;71(1):116-24. doi: 10.1016/j.pec.2007.11.020. Epub 2008 Feb 6.
• Guise JM, Eden K, Emeis C, Denman MA, Marshall N, Fu RR, Janik R, Nygren P, Walker M, McDonagh M. Vaginal birth after cesarean: new insights. Evid Rep Technol Assess (Full Rep). 2010 Mar;(191):1-397.
• Grobman WA, Lai Y, Landon MB, Spong CY, Rouse DJ, Varner MW, Caritis SN, Harper M, Wapner RJ, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. The change in the rate of vaginal birth after caesarean section. Paediatr Perinat Epidemiol. 2011 Jan;25(1):37-43. doi: 10.1111/j.1365-3016.2010.01169.x. Epub 2010 Oct 25.
• Landon MB, Hauth JC, Leveno KJ, Spong CY, Leindecker S, Varner MW, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM, Gabbe SG; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal and perinatal outcomes associated with a trial of labor after prior cesarean delivery. N Engl J Med. 2004 Dec 16;351(25):2581-9. doi: 10.1056/NEJMoa040405. Epub 2004 Dec 14.
• Macones GA, Peipert J, Nelson DB, Odibo A, Stevens EJ, Stamilio DM, Pare E, Elovitz M, Sciscione A, Sammel MD, Ratcliffe SJ. Maternal complications with vaginal birth after cesarean delivery: a multicenter study. Am J Obstet Gynecol. 2005 Nov;193(5):1656-62. doi: 10.1016/j.ajog.2005.04.002.
• Lavin JP, Stephens RJ, Miodovnik M, Barden TP. Vaginal delivery in patients with a prior cesarean section. Obstet Gynecol. 1982 Feb;59(2):135-48.
• Silver RM. Delivery after previous cesarean: long-term maternal outcomes. Semin Perinatol. 2010 Aug;34(4):258-66. doi: 10.1053/j.semperi.2010.03.006.
• Lydon-Rochelle M, Holt VL, Martin DP, Easterling TR. Association between method of delivery and maternal rehospitalization. JAMA. 2000 May 10;283(18):2411-6. doi: 10.1001/jama.283.18.2411.
• Kuppermann M, Kaimal AJ, Blat C, Gonzalez J, Thiet MP, Bermingham Y, Altshuler AL, Bryant AS, Bacchetti P, Grobman WA. Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial. JAMA. 2020 Jun 2;323(21):2151-2159. doi: 10.1001/jama.2020.5952.

Helpful Links

• Decisional Conflict Scale
• Decision Self-Efficacy Scale

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 31, 2015
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Shared decision making; Trial of labor after cesarean; Elective repeat cesarean delivery; Decision tool
• Other Study ID Numbers: 1R01HD078748 (U.S. NIH Grant/Contract)