Effect of a Patient-Centered Decision App on TOLAC

NCT02646423 | Completed Results

• 1 other identifier: 1R01HD078748
• Study Type: interventional
• Target: 1,485
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Pregnancy; Repeat Cesarean Section; Vaginal Births After Cesarean

Keywords

Trial of labor after cesarean; Elective repeat cesarean delivery; Decision tool; Shared decision making

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC)

  0 to 8 weeks after delivery

• Knowledge About TOLAC and ERCD

  Approx 34-37 weeks gestation

• Decisional Conflict

  Approx 34-37 weeks gestation

• Shared Decision Making

  Approx 34-37 weeks gestation

• Decision Self-Efficacy

  Approx 34-37 weeks gestation

Study Arms (2)

Prior CD Decision App (PCDDA)

EXPERIMENTAL

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

Usual Care - No App

NO INTERVENTION

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

Interventions

Prior CD Decision App BEHAVIORAL

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.

Prior CD Decision App (PCDDA)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Northwestern Memorial Hospital: collaborator
• Massachusetts General Hospital: collaborator
• Marin Community Clinics: collaborator
• Sutter Health: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (5)

Sutter Health, California Pacific Medical Center, St. Luke's Campus

San Francisco, California, 94110, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Marin Community Clinic

San Rafael, California, 94901, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (15)

• 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.

  PMID: 22939727 BACKGROUND

• 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.

  PMID: 18255248 BACKGROUND

• O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.

  PMID: 7898294 BACKGROUND

• 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.

  PMID: 19879711 BACKGROUND

• 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.

  PMID: 8717600 BACKGROUND

• Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2012. Natl Vital Stat Rep. 2013 Sep;62(3):1-20.

  PMID: 24321416 BACKGROUND

• Guise J-M, Eden K, Emeis C, Denman MA, Marshall N, Fu R, Janik R, Nygren P, Walker M, McDonagh M. Vaginal birth after cesarean: New insights. Evidence report/Technology assessment no.191. (prepared by the Oregon Health & Science University Evidence-based Practice Center under contract no. 290-2007-10057-I). AHRQ publication no. 10-E003. Rockville, MD: Agency for Healthcare Research and Quality. March 2010.

  BACKGROUND

• 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.

  PMID: 22670489 BACKGROUND

• 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.

  PMID: 21133967 BACKGROUND

• 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.

  PMID: 15598960 BACKGROUND

• 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.

  PMID: 16260206 BACKGROUND

• 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.

  PMID: 7078857 BACKGROUND

• 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.

  PMID: 20654776 BACKGROUND

• 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.

  PMID: 10815084 BACKGROUND

• 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.

  PMID: 32484533 RESULT

Related Links

• Decisional Conflict Scale
• Decision Self-Efficacy Scale

Results Point of Contact

• Title: Miriam Kupperman, PhD, MPH
• Organization: University of California, San Francisco

miriam.kupperman@ucsf.edu

415-502-4089

Study Officials

• Miriam Kupperman, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: January 5, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 2, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-01

Locations

US (5)