Effect of a Patient-Centered Decision App on TOLAC

Pregnancy Clinical Trial

— PROCEED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646423
• Other study ID #: 1R01HD078748
• Secondary ID: 1R01HD078748
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: June 2019

Study information

• Verified date: January 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1485
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy
• Repeat Cesarean Section
• Vaginal Births After Cesarean

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Sutter Health, California Pacific Medical Center, St. Luke's Campus	San Francisco	California
United States	UCSF	San Francisco	California
United States	Marin Community Clinic	San Rafael	California

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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.

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

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. — View Citation

Kriston L, Scholl I, Hölzel L, Simon D, Loh A, Härter 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. — View Citation

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 C — View Citation

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. Epub 2004 Dec 14. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. — View Citation

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. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   Decision Self-Efficacy Scale
•   Decisional Conflict Scale