Trial Outcomes & Findings for Effect of a Patient-Centered Decision App on TOLAC (NCT NCT02646423)

Results Overview

Number of participants who underwent a trial of labor after cesarean (TOLAC) delivery, as noted in the medical record.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1485 participants

Primary outcome timeframe

0-8 weeks after delivery

Results posted on

2021-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Usual Care - No App Women randomized to the Usual Care - No App group will simply continue with usual care.
Overall Study STARTED	742	743
Overall Study COMPLETED	735	735
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Usual Care - No App Women randomized to the Usual Care - No App group will simply continue with usual care.
Overall Study Adverse Event	5	7
Overall Study Ineligible	2	1

Baseline Characteristics

Effect of a Patient-Centered Decision App on TOLAC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prior CD Decision App (PCDDA) n=735 Participants 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.	Usual Care - No App n=735 Participants Women randomized to the Usual Care - No App group will simply continue with usual care.	Total n=1470 Participants Total of all reporting groups
Age, Continuous	34.1 years STANDARD_DEVIATION 4.6 • n=5 Participants	34.0 years STANDARD_DEVIATION 4.5 • n=7 Participants	34.0 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	735 Participants n=5 Participants	735 Participants n=7 Participants	1470 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · White	394 Participants n=5 Participants	411 Participants n=7 Participants	805 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · Latina	124 Participants n=5 Participants	124 Participants n=7 Participants	248 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · Asian or Pacific Islander	110 Participants n=5 Participants	106 Participants n=7 Participants	216 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · Black	64 Participants n=5 Participants	52 Participants n=7 Participants	116 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · Biracial or multiracial/multiethnic	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · Other	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States · University of California, San Francisco	192 Participants n=5 Participants	193 Participants n=7 Participants	385 Participants n=5 Participants
Region of Enrollment United States · Marin Community Clinic, San Rafael, California	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment United States · St Luke's Women's Clinic, San Francisco	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States · Massachusetts General Hospital, Boston	274 Participants n=5 Participants	278 Participants n=7 Participants	552 Participants n=5 Participants
Region of Enrollment United States · Northwestern University Medical Center, Chicago	225 Participants n=5 Participants	221 Participants n=7 Participants	446 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0-8 weeks after delivery

Population: Prior CD Decision App (PCDDA): no data available for N=8 participants who delivered at outside institution and no chart or outside questionnaire obtained. Usual Care - No App: no data available for N=3 participants who delivered at outside institution and no chart or outside questionnaire obtained.

Number of participants who underwent a trial of labor after cesarean (TOLAC) delivery, as noted in the medical record.

Outcome measures

Outcome measures
Measure	Prior CD Decision App (PCDDA) n=727 Participants 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.	Usual Care - No App n=732 Participants Women randomized to the Usual Care - No App group will simply continue with usual care.
Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery	315 Participants	338 Participants

SECONDARY outcome

Timeframe: 0 to 8 weeks after delivery

Population: Prior CD Decision App (PCDDA): no data available for N=8 participants who delivered at outside institution and no chart or outside questionnaire obtained. Usual Care - No App: no data available for N=3 participants who delivered at outside institution and no chart or outside questionnaire obtained.

Number of participants who underwent vaginal birth after cesarean (VBAC), as noted in the medical record.

Outcome measures

Outcome measures
Measure	Prior CD Decision App (PCDDA) n=727 Participants 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.	Usual Care - No App n=732 Participants Women randomized to the Usual Care - No App group will simply continue with usual care.
Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC)	231 Participants	233 Participants

SECONDARY outcome

Timeframe: Approx 34-37 weeks gestation

Population: Prior CD Decision App (PCDDA): 676 Follow-up telephone interviews obtained, 31 Could not be reached for follow-up, 26 Delivered prior to follow-up interview, 2 Had pregnancy loss ≥22 wk. Usual Care - No App: 681 Follow-up telephone interviews obtained, 31 Could not be reached for follow-up, 23 Delivered prior to follow-up interview.

8-item knowledge scale, administered during telephone interview. Scores ranged from 0 to 8 with higher scored indicating greater knowledge.

Outcome measures

Outcome measures
Measure	Prior CD Decision App (PCDDA) n=676 Participants 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.	Usual Care - No App n=681 Participants Women randomized to the Usual Care - No App group will simply continue with usual care.
Knowledge About TOLAC and ERCD	5.0 score on a scale Standard Deviation 1.8	5.0 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Approx 34-37 weeks gestation

Population: Prior CD Decision App (PCDDA): 676 Follow-up telephone interviews obtained. Responses on the Decisional Conflict Scale missing for 5 participants with PCDAA. Usual Care-No App: 681 Follow-up interviews obtained. Responses on the Decisional Conflict Scale missing for 6 participants with usual care.

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.

Outcome measures

Outcome measures
Measure	Prior CD Decision App (PCDDA) n=671 Participants 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.	Usual Care - No App n=675 Participants Women randomized to the Usual Care - No App group will simply continue with usual care.
Decisional Conflict	17.2 score on a scale Standard Deviation 12.9	17.5 score on a scale Standard Deviation 13.9

SECONDARY outcome

Timeframe: Approx 34-37 weeks gestation

Population: Prior CD Decision App (PCDDA): 676 Follow-up telephone interviews obtained. Responses on the Shared Decision Making Scale missing for 12 participants with PCDAA. Usual Care-No App: 681 Follow-up interviews obtained. Responses on the Shared Decision Making Scale missing for 9 participants with usual care.

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.

Outcome measures

Outcome measures
Measure	Prior CD Decision App (PCDDA) n=664 Participants 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.	Usual Care - No App n=672 Participants Women randomized to the Usual Care - No App group will simply continue with usual care.
Shared Decision Making	74.4 score on a scale Standard Deviation 14.9	74.8 score on a scale Standard Deviation 15.9

SECONDARY outcome

Timeframe: Approx 34-37 weeks gestation

Population: Prior CD Decision App (PCDDA): 676 Follow-up telephone interviews obtained. Responses on the Decisional Self-Efficacy Scale missing for 6 participants with PCDAA. Usual Care-No App: 681 Follow-up interviews obtained. Responses on the Decisional Self-Efficacy Scale missing for 9 participants with PCDAA.

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).

Outcome measures

Outcome measures
Measure	Prior CD Decision App (PCDDA) n=670 Participants 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.	Usual Care - No App n=672 Participants Women randomized to the Usual Care - No App group will simply continue with usual care.
Decision Self-Efficacy	90.7 score on a scale Standard Deviation 12.3	90.3 score on a scale Standard Deviation 12.2

SECONDARY outcome

Timeframe: Approx 34-37 weeks gestation

Population: Prior CD Decision App (PCDDA): 676 Follow-up telephone interviews obtained. Responses on the Decisional Satisfaction Scale missing for 1 participant with PCDAA. Usual Care-No App: 681 Follow-up interviews obtained. Responses on the Decisional Satisfaction Scale missing for 2 participants with PCDAA.

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.