An Interactive Web-based Birth Decision Aid for Shared Decision Making

NCT05091944 | Unknown DMC

• 1 other identifier: 2021-02-003A
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

An interactive web-based decision aid for shared decision making: birth choice after cesarean in Taiwan Background: Taiwan has a high national caesarean rate coupled with a low vaginal birth after caesarean (VBAC) rate. Studies suggest that pregnant women do not receive sufficient information about birth choices after caesarean in Taiwan and shared decision making (SDM) is not an expectation. Chen conducted a pilot study. Improvements in knowledge for the decision aid group were larger than for the usual care group, although differences between groups were not statistically significant. An interactive multimedia technology and humanity communication may provide opportunities to increase engagement and support women during decision consultations. Following previous pilot study, the study aims to examine the effectiveness of an interactive web-based birth decision aid for SDM in pregnant women who have had a previous cesarean. Methods: A quantitative approach will be conducted with a randomized pre-test and post-test experimental design in a medical center in northern Taiwan. Participants who have had one previous CS will be recruited at 14-16 weeks. A total of 172 women will be completed a baseline survey and will be randomly allocated to either the intervention (usual care plus an interactive web-based birth decision aid ) or usual care (general maternal health booklet) group. A follow up survey at 35-38 weeks measured change in decisional conflict, knowledge, birth preference and decision aid acceptability. Actual birth outcomes and satisfaction will be assessed one month after birth. Contributions/ Implementation of clinical practice The study will potentially increase women and obstetricians to support VBAC and SDM. The interactive decision aid tool may reduce time-consumption for health education. Linking web-based data analysis of AI into medical record can be beneficial for clinical practice and research in the future.

Conditions

Shared Decision Making; Vaginal Birth After Cesarean

Keywords

communication aids; web-based decision aids

Outcome Measures

Primary Outcomes (4)

• change is being assessed-decisional conflict

  Decisional conflict score (DCS)includes 16 questions. Using the 5-point Likert 5 rating, from "strongly agree" (0 points) to "strongly disagree" (4 points)

  14-16 week gestation and 35-38week gestation

• change is being assessed-knowledge

  Knowledge measurement consists of a 15-item questionnaire asking participants to answer ''true,'' ''false,'' or ''unsure'' to a series of statements regarding risks and benefits of each birth mode

  14-16 week gestation and 35-38week gestation

• change is being assessed-birth preference

  VBAC/ERCS

  14-16 week gestation and 35-38week gestation

• decision aid acceptability

  Decision aid acceptability included nine questions to measure women's acceptability regarding decision aid , using the Likert 5 rating, from "not at all" (1 points) to "a great deal" (5 points)

  35-38week gestation

Secondary Outcomes (2)

• Actual birth outcomes

  one month after birth

• satisfaction of decision

  one month after birth

Study Arms (2)

intervention

EXPERIMENTAL

usual care plus web-based birth decision aid

Device: web-based birth decision aid

control

NO INTERVENTION

ususal care

Interventions

web-based birth decision aid DEVICE

Women in the intervention group receive both usual care and decision support (an interactive web-based birth decision aid). The innovative interactive web-based birth decision aid comprised five components: Component 1-a communication aid video involves 2 expert's talk about how to participate in SDM and prepare self with choice talk, option talk and decision talk(10 minutes )and practice communication skills with clinician(10 minutes); Component 2-overall of the function and features of birth decision aid. Component 3-introduce the benefits and risk of vaginal birth after cesarean; Component 4- the benefits and risk of elective repeat cesarean section; Component 5 -a quit to confirm women's knowledge regarding the two choices and confirm women's values.

intervention

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women had experienced one previous cesarean
• pregnant women had at least a half year interval between current pregnancy and the previous birth

You may not qualify if:

• women are multiple pregnancy
• women had previous classic CS or myomectomy
• pregnant women have high risk of complications

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Related Publications (1)

• Chen SW, Shorten A, Yeh CC, Kao CH, Lu YY, Hu HW. An innovative web-based decision-aid about birth after cesarean for shared decision making in Taiwan: study protocol for a randomized control trial. Trials. 2023 Feb 9;24(1):103. doi: 10.1186/s13063-023-07103-8.

  PMID: 36759893 DERIVED

Study Officials

• Shu Wen Chen, PhD

  National Taipei University of Nursing and Health Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu Wen Chen, PhD

CONTACT

886-2-28227101; shuwen@ntunhs.edu.tw

Chang-Ching Yeh, PhD

CONTACT

886-2-28757826; ccyeh39@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 25, 2021
• Study Start: September 15, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

TW (1)