An Interactive Web-based Decision Aid for Shared Decision Making: Birth Choice After Cesarean in Taiwan
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- change is being assessed-decisional conflict
Study Overview
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.
Detailed Description
Study design:
A sequential mixed methods approach was conducted based on the Ottawa Decision Support Framework (ODSF). The current study will represent Aim 4 (Intervention implementation phase), comprising two stages. Stage 1 involves a randomized pre-test and post-test experimental design. Decisional conflict, knowledge, birth preference, and decision aid acceptability are assessed. Stage 2 consists of a survey, actual birth outcome and satisfaction are assessed.
Setting and participants:
The study will be conducted in a medical center in northern Taiwan. The medical center offers 24-hour system of the designated obstetrician. Using purposive sampling, the selection criteria include women who are medically eligible for VBAC in the study site, had experienced one previous CS, 14-16 weeks' gestation, had at least a half year interval between current pregnancy and the previous birth and are fluent in English or Mandarin. Exclusion criteria included women with multiple pregnancy, previous classic CS or myomectomy, and/or pregnancy with high risk of complications (for example, women who had risk factors such as hypertension, heart disease, diabetes, epilepsy, threatened premature labor, or another pre-existing medical problem).
Randomization:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pregnant women had experienced one previous cesarean
- •pregnant women had at least a half year interval between current pregnancy and the previous birth
Exclusion Criteria
- •women are multiple pregnancy
- •women had previous classic CS or myomectomy
- •pregnant women have high risk of complications
Arms & Interventions
intervention
usual care plus web-based birth decision aid
Intervention: web-based birth decision aid (Device)
control
ususal care
Outcomes
Primary Outcomes
change is being assessed-decisional conflict
Time Frame: 14-16 week gestation and 35-38week gestation
Decisional conflict score (DCS)includes 16 questions. Using the 5-point Likert 5 rating, from "strongly agree" (0 points) to "strongly disagree" (4 points)
decision aid acceptability
Time Frame: 35-38week gestation
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)
change is being assessed-knowledge
Time Frame: 14-16 week gestation and 35-38week gestation
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
change is being assessed-birth preference
Time Frame: 14-16 week gestation and 35-38week gestation
VBAC/ERCS
Secondary Outcomes
- Actual birth outcomes(one month after birth)
- satisfaction of decision(one month after birth)
Investigators
She Wen Chen
Assistant Professor
National Taipei University of Nursing and Health Sciences