An Interactive Web-based Decision Aid for Shared Decision Making: Birth Choice After Cesarean in Taiwan
试验速览
- 阶段
- 不适用
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- decision aid acceptability
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women had experienced one previous cesarean
- •pregnant women had at least a half year interval between current pregnancy and the previous birth
排除标准
- •women are multiple pregnancy
- •women had previous classic CS or myomectomy
- •pregnant women have high risk of complications
结局指标
主要结局
decision aid acceptability
时间窗: 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
时间窗: 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
时间窗: 14-16 week gestation and 35-38week gestation
VBAC/ERCS
change is being assessed-decisional conflict
时间窗: 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)
次要结局
- Actual birth outcomes(one month after birth)
- satisfaction of decision(one month after birth)
研究者
She Wen Chen
Assistant Professor
National Taipei University of Nursing and Health Sciences