RCT Protocol for Evaluating an Online Training Program on Shared Decision-making About Screening for Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change of intention to use a decision aid after completing the online training program on SDM in prenatal screening
研究概览
简要总结
The investigators aim to evaluate an online training program on shared decision making within the prenatal context. The main outcome is intention on using a decision aid in prenatal screening consultation and study population is nurses. Secondary outcomes are; knowledge acquisition, acceptability of the formation and perceived usefulness. The investigators hypothesise that this web-based SDM training program developed for the prenatal screening of Down Syndrome will significantly increase nurses' intentions to use the decision aid in their clinical practice with pregnant women and their partner.
详细描述
Pregnant women have difficulty choosing among the wide variety of prenatal screening options available. To help pregnant women and their partners make informed decisions based on their values, needs and preferences, a decision aid (DA) has been developped and online shared decision-making (SDM) training program for health professionals has been created to support the use of this DA and give health care professionals key elements on SDM. The decision aid was found relevant and acceptable to pregnant women and their partners; the relevance and acceptability of the online SDM training program aren't evaluated yet. This study aim to assess the intention on using a DA after taking the online training program, to evaluate knowledge acquisition and to assess the program's acceptability and perceived usefulness. This is a multi-center, two-arm, controlled trial (RCT). Thirty-six participants will be randomly allocated to either 1) an experimental group that is exposed to the investigator's complete 3 hours online training program intervention (n = 18) or 2) a control group that is exposed to an intervention which will be a 3 hours online training program focused on prenatal screening alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
When a participant is randomised to the trial, the private firm will assign a trial group following a pre-selected list of randomisation (given by the private firm). The employee of the private firm will be the one non-blinded in our study, by giving participant access to one of the formation. The ''Care Provider'' is not present in this study; in fact, all interactions are via the private firm and is directed towards an online-intervention. A randomisation list will be kept by the private firm and send to the research team after the data analysis. The Investigator are blinded also by the randomisation process. There is no officially Outcomes Assessor, because the outcomes of interest are self-reported (intention of using a DA) or pre-measured (for example; with the knowledge test, rightful answer are already known).
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be a certified nurse
- •Be involved in supporting prenatal screening decision-making or involved in prenatal screening processes in the province of Quebec;
- •Speak and write in French
- •Being in active practice within the last year.
排除标准
- 未提供
结局指标
主要结局
Change of intention to use a decision aid after completing the online training program on SDM in prenatal screening
时间窗: The intention will be measured initially before accessing the formation. After the formation completed (duration is variable), the participant will have access to the questionnaire once again in a delay of 24-72 hours.
Nurses intention of using a decision aid for prenatal screening in clinical practice is the primary outcome. To be measured, the CPD (Continuing professional development) reaction questionnaire will be used. This questionaire scores on 5 constructs; intention, social influence, beliefs about capabilities, moral norm and beliefs about consequences and has 12 questions. The constructs intention will be targeted, however the others constructs will be also evaluated for their potential on predicting behavior of health professionals. It is a self-reported questionnaire. The use of decision aid has been chosen as an outcome become it is a main component of SDM itself and of the training. The score is on a scale from 1 to 7 (Likert type), which 1 is the minimum and 7 the maximum value (except one question that has a 5 intervals of pourcentage, that will be adjusted on 7 items scale in the analysis). The higher score means better outcome.
次要结局
- Knowledge on aspects surrounding prenatal screening and SDM(After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.)
- Perceived usefulness(After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.)
- Satisfaction with training: self-reported questionnaire(After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.)
- Acceptability of the training: self-reported questionnaire(After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.)
研究者
France Legare
Principal investigator
CHU de Quebec-Universite Laval