Effects of Parents Included in Decision-making During Medical Round in Neonatal Intensive Care Unit: Cross-over Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Quality of family centered care assessed by healthcare staff
研究概览
简要总结
The goal of this cross-over randomized controlled study is to evaluate the effects of medical rounds with parents. The main questions it aims to answer are:
- How feasible the protocol of this study is to include parents in the medical round?
- Does the Family Round promote the quality of family centered care in the NICU perceived by parents and healthcare staff?
- Does the Family Round promote parent-infant bonding?
- Does the Family Round reduce parents' anxiety?
- Does the Family Round increase parents' satisfaction?
- Does the Family Round improve staff's communication skills to integrate parents in the discussion of medical rounds?
Participants will participate in the Family Round for two weeks, which is organized by healthcare staff following a protocol aiming to integrate parents into the discussion.
They will be compared to the two-week period without the Family Round.
详细描述
[Intervention] The intervention included in this study is called "Parents Round," which aims to integrate parents into the discussion of medical rounds. Parents Round is organized by healthcare staff following the protocol. The protocol details are described below.
Essential requirements
- Limited number of participants: infant, parents, other important family members if present, up to 2 doctors, and up to 4 healthcare staff including doctors
- At the bedside of the infant
- All participants, excluding the infant, sit on the chair
- Privacy consideration: ask the other parents in the same room to go out or wear headphone
- Ask parents about their infant's condition and their opinion before the healthcare staff speaks
- Mention the respiration, feeding, skin-to-skin contact, and involvement in care-taking and try to make a decision collaboratively with parents about the short- or long-term plan in each item
Recommended requirements
- Quiet environment: turn off or reduce the volume of the monitor alarm
- Effective communication to promote parents' participation and involvement: parents speaking first, empathetic attitude, not interrupting while parents speak, and not frequently using the technical term, for example.
- Encourage psychologists to participate
- Nurses complement parents' role and may lead some parts of the discussion: e.g. discharge preparation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants in the NICU and their parents/partner
- •Infants who are expected to stay in the NICU for more than one month in the future at consent
排除标准
- •no exclusion criteria
研究组 & 干预措施
Group A (Parents Round, then no special round)
Parents of enrolled patient receive the intervention for two weeks after the consent to the study (Period I). For two weeks after the intervention in Period I, the parents do not receive the intervention (Period II).
干预措施: Parents Round (Behavioral)
Group B (no special round, then Parents Round)
Parents of enrolled patient receive no intervention for two weeks after the consent to the study (Period I). For two weeks after Period I, the parents receive the intervention (Period II).
干预措施: Parents Round (Behavioral)
结局指标
主要结局
Quality of family centered care assessed by healthcare staff
时间窗: 1 month after the end of the intervention of the last patient
The family centered care provided by the NICU is assessed by parents or healthcare staff using FCC-Q, which was modified from DigFCC SMS questions. It consists of 8 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) received information, and 8) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.
Quality of family centered care assessed by parents
时间窗: 4 weeks
The family centered care provided by the NICU is assessed by parents using FCC-Q, which was modified from DigFCC SMS questions. It consists of 9 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) participation in medical round/medical care decision making, 8) received information, and 9) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.
Quality of family centered care assessed by parents
时间窗: 2 weeks
The family centered care provided by the NICU is assessed by parents using FCC-Q, which was modified from DigFCC SMS questions. It consists of 9 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) participation in medical round/medical care decision making, 8) received information, and 9) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.
Quality of family centered care assessed by healthcare staff
时间窗: before the enrollment of the first patient
The family centered care provided by the NICU is assessed by parents or healthcare staff using FCC-Q, which was modified from DigFCC SMS questions. It consists of 8 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) received information, and 8) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.
次要结局
- Parents' anxiety(4 weeks)
- Quality of medical round with parents assessed by parents(4 weeks)
- Collaboration competence questionnaire of healthcare staff(1 month after the end of the intervention of the last patient)
- Bonding feeling of parens toward their infant(4 weeks)
- Parents' satisfaction(4 weeks)
- Quality of family centered care assessed by healthcare staff using the Bliss Baby Charter audit tool(1 month after the end of the intervention of the last patient)
- Bonding feeling of parens toward their infant(2 weeks)
- Parents' anxiety(2 weeks)
- Parents' satisfaction(2 weeks)
- Collaboration competence questionnaire of healthcare staff(before the enrollment of the first patient)
- Quality of family centered care assessed by healthcare staff using the Bliss Baby Charter audit tool(before the enrollment of the first patient)
研究者
Ryo Itoshima
Principal Investigator
Nagano Children's Hospital