Workplace Intervention Among Pregnant Hospital Employees - a Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Number of days on sick leave
研究概览
简要总结
The aim of this study is to reduce sick leave and improve wellbeing. This is measured as physical and mental health, general work ability, work-life balance, manager support and completed work adjustments among pregnant health care professionals. It is hypothesised that pregnant employees participating in preventive sessions with their manager and a midwife in addition to the hospital standard pregnancy policy management will have less sick leave and report better wellbeing compared to the reference group.
详细描述
Sick leave during pregnancy is frequent and studies report proportions of employees on sick leave between 36-75%. Reasons for sick leave in early pregnancy are nausea, vomiting and dizziness whereas Braxton Hicks contractions, low back and pelvic girdle pain are more common in late pregnancy. Further, sick leave is strongly associated with working conditions and appropriate work adjustment.
The study design is cluster randomization with participation of all departments at Aarhus University Hospital (AUH), Denmark. Half of the departments are randomized to the intervention and the remaining to the reference group. The intervention group will receive a protocolized intervention with midwifery support as an add-on to usual practice. The reference group will receive protocolized usual practice.
Data are obtained from the hospital payment system and by survey (RedCap).
The sample size is calculated to find a difference of ≥ 7 days with a standard deviation of 25. To achieve a statistical power of 80% with a significance level of p ≤ 0.05 an estimated 202 participants will be required in each of the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant employees working as health care professionals at Aarhus University Hospital
排除标准
- •Gest. week > 20
研究组 & 干预措施
Intervention
The intervention implies a letter of invitation for a session between the employee, the department manager, and a midwife concerning workplace risk assessment and agreement on feasible work adjustments if necessary. A second session within gestational week 26-28 is scheduled to follow-up and readjust if necessary. A systematic frame for sessions is developed by the research team and conclusions from the sessions are registered within a piloted standardized template.
The employee and the manager can initiate contact with the midwife at any time, e.g in case of new symptoms or discomfort and need for support or guidance. If sick leave is considered, a new session is recommended and may be scheduled at any time.
To ensure transparency of guidance and workplace adjustments for other relevant healthcare professionals, the employee is asked to inform her general practitioner (GP) and midwife of the program.
干预措施: Preventive sessions (Other)
Usual practice
Hospital pregnancy policy is usual practice and implies a meeting between the pregnant employee and her manager concerning an individual risk assessment. A risk assessment-template can be downloaded from the hospital website.
If minimizing potential risks by adjustments is not possible the employee should be redeployed. If redeployment is not possible the pregnant employee may be absent due to pregnancy related symptoms.
The pregnant employee is requested to inform her GP about agreements.
结局指标
主要结局
Number of days on sick leave
时间窗: gestational period until gestational week 32
Sick leave is specified by mean number of days on sick leave and the proportion of employees on sick leave throughout pregnancy and within trimesters (first trimester defined as gestational week 1 - 12, second trimester being gestational week 13 - 27 and third trimester being gestational week 28 - maternity leave)
次要结局
- Influence(At inclusion and at gestational week 30)
- Self-rated health(at inclusion and at gestational week 30)
- Psycho-social working environment(At inclusion and at gestational week 30)
- Work ability(At inclusion and at gestational week 30)
- Relation to immediate superior(At inclusion and at gestational week 30)
研究者
Rikke Damkjær Maimburg
Ass. prof.
University of Aarhus