Workplace Intervention Among Pregnant Hospital Employees

Workplace Intervention Among Pregnant Hospital Employees - a Cluster Randomized Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Midwifery; Sick Leave
• Intervention / Treatment: Other: Preventive sessions

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 404
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant employees working as health care professionals at Aarhus University Hospital

Exclusion Criteria:

• Gest. week > 20

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Preventive sessions; Preventive sessions between the pregnant employee, her manager and a midwife.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days on sick leave	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)	gestational period until gestational week 32

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-rated health	Self-rated health is explored with the item from Short Form 36 Health Survey Questionnaire: "In general, would you say your health is?: Excellent, very good, good, fair and poor?" Item values are coded from 1-5 with 1 being "excellent". Self-rated health is specified by mean scores.	at inclusion and at gestational week 30
Work ability	Work ability is explored with three items from The Work Ability Index: "Assume that your work ability at its best has a value of 10 points. How many points would you give to your current work ability?" with answers on a scale from 1-10. Furthermore, "How do you rate your current work ability with respect to the physical demands of your work?" and "How do you rate your current work ability with respect to the mental demands of your work?" are included with response choices: "Very good, rather good, moderate, rather poor, very poor". Answers are coded 1-5 with 1 being "very poor". Work ability is specified by mean scores.	At inclusion and at gestational week 30
Psycho-social working environment	The Copenhagen Psychosocial Questionnaire short version (COPSOQ) explores psycho-social working environment with the items: "How often have you felt worn out?" and "How often have you been emotionally exhausted?". Response choices are: "All the time, a large part of the time, part of the time, a small part of the time, not at all". Responses are coded from 1-5 with 1 being "all the time". The dimension of influence is explored with the questions: "Do you have a large degree of influence concerning your work?" and "Can you influence the amount of work assigned to you?" with response choices: "Always, often, sometimes, seldom, never/hardly ever". Answers are coded 1-5 with 1 being never/hardly. Psycho-social working environment is specified by mean scores.	At inclusion and at gestational week 30
Relation to immediate superior	COPSOQ explores the dimension of relation to immediate superior is included with the items: "To what extend would you say that your immediate superior gives high priority to job satisfaction?" and "To what extend would you say that your immediate superior is good at work planning" Response choices are: "To a very large extend, to a large extend, somewhat, to a small extend, to a very small extend". Answers are coded from 1-5 with 1 being "to a very small extend". Relation to immediate superior is specified by mean scores.	At inclusion and at gestational week 30
Influence	COPSOQ explores the dimension of influence is explored with the questions: "Do you have a large degree of influence concerning your work?" and "Can you influence the amount of work assigned to you?" with response choices: "Always, often, sometimes, seldom, never/hardly ever". Answers are coded 1-5 with 1 being never/hardly. Influence is specified by mean scores.	At inclusion and at gestational week 30

Collaborators and Investigators

• Sponsor: Region MidtJylland Denmark
• Collaborators: Aarhus University Hospital; Herning Hospital; Defactum, Central Denmark Region

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Risk factors; Intervention; Workplace; Health Care Professionals
• Other Study ID Numbers: 29-2019-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No