Background
In Europe, one in four employees experience work-related stress [
1]. Work-related stress can adversely influence health and cause a substantial amount of sick leave in organizations. Common mental disorders related to work-related stress, such as depression and anxiety, contribute the most to this sick leave [
2,
3]. For example, the percentage of total number of sick leave days caused by psychological complaints, being stressed out, or being burned out was 22% in the Netherlands in 2015 [
4].
Organizational work-related stress management interventions have shown positive effects on both sick leave and productivity [
5,
6]. In addition, organizational work-related stress management interventions have shown positive effects on employee outcomes, such as confidence, coping, general health, and job satisfaction [
7‐
10]. In addition to organizational interventions, stress management interventions on an individual level (e.g., a mindfulness program or assertiveness training) have shown positives effects on employees’ mental health, such as perceived stress, emotional exhaustion and anxiety state [
10,
11]. Given the body of evidence, it is surprising that work-related stress management interventions are rarely used by organizations [
12], in particular since the costs related to the consequences of work-related stress are high.
The key issue appears to be an implementation problem. Given the large number of available stress prevention strategies available on search engines such as google, information overload is likely. This results in difficulty selecting an intervention that fits well within an organization. Previous studies have shown that barriers associated with the implementation of work-related stress management interventions in organizations are present on three levels: sector, organization and employee [
13]. To overcome implementation barriers at various levels across organisations, a combination of strategies has proven to be more effective than a single strategy [
14,
15]. Therefore, we have developed a multifaceted, integral stress prevention strategy, Stress Prevention@Work (SP@W), to facilitate the selection and use of interventions in organizations. SP@W consists of two elements: 1) a digital platform (DP), which is an information technology platform containing a stepwise protocol to select and implement work-related stress management interventions, and 2) a collaborative learning network. The DP facilitates access to and the selection of matching work-related stress management interventions (evidence-based and/or practice-based). Interventions can be tailored to the specific needs of the team or organization either by someone within the organization or by an external coach or an implementation specialist. In previous research, a stepwise protocol has been shown to be effective by providing a framework for organizations that can be used to make suitable choices for work-related stress management interventions [
16‐
18]. In addition to the DP, we initiated a collaborative learning network that provides contact between organizations to allow and facilitate the exchange of lessons learnt during the implementation of work-related stress management interventions. The network builds on earlier research showing that for the selection of suitable interventions, organizations often rely on a limited network of peer organizations for information about interventions [
15,
19].
This paper describes SP@W and the protocol for the evaluation of SP@W by a cluster controlled trial, including an intervention and control group. We hypothesize that SP@W will decrease the employees’ perceived stress by reducing implementation barriers and increasing the implementation of work-related stress management interventions. A process evaluation will be guided by the framework of the Nielsen & Randall model for process evaluation of organizational interventions [
20], while taking into account criteria described by Steckler and Linnan [
21] that are relevant to the implementation process of SP@W, including barriers and facilitators.
Methods
First, we describe SP@W, and next the protocol for the effect and process evaluation of SP@W.
Integral stress prevention strategy Stress Prevention@Work (SP@W)
SP@W consists of two elements: 1) a digital platform (DP) with a stepwise protocol to select and implement work-related stress management interventions, and 2) a collaborative learning network. This two-element strategy was developed in close collaboration with several organizations from various sectors, including the healthcare sector. This participatory format enabled tailoring of the strategy to the needs of organizations. This is necessary because work-related stress has a wide range of determinants [
8,
22]. Both elements of SP@W are described below.
The DP consists of a stepwise protocol, multiple interventions, and screening instruments. The stepwise protocol consists of with five steps: 1) awareness, 2) assessment, 3) prioritizing and planning, 4) implementation, and 5) evaluation. The interventions are either at organizational or employee level with a focus on: online or offline groups or individuals; primary or secondary prevention, or specific sectors and organization types (e.g. small vs. medium-sized enterprises). An example of an offline organizational intervention is a guideline to start a dialogue between employees and their manager(s) about the presence of work-related stress within the organization or team [
23]. An example of an individual online intervention is a self-help module to reduce work-related psychosocial risk factors [
24]. Additionally, the DP provides screening instruments for (work-related) stress and psychosocial risk factors, and contains references to intervention providers who can assist in the implementation process if needed.
Development of the digital platform
We piloted the DP in five organizations in the educational, healthcare, transport and ICT sector aiming to achieve the optimization of the DP for use in multiple sectors. Supervisors, managers and Human Resource (HR) managers participated in these sessions. At the end of each session, a structured interview was performed about several aspects of the usability of the DP within their organisation, such as feasibility and accessibility, attitude towards the DP, motivation for use, financial feasibility, barriers, facilitators, and satisfaction. Based on these sessions, we optimized the DP to ensure that the steps of the DP’s stepwise protocol were easy to follow for the target group of HR managers in medium or large organizations.
The stepwise protocol
The first step focuses on evaluating the awareness and commitment the organisation. The second step focuses on finding or confirming the main work-related psychosocial risk factors of stress within a team and prioritizing the risks that will be tackled. The third step focuses on choosing the appropriate intervention(s). The fourth step focuses on implementing the chosen work-related stress management intervention(s), and the fifth step focuses on the evaluation of the process and effects, and evaluates if further interventions are necessary. The steps are described below.
Collaborative learning network
The second element of SP@W is the collaborative learning network. The collaborative learning network aims to stimulate communication between organizations in enabling, sharing, and exchanging knowledge about implementation experiences and discussing good practices about implementing a stress-management intervention, and case histories for implementation between organizations. The aim of this network is that organization may learn from the other organizations, but may also be stimulated and energized by other organizations. Three learning networks were set up in three regions in the Netherland, including stakeholders from 20 distinct organizations from several sectors. We aim to organize three learning-network meetings over the trial one-year trial period, across all three regions, and one annual general meeting for all geographic regions together. Each meeting is approximately two hours, and addresses, e.g., one specific step from the stepwise protocol guided by the specific needs of the participating organizations. The meetings are chaired by an implementation expert.
Effect and process evaluation of Stress Prevention@Work
Study design and measurements
The effectiveness of SP@W will be evaluated in a cluster controlled trial. The study population consists of employees of a Dutch healthcare organization. This organization has more than 4000 employees throughout the Netherlands, who are organized in self-directing teams. The organization facilitates care in nursing homes (including geriatric rehabilitation care), residential care homes, and home-based care. SP@W will be implemented in intervention teams during the first six months of the trial period. After the final follow-up measurement (12 months after baseline), SP@W will also be offered to the control teams. Digital questionnaires will be sent to employees from both the intervention and control teams at baseline and after six and 12 months to measure the short- and long-term effectiveness of SP@W. To maximize the response rate, two reminders will be sent to the employees for each questionnaire. The questionnaires will be in Dutch. The SP@W implementation process will be assessed by performing a process evaluation. The study procedures and design have been approved by the Medical Ethics Committee of the VU University Medical Center, Amsterdam, The Netherlands (2015.480).
Recruitment, and inclusion and exclusion criteria
Recruitment of employees from a healthcare organization will involve a stepwise procedure. First, the management will decide which unit of the organisation will participate in the trial. Next, team coaches from the participating unit will be asked to select eligible teams to participate in the trial. Eligibility implies that the teams are willing to participate in the trial and able to provide a team member who will be responsible for the implementation of SP@W within the team during the trial period. A Human Resource (HR) manager or the team coach can also choose to take responsibility for implementing the SP@W within a team. Second, the employees within the eligible teams will receive an e-mail with the study information, inclusion and exclusion criteria, and the baseline questionnaire. The inclusion criteria are a minimum age of 18 years and an employment contract at the healthcare organization. Exclusion criteria are sick leave of more than one month at the time of inclusion or planned retirement within one year. Informed consent for participation in this study will be retrieved through an opt-in construction in accordance with the Dutch law on Medical Research in Humans. By completing the baseline questionnaire, eligible workers declare their agreement to participate in scientific research.
Allocation and matching teams
After the baseline measurement, teams will be matched on their specific work setting (e.g. home-based care or nursing home care) and team size. The aim is to have both comparable teams and an equal number of participants in the intervention and control condition. This information will be obtained from the team coaches. Following the match, allocation to the two conditions will be performed by an independent researcher who does not have information about the perceived stress levels in the teams. After allocation, the teams are informed about the condition they are assigned to: intervention or control (waiting list) condition. A secure login code for the digital platform (DP) for all intervention teams will be sent to the employees responsible for applying SP@W within their team. The use of the DP will be explained during a training by an implementation expert. An invitation for this training will be sent to all responsible employees for the intervention teams. They will also receive an invitation for collaborative learning network meetings and the contact information of all employees responsible for the DP in the intervention teams.
Effect evaluation
Primary outcome
The primary outcome stress will be measured by the stress subscale of the Depression, Anxiety and Stress Scale (DASS-21) at employee level [
25]. The stress subscale consists of seven questions with a score range of 0–21. These questions relate to the experience of symptoms in the past week. The stress subscale measures the level of arousal. Examples of questions are “I found that I was very irritable”, “I found myself getting impatient when I was delayed in any way (e.g. lifts, traffic lights, being kept waiting)”, and “I found it difficult to relax”. The answering categories were “Did not apply to me at all”, “Applied to me to some degree, or some of the time”, “Applied to me to a considerable degree, or a good part of time”, and “Applied to me very much, or most of the time”. The internal consistency of the scale was good (Cronbach’s α 0.85). Construct validity and criterion validity of the DASS-21 have been measured before, and the criterion validity was good [
25].
Prognostic factors
Several prognostic factors will be investigated at baseline to gain insight into the differences between the intervention and control teams.
Process evaluation
Alongside the effectiveness evaluation, a process evaluation will be conducted. The Nielsen & Randall model for organizational interventions and the Steckler and Linnan framework for process evaluations will be used to gain insight into the implementation process of the SP@W strategy [
20,
21]. The criteria described by Steckler and Linnan that are most relevant to the implementation goal are: ‘reach’ and ‘dose received’. Reach is the percentage of intervention teams that participated in SP@W. Dose received will be operationalized as the number of steps of the stepwise DP protocol that are completed. Both reach and dose received will be assessed at the team level. Data for the process evaluation will be collected using questionnaires completed by participants of the intervention teams, interviews with stakeholders, team and stakeholder meeting notes, and DP data logs.
Sample size
A power analysis has been performed for the main outcome measure: the stress subscale of the DASS-21. This scale has a mean of 4.06 and a standard deviation of 3.81 in a non-clinical sample of North American adults [
29]. With a power of 0.80 (1-beta) and an alpha of 0.05, we need 208 participants (104 per group) to demonstrate a relevant effect in the stress scale of 1.5 points. Taking into account a loss to follow-up of 25% after 12 months, a total of 278 employees need to be included.
Statistical analyses
To investigate the effectiveness of SP@W, all analyses will be performed according to the intention-to-treat principle. Descriptive statistics (means, standard deviations, or frequencies) will be calculated for all measured variables, and will be compared between the intervention and control groups. The effects of SP@W will be analysed by performing a multilevel analysis, while taking into account clustering within teams. A two-tailed significance level of p < 0.05 will be considered statistically significant.
Discussion
This paper described the study protocol of the multifaceted and integral stress prevention strategy, SP@W. It is hypothesized that after a successful implementation of SP@W, the strategy will increase the mean number of work-related stress management interventions implemented within the intervention teams compared to the control teams and lead to a decrease in employee stress over 12 months.
Strengths and limitations
The first strength of this study is our controlled design. This allows for a comparison between teams within the participating healthcare organization who are exposed to similar environmental conditions that may lead to stress (e.g. organizational changes), if not for access to SP@W. The second strength of this study design is the follow-up period of one year, which allows insight into short-term effects of the intervention after six months and in the longer term after 12 months. Third, by incorporating a process evaluation, we will gain insight into the strategy’s implementation process within the intervention teams. Last, this study will be executed in a real-life setting, which will make it easier to generalize the effects to similar healthcare organizations.
Since SP@W focuses on the organization and not on individual workers, individual randomisation is not feasible. Matching controls may induce bias since matching a limited number of known parameters may lead to differences between teams in the intervention and control group that we are unaware of. Furthermore, we cannot completely rule out contamination since all teams belong to one healthcare organization. A cross-over of information can reduce the contrast between the groups and consequently, the impact of the effects.
Impact of the results
A combination of several implementation strategies into one integral stress prevention strategy is important to overcome barriers at multiple levels within organizations. SP@W may lead to a reduction of stress and sick leave and an increase in productivity, which is beneficial for employees as well as for the organization.
Acknowledgements
Not applicable.
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