Study Design

This is a randomised controlled trial with an intervention group and waitlist control group. There will be four measurement moments: at baseline (T0), 6 months (T6), 9 months (T9) and 12 months after baseline (T12). Data collection started in May 2021. The study protocol was approved by the Ethical Committee Social Sciences of the Radboud University (number: ECSW-2021-012).

Setting

This study will be conducted in long-term care organisations that work with self-managing teams in the Netherlands.

Procedure

Long-term care organisations are invited to participate in the study. After permission has been obtained, care teams are invited to participate via internal communication tools (e.g., intranet), and a personal e-mail with a link to the baseline questionnaire (T0). The questionnaire starts with an eligibility check followed by a digital informed consent. After participants have given their consent and their contact details, they are redirected to the main questionnaire. Information and questionnaires are also available in print. To enhance the response rate, the researcher will contact the teams to ask them how the research team can support them in filling out the questionnaires, for example by visiting with a laptop, or by bringing over hardcopy questionnaires. Recruitment of participants will continue until target sample size is reached.

Participants

All professionals who both directly and indirectly contribute to providing good quality of care to residents in long-term can participate in the study. The eligibility check in the first questionnaire verifies whether the individual meets the following inclusion criteria:

Long-term care workers are excluded from participation when meeting the following exclusion criteria:

  • The long-term care worker is on sick leave for one month or more before completing the baseline questionnaire;

  • The employment contract of the long-term care worker ends within six months after completing the baseline questionnaire.

Because the intervention is at team level, teams are included in the study if at least a third of the team members have completed the baseline questionnaire and at least three team members are willing to represent their team in the three meetings of the intervention (i.e. take part in the working group).

Participant involvement

Long-term care workers are involved in the design of the Healthy Working Approach by means of interviews in which their needs regarding sustainable employability are explored. Their needs formed the basis for the development of the Healthy Working Approach, which we presented to several teams/team members in order to check the feasibility and acceptability of the intervention. Key persons involved in healthy working within the long-term care organisation are involved in designing the recruitment process of facilitators and participating teams as well as in an appropriate dissemination plan for the facility. Outcomes are chosen based on interviews with employees and key figures within the long-term care organisation.

Intervention: the Healthy Working Approach

The intervention consists per team of three meetings of one hour each led by a facilitator, who is a trained employee from within the long-term care organisation. Teams choose at least three representatives of their team to take part in a working group that will attend the meetings. The working group is responsible for representing the entire team and for reporting back to the team. The approach aims to result in improvements that benefit the whole team.

Meeting 1: Problem analysis (± one month after baseline)

In the first meeting, the working group starts with a brainstorm about problems within their team related to healthy working in the context of the three basic psychological needs, namely autonomy, relatedness and competence. Next, the working group starts prioritizing and chooses two or three problems that have great impact (high severity and frequency) for the entire team. The working group reports the chosen problems to the entire team, to make sure that everyone agrees these are problems that need to be tackled within their team. The facilitator ensures a safe and confidential environment, where everyone and every opinion is equal and respected.

Meeting 2: Solutions & action plan (one to two weeks after meeting 1)

After two or three problems that are agreed upon by the whole team, the working group brainstorms about solutions for these problems in the second meeting. The brainstorm about solutions starts broad and may include different sorts of solutions (technical or organisational solutions, working conditions or support). Potential solutions are prioritized based on criteria simplicity, feasibility, support, practicability and expected effectiveness. The working group formulates an implementation plan for the best one or two solutions for each problem. The plan includes specific, measurable, achievable, relevant and timebound (SMART) actions. The working group reports the solutions back to the entire team, to make sure that everyone knows which actions are agreed upon and what is expected from them.

Meeting 3: Implementation and evaluation (one to two months after meeting 2)

In the implementation phase, teams are guided and supported by the facilitator where necessary in carrying out the solutions. In the third meeting, the implementation status of the solutions are discussed (implemented, not implemented, in progress). If needed, solutions or additional steps will be discussed to improve the implementation status of solutions.

Allocation of intervention and waitlist control group

Randomisation will take place at team level. The randomisation is performed by a research assistant who has no knowledge about the teams, using randomizer.org. In this tool, teams are inserted as pairs: of each pair one team is assigned to the intervention group and the other to the control group. The waitlist control group will start the intervention after completing the 12-month follow-up questionnaire. The intervention and control groups are aware of their own allocation status, but not of the allocation status of other teams. The allocation status of teams are known to the researchers involved in this study. In case of close collaboration between multiple teams within a department, the department is randomised to avoid contamination between these teams.

Effectiveness evaluation

The Healthy Working Approach will be evaluated in a randomised controlled trial with one year of follow-up, including four measurement moments in which the following primary and secondary outcomes will be measured.

Outcomes

Primary outcome

Need for Recovery will be measured with the 11 dichotomous items (0 no or 1 yes) of the Questionnaire on Psychosocial Job Demands and Job Stress [38]. The need for recovery score is a percentage score (0 to 100) of positive answers on the items. Higher scores indicate a higher degree of need for recovery after work. The scale has shown to possess good psychometric qualities in terms of (content) validity and internal consistency (Cronbach’s alpha ranging from .83 to .92) [39].

Secondary outcomes

Within the intervention teams will uncover bottlenecks regarding their need for autonomy, competence and relatedness. We expect most of the bottlenecks to focus on reducing job demands and improving job resources, which benefit the satisfaction of the three needs at work and ultimately lessen the need for recovery. Therefore, the satisfaction of the needs for autonomy, competence and relatedness, as well as several psychosocial job factors were measured as secondary outcomes.

Satisfaction of the needs for Autonomy, Competence and Relatedness will be measured with 16 items of the validated Work-related Basic Need Satisfaction Scale on a 5-point scale (ranging from 1 totally disagree to 5 totally agree) [40]. Mean scores will be calculated for the subscales autonomy (6 items), competence (4 items) and relatedness (6 items). The Work-related Basic Need Satisfaction Scale is widely used and validated in the Dutch language [40]. The scales for autonomy, competence and relatedness satisfaction show good reliabilities with Cronbach’s alpha’s of on average .81, .85 and .82 respectively [40].

Work engagement will be measured with 9 items of the Utrecht Work Engagement Scale on a 7-point scale (ranging from 0 never to 6 always) [41]. Mean scores will be calculated for the subscales vigour (3 items), absorption (3 items) and dedication (3 items), as well as an average total score work engagement (9 items). The Utrecht Work Engagement Scale has shown good internal consistency and test-retest reliability. Across different nations the Cronbach’s alpha of the scale is satisfying with a value of .86 [41].

Physical demands will be measured with 3 items of the Netherlands Working Conditions Survey on a 3-point scale (ranging from 1 no, 2 yes, sometimes and 3 yes, regularly) [42]. With monitoring data of over 15 years, the Netherlands Working Conditions Survey is a well-known and used tool to assess working situations of Dutch employees [42]. For this study a mean score will be calculated, whereby a higher score means more physical demands (more pushing/pulling, repetitive movements and uncomfortable working postures).

Quantitative job demands will be measured with 3 items of the Netherlands Working Conditions Survey on a 4-point scale (ranging from 1 never to 4 always) [42]. A mean score will be calculated, whereby a higher score means a higher workload (working more quickly, having a lot of work and working extra hard). Cronbach’s Alpha of the scale is good with a value of .80 [42].

Self-reported health will be measured with the Dutch translation of 2 items from the third version of the Copenhagen Psychosocial Questionnaire [43, 44]. One item askes participants to rate their health either as excellent (100), very good (75), good (50), fair (25) or poor (0). The second item askes them to give points to their present state of health (0 for worst and 10 for best conceivable state of health). A higher scores on each item reflects a better general health. The Copenhagen Psychosocial Questionnaire is internationally widely used to study work characteristics and is recently well validated in Dutch [44, 45].

Several psychosocial work factors will also be measured with items from the Dutch translation from the third version of the Copenhagen Psychosocial Questionnaire [43, 44]. It concerns the core items for influence at work (1 item), job satisfaction (1 item), possibilities for development (2 items) and the long measurement of social support from colleagues (3 items). Answer categories of all factors range from 0 rarely to 100 always. Mean scores will be calculated in case of multiple items per subscale, whereby a higher score means more of the psychosocial work factor at hand. Previous research shows the items and scales of this questionnaire are reliable [44, 45].

Prognostic factors

At baseline, several prognostic factors will be included in the survey, namely: age, gender, educational level, job title, years employed and type of contract (temporary or permanent), number of contractual working hours, hours of informal care provision per week in the last six months and frequency and total number of working days of sickness absence in the last six months.

Participant time line

Figure 1 shows an overview of the time line for participants in the intervention and waitlist control group. To promote participant retention and the completion of follow-up questionnaires, we will apply response-enhancing measures by offering teams that achieve a 75% response rate in the follow-up measurements a gift of their choice (e.g. fruit or flowers for the team).

Fig. 1

Timeline detailing the recruitment process, enrollment, randomization, and the different measurements and intervention meetings over time for participants of the Healthy Working Approach

Sample size calculation

The primary outcome of this study is need for recovery [38], which we used for the calculation of the sample size. The mean need for recovery score of employees in occupational health services is 27.30 (SD = 29.75) on a scale of 0 to 100 [39]. The minimum relevant difference on the scale is 12 [46, 47]. An intraclass correlation (ICC) of 0.025 is assumed because previous studies have shown that ICCs at the workplace level for health-related outcomes are generally small [48,49,50]. Using the ICC for teams, a power of 80% and an alpha of 5%, the power analysis showed that a sample size of 161 employees will be needed to detect a difference of at least 12 points. Taking into account a 25% withdrawals and dropouts, the entire study population must consist of 202 long-term care workers (101 in intervention and 101 in control group).

Data management and analysis

Before the start of the project, all issues of data management will be addressed in a data management plan. For this, Radboud University has a tool, that includes feedback from Research Data Management (RDM) Support. Training and support in writing a data management plan are offered by the section RDM Support and the data steward of the institute. In order to check whether the research has been carried out properly and reliably, authorised persons within the Behavioural Science Institute or Radboud University and (inter)national supervisory authorities (for example, the Netherlands Authority for the Protection of Personal Data) are able to inspect the data. While research is ongoing, data will be stored on the Radboud University’s network. The server space allows for managed access to and the sharing of data between and among partners and guests during the project. Safe and secure storage of data is guaranteed by the Information Technology security and safety protocols of the campus network.

We will perform descriptive analyses (means, standard deviation, frequencies) on all outcomes and covariates. For the main analysis, we will perform linear mixed model analyses with need for recovery as primary outcome, and group (intervention/control) x time interaction as independent variable, taking into account potential confounding prognostic factors. Potential confounders are included in the model when they account for at least 10% change in the main effect size of the group x time interaction. We will take into account nesting of the data. Similar analyses will be done with the secondary outcome measures.

Main analyses are performed according to the “intention to treat” principle and the unit of analysis is on the individual level. In addition, we will perform a per-protocol analysis to take into account teams in the intervention group that did not participate in the intervention or did not implement the intervention as planned. Any cases of missing data will be dealt with by imputation.

Process evaluation

We will perform a process evaluation to evaluate the barriers and facilitators of the implementation process of the Healthy Working Approach using a combination of quantitative and qualitative methods. For the process evaluation, we will gain insight into recruitment, reach, dose received, dose delivered and fidelity in order to monitor the adherence to the procedures [51]. In addition, we will investigate barriers and facilitators of the implementation and satisfaction with the Healthy Working Approach. Table 1 provides an overview of who is involved in what element of the evaluation to provide an insight in the effectiveness, barriers and facilitators of the implementation process.

Table 1 Overview of process and evaluation set up of the Healthy Working Approach by means of source, type of info and data collection method

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