Background
Section/item | Item No | Description | Addressed on page number |
Administrative information | |||
Title | 1 | Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym | 1 |
Trial registration | 2a | Trial identifier and registry name. If not yet registered, name of intended registry | 2 |
2b | All items from the World Health Organization Trial Registration Data Set | not yet available | |
Protocol version | 3 | Date and version identifier | 3; 2 |
Funding | 4 | Sources and types of financial, material, and other support | 15 |
Roles and responsibilities | 5a | Names, affiliations, and roles of protocol contributors | 1; 15 |
5b | Name and contact information for the trial sponsor | 15 | |
5c | Role of study sponsor and funders, if any, in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication, including whether they will have ultimate authority over any of these activities | 15 | |
5d | Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint adjudication committee, data management team, and other individuals or groups overseeing the trial, if applicable (see Item 21a for data monitoring committee) | 13 | |
Introduction | |||
Background and rationale | 6a | Description of research question and justification for undertaking the trial, including summary of relevant studies (published and unpublished) examining benefits and harms for each intervention | 2-3 |
6b | Explanation for choice of comparators | - | |
Objectives | 7 | Specific objectives or hypotheses | 3 |
Trial design | 8 | Description of trial design including type of trial (eg, parallel group, crossover, factorial, single group), allocation ratio, and framework (eg, superiority, equivalence, noninferiority, exploratory) | 3; 11 |
Methods: Participants, interventions, and outcomes | |||
Study setting | 9 | Description of study settings (eg, community clinic, academic hospital) and list of countries where data will be collected. Reference to where list of study sites can be obtained | 3 |
Eligibility criteria | 10 | Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and individuals who will perform the interventions (eg, surgeons, psychotherapists) | 6 |
Interventions | 11a | Interventions for each group with sufficient detail to allow replication, including how and when they will be administered | 6-8 |
11b | Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug dose change in response to harms, participant request, or improving/worsening disease) | 13 | |
11c | Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence (eg, drug tablet return, laboratory tests) | 13 | |
11d | Relevant concomitant care and interventions that are permitted or prohibited during the trial | - | |
Outcomes | 12 | Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended | 8-11 |
Participant timeline | 13 | Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see Figure) | 11 |
Sample size | 14 | Estimated number of participants needed to achieve study objectives and how it was determined, including clinical and statistical assumptions supporting any sample size calculations | 3 |
Recruitment | 15 | Strategies for achieving adequate participant enrolment to reach target sample size | 11 |
Methods: Assignment of interventions (for controlled trials) | |||
Allocation | |||
Sequence generation | 16a | Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction (eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions | 11 |
Allocation concealment mechanism | 16b | Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered, opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned | 11 |
Implementation | 16c | Who will generate the allocation sequence, who will enrol participants, and who will assign participants to interventions | 11 |
Blinding (masking) | 17a | Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome assessors, data analysts), and how | 11 |
17b | If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant’s allocated intervention during the trial | - | |
Methods: Data collection, management, and analysis | |||
Data collection methods | 18a | Plans for assessment and collection of outcome, baseline, and other trial data, including any related processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be found, if not in the protocol | 8-11 |
18b | Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols | 11 | |
Data management | 19 | Plans for data entry, coding, security, and storage, including any related processes to promote data quality (eg, double data entry; range checks for data values). Reference to where details of data management procedures can be found, if not in the protocol | 11-13 |
Statistical methods | 20a | Statistical methods for analysing primary and secondary outcomes. Reference to where other details of the statistical analysis plan can be found, if not in the protocol | 12-13 |
20b | Methods for any additional analyses (eg, subgroup and adjusted analyses) | 12-13 | |
20c | Definition of analysis population relating to protocol non-adherence (eg, as randomised analysis), and any statistical methods to handle missing data (eg, multiple imputation) | 13 | |
Methods: Monitoring | |||
Data monitoring | 21a | Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of whether it is independent from the sponsor and competing interests; and reference to where further details about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed | 13 |
21b | Description of any interim analyses and stopping guidelines, including who will have access to these interim results and make the final decision to terminate the trial | 13 | |
Harms | 22 | Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct | 13 |
Auditing | 23 | Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent from investigators and the sponsor | 13 |
Ethics and dissemination | |||
Research ethics approval | 24 | Plans for seeking research ethics committee/institutional review board (REC/IRB) approval | 15 |
Protocol amendments | 25 | Plans for communicating important protocol modifications (eg, changes to eligibility criteria, outcomes, analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals, regulators) | 15 |
Consent or assent | 26a | Who will obtain informed consent or assent from potential trial participants or authorised surrogates, and how (see Item 32) | 13 |
26b | Additional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable | - | |
Confidentiality | 27 | How personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial | 13 |
Declaration of interests | 28 | Financial and other competing interests for principal investigators for the overall trial and each study site | 15 |
Access to data | 29 | Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that limit such access for investigators | 13 |
Ancillary and post-trial care | 30 | Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial participation | 13 |
Dissemination policy | 31a | Plans for investigators and sponsor to communicate trial results to participants, healthcare professionals, the public, and other relevant groups (eg, via publication, reporting in results databases, or other data sharing arrangements), including any publication restrictions | 13 |
31b | Authorship eligibility guidelines and any intended use of professional writers | 15 | |
31c | Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical code | - | |
Appendices | |||
Informed consent materials | 32 | Model consent form and other related documentation given to participants and authorised surrogates | Supplementary material |
Biological specimens | 33 | Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in the current trial and for future use in ancillary studies, if applicable | - |
Aims and objectives
Methods
Participants, interventions and outcomes
Study setting
Study population
Sample size
Eligibility criteria
- Willingness to participate in the study regardless of randomisation to the intervention or waitlist control arm
- Willingness to complete three questionnaires (applicable to intervention group, waitlist control group and cluster participants)
Intervention
Intervention overview
Intervention modules
Roundtable discussions
Booster sessions
- Appraisal of the developed programs for work place health management
- Critical factors for implementation
- Contribution by management and leadership to work place health promotion
- Need of law revisions
- Need of further development of standards for working conditions
Outcomes
Primary outcome
Secondary outcomes
-
Change in the World-Health Organization Well-Being Index (WHO-5 [19]) from T0 to T1 between the IG and CG.Subjective psychological well-being will be measured using the five-item World Health Organization Well-Being Index (WHO-5). Items are measured on a 6-point Likert scale, ranging from 0 “at no time” to 5 “all of the time”. The raw score ranging from 0 to 25 is multiplied by 4 to give the final score ranging from 0 representing the worst well-being to 100 representing the best well-being.
-
Change in Psychosocial Safety Climate (PSC-12 [20]) from T0 to T1 between the IG and CG.Psychosocial safety climate will be measured using the 12-item Psychosocial Safety Climate Scale [20]. The PSC-12 consists of four dimensions: (1) organisation participation (3 items), (2) organisation communication (3 items), (3) management priority (3 items) and (4) management commitment (3 items). Items are measured on a 5-point Likert scale, ranging from 1 “strongly disagree” to 5 “strongly agree”.
Further secondary outcomes
- World Health Organization Well-Being Index (WHO-5 Well-Being Index)
- Psychosocial Safety Climate (PSC-12)
- Effort-Reward Imbalance Scale – Short version (ERI [35];).Effort will be measured by three items (ERI1-ERI3). Items are measured on a 4-point Likert scale, ranging from 1 “strongly disagree” to 4 “strongly agree” with higher sum score between 3 and 12 indicating more perceived efforts. Reward is measured by seven items (ERI4-ERI10). A low sum score of these items between 7 and 28 represents fewer perceived occupational rewards.
- Work Analysis Instrument for Hospitals – Self-Report Version (Tätigkeits- und Arbeitsanalyseverfahren für das Krankenhaus; TAA-KH-S [36];)Two subscales of a German questionnaire for hospital employees will be used to measure their working conditions: (1) job decision authority (shortened from 9 to 3 items); (2) quantitative job demands (3 items). Items are measured on a 5-point Likert scale, ranging from 1 “no, not at all” to 5 “yes, absolutely”.
- Questionnaire on Integrative Leadership (Fragebogen zur Integrativen Führung, FIF [28])The questionnaire on integrative leadership is a standardized instrument, which records leadership and communication style in four modules (module A: transformational and transactional leadership, module B: instrumental leadership, module C: communication and module D: negative leadership). In this study, module A in its self-assessment version for leaders and its external assessment version for employees will be used. The multidimensional construct of transformational leadership consists of six core behaviours (“fostering innovation”, “team spirit development”, “performance development”, “individuality focus”, “providing a vision” and “being a role model”). Participants have to rate 24 statements at a five point Likert-scale from 1 “agree not at all” to 5 “totally agree”. The items’ ratings can be summarized to 10 different scale scores or to one overall score each (transformational leadership, transactional leadership and negative leadership). The scales of transformational leadership show a sufficient intern consistency with Cronbach’s α = .79–.92 for the external assessment and Cronbach’s α = .71–.83 for the self-assessment [28].
- Short version of the Occupational Self-Efficacy Scale (SOSES [37];)Occupational self-efficacy will be measured using the Short version of the Occupational Self-Efficacy Scale. The instrument consists of 6 items rated on a six-point Likert scale ranging from 1 (not at all true) to 6 (completely true) with higher values reflecting higher occupational self-efficacy.
- Top Management Evaluation SheetAt the beginning and at the end of the module Top Management Training, participants will be asked to complete an evaluation form consisting of 28 items. The questions relate to measures to promote the mental health of employees at the hospital (e.g. offers for stress prevention, activities to improve working conditions) and the role of the management in this issue.
- Organisational indicators on individual/participant level:a.Job satisfaction ([38]; 8 items, measured on different 5-point Likert scales, ranging from 1 “wrong” to 5 “right”, 1 “not at all interesting” to 5 “yes, very interesting”, 1 “very few opportunities” to 5 “yes, a lot of opportunities”, 1 “very discontent” to 5 “yes, very content”, 1 “definitely not” to 5 “yes, for sure”)b.Employer attractiveness ([39]; 5 items, measured on a 7-point Likert scale, ranging from 1 “strongly disagree” to 7 “strongly agree”)c.Presenteeism ([40]; 1 item, measured on a 5-point scale; “never”, “seldom”, “occasionally”, “frequently”, “very often”)d.Intention to leave ([41]; 1 item, measured on a 5-point scale; “never”, “a few times a year”, “a few times a month”, “a few times a week”, “everyday”)e.Recommendation (modified version of Reichheld, 2003 [42]; “How likely is it that you would recommend this company to a friend or colleague?“, measured on an 11-point Likert scale, ranging from 1 “highly unlikely” to 11 “highly likely”)f.Absenteeism (modified version of Caverley et al., 2007 [43]; “Please estimate, how many days on average per month you are being absent due to an illness.”)g.Work overtime (“How many hours have you worked overtime in the past month?”)h.Working hours (“What is your contractually agreed working time per week?”, “What is your average working time per week?”)i.Economic situation of clinic/unit (adapted version of Hall & Rohrbach-Schmidt, 2013 [44], “How do you assess the economic situation of the clinic/unit you work at?”, measured on a 4-point Likert scale, ranging from 1 “very good” to 4 “bad”, with 5 “don’t know”).j.Job security ([45], “My job security is good”, measured on a 4-point Likert scale, ranging from 1 “strongly disagree” to 4 “strongly agree”).k.Cooperation between occupational groups ([36], shortened from 5 to 2 items, TAA-KH-S subscale social climate, measured on a 5-point Likert scale, ranging from 1 “no, not at all” to 5 “yes, absolutely”).Moreover, some organisational indicators on hospital/clinic level will be collected on a regular basis via request from the hospitals accounting division, depending on the availability. These organisational indicators will be assigned to the clusters, if possible, depending on the level of detail of the data and the homogeneity/heterogeneity of the clusters.l.Turnover (\( \mathrm{turnover}\ \mathrm{rate}=\frac{\mathrm{number}\ \mathrm{of}\ \mathrm{employees}\ \mathrm{who}\ \mathrm{left}\ \mathrm{in}\ \mathrm{year}\ \mathrm{x}}{\mathrm{total}\ \mathrm{number}\ \mathrm{of}\ \mathrm{employees}\ \mathrm{at}\ \mathrm{the}\ \mathrm{beginning}\ \mathrm{of}\ \mathrm{year}\ \mathrm{x}}\ \mathrm{x}\ 100 \),number of applicants, number of persons hired, number of persons retired, number of dismissals, number of expiring fixed-term contracts)m.$$ \mathrm{Absence}\ \mathrm{rate}=\frac{\mathrm{absence}\ \left(\mathrm{in}\ \mathrm{hours}\right)\ \mathrm{in}\ \mathrm{year}\ \mathrm{x}}{\mathrm{gross}\ \mathrm{working}\ \mathrm{time}\ \left(\mathrm{number}\ \mathrm{of}\ \mathrm{employees}\ast \mathrm{working}\ \mathrm{hours}\ \mathrm{per}\ \mathrm{week}\right)\ \mathrm{in}\ \mathrm{year}\ \mathrm{x}}\ \mathrm{x}\ 100 $$n.Work overtime rate = \( \frac{\mathrm{work}\ \mathrm{overtime}\ \left(\mathrm{in}\ \mathrm{hours}\right)\ \mathrm{in}\ \mathrm{year}\ \mathrm{x}}{\mathrm{contracted}\ \mathrm{working}\ \mathrm{time}\ \left(\mathrm{in}\ \mathrm{hours}\right)\ \mathrm{in}\ \mathrm{year}\ \mathrm{x}}\ \mathrm{x}\ 100 \)o.$$ \mathrm{Sickness}\ \mathrm{absence}\ \mathrm{rate}=\frac{\mathrm{sickness}\ \mathrm{absence}\ \left(\mathrm{in}\ \mathrm{hours}\right)\ \mathrm{in}\ \mathrm{year}\ \mathrm{x}}{\mathrm{planned}\ \mathrm{working}\ \mathrm{time}\ \left(\mathrm{in}\ \mathrm{hours}\right)\ \mathrm{in}\ \mathrm{year}\ \mathrm{x}}\ \mathrm{x}\ 100 $$p.Age distribution = number of employees sorted by age classes
- IRR [18], as described above,
- WHO-5 [19], as described above and
- PSC-12 [20], as described above,
- Global Transformational Leadership Scale (GTL [46];)To keep the questionnaire for cluster participants short, the Questionnaire on Integrative Leadership (FIF [28]) was replaced by the GTL, which is a 7-item questionnaire to measure transformational leadership [27] from 1 “to a very small extent” to 5 “to a very large extent”. Higher scores indicate higher transformational leadership behaviour. The German version of the questionnaire was already used in Rigotti et al., 2014 ([47] p.67) the same translation will be used here.
Process evaluation
Participant timeline
Preliminary timeline
Total study duration | [24 months] |
---|---|
Process evaluation: | [10 months] |
Duration of longest intervention: | [6 months] |
Duration of whole intervention and observation phase: | [9 months] |
Beginning of the preparation phase: | [11/2018] |
Start of recruitment: | [10/2019] |
End of recruitment: | [01/2020] |
End of observation phase: | [12/2020] |
Data base lock | [03/2021] |
End of waitlist control intervention: | [04/2021] |
Statistical analyses completed: | [08/2021] |
Study report completed: | [09/2021] |