An interventional study of Leadership for recovery in Recovery, Psychological, Sleep and Burnout, sponsored by Karolinska Institutet. Recruiting at 2 sites in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Other
The goal of this intervention study is to evaluate a group intervention programme that aims to support first-line healthcare managers in promoting their employees' recovery through a "leadership for recovery".
In the study, the researchers will investigate if the intervention programme can improve the recovery (including sleep) of healthcare employees. The intervention programme consists of 6 group sessions for managers.
The main question the study aims to answer are:
- Can a group-based intervention programme with a focus on strengthening first-line healthcare managers' leadership for recovery improve their employees' recovery?
The intervention programme will be delivered to first-line healthcare managers in Swedish hospital care settings. Researchers will compare survey, diary and actigraphy data between employees of 1) managers who participate in the programme and 2) managers who has not participated in the programme.
Background
Healthcare staff are often subjected to high workload and insufficient opportunities for recovery. Recovery (including sleep) is an important factor for good health and performance , not least during periods of high stress and strain. Previous research has shown that leadership and organisational factors play a major role in employee health and performance. However, managers in healthcare often report a demanding work situation themselves, which might affect their own health and become an obstacle for the leadership. Thus, healthcare managers have a key role in promoting their employees' recovery, but to be able to manage that important task, they may also need support for managing their own recovery. Furthermore, there is a lack of research on how healthcare managers can work with supporting employees' recovery.
In a previous research project, the investigators developed and evaluated a group-administered proactive recovery programme for new nurses, focusing on enhancing beneficial strategies for recovery. The programme showed promising effects in terms of reduced burnout and fatigue symptoms. However, the intervention was directed only towards the employees, on the individual level. A focus on interactions with organisational factors and leadership is likely needed to support long-term recovery among healthcare staff.
Aims
To evaluate an intervention programme, "Leadership for recovery", for first-line healthcare managers in Swedish hospital settings, focusing on both 1) strategies for promoting own recovery and 2) strengthening a "leadership for recovery" (a leadership that promotes employee recovery).
The main question the study aims to answer are:
- Can a group-based intervention programme with a focus on strengthening first-line healthcare managers' own recovery and leadership for recovery improve their employees' recovery?
The hypotheses are:
The leadership for recovery program will:
Research design
The study is a cluster randomised controlled trial. Participating managers will be randomised to either intervention group or control group. Employees of managers in both the intervention and control group will be invited to participate in the study. Thus, the employees are beforehand (before recruitment) already assigned (cluster randomised) to intervention or control group based on which group their manager belongs to.
Recruitment
Managers are recruited from Swedish hospitals through contacts with Human Resources Departments and second-line managers. All employees of participating managers will be invited via e-mail for participation in the study.
Procedure
The intervention programme for managers includes both educative and reflective parts with a focus on promoting strategies for recovery. It is based on previous interview studies with nurses and first-line healthcare managers (unpublished results), previous interventions for a health promoting leadership, our previously evaluated recovery programme for nurses, and organisational behavioural management techniques. The first parts of the programme focus mostly on managers' own recovery, and the latter parts focus on ways to promote employees' recovery. The programme consists of 6 group sessions distributed over approximately 6 months.
Employees in both intervention and control group will fill out surveys at baseline (before intervention group managers' start the leadership intervention) post-intervention (about 1 month after intervention group managers' fifth session) and at follow-up (12 months after baseline). A subsample (voluntary) will also fill out diaries and wear actigraphy wristbands (objective sleep measure) at baseline and follow-up. Employees in the intervention and control group will be compared in terms of effects of the programme. Primary outcomes will be measures of recovery (including sleep). Secondary outcomes include measures of general health; somatic symptoms; burnout symptoms; cognition and work performance; work interference with personal life and intention to leave work. Both primary and secondary outcomes will be measured in both surveys and diaries. Sleep will also be measured through actigraphy wristbands. Data from surveys and diaries/actigraphy will be analysed and reported separately.
Randomisation and masking
The randomisation will be performed by a person not working in the project that is blinded to the participants. Block randomisation will be used. The randomisation will be made separately for different hospital sites (i.e. managers from the same hospital site will be randomised together, so that the ratio will be 1:1 for intervention/control group in each hospital site if possible). The randomisation may occur continuously as participants sign up for the study. If two or more managers work at the same unit/ward (shared leadership) they will be assigned to the same group.
It is not possible for participants or group leaders to be blinded to group allocation.
Sample size
The aim is to recruit approximately 80 first-line healthcare managers to be randomized to intervention or control group. Employees of participating managers will be invited to participate in the study. Based on the assumption that every manager has ≈ 40 employees, in total ≈ 3200 employees will be invited to participate. The investigators expect approximately 30% to sign up for the study, i.e. 960 participants.
Drop out from the program
Managers who drop out of the leadership program will be asked if they are willing to continue filling out questionnaires.
Data analysis plan
To be published. The analyses will follow the intention to treat principle. Per-protocol analysis will also be conducted.
458 studies on the registry are indexed under Burnout, Psychological; 110 are open to participants now.
This study's planned enrollment of 960 is above the median of 80 across 331 interventional studies indexed under Burnout, Psychological.
Browse Burnout, Psychological studies →Karolinska Institutet is the lead sponsor of 1,145 studies on the registry; 274 are open to participants now.
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Managers:
First line manager of nursing or laboratory staff in hospital care
Employees:
Having a first-line manager who participates in the study
Exclusion Criteria
Managers:
Less than 6 months' work experience as a manager at baseline measurement
Less than 50 % employment as a manager
Employees:
Casual worker
Exclusion criterium only for the diary and actigraphy study (employees):
Less than 6 months' work experience in profession at baseline measurement
Participants in this arm includes employees of managers in the intervention group (that are participating in the intervention programme).
Behavioral: Leadership for recovery
Participants in this arm includes employees of managers randomised to the control group (that are not participating in the intervention programme during the study period). Managers randomised to the control group will be offered to participate in the intervention programme after the last follow-up assessment. No further employee assessments will be made after the follow-up.
The intervention will be delivered as a group-based programme (6 sessions) to the managers of the included employees. The programme includes educative and reflective parts as well as various strategies promoting both managers' own recovery and the recovery of employees.
Survey measure of recovery experiences
Psychological detachment from work and Relaxation indexes from the Recovery Experience Questionnaire. + Additional single items on experiences of active recovery experiences. Minimum mean score 1, maximum mean score 5 (of each subscale/items). Lower scores indicate worse psychological detachment, worse relaxation and less active recovery experiences respectively. Single items: Do you get sufficient sleep? and Beyond sleep, do you get sufficient recovery? (1 yes, definitely sufficient - 5 no, far from sufficient)
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of need for recovery after work
Short-form versions of the Need For Recovery Scale, in total 5 items about work-induced fatigue. Minimum score 1, maximum score 5. Higher scores indicate a higher need for recovery.
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of insomnia symptoms
Insomnia Severity Index (ISI) which consists of 7 questions related to sleep. The total score is summarised with a minimum score 0, maximum score 28. Higher scores indicate more insomnia symptoms/sleep problems.
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Diary measure of recovery experiences during work and off-work time
Single items measured in diary study. During work today, I had time for reflection, I experienced periods of extreme fatigue, I could take breaks when needed, I had a good variety in work tasks, shift hand-overs worked out well, I detached from work when leaving. And Today during free-time, I did relaxing things, I did things that gave me energy, I took time for leisure, I had a break from the demands at work, I distanced myself from work, I was not disturbed by work-related questions. Rated from 1 = do not agree - 5 = totally agree.
Time frame: 7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).
Sleep (objective measure)
Actigraphy (wristband). Measuring of movements during sleep through a sensitive accelerometer. Preprogrammed algorithms make it possible to classify if the participant has slept or not. Example of parameters that can be estimated: Actual sleep time: The total time spent in sleep according to the epoch-by-epoch wake/sleep categorisation. Actual sleep %: Actual sleep time expressed as a percentage of the assumed sleep time. Sleep fragmentation: The sum of the "Mobile time (%)" and the "Immobile bouts \<=1min (%)". This is an indication of the degree of fragmentation
Time frame: 7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).
Survey measure of general health
Single item: Self-rated health during the last month on a scale ranging from 1=very good to 7=very bad.
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of somatic symptom burden
Somatic Symptoms Scale-8. Minimum score 0, maximum score 32. Higher scores indicate higher somatic symptom burden.
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of burnout symptoms
Shirom-Melamed Burnout Questionnaire-12 \[SMBQ-12\]: Minimum score 1, maximum score 7. Higher scores indicate more burnout. Index Emotional Impairment from Burnout Assesment Tool-12: Minimum score 1, maximum score 5. Higher scores indicate higher levels of emotional impairment.
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of cognition and work performance
Ratings (single items). Self-rated work performance through the following items: During the past month how often have you during you work .... 1) experienced a risk of mistakes 2) found it hard to make decisions 3) been present during interaction with others 4) experienced that you could perform your work safely (1 = never, 5 = always).
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of intention to leave work
Item from COpenhagen PsychoSOcial Questionnaire (COPSOQ): How often do you consider looking for work elsewhere? 1 always - 5 never/hardly ever.
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of work interference with personal life
The Work Interference with Personal Life index from the Work Home Interference scale. Consists of four items measuring the extent to which work affects free time (1 not at all-5 almost all the time). Higher scores indicate more work-home interference.
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Diary measure of stress/health symptoms
Single items measured in diary study. Questions if the respondent felt e.g. tense, irritated, exhausted, fatigued, emotionally strained, engaged, unfocused or had difficulties detaching from thoughts at work during free-time, during the day. Rated from 1 not at all - 5 to a high degree.
Time frame: 7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).
Diary measure of cognition and work performance
Ratings (single items) in diary study. Self-rated cognitive function through the following items: During the day at work, how well did you manage the following aspects: 1) decision making, 2) keeping things in mind, 3) keeping the overall picture, 4) performing work safely and 5) being present during interaction with others. rated from 1 = very well, 5 = very bad).
Time frame: 7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).
Negative effects/events of intervention
Singe items covering potential negative effects/events of participation
Time frame: Post-intervention (approx. 1 month after managers 5th intervention programme session) and follow-up (1 year after baseline measurement).
Plan to share: No — Individual participant data from this study fall under Swedish and European Union data protection and privacy legislation and can therefore not be share in their entirety. Reasonable requests may be directed to the corresponding author, and will be considered on a case-by-case basis
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