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Leadership for Recovery: Evaluation of an Intervention Programme for First-line Healthcare Managers

Not Applicable
Recruiting
Conditions
Recovery, Psychological
Sleep
Burnout
Work Related Stress
Insomnia
Fatigue
Registration Number
NCT06678347
Lead Sponsor
Karolinska Institutet
Brief Summary

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.

Detailed Description

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:

* improve the employees' recovery (including sleep)

* improve the employees' health, including somatic symptoms and burnout symptoms

* improve the employees' cognition

* reduce the employees' work interference with personal life

* reduce the employees' intention to leave work

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
960
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Survey measure of recovery experiencesPre-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).

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)

Survey measure of need for recovery after workPre-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).

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.

Survey measure of insomnia symptomsPre-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).

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.

Diary measure of recovery experiences during work and off-work time7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).

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.

Sleep (objective measure)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).

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

Secondary Outcome Measures
NameTimeMethod
Survey measure of general healthPre-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).

Single item: Self-rated health during the last month on a scale ranging from 1=very good to 7=very bad.

Survey measure of somatic symptom burdenPre-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).

Somatic Symptoms Scale-8. Minimum score 0, maximum score 32. Higher scores indicate higher somatic symptom burden.

Survey measure of burnout symptomsPre-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).

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.

Survey measure of cognition and work performancePre-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).

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).

Survey measure of intention to leave workPre-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).

Item from COpenhagen PsychoSOcial Questionnaire (COPSOQ): How often do you consider looking for work elsewhere? 1 always - 5 never/hardly ever.

Survey measure of work interference with personal lifePre-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).

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.

Diary measure of stress/health symptoms7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).

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.

Diary measure of cognition and work performance7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).

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).

Trial Locations

Locations (2)

Sahlgrenska Universitetssjukhuset

🇸🇪

Gothenburg, Sweden

Karolinska Universitetssjukhuset

🇸🇪

Stockholm, Sweden

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