Magnet4Europe - Improving mental health and wellbeing in the health care workplace
| ISRCTN | ISRCTN10196901 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10196901 |
| IRAS number | 274132 |
| Secondary identifying numbers | 848031, IRAS 274132 |
- Submission date
- 31/03/2020
- Registration date
- 10/04/2020
- Last edited
- 16/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Mental health and wellbeing are among the highest priorities of the public health agenda in the European Union (EU). A large-scale European study of hospital work conditions and associated nurse and patient outcomes revealed high rates of job dissatisfaction and burnout, with burnout rates varying between 10% and 78%. Physician burnout rates ranging from 25% to 60% have been reported, varying across organizations and medical specialties. Magnet4Europe aims to redesign clinical environments in sixty hospitals in five European countries (Belgium, United Kingdom, Germany, Ireland, and Sweden) to promote the mental health and wellbeing of health professionals. Magnet4Europe will implement an evidence-based intervention based on the successful Magnet Recognition Program®, a voluntary hospital designation for nursing care excellence by the American Nurses Credentialing Center. Countless studies have shown that Magnet-recognized hospitals have lower health professional burnout and safer patient care suggesting that the Magnet journey is an intervention that results in positive changes Magnet4Europe seeks to achieve.
Who can participate?
Hospitals with more than 150 beds focused on acute care for adults.
Health professionals working at these hospitals who have direct patient contact and work on inpatient units.
What does the study involve?
In the Magnet4Europe study we will be studying and measuring various items in relation work environment (work relations, job satisfaction, perception of the quality of care and workload) and mental health of health professionals working in acute care hospitals. These items and topics will be measured using standardised and validated questionnaires. The Magnet4Europe study will run for four years and during this period you will be annually invited to take part in a survey. When you decide to take part in the Magnet4Europe study and engage in the survey, you will be asked to register yourself on the Meplis Care Monitor. The Care Monitor will provide access to the survey. You will receive an activation URL, allowing you to register yourself on the Care Monitor. You will receive instructions through the application on how to get started with the questionnaire. You will then be asked a number of questions about your perception of your working environment: the relationship with the doctors, the workload and staffing of the ward, any intention (if any) to leave the profession, patient safety, etc. The questionnaire takes approx. 20 minutes to complete; it should be completed within two weeks of receiving the invitation. You will receive three more invitations after this (i.e. one invitation every following year).
What are the possible benefits and risks of participating?
Benefits: You have no benefit from participating in the Magnet4Europe study and will not be compensated for your participation. However, we hope that your participation in the study will help us to gain more insight on how you perceive hospital care and the demands that are placed on clinical staff. By doing so, you can help to improve the working environment and safety of patient care.
Risks: There are no disadvantages associated with participation. Neither the research team nor the hospital will know whether you have participated in the study or not. A possible refusal to participate in the study will have no adverse effect on your employment at this hospital; nor will your answers have any effect on your participation.
Where is the study run from?
University Hospitals Leuven (Belgium) and recruiting in Belgium, United Kingdom, Sweden, Ireland, Norway, and Germany.
When is the study starting and how long is it expected to run for?
September 2020 to June 2024
Who is funding the study?
European Commission Horizon 2020
Who is the main contact?
Prof. Luk Bruyneel (scientific), luk.bruyneel@kuleuven.be
Prof. Walter Sermeus (public), walter.sermeus@kuleuven.be
Prof. Matthew McHugh (scientific), mchughm@nursing.upenn.edu
Prof. Linda Aiken (scientific), laiken@nursing.upenn.edu
Simon Dello (scientific), simon.dello@kuleuven.be
Dorothea Kohnen (scientific), dorothea.kohnen@kuleuven.be
Contact information
Scientific
Leuvens Instituut voor Gezondheidszorgbeleid
Kapucijnenvoer 35 blok d - bus 7001
Leuven
3000
Belgium
 ORCID ID |
0000-0003-1209-692X |
|---|---|
| Phone | +32 16373306 |
| luk.bruyneel@kuleuven.be |
Public
Leuvens Instituut voor Gezondheidszorgbeleid
Kapucijnenvoer 35 blok d - bus 7001
Leuven
3000
Belgium
| Phone | +32 16373349 |
|---|---|
| walter.sermeus@kuleuven.be |
Scientific
418 Curie Blvd.
University of Pennsylvania
Philadelphia
19012
United States of America
| Phone | +1 (215) 746-0205 |
|---|---|
| mchughm@nursing.upenn.edu |
Scientific
418 Curie Blvd.
University of Pennsylvania
Philadelphia
19012
United States of America
| Phone | +1 (215) 898-9759 |
|---|---|
| laiken@nursing.upenn.edu |
Scientific
Leuvens Instituut voor Gezondheidszorgbeleid
Kapucijnenvoer 35 blok d - bus 7001
Leuven
3000
Belgium
| Phone | +32 16 32 47 12 |
|---|---|
| simon.dello@kuleuven.be |
Scientific
Leuvens Instituut voor Gezondheidszorgbeleid
Kapucijnenvoer 35 blok d - bus 7001
Leuven
3000
Belgium
| Phone | +32 16 32 24 93 |
|---|---|
| dorothea.kohnen@kuleuven.be |
Study information
| Study design | Multicenter hospital-based matched pairs usual-practice wait-list cluster randomized controlled trial with a nested mixed-methods process evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request participant information sheet. |
| Scientific title | A workplace organizational intervention to improve hospital nurses’ and physicians’ mental health: protocol for the Magnet4Europe wait-list cluster randomized controlled trial |
| Study acronym | Magnet4Europe |
| Study hypothesis | The objective is the implementation of the Magnet® Model of organizational redesign in acute care hospitals in Europe using a multi-component implementation strategy, reduces burnout rate and mental health morbidity among physicians and nurses. |
| Ethics approval(s) | Belgium: Approved 02/10/2020, Ethics Committee Research UZ/KU Leuven (Herestraat 49, 3000 Leuven, Belgium; +32 (0)16 34 86 00; ec@uzleuven.be), ref: S64213 Sweden: Approved 23/09/2020, Swedish Ethical Review Authority (Postal address Box 2110, SE-750 02 Uppsala, Sweden; registrator@etikprovning.se), ref: 2020-03842 UK: Approved 01/09/2020, University of Southampton Ethics and Research Governance (ERGO, Head of Research Integrity and Governance, Research and Innovation Services, Southampton, SO17 1BJ, UK; +44 (0)2380595058; rgoinfo@soton.ac.uk), ref: 52986 UK: Approved 30/10/2020, NHS Health Research Authority (2 Redman Place, Stratford, London, E20 1JQ, UK; tel: not provided; approvals@hra.nhs.uk), ref: 274132 Ireland: Approved 12/08/2020, Clinical Research Ethics Committee of the Cork Teaching Hospitals (CREC; University College Cork, Lancaster Hall, 6 Little Hanover Street Cork, Ireland; +353 (0)21 4901901; crec@ucc.ie), ref: ECM 4 (s) 11/08/2020 Germany: Approved 30/10/2020, Ethikkommission Charité – Universitätsmedizin Berlin (Ethikausschuss am Campus Charité Mitte, Vorsitzender Prof. Dr. R. Morgenstern, Charité Universitätsmedizin Berlin, Ethikkommission der Charité, z.Hd. Dr. K. Orzechowski, Charitéplatz 1, 10117 Berlin, Germany; +49 (0)30 450 517222; Ethikkommission@charite.de), ref: EA1/243/20 Norway: Approved 05/11/2020, Regional Committee for Medical and Health Research Ethics (REC), South East (REK Sør-øst D, PO Box 1130, Blindern, N-0318 Oslo, Norway; +47 (0)2284 5511; re-sorost@medisin.uio.no), ref: 166980 |
| Condition | The impact of organizational redesign of acute care hospitals according to the Magnet© principles of organizational redesign on mental health and wellbeing of health professionals |
| Intervention | A multicenter hospital-based matched pairs usual-practice wait-list cluster randomized controlled trial with a nested mixed-methods process evaluation is used. The order in which hospitals receive the intervention is randomized. Using computer-generated randomization with a 1:1 allocation ratio within each country hospitals will be randomized into an immediate intervention group or a usual-practice wait-list control group. Hospitals allocated to the immediate intervention group, start immediately with the intervention; hospitals in the wait-list group start 12 months later with the intervention. The design of the study inherently makes it impossible to blind hospitals to the intervention. A multicomponent intervention aimed at organizational redesign of hospitals is applied. Hospitals in the wait-list control group do not access any intervention components until the start of the intervention period in their hospital. The Magnet4Europe intervention will be launched in the immediate intervention group in month 9 of the project with the first learning collaborative taking place, and will have a total duration of 32 months. The intervention will be initiated in the usual-practice wait-list control group in month 19 and will last for 22 months. At month 9, hospitals allocated to the immediate intervention group will engage in full exposure to the multi-component intervention. Full exposure entails following active components being operationalised: 1. The hospital start the implementation of the Magnet© components as outlined in the Magnet Manual© of organisational redesign. Using the Magnet4Europe Magnet© Gap Analysis Tool they will perform a gap analysis in close collaboration with their assigned twinning partner. Based on the results of the gap analysis, each intervention hospital is responsible for tailoring and individualizing the interventions to their hospital-specific context and develop a concrete, written implementation plan (in collaboration with the twinning hospital) that will be executed during the course of the intervention period 2. In close relation to element one of the intervention: hospitals engage in an active one-to-one twinning relationship with a Magnet© designated hospital. Twinning entails bi-annual on-site visits of the Magnet© partner to the intervention hospital (or vice-versa) and monthly virtual meetings 3. All hospitals allocated to the immediate intervention group will attend an international Learning collaborative taking place at month 9 (i.e. current plan in protocol) 4. The group of intervention hospitals is actively involved in creating critical mass. They promote innovation, draw public interest and foster replication. Tangibility of critical mass is difficult; nonetheless will it serve catalyst for improvement and enables improvements to take hold and to be more sustainable 5. Provide near real-time feedback to hospitals on clinicians’ reports on work conditions and wellbeing after each of the quantitative data collection periods using rapid document delivery via SAS Output Delivery System. The duration of exposure in the immediate intervention group is 32 months The intervention in the usual-practice waitlist control group is employed 10 months later compared to the immediate intervention group and is - to a large extent - identical. At month 19 these hospitals engage in full exposure to the different intervention components. The only minor difference can be found in component three: i.e. the usual-practice waitlist hospitals now have access to implementation strategies of hospitals in the immediate intervention group allowing for expeditated implementation of the Magnet© principles. This knowledge is not available for the immediate intervention group. The usual-practice waitlist control group will receive feedback on clinicians’ reports on work conditions and wellbeing for the first time. The duration of exposure in usual-practice waitlist control group is 22 months |
| Intervention type | Behavioural |
| Primary outcome measure | Burnout measured among nurses and physicians using the validated Emotional Exhaustion subscale of the Maslach Burnout Inventory (9-items) and the Burnout Assessment Tool (12-items). Burnout is measured at every measurement occasion, i.e. at month 9, 17, 29 and 41 in the intervention group and the wait-list control group. |
| Secondary outcome measures | Current secondary outcome measures as of 26/05/2020: Measured among nurses at each measurement occasion i.e. at month 9, 17, 29 and 41 in both the immediate intervention group and the wait-list control group: 1. Work engagement (UWES-3) 2. Job satisfaction measured using a single question 3. Depression (PHQ-2) 4. Anxiety (GAD-2) 5. General health (SF-8) 6. Sleep quality (PSQ) 7. Intent to leave the hospital measured using two items 8. Absenteeism (HPQ) and presenteeism (HPQ) 9. Workability measured using a single question 10. Work-life conflict measured using a single question 11. Team commitment measured using a single question 12. Organizational commitment measured using a single question 13. Whether clinicians would recommend the hospital measured using two items 14. Work environment (PES-NWI) 15. Various measures of staffing and workload (NPQS) 16. Safety and quality measured using 10 items 17. Necessary nursing care left undone measured using a single question 18. Operational failures measured using a single question 19. Emotional demands (SIMPH) 20. Red tape measured using a single question 21. Role conflicts (NPQS) 22. Job control measured using a single question 23. Skill use measured using a single question 24. Value congruence measured using a single question 25. Performance feedback measured using three items 26. Opportunities for learning and development measured using a single question 27. Task variety (QEEW) 28. Role clarity (NPQS) 29. Intrinsic motivation (WEIMS) 30. Additional survey items to quantify associations will be measured among nurses in measurement occasions 2 and 4 (i.e. month 17 and 41) in the wait-list control group: 30.1. Emotional dissonance measured using a single question 30.2. Qualitative job insecurity measured using a single question 30.3. Basic need satisfaction measured using a six items 30.4. Engaging leadership measured using a twelve items 31. To survey physicians at each measurement occasion in both the immediate intervention group and the wait-list control group (measures as above): 31.1. Work engagement 31.2. Job satisfaction 31.3. Depression 31.4. Anxiety 31.5. General health 31.6. Sleep quality 31.7. Intent to leave the hospital 31.8. Absenteeism and presenteeism 31.9. Work-life conflict 31.10. Whether clinicians would recommend the hospital 31.11. Work environment 31.12. Measures of staffing and workload 31.13. Safety and quality 31.14. Red tape _____ Previous secondary outcome measures: Measured among nurses at each measurement occasion i.e. at month 9, 17, 29 and 41 in both the immediate intervention group and the wait-list control group: 1. Work engagement (UWES-3) 2. Job satisfaction measured using a single question 3. Depression (PHQ-2) 4. Anxiety (GAD-2) 5. General health (SF-8) 6. Sleep quality (PSQ) 7. Intent to leave the hospital measured using a single question 8. Absenteeism (HPQ) and presenteeism (HPQ) 9. Workability measured using a single question 10. Work-life conflict measured using a single question 11. Team commitment measured using a single question 12. Organizational commitment measured using a single question 13. Whether clinicians would recommend the hospital measured using a single question 14. Work environment (PES-NWI) 15. Various measures of staffing and workload (NPQS) 16. Safety and quality measured using a single question 17. Necessary nursing care left undone measured using a single question 18. Operational failures measured using a single question 19. Emotional demands (SIMPH) 20. Red tape measured using a single question 21. Role conflicts (NPQS) 22. Job control measured using a single question 23. Skill use measured using a single question 24. Value congruence measured using a single question 25. Performance feedback measured using a single question 26. Opportunities for learning and development measured using a single question 27. Task variety (QEEW) 28. Role clarity (NPQS) 29. Intrinsic motivation (WEIMS) 30. Additional survey items to quantify associations will be measured among nurses in measurement occasions 2 and 4 (i.e. month 17 and 41) in the wait-list control group: 30.1. Emotional dissonance measured using a single question 30.2. Qualitative job insecurity measured using a single question 30.3. Basic need satisfaction measured using a single question 30.4. Engaging leadership measured using a single question 31. To survey physicians at each measurement occasion in both the immediate intervention group and the wait-list control group (measures as above): 31.1. Work engagement 31.2. Job satisfaction 31.3. Depression 31.4. Anxiety 31.5. General health 31.6. Sleep quality 31.7. Intent to leave the hospital 31.8. Absenteeism and presenteeism 31.9. Work-life conflict 31.10. Whether clinicians would recommend the hospital 31.11. Work environment 31.12. Measures of staffing and workload 31.13. Safety and quality 31.14. Red tape |
| Overall study start date | 01/01/2020 |
| Overall study end date | 30/06/2024 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Power and sample size calculation was performed for the primary outcome of interest, i.e. burnout, exemplified by using the emotional exhaustion subscale of the Maslach Burnout Inventory. In total 10,253 participants divided in 51 clusters with an average cluster size of 200 are required per measurement occasion. |
| Participant inclusion criteria | Hospitals: 1. No Magnet© designation by the American Nursing Credentialing Center (ANCC) has been acquired in the past or at the time of the start of the intervention 2.Bed size greater or equal to 150 3. The hospital is focused on acute care for adults, including at least wards on internal medicine and/or surgery Health professionals: 1. They have direct patient contact 2. Meet the minimum qualifications as stipulated by Directive 2013/55/EU amending Directive 2005/35/EC on the recognition of professional qualifications 3. Work on adult inpatient units including intensive care units (ICU) and the emergency room (ER) |
| Participant exclusion criteria | Hospitals: 1. Highly specialized hospitals, e.g. psychiatric hospitals, tropical medicines or pediatrics Health professionals: 1. Working in neonatology, pediatrics, obstetrics, psychiatry, operating room, pathology, microbiology, radiology and medical imaging |
| Recruitment start date | 19/10/2020 |
| Recruitment end date | 24/12/2023 |
Locations
Countries of recruitment
- Belgium
- England
- Germany
- Ireland
- Norway
- Sweden
- United Kingdom
Study participating centres
Belgium
Belgium
Belgium
Belgium
Belgium
Belgium
Belgium
Belgium
Belgium
Belgium
Belgium
Belgium
Germany
Germany
Germany
Germany
Germany
Germany
Germany
Germany
Germany
Germany
Germany
Germany
Sweden
Sweden
Sweden
Norway
Ireland
Ireland
Ireland
Ireland
Ireland
Ireland
Ireland
Ireland
Ireland
Ireland
Ireland
Ireland
Ireland
Ireland
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Belgium
Belgium
Belgium
Germany
Germany
Germany
Germany
Germany
Germany
Germany
Germany
Germany
Ireland
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
152 40
Sweden
Sponsor information
University/education
Oude Markt 13
Leuven
3000
Belgium
| Phone | +32 16373349 |
|---|---|
| walter.sermeus@kuleuven.be | |
| Website | https://www.kuleuven.be/samenwerking/ligb/Home |
"ROR" |
https://ror.org/05f950310 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Magnet4Europe has a strong focus on strengthening the evidence on the impact of work environment on mental health of health professionals. Findings will be published in peer reviewed journals and through other channels designed to reach a diverse community of researchers, practitioners, and other stakeholders. Gold open access will be used for the key findings of the study to ensure maximum exposure to a practice community. Beyond the funded life of the project the aim is to maximize accessibility by fully exploiting the opportunity for green open access and, where possible, identifying additional funds to support further gold open access. The study protocol is the first publication aimed for in this project. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 28/07/2022 | 29/07/2022 | Yes | No | |
| Interim results article | 15/01/2024 | 16/01/2024 | Yes | No |
Editorial Notes
16/01/2024: Publication reference added.
13/12/2023: The recruitment end date was changed from 15/12/2023 to 24/12/2023.
25/07/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 31/12/2023 to 15/12/2023.
2. The intention to publish date was changed from 30/06/2024 to 30/09/2024.
10/07/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 31/07/2023 to 31/12/2023.
2. The overall end date was changed from 31/12/2023 to 30/06/2024.
3. The intention to publish date was changed from 01/11/2023 to 30/06/2024.
4. The plain English summary was updated to reflect these changes.
20/12/2022: The trial participating centre Södertälje Sykehus was added.
29/07/2022: Publication reference added.
29/07/2021: Ethics approval details added. Salford Royal NHS Foundation Trust and the Pennine Acute Hospitals NHS Trust were removed from the trial participating centres.
11/03/2021: Guy’s and St Thomas’s NHS Foundation Trust and Portsmouth Hospitals University NHS Trust were removed as trial participating centres.
17/02/2021: Ethics approval details added.
16/02/2021: The following changes were made to the trial record:
1. The following trial participating centres were added: Ziekenhuis Netwerk Antwerpen, Gasthuiszusters Antwerpen, AZ Damiaan Oostende, Universitätsklinikum Freiburg, Klinikum Osnabrück, Universitaetsklinikum Regensburg, Kreiskliniken Reutlingen, Krankenhaus vom Roten Kreuz Bad Cannsatt, Sana Herzchirurgie Stuttgart, Universitätsklinikum Tübingen, Städtisches Klinikum Lüneburg, Klinikum Bremerhaven-Reinkenheide, Mercy University Hospital, Frimley Health NHS Foundation Trust, Portsmouth Hospitals University NHS Trust, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, Chelsea and Westminster Hospital NHS Foundation Trust, King’s College Hospitals NHS Foundation Trust, Guy’s and St Thomas’s NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust, Lancashire Teaching Hospitals, Salford Royal NHS Foundation Trust, The Pennine Acute Hospitals NHS Trust.
2. The following trial participating centres were removed: Universitats Herzzentrum Freiburg Bad Krozingen, Karolinska University Hospital, Blekinge Hospital, St. Vincent's University Hospital, NHS Grampian, South Tyneside and Sunderland NHS Foundation Trust, University Hospitals of Derby and Burton NHS Foundation Trust.
08/12/2020: Ethics approval details added.
24/11/2020: Ethics approval details added.
20/11/2020: Ethics approval details added.
20/10/2020: Ethics approval details added.
19/10/2020: Ethics approval details added, the recruitment start date was changed from 05/10/2020 to 19/10/2020.
11/09/2020: The recruitment start date was changed from 01/09/2020 to 05/10/2020.
26/05/2020: The secondary outcome measures were changed.
21/05/2020: Internal review.
08/04/2020: Trial’s existence confirmed by European Commission.
