Condition category
Not Applicable
Date applied
31/03/2020
Date assigned
10/04/2020
Last edited
24/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 December 2023

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

Trial website

http://www.magnet4europe.eu/

Contact information

Type

Scientific

Primary contact

Dr Luk Bruyneel

ORCID ID

https://orcid.org/0000-0003-1209-692X

Contact details

Leuvens Instituut voor Gezondheidszorgbeleid
Kapucijnenvoer 35 blok d - bus 7001
Leuven
3000
Belgium
+32 16373306
luk.bruyneel@kuleuven.be

Type

Public

Additional contact

Prof Walter Sermeus

ORCID ID

Contact details

Leuvens Instituut voor Gezondheidszorgbeleid
Kapucijnenvoer 35 blok d - bus 7001
Leuven
3000
Belgium
+32 16373349
walter.sermeus@kuleuven.be

Type

Scientific

Additional contact

Prof Matthew McHugh

ORCID ID

Contact details

418 Curie Blvd.
University of Pennsylvania
Philadelphia
19012
United States of America
+1 (215) 746-0205
mchughm@nursing.upenn.edu

Type

Scientific

Additional contact

Prof Linda Aiken

ORCID ID

Contact details

418 Curie Blvd.
University of Pennsylvania
Philadelphia
19012
United States of America
+1 (215) 898-9759
laiken@nursing.upenn.edu

Type

Scientific

Additional contact

Mr Simon Dello

ORCID ID

Contact details

Leuvens Instituut voor Gezondheidszorgbeleid
Kapucijnenvoer 35 blok d - bus 7001
Leuven
3000
Belgium
+32 16 32 47 12
simon.dello@kuleuven.be

Type

Scientific

Additional contact

Mrs Dorothea Kohnen

ORCID ID

Contact details

Leuvens Instituut voor Gezondheidszorgbeleid
Kapucijnenvoer 35 blok d - bus 7001
Leuven
3000
Belgium
+32 16 32 24 93
dorothea.kohnen@kuleuven.be

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

848031

Study information

Scientific title

A workplace organizational intervention to improve hospital nurses’ and physicians’ mental health: protocol for the Magnet4Europe wait-list cluster randomized controlled trial

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

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: Approval pending, ethical approval will go through the Health Research Authority Integrated Research Application Process
Ireland: Approval pending, relevant authorities are determined based on participating hospitals (i.e. not central)
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

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

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request participant information sheet.

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

Phase

Drug names

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 trial start date

01/01/2020

Overall trial end date

31/12/2023

Reason abandoned (if study stopped)

Eligibility

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 type

Health professional

Age group

Adult

Gender

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 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

31/07/2023

Locations

Countries of recruitment

Belgium, Germany, Ireland, Norway, Sweden, United Kingdom

Trial participating centre

University Hospitals Leuven
3000
Belgium

Trial participating centre

OLV Aalst
9300
Belgium

Trial participating centre

University Hospitals Brussels
1090
Belgium

Trial participating centre

Ziekenhuis Oost Limburg
3600
Belgium

Trial participating centre

Jessa Ziekenhuis
3500
Belgium

Trial participating centre

RZ Heilig Hart Leuven
3000
Belgium

Trial participating centre

AZ Delta
8800
Belgium

Trial participating centre

AZ Vesalius
3700
Belgium

Trial participating centre

OLV van Lourdes Ziekenhuis Waregem
8790
Belgium

Trial participating centre

AZ Sint-Maarten
2800
Belgium

Trial participating centre

AZ Maria Middelares
9000
Belgium

Trial participating centre

AZ Sint-Vincentius Deinze
9800
Belgium

Trial participating centre

Universitats Herzzentrum Freiburg Bad Krozingen
79189
Germany

Trial participating centre

Universitätsklinikum Hamburg-Eppendorf
20251
Germany

Trial participating centre

Universitätsklinikum Heidelberg
69120
Germany

Trial participating centre

Universitätsklinikum Düsseldorf
40225
Germany

Trial participating centre

Ulm Universitäts und Rehabilitationskliniken
89081
Germany

Trial participating centre

Universitätsklinikum Münster
48149
Germany

Trial participating centre

Universitatsklinikum Bonn
53127
Germany

Trial participating centre

Johanna Etienne Krankenhaus Kreiskliniken Reutlingen
72764
Germany

Trial participating centre

Deutsches Herzzentrum München
80636
Germany

Trial participating centre

Deutsches Herzzentrum Berlin
13353
Germany

Trial participating centre

Robert-Bosch-Krankenhaus
70376
Germany

Trial participating centre

Städtisches Klinikum Dessau
06847
Germany

Trial participating centre

Universitätsklinikum Halle
06120
Germany

Trial participating centre

Kalmar Länssjukhus
39244
Germany

Trial participating centre

Blekinge Hospital
37141
Sweden

Trial participating centre

Karolinska University Hospital
17176
Sweden

Trial participating centre

Skåne University Hospital Malmö/Lund
20501
Sweden

Trial participating centre

Uppsala University Hospital
75185
Sweden

Trial participating centre

Lovisenberg Diakonale Sykehus
0456
Norway

Trial participating centre

Beaumont Hospital
D09 V2N0
Ireland

Trial participating centre

Connolly Hospital
D15 X40D
Ireland

Trial participating centre

Cork University Hospital
T12 DFK4
Ireland

Trial participating centre

Galway University Hospital
H91 YR71
Ireland

Trial participating centre

Letterkenny University Hospital
X75 8X8
Ireland

Trial participating centre

Limerick University Hospital
V94 F858
Ireland

Trial participating centre

Our Lady of Lourdes Hospital
A92 VW28
Ireland

Trial participating centre

South Infirmary-Victoria University Hospital
T12 X23H
Ireland

Trial participating centre

St. James's Hospital
D08 NHY1
Ireland

Trial participating centre

St. Vincent's University Hospital
D04 T6F4
Ireland

Trial participating centre

Tipperary South Hospital
E91 VY40
Ireland

Trial participating centre

Waterford University Hospital
X91 ER8E
Ireland

Trial participating centre

Tallaght University Hospital
D24 NR0A
Ireland

Trial participating centre

Mater Misericordiae University Hospital
D07 R2WY
Ireland

Trial participating centre

Bons Secours Hospital
D09 YN97
Ireland

Trial participating centre

University Hospitals of Derby and Burton NHS Foundation Trust
DE22 3NE
United Kingdom

Trial participating centre

East and North Hertfordshire NHS Trust
SG1 4AB
United Kingdom

Trial participating centre

Gloucestershire Hospitals NHS Foundation Trust
GL53 7AN
United Kingdom

Trial participating centre

NHS Grampian
AB25 2ZN
United Kingdom

Trial participating centre

Torbay and South Devon Health Care NHS Foundation Trust
TQ2 7AA
United Kingdom

Trial participating centre

West Hertfordshire Hospitals NHS Trust
WD18 0HB
United Kingdom

Trial participating centre

Bradford Teaching Hospitals NHS Foundation Trust
BD9 6RJ
United Kingdom

Trial participating centre

University Hospitals of Morecambe Bay NHS Foundation Trust
LA97RG
United Kingdom

Trial participating centre

South Tyneside and Sunderland NHS Foundation Trust
NE34 0PL
United Kingdom

Sponsor information

Organisation

KU Leuven

Sponsor details

Oude Markt 13
Leuven
3000
Belgium
+32 16373349
walter.sermeus@kuleuven.be

Sponsor type

University/education

Website

https://www.kuleuven.be/samenwerking/ligb/Home

Funders

Funder type

Government

Funder name

European Commission Horizon 2020

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

01/11/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.