Participatory Organizational Intervention for Improved Use of Assistive Devices for Patient Handling (IRMA12)
Primary Purpose
Musculoskeletal Disorders, Occupational Injuries
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Participatory Organizational Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Musculoskeletal Disorders
Eligibility Criteria
At the department level:
Hospital departments with frequent patient handling will be eligible for participation in the cluster-randomized study.
At the individual level (questionnaire replies):
Inclusion Criteria:
- Healthcare workers with daily patient handling (based on questionnaire reply at baseline)
Exclusion Criteria:
- None
Sites / Locations
- National Research Centre for the Working Environment
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Participatory Organizational Intervention
Control
Arm Description
Participatory intervention (workshops) with workers, consultants and leaders. The workshops will find solutions for increased use of assistive devices
This group will go through the same baseline and follow-up tests as the intervention group, but will not receive any intervention.
Outcomes
Primary Outcome Measures
Use of assistive devices (push-button)
The healthcare workers are encouraged to push one of the following two buttons every time they leave the room after having performed patient transfer; button 1 "Press this button if you used the necessary assistive devices for your patient transfer" and button 2 "Press this button if you did not use the necessary assistive devices for your patient transfer". The number of Button 1 counts as a percentage of total counts (Button 1+2) will be calculated for set of counters and used as primary outcome.
Secondary Outcome Measures
Use of assistive devices (accelerometer)
Accelerometers will be placed on the assistive devices. The method is currently being validated in the laboratory and will be finalized before initiation of the 1 year follow-up measurement. Accelerations of a certain time frame will be defined as "use", whereas brief accelerations will be considered as noise
Pain intensity (VAS scale)
Pain intensity in the low-back is rated subjectively using a 0-10 modified VAS scale, where 0 indicates "no pain at all" and 10 indicate "worst pain imaginable"
Perceived physical exertion (Borg CR10 scale)
Perceived physical exertion during patient handling. Borg CR10 scale
Back injury
The specific question reads: "Have you within the last 12 months injured your back during patient transfer? (Think of situation where the pain appeared suddenly and unexpectedly)." The respondent replies "yes" or "no"
Work ability (Index questionnaire)
The full Work Ability Index questionnaire (Ilmarinen)
Social capital (Questionnaire)
Questionnaire concerning bonding, bridging, linking A, and linking B social capital (Andersen LL 2015 Scandinavian Journal of Public Health)
Knowledge (Questionnaire)
Specific questionnaire about knowledge about patients transfer and safety at work
Organizational Readiness to Change (Questionnaire)
Questionnaire about Organizational Readiness to Change
Use of assistive devices (Questionnaire)
Questionnaire about frequency of use of the different types of assistive devices
Full Information
NCT ID
NCT02708550
First Posted
March 4, 2016
Last Updated
August 10, 2018
Sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
Aalborg University
1. Study Identification
Unique Protocol Identification Number
NCT02708550
Brief Title
Participatory Organizational Intervention for Improved Use of Assistive Devices for Patient Handling
Acronym
IRMA12
Official Title
Deltagerinvolverende Intervention for Bedre Brug af hjælpemidler i hospitalsvæsenet
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
Aalborg University
4. Oversight
5. Study Description
Brief Summary
Epidemiological studies have shown that patient transfer is a risk factor for back pain, back injuries and long term sickness absence, whereas consistent use of assistive devices during patient transfer is associated with reduced risk of back injury. In consequence, Danish hospitals have made great efforts to increase knowledge, availability and use of assistive devices to reduce work-related physical strain due to patient transfer. Yet, a recent survey among more than 300 nurses and nurses' aides showed that two thirds rarely uses assistive devices during patient transfer. Thus it seems relevant to investigate barriers, opportunities and practical solutions for increasing use of assistive devices among healthcare workers. The purpose of this study is to evaluate a participatory organizational intervention for improved use of assistive devices during patient transfer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disorders, Occupational Injuries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
625 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participatory Organizational Intervention
Arm Type
Experimental
Arm Description
Participatory intervention (workshops) with workers, consultants and leaders. The workshops will find solutions for increased use of assistive devices
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will go through the same baseline and follow-up tests as the intervention group, but will not receive any intervention.
Intervention Type
Behavioral
Intervention Name(s)
Participatory Organizational Intervention
Primary Outcome Measure Information:
Title
Use of assistive devices (push-button)
Description
The healthcare workers are encouraged to push one of the following two buttons every time they leave the room after having performed patient transfer; button 1 "Press this button if you used the necessary assistive devices for your patient transfer" and button 2 "Press this button if you did not use the necessary assistive devices for your patient transfer". The number of Button 1 counts as a percentage of total counts (Button 1+2) will be calculated for set of counters and used as primary outcome.
Time Frame
Average use during the entire 1-year follow-up (i.e. continous measurement during 1 year) adjusted for use during 4 weeks prior to the intervention (baseline)
Secondary Outcome Measure Information:
Title
Use of assistive devices (accelerometer)
Description
Accelerometers will be placed on the assistive devices. The method is currently being validated in the laboratory and will be finalized before initiation of the 1 year follow-up measurement. Accelerations of a certain time frame will be defined as "use", whereas brief accelerations will be considered as noise
Time Frame
change from baseline to 1-year follow-up
Title
Pain intensity (VAS scale)
Description
Pain intensity in the low-back is rated subjectively using a 0-10 modified VAS scale, where 0 indicates "no pain at all" and 10 indicate "worst pain imaginable"
Time Frame
change from baseline to 1-year follow-up
Title
Perceived physical exertion (Borg CR10 scale)
Description
Perceived physical exertion during patient handling. Borg CR10 scale
Time Frame
change from baseline to 1-year follow-up
Title
Back injury
Description
The specific question reads: "Have you within the last 12 months injured your back during patient transfer? (Think of situation where the pain appeared suddenly and unexpectedly)." The respondent replies "yes" or "no"
Time Frame
change from baseline to 1-year follow-up
Title
Work ability (Index questionnaire)
Description
The full Work Ability Index questionnaire (Ilmarinen)
Time Frame
change from baseline to 1-year follow-up
Title
Social capital (Questionnaire)
Description
Questionnaire concerning bonding, bridging, linking A, and linking B social capital (Andersen LL 2015 Scandinavian Journal of Public Health)
Time Frame
change from baseline to 1-year follow-up
Title
Knowledge (Questionnaire)
Description
Specific questionnaire about knowledge about patients transfer and safety at work
Time Frame
change from baseline to 1-year follow-up
Title
Organizational Readiness to Change (Questionnaire)
Description
Questionnaire about Organizational Readiness to Change
Time Frame
change from baseline to 1-year follow-up
Title
Use of assistive devices (Questionnaire)
Description
Questionnaire about frequency of use of the different types of assistive devices
Time Frame
change from baseline to 1-year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
At the department level:
Hospital departments with frequent patient handling will be eligible for participation in the cluster-randomized study.
At the individual level (questionnaire replies):
Inclusion Criteria:
Healthcare workers with daily patient handling (based on questionnaire reply at baseline)
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars L Andersen, PhD
Organizational Affiliation
National Research Centre for the Working Environment
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Research Centre for the Working Environment
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
32496600
Citation
Jakobsen MD, Clausen T, Andersen LL. Can a participatory organizational intervention improve social capital and organizational readiness to change? Cluster randomized controlled trial at five Danish hospitals. J Adv Nurs. 2020 Oct;76(10):2685-2695. doi: 10.1111/jan.14441. Epub 2020 Aug 14.
Results Reference
derived
PubMed Identifier
27998265
Citation
Jakobsen MD, Aust B, Dyreborg J, Kines P, Illum MB, Andersen LL. Participatory organizational intervention for improved use of assistive devices for patient transfer: study protocol for a single-blinded cluster randomized controlled trial. BMC Musculoskelet Disord. 2016 Dec 20;17(1):501. doi: 10.1186/s12891-016-1339-6.
Results Reference
derived
Learn more about this trial
Participatory Organizational Intervention for Improved Use of Assistive Devices for Patient Handling
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