Musculoskeletal DisordersIRMA12NCT02708550
Participatory Organizational Intervention for Improved Use of Assistive Devices for Patient Handling
A study testing Participatory Organizational Intervention in people with Musculoskeletal Disorders and Occupational Injuries, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Disorders, Occupational Injuries
- What is being tested?
- Participatory Organizational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare workers with daily patient handling (based on questionnaire reply at baseline)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National Research Centre for the Working Environment
Copenhagen, 2100
About this study
Official title: Deltagerinvolverende Intervention for Bedre Brug af hjælpemidler i hospitalsvæsenet
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.
- Conditions
- Musculoskeletal Disorders, Occupational Injuries
- Being tested
- Participatory Organizational Intervention
- Medical subject headings
- Musculoskeletal Diseases, Occupational Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory Organizational InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Participatory Organizational Intervention | Experimental | Participatory intervention (workshops) with workers, consultants and leaders. The workshops will find solutions for increased use of assistive devices Receives: Behavioral: Participatory Organizational Intervention |
| Control | No intervention | This group will go through the same baseline and follow-up tests as the intervention group, but will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (9)
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
Measured: change from baseline to 1-year follow-up
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"
Measured: change from baseline to 1-year follow-up
Perceived physical exertion (Borg CR10 scale)
Perceived physical exertion during patient handling. Borg CR10 scale
Measured: change from baseline to 1-year follow-up
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"
Measured: change from baseline to 1-year follow-up
Work ability (Index questionnaire)
The full Work Ability Index questionnaire (Ilmarinen)
Measured: change from baseline to 1-year follow-up
Social capital (Questionnaire)
Questionnaire concerning bonding, bridging, linking A, and linking B social capital (Andersen LL 2015 Scandinavian Journal of Public Health)
Measured: change from baseline to 1-year follow-up
Knowledge (Questionnaire)
Specific questionnaire about knowledge about patients transfer and safety at work
Measured: change from baseline to 1-year follow-up
Organizational Readiness to Change (Questionnaire)
Questionnaire about Organizational Readiness to Change
Measured: change from baseline to 1-year follow-up
Use of assistive devices (Questionnaire)
Questionnaire about frequency of use of the different types of assistive devices
Measured: change from baseline to 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 625 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Lars L. Andersen, National Research Centre for the Working Environment, Denmark
- Investigators
- Lars L Andersen, PhD, Principal investigator, National Research Centre for the Working Environment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708550
- Sponsor's protocol ID
- IRMA12
- Acronym
- IRMA12
- Status last verified
- Aug 2018
- First submitted
- 4 Mar 2016
- Last updated
- 13 Aug 2018
- Results posted
- No
Publications
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.
PubMed 32496600Jakobsen 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.
PubMed 27998265
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deltagerinvolverende Intervention for Bedre Brug af hjælpemidler i hospitalsvæsenet
- ClinicalTrials.gov ID
- NCT02708550
- Acronym / sponsor ID
- IRMA12 / IRMA12
- Conditions
- Musculoskeletal Disorders, Occupational Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 625 participants (actual)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Collaborators
- Aalborg University
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participatory Organizational Intervention | Experimental | Behavioral: Participatory Organizational InterventionParticipatory intervention (workshops) with workers, consultants and leaders. The workshops will find solutions for increased use of assistive devices |
| Control | No intervention | –This group will go through the same baseline and follow-up tests as the intervention group, but will not receive any intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthcare workers with daily patient handling (based on questionnaire reply at baseline)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participatory Organizational Intervention | Behavioural | Participatory Organizational Intervention |
Primary outcome
Use of assistive devices (push-button)
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)
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.
9 secondary outcomes
Use of assistive devices (accelerometer)
Time frame: change from baseline to 1-year follow-up
Pain intensity (VAS scale)
Time frame: change from baseline to 1-year follow-up
Perceived physical exertion (Borg CR10 scale)
Time frame: change from baseline to 1-year follow-up
Back injury
Time frame: change from baseline to 1-year follow-up
Work ability (Index questionnaire)
Time frame: change from baseline to 1-year follow-up
Social capital (Questionnaire)
Time frame: change from baseline to 1-year follow-up
Knowledge (Questionnaire)
Time frame: change from baseline to 1-year follow-up
Organizational Readiness to Change (Questionnaire)
Time frame: change from baseline to 1-year follow-up
Use of assistive devices (Questionnaire)
Time frame: change from baseline to 1-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Derived from this study: PubMed 32496600Jakobsen 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.
- Derived from this study: PubMed 27998265Jakobsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars L Andersen, PhD principal investigator
National Research Centre for the Working Environment
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participatory Organizational Intervention in people with Musculoskeletal Disorders and Occupational Injuries, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of assistive devices (push-button) (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02708550, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.