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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02708550
Other study ID # IRMA12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date April 2018

Study information

Verified date August 2018
Source National Research Centre for the Working Environment, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 625
Est. completion date April 2018
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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:

Study Design


Intervention

Behavioral:
Participatory Organizational Intervention


Locations

Country Name City State
Denmark National Research Centre for the Working Environment Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
National Research Centre for the Working Environment, Denmark Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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 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 change from baseline to 1-year follow-up
Secondary 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" change from baseline to 1-year follow-up
Secondary Perceived physical exertion (Borg CR10 scale) Perceived physical exertion during patient handling. Borg CR10 scale change from baseline to 1-year follow-up
Secondary 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" change from baseline to 1-year follow-up
Secondary Work ability (Index questionnaire) The full Work Ability Index questionnaire (Ilmarinen) change from baseline to 1-year follow-up
Secondary Social capital (Questionnaire) Questionnaire concerning bonding, bridging, linking A, and linking B social capital (Andersen LL 2015 Scandinavian Journal of Public Health) change from baseline to 1-year follow-up
Secondary Knowledge (Questionnaire) Specific questionnaire about knowledge about patients transfer and safety at work change from baseline to 1-year follow-up
Secondary Organizational Readiness to Change (Questionnaire) Questionnaire about Organizational Readiness to Change change from baseline to 1-year follow-up
Secondary Use of assistive devices (Questionnaire) Questionnaire about frequency of use of the different types of assistive devices change from baseline to 1-year follow-up
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