Participatory Organizational Intervention for Improved Use of Assistive Devices for Patient Handling (IRMA12)

August 10, 2018 updated by: Lars L. Andersen, National Research Centre for the Working Environment, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

625

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • National Research Centre for the Working Environment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participatory Organizational Intervention
Participatory intervention (workshops) with workers, consultants and leaders. The workshops will find solutions for increased use of assistive devices
Behavioral: Participatory Organizational Intervention
No Intervention: Control
This group will go through the same baseline and follow-up tests as the intervention group, but will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Use of assistive devices (accelerometer)
Time Frame: change from baseline to 1-year follow-up
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
Pain intensity (VAS scale)
Time Frame: change from baseline to 1-year follow-up
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
Perceived physical exertion (Borg CR10 scale)
Time Frame: change from baseline to 1-year follow-up
Perceived physical exertion during patient handling. Borg CR10 scale
change from baseline to 1-year follow-up
Back injury
Time Frame: change from baseline to 1-year follow-up
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
Work ability (Index questionnaire)
Time Frame: change from baseline to 1-year follow-up
The full Work Ability Index questionnaire (Ilmarinen)
change from baseline to 1-year follow-up
Social capital (Questionnaire)
Time Frame: change from baseline to 1-year follow-up
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
Knowledge (Questionnaire)
Time Frame: change from baseline to 1-year follow-up
Specific questionnaire about knowledge about patients transfer and safety at work
change from baseline to 1-year follow-up
Organizational Readiness to Change (Questionnaire)
Time Frame: change from baseline to 1-year follow-up
Questionnaire about Organizational Readiness to Change
change from baseline to 1-year follow-up
Use of assistive devices (Questionnaire)
Time Frame: change from baseline to 1-year follow-up
Questionnaire about frequency of use of the different types of assistive devices
change from baseline to 1-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Centre for the Working Environment, Denmark

Collaborators

Aalborg University

Investigators

  • Principal Investigator: Lars L Andersen, PhD, National Research Centre for the Working Environment

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

March 4, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Actual)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRMA12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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