NCT02708550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
625

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

March 4, 2016

Last Update Submit

August 10, 2018

Conditions

Musculoskeletal DisordersOccupational Injuries

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Use of assistive devices (accelerometer)

    change from baseline to 1-year follow-up

  • Pain intensity (VAS scale)

    change from baseline to 1-year follow-up

  • Perceived physical exertion (Borg CR10 scale)

    change from baseline to 1-year follow-up

  • Back injury

    change from baseline to 1-year follow-up

  • Work ability (Index questionnaire)

    change from baseline to 1-year follow-up

  • +4 more secondary outcomes

Study Arms (2)

Participatory Organizational Intervention

EXPERIMENTAL

Participatory intervention (workshops) with workers, consultants and leaders. The workshops will find solutions for increased use of assistive devices

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.

Interventions

Participatory Organizational InterventionBEHAVIORAL
Participatory Organizational Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthcare workers with daily patient handling (based on questionnaire reply at baseline)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Centre for the Working Environment

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 32496600DERIVED

  • 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.

    PMID: 27998265DERIVED

MeSH Terms

Conditions

Musculoskeletal DiseasesOccupational Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Lars L Andersen, PhD

    National Research Centre for the Working Environment

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 15, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2018

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

DK(1)