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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
625

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Research Centre for the Working Environment, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aalborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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