Evaluation of Interventions for Safe Patient Handling and Movement in the Healthcare Sector

NCT05276180 | Completed

• 1 other identifier: Dnr: 190144 (AFA insurance)
• Study Type: interventional
• Target: 2,060
• Locations: 1 country
• Sites: 1

Brief Summary

There are several situations in the workplace in which both healthcare workers and patients are at risk of injury. Frequent patient transfers, heavy lifting and patient mobilization are proven risk factors for musculoskeletal disorders among healthcare workers. Falls and patient transfers are frequently reported causes of patient injuries. Swedish occupational safety and health legislation and the Patient Safety Act require employers to provide good, safe care and to conduct risk assessments to prevent risks and injuries in the healthcare sector. It has been suggested that a combination of workplace interventions is needed to facilitate safe patient handling and movement and to prevent musculoskeletal disorders and injuries among healthcare workers and patients. The main aim of the cluster randomized and controlled trial (RCT) is to evaluate a multifactorial intervention strategy that includes risk assessment instruments as well as guidelines and training. This strategy will be compared with a single intervention strategy for safe patient handling and movement in workplaces in the Swedish regional and municipal healthcare system. All healthcare workers in the care units recruited to this RCT will be invited to participate. The study will evaluate the intervention strategies with regard to primary outcome measures given equal priority according to a hybrid 2 design of the RCT. These are: 1) the implementation process (acceptability, appropriateness and feasibility), here called the implementation outcome, and 2) the effect of the applied strategies (measured with regard to the workplace safety climate and additional questions about safety for patient handling and movement), here called intervention effectiveness. This RCT is part of the Swedish Patient and Workers Safety Study (PAWSS). The aim of the PAWSS project is to contribute to a regional and municipal healthcare that is evidence-based and organized for both patient safety and a safe working environment for healthcare workers. The long-term goal is to facilitate safe patient handling and movement practices which prevent both care injuries and work injuries.

Conditions

Occupational Health

Keywords

healthcare; Safety climate; patient handling; risk assessment; guideline; education; occupational safety and health; healthcare workers

Outcome Measures

Primary Outcomes (7)

• Intervention effectiveness - Change in 50 items across 7 safety climate dimensions and 14 items of safety for patient handling and movement

  NOSACQ-50 The questionnaire consists of 50 items across 7 safety climate dimensions (Management safety priority, commitment, and competence, Management safety empowerment, Management safety justice, Workers' safety commitment, Workers' safety priority and risk non-acceptance, Safety communication, learning, and trust in co-workers safety competence, Trust in the efficacy of safety systems) in the workplace, additional 14 specific research-based questions to evaluate the safety climate for patient handling and movement will be used. Involving dimensions of using equipment, other aspects of safety, performing risk assessment and co-production between caregivers and patients. The questionnaire use a score with the scale 1-4, where 1 is labeled as "Not correct at all" and 4 is labeled as "Completely correct". A score of more than 3.30 indicates a good level of safety climate.

  Change from Baseline at 4 months follow up and 12 months follow up.

• Acceptability - Implementation outcome

  Acceptability of Intervention Measure (AIM), 4 questions with five units on a scale (1-5), 1 is labeled "disagree" and 5 is labeled "fully agree". Higher scores indicates a better outcome.

  4 months follow up

• Acceptability - Implementation outcome

  Acceptability of Intervention Measure (AIM), 4 questions with five units on a scale (1-5), 1 is labeled "disagree" and 5 is labeled "fully agree". Higher scores indicates a better outcome.

  12 months follow up

• Appropriateness - Implementation outcome

  Intervention Appropriateness Measure (IAM), 4 questions with five units on a scale (1-5), 1 is labeled "disagree" and 5 is labeled "fully agree". Higher scores indicates a better outcome.

  4 months follow up

• Appropriateness - Implementation outcome

  Intervention Appropriateness Measure (IAM), 4 questions with five units on a scale (1-5), 1 is labeled "disagree" and 5 is labeled "fully agree". Higher scores indicates a better outcome.

  12 months follow up

• Feasability - Implementation outcome

  Feasibility of Intervention Measure (FIM), 4 questions with five units on a scale (1-5), 1 is labeled "disagree" and 5 is labeled "fully agree". Higher scores indicates a better outcome.

  4 months follow up

• Feasability - Implementation outcome

  Feasibility of Intervention Measure (FIM), 4 questions with five units on a scale (1-5), 1 is labeled "disagree" and 5 is labeled "fully agree". Higher scores indicates a better outcome.

  12 months follow up

Secondary Outcomes (18)

• Evaluation of the work environment

  Change from baseline at four months follow up and twelve months follow up.

• Global Health

  Change from baseline at 4 months follow up and 12 months follow up.

• Work strain

  Change from Baseline at 4 months follow up and 12 months follow up.

• Work performance - work ability

  Change from baseline at 4 months follow up and 12 months follow up.

• Perceived work environment problems

  Change from baseline at 4 months follow up and 12 months follow up.

Study Arms (2)

Arm A) Multifactorial intervention strategy

EXPERIMENTAL

Experimental: Multifactorial intervention strategy for safe patient handling and movement (PHM) - Arm A The multifactorial intervention strategy for care units randomized to Arm A includes: 1) Swedish guideline for PHM and digital introduction for using the guideline (two workshops for manager and implementation team) 2) Training modules (theoretical and practical - one session) 3) Risk assessment with TilThermometer (four times) and 4) Fall risk assessment using Downton Fall Risk Index (DFRI) or existing fall risk assessment instrument at the care unit (all patients) and 5) Work environment mapping with Structured Multidisciplinary Work Environment Survey (SMET) including active/personal feedback

Other: Arm A) Multifactorial intervention strategy

Arm B) Single intervention strategy

ACTIVE COMPARATOR

No further interventions other than access to the Swedish guideline for patient handling and movement and the results from the SMET questionnaire will be presented to the manager. Arm B will be assigned an external facilitator who provides information, is present at the start-up meeting and will be the contact person during the study period. No further support will be given to the care units in arm B.

Other: Arm B) Single intervention strategy

Interventions

Arm A) Multifactorial intervention strategy OTHER

Implementation of the multifactorial intervention strategy will be supported by the following components: 1\) An implementation team at each intervention unit consisting of 5-6 HCWs is responsible for informing and engaging all HCWs at the unit. For implementing the various components of the strategy. They will have the role of planning regular workplace meetings. 2) One or two internal facilitators will be the link between the external facilitator and the care unit. The internal facilitator will give support with material, information and will be able to ask questions of the external facilitator. 3\) External facilitator will ensure that the implementation process works according to plan. The research team will present the results of SMET to the implementation team. 4\) The research group will be project leaders and support the external facilitators. They will provide workshops and will also be responsible for data collection.

Arm A) Multifactorial intervention strategy

Arm B) Single intervention strategy OTHER

No further interventions other than access to the Swedish guideline for patient handling and movement and the results from the SMET questionnaire will be presented to the manager. Arm B will be assigned an external facilitator who provides information, is present at the start-up meeting and will be the contact person during the study period. No further support will be given to the care units in arm B.

Arm B) Single intervention strategy

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In regional healthcare: inpatient units/wards.
• In municipal healthcare: nursing homes for the elderly.
• Where a recruited clinic has several care units, they will be counted as one cluster.

You may not qualify if:

• Units providing home nursing outpatient clinics
• Clinics at hospitals providing paediatric care
• Clinics at hospital providing emergency care
• Clinics at hospital providing psychiatric care.

Sponsors & Collaborators

• Region Östergötland: lead
• Linkoeping University: collaborator

Study Sites (1)

Depatment of Occupational Medicine

Linköping, Ösgtergötland, 581 85, Sweden

Location

Related Publications (4)

• Strid EN, Wahlin C, Ros A, Kvarnstrom S. Health care workers' experiences of workplace incidents that posed a risk of patient and worker injury: a critical incident technique analysis. BMC Health Serv Res. 2021 May 27;21(1):511. doi: 10.1186/s12913-021-06517-x.

  PMID: 34044852 BACKGROUND

• Wahlin C, Stigmar K, Nilsing Strid E. A systematic review of work interventions to promote safe patient handling and movement in the healthcare sector. Int J Occup Saf Ergon. 2022 Dec;28(4):2520-2532. doi: 10.1080/10803548.2021.2007660. Epub 2021 Dec 19.

  PMID: 34789085 BACKGROUND

• Wahlin C, Sandqvist J, Enthoven P, Buck S, Karlsson N, Strid EN. Perceived health, musculoskeletal disorders, work conditions and safety climate in relation to patient handling and movement - a multicentre cross-sectional study at healthcare workplaces. BMC Musculoskelet Disord. 2025 Nov 14;26(1):1048. doi: 10.1186/s12891-025-09330-3.

  PMID: 41239349 DERIVED

• Wahlin C, Buck S, Sandqvist J, Enthoven P, Fock J, Andreassen M, Strid EN. Evaluation of the implementation and effectiveness of a multifactorial intervention strategy for safe patient handling and movement in the healthcare sector: a study protocol of a cluster randomised controlled trial. BMJ Open. 2023 Feb 3;13(2):e067693. doi: 10.1136/bmjopen-2022-067693.

  PMID: 36737081 DERIVED

Study Officials

• charlotte Wåhlin, Ass. prof.

  Arbets- och miljömedicin, Region Östergötland/Linköpings Universitet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 11, 2022
• Study Start: February 1, 2023
• Primary Completion: March 15, 2024
• Study Completion: April 30, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available after scientific publication. Estimated earliest at 2026.
• Access Criteria: Data can be requested from the principal investigator.

Locations

SE (1)