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Clinical Trials/NCT05276180
NCT05276180CompletedNot Applicable

Evaluation of Implementation and Effectiveness of a Multifactorial Intervention Strategy for Safe Patient Handling and Movement in the Healthcare Sector - A Cluster Randomized Controlled Trial

Region Östergötland2 sites in 1 country2,060 target enrollmentStarted: February 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,060
Locations
2
Primary Endpoint
Intervention effectiveness - Change in 50 items across 7 safety climate dimensions and 14 items of safety for patient handling and movement

Study Overview

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.

Detailed Description

There are several risk factors in the healthcare environment which lead to work-related injuries among healthcare workers (HCWs) and harmful incidents for patients. In previous research on patient injuries and HCW incidents and injuries, the results indicate that both patient safety and occupational safety for HCWs are insufficient. Common occupational injuries among healthcare professionals were those caused by sharp objects or needles; exposure to infection; injuries that occur in threatening and violent situations; and injuries that occur during patient handling and movement (PHM). Musculoskeletal disorders that occur in connection with PHM are one of the most common injuries. The starting point for a safe environment and a strengthened safety climate is that the employer, together with HCWs and safety representatives, regularly examines and assesses the risks that exist in the daily work routine and provides proper interventions to create a good work environment. A Swedish national guideline for safe PHM is being developed by the research group in 2022. It will be used in the present study in combination with the participating care units' existing patient safety work and work environment policies. There is a need to increase the use of risk assessment and promote intervention strategies in the healthcare sector that can facilitate safe PHM. A recent systematic review by Wåhlin and co-authors shows that a number of work interventions can be effective for safe PHM. These include providing equipment and training workers, since it can increase their use of equipment. Training workers to be peer coaches is also associated with fewer injuries. Other effective strategies for safe PHM are participatory ergonomics and management engagement with staff. There is great interest among employers, HCWs and other stakeholders in providing effective interventions that can promote health, prevent musculoskeletal disorders among HCWs and prevent patient injuries. At present, however, there is a lack of knowledge regarding how risk assessments and comprehensive interventions need to be tailored to be effective and how learning for safe PHM should be designed to be perceived as useful in a clinical setting.

The main aim of the cluster randomized controlled trial (RCT) is to implement and evaluate a multifactorial intervention strategy for safe PHM and compare it with a single intervention strategy. The trial will be carried out in workplaces in the regional and municipal healthcare system. The study will evaluate the two strategies with regard to the implementation outcome (acceptability, appropriateness and feasibility) and the intervention effectiveness of the applied strategies (safety climate in relation to aspects of patient handling and movement). With a hybrid 2 design, implementation outcome and intervention effectiveness are given equal priority. The hypothesis in this study is that care units that receive the multifactorial intervention strategy develop a stronger and more appropriate safety climate with specific focus on PHM compared with units that receive a single intervention strategy. The hypothesis is tested by performing a randomized controlled study with pre- and post-measurements among care units in regions and municipalities in Sweden.

Method and material: The study for the implementation of intervention strategies for safe PHM will be carried out in least twelve units in regional and municipal health care in Sweden. The study design is a cluster randomized controlled study in which participating care units are randomized into two randomization arms: Arm A or Arm B. At least six units (Arm A) will receive a multifactorial intervention strategy and at least six will receive a single intervention strategy (Arm B).

The multifactorial intervention strategy for care units randomized to Arm A consists of: 1) a Swedish guideline for PHM and a digital introduction to using the guideline, 2) training modules (theoretical and practical), 3) risk assessment with TilThermometer, 4) a fall risk assessment using Downton Fall Risk Index or a fall risk assessment instrument in use at the care unit, and 5) work environment mapping with the Structured Multidisciplinary Work Environment Survey (SMET). The intervention strategies for safe PHM will be used at the participating units over a 4-month period. They will however be encouraged by the project coordinators to continue to promote safe PHM until the 12-month follow up questionnaire is answered by HCWs at the participating units.

An implementation team will be created at each intervention unit. The team will consist of 5-6 people, including the manager, a range of healthcare professions and safety representatives. The intervention units (Arm A) will be offered support from the project during the implementation process (four months) to create good conditions for implementation (facilitator). The results from the SMET questionnaire will be presented to the implementation team along with interviews with the manager and discussions about the systematic work environment management. The results from SMET will also be presented to the process team after four months.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 67 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Change from Baseline at 4 months follow up and 12 months follow up.

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.

Acceptability - Implementation outcome

Time Frame: 12 months follow up

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.

Feasability - Implementation outcome

Time Frame: 12 months follow up

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.

Appropriateness - Implementation outcome

Time Frame: 12 months follow up

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.

Secondary Outcomes

  • Sickness influence on ability to work(Change from baseline at 4 months follow up and 12 months follow up.)
  • Fidelity(Through study completion, an average of 4 months)
  • Healthcare workers' experiences of the intervention strategy and implementation process(After the 4 months study period.)
  • Work strain(Change from Baseline at 4 months follow up and 12 months follow up.)
  • Work environment related production loss(Change from baseline at 4 months follow up and 12 months follow up.)
  • Sickness presence(Change from baseline at 4 months follow up and 12 months follow up.)
  • Time of daily physical activity(Change from baseline at 4 months follow up and 12 months follow up.)
  • Managers and implementation team members' experiences with the intervention strategy and implementation process(After the 4 months study period.)
  • 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.)
  • Physcial exercise the last 12 months(Change from baseline at 4 months follow up and 12 months follow up.)
  • Work related musculoskeletal disorders (WMSD)(Change from baseline at 4 months follow up and 12 months follow up.)
  • Fit for work - physical strength(Change from baseline at 4 months follow up and 12 months follow up.)
  • Daily physcial acitivty(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.)
  • Sickness absence(Change from baseline at 4 months follow up and 12 months follow up.)
  • Strenuous physical activity(Change from baseline at 4 months follow up and 12 months follow up.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Charlotte Wåhlin

Associate professor

University Hospital, Linkoeping

Study Sites (2)

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