Clinical trial NCT05276180: Evaluation of Interventions for Safe Patient Handling and Movement in the Healthcare Sector
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Health
Keywords: healthcare
Safety climate
patient handling
risk assessment
guideline
education
occupational safety and health
healthcare workers
Lead sponsor: Region Östergötland
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2022-03-11
Enrollment: 2060
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Training will be offered to all HCWs. One session of practical training for safe PHM and theoretical education will be offered online. Participating units in Arm A will be able to discuss the Swedish guideline for PHM at two workshops. Here, participants will discuss themes and the guidelines' recommendations. The process team will formulate a number of problem areas they want to work with in the workplace using a participatory approach. The TilThermometer will be used for risk assessment four times during the implementation period.

Arm A will be encouraged to involve their occupational health care services and have an active collaboration during the 4-month implementation period.

The active comparator, healthcare units randomized to Arm B, will receive the single intervention strategy. The participants will receive an online introduction to the Swedish guideline for PHM. They will be encourage to apply the content of the guideline in order to promote safe PHM at their care unit. The results from the SMET questionnaire will be presented to the manager.

Recruitment of units: To recruit care units, information will be distibuted to workplaces in the Swedish regional and municipal healthcare system, via contact persons such as HR managers and managers. The research project will have the support of the reference group that has been put together for the project and consists of various stakeholders. Information will also be disseminated via advertisements in trade union newspapers and the project will be highlighted by means of newspaper interviews. Several communication channels will also be used to recruit units.

Information about the study and what participation entails will be sent out to managers and given at workplace meetings or the equivalent. The manager will sign a written consent before the care unit's participation in the study.

Prior to start-up, staff from the research group will give further information about the study and the procedure for collecting consent to each group. The HCWs will be invited to participate in the study via the care unit's common email groups or equivalent. They will also be given further information at workplace meetings or equivalent. All participants will be given the opportunity to ask questions and get more information.

Each unit that has agreed to participate in the study will have a start-up meeting to introduce the strategy that the unit will work with, Arm A or Arm B.

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; and clinics providing paediatric, emergency and psychiatric care.

A power calculation has been made where estimation of number of cluster and participants in each cluster was calculated. A power level of 0.8 (80%) and alpha 0.05 is used. The calculation resulted in at least six units/clusters for each arm with minimum of 15 participants in each unit/cluster.

The care units will be randomized by a computer-generated randomization-list to either Arm A or Arm B after stratification in blocks by the size of the care unit and type of organization. A care unit is defined as one which has one manager who is responsible for all employees (HCWs) at the unit.

Outcome and data collection HCWs working in care units which are participating in the study will be able to read the consent and send in their own consent. In doing so they agree to participate in the study and answer three questionnaires. Data collection will be performed at baseline and at 4-month and 12-month follow ups. In the case of participating care units (Arm A), information about the interview study will be disseminated during the implementation period by means of workplace meetings, email and the project's website. Prior to participating in individual interviews and focus group discussions, participants will sign a consent form, either digitally or in paper format.

This study will evaluate a multifactorial versus a single strategy for safe PHM. It will look at the implementation process (acceptability, appropriateness and feasibility) and the effect of the applied strategies (safety climate in relation to aspects of patient handling and movements). These are the primary outcomes which are refered to as implementation outcome and intervention effectiveness. The following contextual factors will be collected from each participating care unit: number of risk assessments the previous year; number of managers; number of HCWs; number of admissions care recipients / places; care burden; number of inpatients; completed work environment training previous year; current work environment policy; completed training in PHM.

At the start of the study (baseline), the participating HCWs and managers (Arm A and Arm B) will be asked to answer a questionnaire. The questionnaire will be sent out again after completion of the implementation (four months) and at follow-up after 12 months. The participating units will be encouraged to continue on their own to promote safe patient handling and movement and to work according to the multifactorial intervention strategy or the single intervention strategy. Background data will be included in the baseline questionnaire, such as age, education, gender, working full time/part time, overtime, profession, years of experience in the profession and current workplace. Contextual factors and changes (mediators) at the unit that may affect the implementation process will be collected. A study specific logbook will be used. Contextual factors can be for example staff turnover, work organizational changes, interventions for occupational safety and health, unforeseen events and so on.

Primary outcome, implementation outcome: the implementation outcome (acceptability, appropriateness and feasibility) will be measured by a standardized questionnaire to evaluate the usefulness/benefit of the multifactorial intervention strategy. For the evaluation of the implementation process, a mixed design will be used that includes both quantitative and qualitative data. Primary outcome, intervention effectiveness: The intervention effectiveness will be measured with regard to the safety climate in the workplace and an additional question about safety for patient handling and movement.

All data will be documented via digital collection platforms and collected at baseline and at 4-month and 12-month follow ups. All data in the research project will be collected in a digital data collection tool. Interviews will be collected after the 4-month implementation period.

All collected data will be stored so that no unauthorized persons have access to it. Results and characteristics of participating individuals will be presented at group level or in such a way that individuals cannot be identified.

Eligibility criteria: 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.

Primary outcomes:
measure: Intervention effectiveness - Change in 50 items across 7 safety climate dimensions and 14 items of safety for patient handling and movement
timeFrame: Change from Baseline at 4 months follow up and 12 months follow up.
measure: Acceptability - Implementation outcome
timeFrame: 4 months follow up
measure: Acceptability - Implementation outcome
timeFrame: 12 months follow up
measure: Appropriateness - Implementation outcome
timeFrame: 4 months follow up
measure: Appropriateness - Implementation outcome
timeFrame: 12 months follow up
measure: Feasability - Implementation outcome
timeFrame: 4 months follow up
measure: Feasability - Implementation outcome
timeFrame: 12 months follow up
Secondary outcomes:
measure: Evaluation of the work environment
timeFrame: Change from baseline at four months follow up and twelve months follow up.
measure: Global Health
timeFrame: Change from baseline at 4 months follow up and 12 months follow up.
measure: Work strain
timeFrame: Change from Baseline at 4 months follow up and 12 months follow up.
measure: Work performance - work ability
timeFrame: Change from baseline at 4 months follow up and 12 months follow up.
measure: Perceived work environment problems
timeFrame: Change from baseline at 4 months follow up and 12 months follow up.
measure: Work environment related production loss
timeFrame: Change from baseline at 4 months follow up and 12 months follow up.
measure: Sickness presence
timeFrame: Change from baseline at 4 months follow up and 12 months follow up.
measure: Sickness influence on ability to work
timeFrame: Change from baseline at 4 months follow up and 12 months follow up.
measure: Sickness absence
timeFrame: Change from baseline at 4 months follow up and 12 months follow up.
measure: Work related musculoskeletal disorders (WMSD)
timeFrame: Change from baseline at 4 months follow up and 12 months follow up.
measure: Fit for work - physical strength
timeFrame: Change from baseline at 4 months follow up and 12 months follow up.
measure: Daily physcial acitivty
timeFrame: Change from baseline at 4 months follow up and 12 months follow up.
measure: Physcial exercise the last 12 months
timeFrame: Change from baseline at 4 months follow up and 12 months follow up.
measure: Strenuous physical activity
timeFrame: Change from baseline at 4 months follow up and 12 months follow up.
measure: Time of daily physical activity
timeFrame: Change from baseline at 4 months follow up and 12 months follow up.
measure: Fidelity
timeFrame: Through study completion, an average of 4 months
measure: Managers and implementation team members' experiences with the intervention strategy and implementation process
timeFrame: After the 4 months study period.
measure: Healthcare workers' experiences of the intervention strategy and implementation process
timeFrame: After the 4 months study period.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Depatment of Occupational Medicine
state: Ösgtergötland
Study officials:
affiliation: Arbets- och miljömedicin, Region Östergötland/Linköpings Universitet
name: charlotte Wåhlin, Ass. prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.