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The effects of integrating work-related factors and improving cooperation in musculoskeletal physical therapy practice: protocol for the 'WORK TO BE DONE' cluster randomised controlled trial.

ABSTRACT: BACKGROUND:Musculoskeletal disorders (MSDs) are the primary cause of disability worldwide and a major societal burden. Recent qualitative research found that although a patient's work is considered important, physical therapists take work participation insufficiently into account as a determining factor in the treatment of patients with MSDs. Therefore, the aim of this study is to improve the effectiveness of physical therapy (in primary healthcare) with respect to the work participation of employees with MSDs by increasing the knowledge and skills of generalist physical therapists and by improving the collaboration between generalist physical therapists and physical therapists specialised in occupational health. METHODS/DESIGN:This trial is a two-arm non-blinded cluster randomised controlled trial. Working patients with MSDs visiting a physical therapy practice are the target group. The control group will receive normal physical therapy treatment. The intervention group will receive treatment from a physical therapist with more knowledge about work-related factors and skills in terms of integrating work participation into the patients' care. Data are gathered at baseline (T0), at four months (T1) and eight months (T2) follow-up. Most outcomes will be assessed with validated patient-reported questionnaires. Primary outcomes are the limitations in specific work-related activities and pain during work. Secondary outcomes include limitations in general work-related activities, general pain, quality of life, presenteeism, sick leave (absenteeism), estimated risk for future work disability, work-related psychosocial risk factors, job performance, and work ability. Based on a sample size calculation we need to include 221 patients in each arm (442 in total). During data analysis, each outcome variable will be analysed independently at T1 and at T2 as a dependent variable using the study group as an independent variable. In addition to the quantitative evaluation, a process evaluation will be performed by interviewing physical therapists as well as patients. DISCUSSION:The trial is expected to result in a more effective physical therapy process for working patients with MSDs. This will lead to a substantial reduction of costs: lower costs thanks to a more effective physical therapy process and lower costs due to less or shorter sick leave and decreased presenteeism. TRIAL REGISTRATION:Netherlands Trial Register, registration number: NL8518, date of registration 9 April 2020, URL registration: https://www.trialregister.nl/trial/8518.

SUBMITTER: Hutting N

PROVIDER: S-EPMC7281957 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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The effects of integrating work-related factors and improving cooperation in musculoskeletal physical therapy practice: protocol for the 'WORK TO BE DONE' cluster randomised controlled trial.

Hutting Nathan N Oswald Wiebke W Nijhuis-van der Sanden Maria W G MWG Filart Monique M Raaijmakers Tamara T Bieleman Hendrik J HJ Staal J Bart JB Heerkens Yvonne F YF

BMC musculoskeletal disorders 20200608 1

<h4>Background</h4>Musculoskeletal disorders (MSDs) are the primary cause of disability worldwide and a major societal burden. Recent qualitative research found that although a patient's work is considered important, physical therapists take work participation insufficiently into account as a determining factor in the treatment of patients with MSDs. Therefore, the aim of this study is to improve the effectiveness of physical therapy (in primary healthcare) with respect to the work participation ...[more]

PMID: 32513153

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Project description:IntroductionManaging patients with multiple conditions (multimorbidity) is a major challenge for healthcare systems internationally, particularly in older patients. Multimorbidity and subsequent polypharmacy increase treatment burden and the risk of potentially inappropriate prescribing, and both are complex to manage in primary care. Limited evidence suggests integration of pharmacists into general practice teams could improve medication management for patients with multimorbidity and polypharmacy. Building on findings from a non-randomised, uncontrolled General Practice Pharmacist (GPP) feasibility study conducted in Irish primary care, the aim of this study is to conduct a pilot cluster randomised controlled trial (cRCT) of the GPP study, to assess feasibility, intervention impact, costs and appropriateness of continuing to a definitive cRCT.Methods and analysisThis pilot cRCT will involve 8 general practitioner (GP) practices and 120 patients. Practices will identify and recruit patients aged ≥65 years, who are taking ≥10 regular medications. Practices will be allocated to intervention or control after baseline data collection. Intervention practices will have a pharmacist integrated within their service, working with GPs, patients and practice staff to optimise prescribing and other medication-related activities. Control practices will provide standard GP care. The primary feasibility outcomes will include recruitment rate, uptake of medication reviews and study retention. For the primary clinical outcome, the number of potentially inappropriate prescribing incidences per patient will be collected. Secondary outcomes will include medication-related outcomes, patient-reported outcome measures, and data pertaining to the role and impact of the pharmacist on prescribing. In addition, economic and process evaluations will be conducted.Ethics and disseminationThis trial has been approved by the Irish College of General Practitioners Research Ethics Committee and will be performed in accordance with the Declaration of Helsinki. The results will be reported in peer-reviewed journals and be presented at national and international conferences.Trial registration numberISRCTN Registry (https://doi.org/10.1186/ISRCTN18752158).

Project description:An increasing number of people are living with multimorbidity. The evidence base for how best to manage these patients is weak. Current clinical guidelines generally focus on single conditions, which may not reflect the needs of patients with multimorbidity. The aim of the 3D study is to develop, implement and evaluate an intervention to improve the management of patients with multimorbidity in general practice.This is a pragmatic two-arm cluster randomised controlled trial. 32 general practices around Bristol, Greater Manchester and Glasgow will be randomised to receive either the '3D intervention' or usual care. 3D is a complex intervention including components affecting practice organisation, the conduct of patient reviews, integration with secondary care and measures to promote change in practice organisation. Changes include improving continuity of care and replacing reviews of each disease with patient-centred reviews with a focus on patients' quality of life, mental health and polypharmacy. We aim to recruit 1383 patients who have 3 or more chronic conditions. This provides 90% power at 5% significance level to detect an effect size of 0.27 SDs in the primary outcome, which is health-related quality of life at 15 months using the EQ-5D-5L. Secondary outcome measures assess patient centredness, illness burden and treatment burden. The primary analysis will be a multilevel regression model adjusted for baseline, stratification/minimisation, clustering and important co-variables. Nested process evaluation will assess implementation, mechanisms of effectiveness and interaction of the intervention with local context. Economic analysis of cost-consequences and cost-effectiveness will be based on quality-adjusted life years.This study has approval from South-West (Frenchay) National Health Service (NHS) Research Ethics Committee (14/SW/0011). Findings will be disseminated via final report, peer-reviewed publications and guidance to healthcare professionals, commissioners and policymakers.ISRCTN06180958; Pre-results.

Project description:BackgroundPatients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS). General practitioners (GPs) play a key role in the management of PPS and require further training. Patients are often frustrated with the care they receive. This study aims to assess the acceptability of an 'integrated GP care' approach which consists of offering self-help materials to patients with PPS and offering their GPs training on how to utilise cognitive behavioural skills within their consultations, as well as assessing the feasibility of conducting a future trial in primary care to evaluate its benefit.MethodsA feasibility cluster randomised controlled trial was conducted in primary care, South London, UK. GP practices (clusters) were randomly allocated to 'integrated GP care plus treatment as usual' or 'treatment as usual'. Patients with PPS were recruited from participating GP practices before randomisation. Feasibility parameters, process variables and potential outcome measures were collected at pre-randomisation and at 12- and 24-weeks post-randomisation at cluster and individual participant level.ResultsTwo thousand nine hundred seventy-eight patients were identified from 18 GP practices. Out of the 424 patients who responded with interest in the study, 164 fully met the eligibility criteria. One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study. Most feasibility parameters indicated that the intervention was acceptable and a future trial feasible. 50 GPs from 8 GP practices (randomised to intervention) attended the offer of training and provided positive feedback. Scores in GP knowledge and confidence increased post-training. Follow-up rate of patients at 24 weeks was 87%. However estimated effect sizes on potential clinical outcomes were small.ConclusionsIt was feasible to identify and recruit patients with PPS. Retention rates of participants up to 24 weeks were high. A wide range of health services were used. The intervention was relatively low cost and low risk. This complex intervention should be further developed to improve patients'/GPs' utilisation of audio/visual and training resources before proceeding to a full trial evaluation.Trial registrationNCT02444520 (ClinicalTrials.gov).

Project description:BackgroundIn this paper, we present the protocol for a cluster randomised controlled trial to evaluate the effectiveness and implementation of a participative risk management intervention to address work-related musculoskeletal disorders (WMSDs). The aims of the study include to evaluate the implementation process and the impact of the intervention on work related musculoskeletal pain and discomfort and exposure to physical and psychosocial hazards in paramedics over a 12-month period.MethodsThe intervention in this study is to implement A Participative Hazard Identification and Risk Management (APHIRM) toolkit in an ambulance service. Eighteen work groups containing eligible participants (registered paramedics) will be randomised into the intervention or wait-list control arm in one of three rolling recruitment periods. The APHIRM toolkit survey will be offered at baseline and 12 months later, to all current eligible participants in each work group allocated to the trial. The intervention work groups will receive the remainder of the APHIRM toolkit procedures. Identifying data about individual participants will not be collected in the survey, to protect participant privacy and encourage participation. Changes in primary (musculoskeletal pain and discomfort) and secondary (exposure to physical and psychosocial hazards at work) outcomes measured in the survey will be analysed comparing the baseline and follow up response of the cluster. A process evaluation is included to analyse the implementation and associated barriers or facilitators.DiscussionThis study is important in providing a comprehensive approach which focusses on both physical and psychosocial hazards using worker participation, to address WMSDs, a well-known and significant problem for ambulance services. The effectiveness of the intervention in work groups will be rigorously evaluated. If significant positive results are observed, the intervention may be adopted in ambulance services, both nationally and internationally.Trial registrationISRCTN77150219. Registered 21 November 2021.

Project description:BackgroundThe prevalence of musculoskeletal pain (MSP) is persistently high throughout the world. Work-related factors such as high physical workload (lifting, bending and twisting of the back) are considered to be among the main causes of MSP. Work in childcare includes the need to lift, carry, and support children in a range of activities, requiring several demanding postures and movements, such as bending forward and twisting of the back and sitting on the floor. Participatory ergonomics may represent a solution for decreasing the physical workload to reduce MSP. We present the protocol of a study aiming to evaluate the effect and process of a participatory ergonomics intervention designed to reduce physical exertion during work and MSP (including MSP interfering with work) among childcare workers.Methods/designThis study will use a two-arm cluster-randomized design employing a wait-list control, with childcare institutions forming the clusters. Three workshops will be conducted during the 4-month intervention period. Participants will identify risk factors for strenuous work and MSP, develop solutions for reducing the identified risk factors, and implement them in their team. An ergonomic consultant will guide the process. The data collection will consist of questionnaires and objective measures of heart rate and physical activity, observations of physical workload, and information on sickness absence based on company records. Primary outcomes are physical exertion during work and MSP (including pain-related work interference) measured at 4 months. Secondary outcomes measured at 4 months are sickness absence due to MSP; objectively measured occupational physical activity and heart rate; and self-reported self-efficacy, employee involvement, and need for recovery. Alongside the trial, a process evaluation and an economic evaluation will be conducted.DiscussionThe study will evaluate the effect and process of a participatory ergonomics intervention to reduce physical exertion at work and MSP among childcare workers. By performing a cluster-randomized controlled trial with an effect evaluation based on both objective and self-reported measures with the addition of a process evaluation and economic evaluation, this study will contribute to the evidence for prevention of MSP among a less studied occupational group. Results are expected in 2018-2019.Trial registrationISRCTN, ISRCTN10928313 . Registered on 11 January 2017.

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The effects of integrating work-related factors and improving cooperation in musculoskeletal physical therapy practice: protocol for the 'WORK TO BE DONE' cluster randomised controlled trial.

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The effects of integrating work-related factors and improving cooperation in musculoskeletal physical therapy practice: protocol for the 'WORK TO BE DONE' cluster randomised controlled trial.

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