Correspondence to Josielli Comachio; [email protected]
STRENGTHS AND LIMITATIONS OF THIS STUDY
A multimedia educational resource for physical activity promotion will be implemented in the waiting room of an outpatient physiotherapy department.
The RE-AIM framework will be used to systematically assess the Reach, Effectiveness, Adoption, Implementation and Maintenance of the intervention.
A combination of quantitative and qualitative data collection to comprehensively evaluate implementation processes.
One limitation of this study is that it is conducted solely within outpatient services, the study’s focus on a specific geographical region may limit the generalisability of the findings to populations in other locations with different healthcare systems or socioeconomic contexts.
Introduction
Low back pain (LBP) is a highly prevalent condition, with 60–80% of the adult population experiencing LBP at some point in their lives.1 While not everyone experiences chronic or severe LBP, it is common for individuals to encounter mild-to-moderate intensity LBP due to various factors, that can significantly impact an individual’s quality of life.2
Commonly, LBP sufferers often adopt a sedentary lifestyle and rely on analgesics like paracetamol (acetaminophen).3 However, a sedentary lifestyle can worsen LBP symptoms,4 and the efficacy of paracetamol has been questioned due to its limited benefits and potential side effects.5 6 As a result, there is increasing emphasis on non-pharmacological interventions, particularly physical activity, to improve LBP management and support patient self-care.7 This issue is critical, given that pain conditions rank among the highest globally in prevalence, absenteeism and disability-adjusted life years, with chronic LBP being a leading contributor to these statistics.8
Engaging in appropriate levels of physical activity has been proven beneficial, not just for those with chronic LBP,9 but also for many other chronic health conditions10–12 and psychological symptoms including depression.13 Engaging in physical activity as a therapeutic intervention for LBP is frequently supported as a safe and effective approach to management. This broad spectrum of benefits underscores the importance of physical activity as a preventive measure and as a therapeutic intervention.
Strategies to encourage people to be more active and take less medication have been implemented for many health conditions, including osteoarthritis,14 diabetes,15 smoking cessation16 and to improve general health.17 A recent feasibility study, the Consumer-focused Education on pAracetamol Side Effects, iNadequate Outcomes and Weaning (CEASE NOW),18 demonstrated that using a patient education booklet improved the motivation, knowledge and self-efficacy in approximately two-thirds of participants taking paracetamol to manage their LBP. Many participants in this study were made aware of the limited role of paracetamol in managing LBP and were given the tools to understand and take the first steps to substitute their medication usage with strategies such as engaging in regular physical activity.
Outpatient clinics in a hospital setting serve as primary care settings for some patients, and waiting rooms have the potential to serve as effective locations for enhancing health literacy by offering easily accessible health information.19 Traditional methods, including distributing printed materials and displaying educational posters, have long been used to enhance health literacy and patient satisfaction across various health domains, such as oral health,20 mental health21 and diabetes management.22 Studies indicate that these tools are effective in increasing patients’ knowledge and awareness, which can positively influence their perceptions of care.23
As healthcare evolves, the integration of digital health messages in waiting rooms is gaining traction.24 Digital materials offer advantages such as interactivity, customisation and scalability.25 However, little is known about how patients interact with such conception quality, especially when supplemented with traditional printed materials and how this interaction affects the overall workflow within the healthcare sector. In addition, LBP and the importance of physical activity for patients with LBP remains unexplored compared with other conditions.26 27 Research in this area could provide insights into optimising waiting room resources to enhance patient-provider communication and improve outcomes for conditions such as LBP.
This study outlines a hybrid design type III feasibility study to evaluate the feasibility of a multimedia strategy implemented in the waiting room outpatient services. A hybrid type III design is crucial for bridging the gap between research and practice, ensuring interventions are not only proven effective but also successfully implemented in real-world healthcare settings.28 This approach helps to identify contextual factors that could enhance or hinder the success of an intervention.
The study aims to assess the feasibility of implementing brief educational resources, including a video and booklet, in the waiting room of a public hospital outpatient physiotherapy department in Sydney, New South Wales, Australia. The objective is to understand the practicality of scaling up these initiatives and promoting active learning at the point of care in a waiting room setting.
Methods
Study design and objectives
This manuscript follows the Standards for Reporting Implementation Studies guidelines.29 The ‘Move to Improve’ study is a hybrid type III effectiveness-implementation feasibility trial aimed at assessing the practicality of scaling up these initiatives and fostering active learning at the point of care in a waiting room setting. Our goal is to evaluate whether the implementation strategy is suitable for further testing.30 The hybrid type III feasibility study will be conducted at a public hospital in Sydney, Australia, from March to September 2024
The study was designed to: (1) evaluate the acceptability the adoption, fidelity and sustainability of implementing a multimedia strategy (animated video and informative booklet) in the waiting room, (2) assess processes, resource utilisation and management systems needed for successful large-scale implementation. Furthermore, as secondary outcomes, we will investigate patient outcomes, such as LBP intensity, physical function and paracetamol intake, after the implementation of the multimedia strategy, in a subsample of individuals seeking outpatient physiotherapy care for LBP.
Study overview
The study is structured to unfold in two distinct phases.
Phase I: pre-implementation
To successfully implement the project, it is crucial to first understand the logistics and context of the setting. During the pre-implementation phase, we will focus on engaging managers, senior physiotherapists and administrative staff to plan how best to present the educational materials without disrupting the daily operations of the outpatient department. The goal is to ensure a seamless integration by discussing practical details such as space allocation, resource maintenance, potential disruptions and how to minimise them. These discussions will also provide staff with a clear understanding of the study’s objectives and methodology, allowing any challenges to be addressed before full implementation.
Phase II: implementation
In the second phase, the study will evaluate the impact of multimedia educational resources on patient knowledge, engagement and behaviour using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework.31 Recruitment will target three distinct groups of participants to assess the multimedia strategy’s effectiveness comprehensively. The first group will include all patients who pass through the waiting room. These participants will be invited to watch a video, read a booklet and provide feedback on both the content and their experience with the materials.
The second group, a subsample of patients attending the outpatient physiotherapy department for LBP will be invited to participate in a more in-depth evaluation. In addition to watching the video and reading the booklet, these patients will provide feedback and additional information related to their LBP experience. A 1-month follow-up will be conducted to measure the clinical outcomes of the multimedia strategy, focusing on pain levels, beliefs, attitudes and engagement with the educational materials.
The third group will involve physiotherapists and administrative staff working in the outpatient department. They will be asked to provide feedback on the multimedia and implementation strategy after the study recruitment phase. This feedback will offer valuable insights into the practicality, usability and overall impact of integrating multimedia resources in a clinical setting.
Description of the multimedia strategy implementation
Development of the video
A brief animated story video (2:15 min duration) was collaboratively developed by the research team in conjunction with Sydney Health Partners and The University of Sydney, Australia. The content of the video was designed to educate individuals about managing LBP through physical activity and encourage the deprescribing of paracetamol following the best available evidence for LBP management.32–35
The video’s narrative is centred around the existing evidence-based practices for managing LBP, incorporating insights from clinical practice guidelines. We employed the art of storytelling as a fundamental approach for the video. The storyline addresses common obstacles encountered by individuals with LBP, including the inclination towards prolonged bed rest and reluctance to engage in physical activity, including usual activities of daily life, stemming from the misconception that physical activity may exacerbate the condition.
Through engaging visual elements and a patient-centred storyline, the video aimed to address misconceptions and encourage the adoption of recommended exercise and physical activity practices, as advocated by clinical guidelines.12 36 37 This collaborative effort reflects a commitment to disseminating evidence-based information in an accessible and relatable format, fostering greater understanding and adherence to best practices in managing LBP. The video script can be found in the online supplemental material 1.
Development of the booklet
The education booklet used in this study includes a 12-page booklet adapted from deprescribing studies implemented by the Australian Deprescribing Network and the Canadian Deprescribing Network, which have shown to be successful in medication deprescribing trials for users of non-steroidal anti-inflammatory drugs, opioids and benzodiazepines.34 38 The textual content of the intervention was based on the work of our group, as well as guidelines concerning the use of paracetamol for LBP.18 34 35 The booklet was designed to change beliefs, increase knowledge and self-efficacy and stimulate discussion with a health professional through the mechanisms of motivation, capacity and opportunity. Additionally, the evaluation of the booklet demonstrated feasibility and positive outcomes for individuals who used it.18 The booklet can be found in online supplemental file 2.
The multimedia strategy booklet and video have been translated by New South Wales Translation Services and will be available in English, Mandarin (Chinese simplified) and Arabic.
Setting
The study will be conducted at the Musculoskeletal Outpatient Physiotherapy Department at Concord Repatriation General Hospital in New South Wales, Australia. The outpatient physiotherapy department provides assessment, diagnosis and treatment of a variety of musculoskeletal presentations, such as acute and gradual onset musculoskeletal disorders and postoperative rehabilitation. Concord Hospital serves a diverse community, localised in the Inner West region of Sydney. The patient population may encompass individuals from various cultural and linguistic backgrounds (eg, Chinese, Arabic, Indian, Italian and Greek populations).
Participants
To explore the feasibility of the implementation and explore patients’ outcomes, the recruitment will involve three arms (ie, three groups of participants, described above), who will be encouraged to access the multimedia strategy and provide feedback on the resources.
Arm I (all participants) will involve all individuals visiting the Musculoskeletal Outpatient Physiotherapy Department at Concord Hospital provided they are: >18 years of age and have a sufficient understanding of English. Arm II (patients-participants) includes participants with non-specific LBP, seeking care for LBP, who will be encouraged to complete additional questions about their LBP and medication intake for their LBP management. Arm III (therapist-participants) will comprise the physiotherapists and staff who work at the Outpatient Physiotherapy Department at Concord Hospital and are employed in any capacity (full-time or part-time and are permanent or casual) or rotate through the Outpatient Physiotherapy Department. They will be invited to participate in the study to offer feedback on the feasibility of implementing the multimedia strategy, which will be collected after the study period. Their feedback will provide valuable data that can contribute to the evidence base on the implementation and effectiveness of multimedia strategies in healthcare settings.
There are no exclusion criteria applied to the feasibility and acceptability assessed in arms I and III. For arm II, patients–participants seeking care for non-specific LBP will be excluded if they: have a specific spinal condition according to the American College of Physicians and the American Pain Society39; report symptoms of radiculopathy and nerve root compromise (ie, pins and needles or numbness in the legs and/or foot), had any surgery in the spine (ie, back or neck), hips, knees or ankles in the past 12 months, and have a cognitive impairment that prevents them from following instructions and understanding the patient information sheet, consent form and study questions.
Recruitment
The study recruitment will occur from March to September 2024. All participants (with or without LBP) attending the Outpatient Physiotherapy Department will be introduced to the project via study flyers placed in the waiting room and invited to participate by watching the short video and reading the booklet while they wait for their physiotherapy appointment. Participants will be able to access both the video and booklet by scanning a barcode on the flyers displayed in the waiting room. Alternatively, they can access the resources through a tablet that can be requested from the reception staff. After providing electronic consent via Research Electronic Data Capture - REDCap (online supplemental file 4), participants will proceed to watch the video and read the booklet. Following this, they will be asked to complete a brief survey through REDCap to share their feedback and describe their experience with the multimedia strategy. The initial stage of the recruitment process will involve collecting anonymous data.
Participants who seek care for LBP will be pre-identified by the researcher staff and will be screened for the eligibility criteria by the site coordinator. These patients will be informed about the study, and those who are interested will be instructed to arrive 30 minutes before their physiotherapy appointment to watch the video and read the booklet. They will then complete the same survey that all participants will complete, about their experience with the booklet. People with non-specific LBP will answer additional questions about their current LBP episode and will be invited to answer additional questions about their LBP after 1 month. No monetary compensation will be provided for participation in this study.
Assessments
For arm I, outcomes will be collected immediately after the participant accesses the multimedia strategy. For participants in arm II, outcomes will be collected immediately after they access the multimedia strategy, as well as at the 1-month follow-up. Telephone calls will be made to participants from arm II to collect the follow-up data for 1 month. For study arm III, outcomes related to the feasibility of the implementation strategy will be collected from the physiotherapy staff working at the outpatient services at the end of the study recruitment. In summary, arm I is crucial for assessing the overall reach of the multimedia strategy, regardless of the reason for the physiotherapy visit, while arm II is specific to patients with LBP to measure the content’s effectiveness. Arm III evaluates the strategy’s feasibility from the healthcare professional’s perspective.
The recruitment process can be viewed in figure 1.
Outcomes
Primary outcomes
Primary and secondary outcome measures for the study are summarised in table 1. Primary outcomes will follow the principles of the RE-AIM framework.31 The RE-AIM framework primarily focuses on evaluating the impact of health interventions across five dimensions: Reach, Effectiveness, Adoption, Implementation and Maintenance.
Table 1Summary of outcomes and time points for assessment
| Outcome | Tool | Primary measures | Participants | Time points |
| Reach | Engagement metrics | Survey participation, booklet collection in multiple languages, completion rates, follow-up calls. | All participants | After watching/reading |
| Effectiveness | Survey question | Exercise intention, paracetamol discussion with clinicians, satisfaction, helpfulness, new information, complexity. | All participants | After watching/reading |
| Adoption | Staff feedback | Integration of resources in the workflow, patient feedback on materials regards to helpfulness, usefulness. | Therapist-participants | End of study |
| Implementation | Open-ended questions | Barriers and facilitators to adoption, logistical challenges observed. | Therapist-participants | End of study |
| Maintenance | Barriers and facilitators | Sustainability at organisational level. | All participants | End of study |
| Secondary outcomes | BMQ, PATD,41 Readiness of change,42 short form of the Pain Self-Efficacy Questionnaire43 and HLQ.44 | LBP intensity, paracetamol intake for LBP/other conditions, health literacy, general beliefs about medication, attitudes towards deprescribing, readiness to change etc. | Patient-participants | After watching/reading, a month |
BMQ, Beliefs about Medicine questionnaire; HLQ, Health Literacy Questionnaire; LBP, low back pain; PATD, Patients’ Attitudes Towards Deprescribing.
Secondary outcomes
Secondary outcomes include the Beliefs about Medicine questionnaire,40 Patients’ Attitudes Towards Deprescribing,41 Readiness of change,42 short form of the Pain Self-Efficacy Questionnaire43 and Health Literacy Questionnaire.44 Secondary outcome measures will also guide the methodology of the full-scale trial processes, sample size calculations and outcome selection (by exploring impacts on patient-level and implementation measures). The complete description of the primary and secondary outcomes is listed in the online supplemental file 3.
Demographic information also will be collected from the respondent’s background, such as age, gender, level of education, native language and the language the participant selected to watch the video and read the booklet. In addition, the number of calls made for arm II. Furthermore, the expenditures will be reported. The budgetary considerations will contribute to accountability, transparency, informed decision-making and effective resource management, all of which are essential for the success of projects and programmes. Furthermore, for a more detailed examination of cost implementation, including budgetary considerations, a detailed breakdown of financial considerations will be provided, encompassing various aspects such as materials, training, technology and other relevant expenses.
Data analysis
Sample size
In this hybrid type III feasibility study, our primary aim is to assess the implementation process while also gathering preliminary data on clinical outcomes.45 We will invite all visitors to the Musculoskeletal Outpatient Physiotherapy Department at Concord Repatriation Hospital. Based on similar feasibility studies and considering the specific engagement challenges often encountered in physiotherapy outpatient settings, we anticipate a participation rate of 30–40%. With an estimated 300 visitors expected during the 6-month recruitment period, we anticipate recruiting approximately 90–120 participants. This sample size is deemed sufficient for this phase of the study, as it balances practicality with the need to gather meaningful data on feasibility metrics such as recruitment capabilities, participant retention (for those included in arm II) and preliminary data on effectiveness. Furthermore, we estimate a 100% participation rate from physiotherapists/staff involved in delivering the intervention, which includes all six physiotherapists working in the department.
Data analysis
Continuous data (eg, knowledge scores and engagement metrics) will be reported descriptively, including the mean, SD, median, minimum, maximum and number of missing values. This approach will provide a clear understanding of the data distribution and variability within the group. Categorical data (eg, participant feedback on the multimedia content and engagement levels) will be summarised using counts and percentages to offer insights into how many participants engaged with the educational materials and their responses.
Completion rates for all outcome measures will be reported overall, allowing us to assess participant engagement and data completeness. Since this is a single-arm study, these rates will also help identify potential barriers to completing the surveys and engaging with the multimedia content. For the qualitative analysis of open-ended responses from the therapist-participants, we will use a thematic analysis approach to identify key themes and patterns in their feedback, using MAXQDA software.46 The open-ended questions will focus on barriers and facilitators to implementing the multimedia educational resource. Responses will be coded, categorised and grouped into overarching themes or trends. MAXQDA’s tools will assist in visualising these patterns, helping to identify the most frequently mentioned barriers and facilitators, and providing valuable insights into participants’ experiences with the implementation process.
For the subset of participants who underwent a 1-month follow-up, we will use McNemar’s test47 for categorical variables to compare proportions before and after accessing the digital materials. Additionally, we will track the recruitment rate throughout the study and report it monthly. The overall recruitment rate will be calculated at the study’s conclusion, and a 95% CI will be estimated. This information will provide insight into the feasibility of recruiting an adequate sample size for a future larger trial.
Data collection and management
Feasibility study process measures and implementation outcomes will be collected via REDCap. Patient-level data and implementation determinants questionnaire data will be entered into a study REDCap database with a license held by the University of Sydney. Data analysis will be conducted using SPSS statistical software and Excel. Most feasibility outcome measures will be descriptively presented using frequencies, total numbers and percentages or proportions. The exception is the patient-level clinical outcomes (arm II) and any feasibility outcome measures collected for arm III (ie, barriers and facilitators of the implementation—open-ended questions). To assess the feasibility of the proposed intervention, the analysis will involve determining whether the proportion of interested patients is sufficient to meet a predefined threshold for feasibility.
We will judge the multimedia strategy as acceptable and worthwhile if 50% or more of participants answer ‘positively’ to questions of the participant feedback survey (table 1). The value of 50% for acceptability and experience of the intervention is based on the results of previous studies from which the pharmacological and video educational tools were well received by participants.48 49
Discussion
Our study underscores the importance of educational interventions in healthcare, specifically in waiting room settings.50 51 By integrating targeted materials and promoting healthcare professional-patient collaboration, we assess the feasibility and impact of a multimedia strategy for patients awaiting physiotherapy appointments in a public hospital. This hybrid type III feasibility study design evaluates both the practicality and preliminary outcomes of using educational resources in the outpatient physiotherapy department’s waiting room.
Our previous feasibility study showed promising results through the deployment of an educational booklet aimed at individuals with LBP to reduce reliance on paracetamol.18 However, while booklets were well-received and effective to an extent, their impact was limited by the static nature of the material and the lack of interactive engagement with patients.52 53 A multimedia strategy could bridge gaps in patient engagement, especially within a clinical setting.54 Recent studies have shown that digital communication tools significantly enhance health literacy, leading to improved health outcomes.54
To further evaluate the impact of the real-world applicability of this approach, we are adopting a hybrid type III design in this study, which integrates elements of implementation and effectiveness research.28 This design allows us to assess not only the impact of the multimedia strategy on LBP management but also the practical aspects of implementing it within routine healthcare settings.55 Results from our primary outcomes will contribute to the evidence base on how pragmatic trials can support effective, scalable interventions in clinical practice.28 In addition, evaluating patients’ secondary outcomes will provide further insights into the broader benefits and potential limitations of this intervention, enhancing our understanding of its impact on various aspects of patient well-being.2 7
The hybrid type III feasibility study is well-suited to understanding how the intervention performs across diverse patient demographics and clinical environments, offering insights into both the barriers and facilitators to successful adoption from the perspectives of patients, clinicians and the setting. This approach allows us to examine the intervention’s adaptability and practicality in real-world contexts, ultimately informing strategies to optimise its implementation and effectiveness across various healthcare settings.
Furthermore, this study serves as a foundation for broader applications, aiming to scale up and refine the implementation of educational resources across different healthcare settings. The insights gained from this initial investigation will inform future strategies for integrating educational content seamlessly into patient care pathways, ensuring that such interventions are not only effective but also sustainable over the long-term.
In addition, our secondary outcomes will examine whether interactions between the patient and clinician in the outpatient environment significantly enhance comprehension, retention and decision-making. This analysis will also explore how these interactions complement or amplify the impact of multimedia educational tools, providing a comprehensive understanding of the synergistic potential between health promotion using technological resources.
Limitations
For the adoption component (RE-AIM, arm III), we will collect feedback from staff at the study’s conclusion. Collecting data at a single time point for arm III provides a snapshot of the current state, capturing feedback, perceptions and experiences in that specific moment. However, it also has limitations: collecting data from the physiotherapists/staff at only one point may increase susceptibility to recall bias, which could skew the accuracy and representativeness of the data.
This study is limited by offering the multimedia strategy in three languages: English, Mandarin (Chinese Simplified) and Arabic.
Justification for language exclusivity
English, Mandarin and Arabic have been identified as the most common languages spoken by patients who attend the Musculoskeletal Outpatient Physiotherapy Department at Concord Hospital. Due to the complexity of the study’s materials and the necessity for a nuanced understanding of these languages, only patients who speak those languages will be included. The decision to exclude non-English speaking participants who do not speak Mandarin or Arabic was made to ensure accurate data interpretation and maintain linguistic fidelity during the research process.
We sincerely thank the clinicians and staff at Concord Repatriation General Hospital, Australia, for their time and effort, and collaborators from Sydney Health Partners, Musculoskeletal Australia, Painaustralia and the Canadian Deprescribing Network for supporting the design of the resources evaluated in this study.
Ethics statements
Patient consent for publication
Not applicable.
X @josiicomachioo, @PT_DPrescribing
Contributors JC and PB contributed to the design and implementation of the research. JC drafted the protocol. MH, PF, TP, DR, EKH and PB provided feedback and approved the protocol. MH and DR also provided perspectives on the research documents and the implementation strategy. JC is the guarantor.
Funding The study was funded by a Sydney Health Partners Implementation Pilot Grant 2023, receiving $A19 905.70 (award/grant number: N/A). The video resource utilised in the study was separately funded with $A11 715.00 from the Sydney Health Partners Medical Research Future Fund Rapid Applied Research Translation Programme, round 3 (award/grant number: N/A). No additional funding was provided for this study. JC is supported by an Australian Government Research Training Program Scholarship.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
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; Halliday, Mark 2 ; Ferreira, Paulo H 3 ; Patterson, Thomas 1
; Roberts, David 4 ; Ho, Emma Kwan-Yee 1
; Beckenkamp, Paula R 1 1 The University of Sydney, Faculty of Medicine and Health, School of Health Sciences, Sydney, New South Wales, Australia
2 The University of Sydney, Faculty of Medicine and Health, School of Health Sciences, Sydney, New South Wales, Australia; Concord Repatriation General Hospital, Sydney Local Health District, Sydney, New South Wales, Australia
3 The University of Sydney, Sydney Musculoskeletal Health, Charles Perkins Centre, Faculty of Medicine and Health, School of Health Sciences, Sydney, New South Wales, Australia
4 Concord Repatriation General Hospital, Sydney Local Health District, Sydney, New South Wales, Australia