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Abstract
Introduction International guidelines recommend the use of exercise, education and weight reduction, when appropriate, as first-line treatment for the conservative management of knee osteoarthritis (OA). These guidelines have not been applied systematically in Switzerland, resulting in an evidence-performance gap. After an analysis of available programmes, the Good Life with osteoArthritis Denmark (GLA:D) programme was determined as the most applicable exercise and education programme for its implementation in Switzerland. The implementation of GLA:D Switzerland OA was initiated to encourage the wider implementation of the clinical guideline recommendations and to improve conservative management of knee OA. The aim of this study protocol is to describe the evaluation of the implementation strategy and its impact on implementation, service and clinical outcomes; as well as to identify contributing barriers and facilitators.
Methods and analysis The Implementation Research Logic Model will be used to evaluate the strategy and analyse its impact on the implementation outcomes by means of a mixed methods approach. This protocol outlines the proposed measures, data sources and strategies for the evaluation. Predefined implementation outcomes will help to identify the implementation impact and analyse barriers and facilitators systematically. The study population will be the healthcare professionals who are involved in the conservative management of knee OA in Switzerland, that is, physiotherapists and medical doctors, and their patients.
Ethics and dissemination The use of the registry data containing data of patients participating in the GLA:D Switzerland OA programme does not fall within the scope of the Swiss Human Research Act (BASEC-Nr. Req-2019-00274). However, all participants involved in the evaluation will be asked to give informed written consent and all measures are taken to protect data and privacy of participants. Research findings will be submitted to journals relevant for the topic.
Trial registration number Not applicable.
- rheumatology
- rehabilitation medicine
- primary care
- quality in health care
- protocols & guidelines
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Strengths and limitations of this study
The structured evaluation by the use of frameworks and implementation theories helps to determine the need for and the types of further implementation activities and can also be transferred to other project in chronic care management.
Participants/patients are involved in the evaluation process to determine if the implementation is meeting their needs.
The mixed-method approach helps to cover many facets for understanding the context and implementation barriers or facilitators.
There is no gold standard for the evaluation of implementation strategies and no clear-cut decision can be made on whether an implementation was successful.
The recruitment rate is yet unclear for survey participants or interview partners; however, in implementation studies the focus is not on sample size, but on selecting representative samples, that is, assessing results in heterogeneous, unselected population and real-life clinical setting.
Introduction
Exercise and education for knee osteoarthritis
Knee osteoarthritis (OA) represents a major burden both for the patient and the healthcare system.1 2 The international clinical guidelines of Osteoarthritis Research Society International (OARSI), European Alliance of Associations for Rheumatology and American College of Rheumatology recommend exercise, education and, when appropriate, weight reduction as the first line intervention in the conservative management of knee OA.3–5 These interventions aim to improve knee OA-related symptoms and enhancing patients’ self-management.6 Exercise and education programmes for knee OA that translate the guideline recommendations into clinical practice have been shown to be feasible and effective.6–14 Some are endorsed by OARSI, for example, ‘Better management of Patients with OsteoArthritis’, ‘OsteoArthritis Chronic Care Program’ or ‘Good Life with osteoArthritis Denmark’ (GLA:D).6 10 11 A prior analysis of the OARSI-approved programmes resulted in the GLA:D programme as the most applicable exercise and education programme for implementation in Switzerland, since it had the highest congruency of settings and the highest chance for successful implementation.15
Implementation of an exercise and education programme in Switzerland
Knee OA is the most treated diagnosis in Swiss hospitals but, since patient data in an outpatient setting are not systematically collected, the prevalence and incidence of knee OA remain unclear and are mainly based on data from the inpatient setting.16 However, even though data from the outpatient setting are missing, clinical observations and the high number of surgeries indicated that the prevalence of knee OA is high. Therefore, a survey among medical specialists, working in primary care, was performed to gain insight on the conservative management of knee OA in the outpatient setting of Switzerland.17 The results showed that the estimated referral rate to exercise was of some 54% only and, thus, indicated an evidence-performance gap in the conservative management of knee OA.17 The study demonstrated that guideline recommendations were not applied systematically in clinical practice and there was a need to implement a structured exercise and education programme to close this evidence-performance gap. Furthermore, there is missing transparency in the management of knee OA assuming that patients with knee OA are usually treated with hands-on techniques in physiotherapy. This assumption that physiotherapists (PTs) seem not to manage patients with knee OA according to the guidelines has also been confirmed in many other countries.18–20 An exercise and education programme might help to systematically translate the guideline recommendations into practice.
As a result, a network of physiotherapy experts in OA management founded the interest group ‘IG GLA:D Switzerland’ in 2019 with the aim of implementing the GLA:D programme in Switzerland. The IG consists of six research PTs from three Universities of Applied Sciences in the German, French and Italian language areas of Switzerland, two clinical practitioners representing two specialist physiotherapy societies, and one patient representative of the Swiss League Against Rheumatism (SLAR). Programmes like GLA:D apply standardised assessments and progress reports which can help to ascertain if the interventions help improving the participants’ symptoms. GLA:D is a treatment concept for OA, developed by the university of Southern Denmark, and is being implemented internationally. Therefore, its adaptability to personal or nation-specific needs is limited to guarantee, that GLA:D is the same to patients and other stakeholders wherever it is provided.11 However, the implementation of a new programme in a healthcare system is complex and involves multiple levels in the healthcare system and healthcare delivery.21 The impact of the implementation can be evaluated through the measurement of implementation outcomes, combined with the effects of the programme and the contextual factors that influence the outcomes.22
Aims and objectives
To understand whether the GLA:D Switzerland OA programme has been implemented appropriately, it is important to evaluate the impact of the implementation strategy itself and not only to focus on the programme’s effects, that is, participants’ clinical outcomes.22–24 The impact of the implementation is conceptualised by various implementation outcomes (eg, acceptability, appropriateness, feasibility, adoption, fidelity, penetration and sustainability) including the effects of the programme.23 Therefore, the overall aim of this study is to describe the implementation strategy and the process how to evaluate its impact.
The specific aims of this evaluation are:
To evaluate the impact of implementation strategy of GLA:D Switzerland OA based on the implementation outcomes and analyse the influencing factors (barriers and facilitators).
To analyse the effect of the implementation strategy on the provision of health service and clinical outcomes.
Methods and analysis
Study design
An implementation-effectiveness hybrid type 3 design with a mixed-method approach will be employed.25
The reporting of this study protocol follows the ‘Standards for Reporting Implementation studies’ statement.
Evaluation framework
This evaluation is guided by the Implementation Research Logic Model (IRLM), developed by Smith et al.26 The IRLM is based on the theory that an implementation strategy is dependent on specific implementation determinants, that is, context-specific barriers and facilitators, and works through a specific mechanism of action to change the behaviours of the involved people within the context.
The IRLM format chosen for this evaluation comprises five foundational elements (see figure 1):
Determinants—the determinants used in the IRLM are based on the Consolidated Framework for Implementation ResearchIR) and provide information on the potential barriers and facilitators in the five different IRLM domains, that is, intervention characteristics, inner setting, outer setting, individual characteristics, and process. For each determinant, valence is noted to indicate the possible impact of the determinant on the implementation from +2 (strong positive=facilitator) to −2 (strong negative=barrier).
Implementation Strategies—the implementation strategies occur on multiple levels to support adoption into usual care. These strategies can be developed specifically for the implementation project, but can also be supported by ongoing strategies.
Mechanism—the mechanism of action, which can also be part of ‘implementation strategy’, has an influence on most of the implementation outcomes. It describes the process through which the strategy operates to affect the desired outcomes.
Intervention—the intervention elucidates the functionality of the programme that has been implemented.
Outcomes—the outcomes in the IRLM are subdivided into implementation, service and clinical/patient outcomes. The implementation outcomes described by Proctor et al23 include acceptability, appropriateness, feasibility, adoption, fidelity, penetration and sustainability.23 The leading indicators for analysing implementation success, that is, acceptability, appropriateness and feasibility, are often evaluated during the implementation process to manage the strategies and predict future trends for the other outcomes.23 The outcomes are interdependent on each other, and their results are influenced by the different ‘Determinants’, ‘Implementation strategies’ and ‘Mechanism’.25–27 The influences on the implementation outcomes acceptability, appropriateness, feasibility, adoption, fidelity, penetration and sustainability are outlined with in online supplemental material 1.
Supplemental material
Implementation Research Logic Model (IRLM) by Smith et al.26
Figure 1 shows the IRLM format with the five foundational elements and figure 2 the IRLM applied for this project. The use of the IRLM elements in this implementation project are explained in detail in the subsequent sections.
Implementation Research Logic Model (IRLM) used for the implementation of Good Life with osteoArthritis Denmark (GLA:D) Switzerland. IG GLA:D, Interest Group GLA:D Switzerland; MDs, medical doctor; NCD, non-communicable disease; OA, osteoarthritis; OAEBI, evidence-based intervention; PTs, physiotherapists; SLR, Swiss League Against Rheumatism; EBI, evidence based intervention; WHO, world health organisation.
IRLM—determinants
The determinants of the implementation of exercise and education as first-line intervention are described in the five different domains. These determinants that act potentially as facilitators or barriers as indicated by valence were examined in the early stage of the implementation process. This was first accomplished through surveys of medical doctors (specialists in general primary care, rheumatology and orthopaedics) and of the PTs who attended the first GLA:D certification courses. Additionally, contextual factors were analysed in a policy brief and a stakeholder dialogue.17 28 29
IRLM—implementation strategies
The guideline-based GLA:D programme involves PTs and referring medical doctors working in a structured treatment pathway and applying their knowledge and skills within their professional roles. The establishment of a database for GLA:D-related data allows standardised reporting of the individual participant’s clinical outcomes and the monitoring of the overall quality of the programme.
For the implementation of the GLA:D Switzerland OA programme, there are several strategies being used. Representatives of three medical doctor and two physiotherapy scientific societies, of a patient organisation and an expert from physiotherapy research, are included as key stakeholders in the implementation process and their attitudes and points of view on a programme are assessed and considered carefully. To increase awareness and acceptance, the programme is actively disseminated and promoted through various means and venues (eg, information flyers and scientific presentations for health professionals; information flyers and mass media reports for the public), as well as through network building. Medical specialists and PTs are the main target groups of the strategy. Medical specialists can refer the patients to the programme and therefore, have to be aware of and accept the programme. PTs are also an important target group, since, after successful participation in the certification courses, they are the programme providers. This topic is described in more detail in ‘mechanism of action’. The GLA:D Switzerland OA programme is embedded within the reimbursement system for physiotherapy treatment, that is, reimbursement of physiotherapy is covered by basic health insurance if referred by a medical doctor. Moreover, this project fits well to existing international and national ongoing strategies, which is beneficial to its implementation and funding: (1) the implementation goals of this project are commensurate with the WHO strategy ‘Health 2020 and 2030’ for the prevention and treatment of non-communicable diseases.27 (2) A national strategy for musculoskeletal diseases also exists, including one for OA management.30
IRLM—mechanism
The mechanism of action for GLA:D Switzerland consists of three components: (1) certification courses for PTs; (2) the GLA:D Switzerland OA programme for patients; and (3) data registry for quality monitoring.
Certification course: the attendance of the 2-day certification course allows Swiss PTs to offer the GLA:D programme within their institutions. The course advances knowledge in the fields of OA and evidence-based treatment. It enables the ability to offer the specific GLA:D educational and exercise sessions, perform the clinical tests and use the data registry. After successful completion of the certification course, PTs can implement GLA:D Switzerland OA within their setting. The certificate is valid for 3 years and must be renewed thereafter.
GLA:D Switzerland OA programme: the GLA:D Switzerland OA programme includes: (1) an initial examination (eg, medical history, personal factors, participant’s characteristics), clinical tests and data registry; (2) education sessions, with the goal that the participants understand the diagnosis and the management of OA; and (3) an evidence-based exercise programme in which PTs individually tailor the standardised exercises to the participants’ needs.
Data registry: all demographic and clinical patient data are registered in a national database. The registry also includes participants’ individual clinical outcomes and allows an evaluation of the quality of the treatment, for example, standardised feedback or reports to the referring doctor, and the monitoring of the overall quality of the programme.
IRLM—intervention
People with knee pain or diagnosed knee OA can participate in the programme. The programme consists of (1) 3 individual sessions for assessments at baseline and information/instruction of the standardised and individually tailored exercises; (2) 2 patient education sessions; and (3) 12 PT-supervised group exercise sessions where the exercises are continuously and individually adapted with regard to dose and difficulty. The baseline assessments are repeated during another individual session on completion of the programme. The predefined outcomes are assessed at the 12-month follow-up. The programme’s goal is to enhance the patient’s ability and skills to self-manage their health condition. Referring doctors receive a short, standardised report informing them of the intervention effect after completion of the programme.
IRLM—outcomes
Implementation outcomes: seven implementation outcomes will be used to analyse the success of the implementation strategy and to determine which factors influenced its success or failure.23 Both the implementation strategy and the mechanism of action can influence the implementation outcomes.26 The combination of all outcomes—implementation, service and clinical/patient—will indicate the implementation success of GLA:D Switzerland OA.
Service outcomes: the annual report of GLA:D Switzerland OA provides information on the service outcomes, such as equity or patient centredness (eg, satisfaction). However, these outcomes will be analysed in more depth to determine whether GLA:D Switzerland OA offers a good clinical pathway.
Clinical/patient outcomes: the programme’s impact on the individual participant is evaluated systematically and a summary of the outcomes for all participants is reported annually.
Evaluation implementation strategy
The primary and secondary evaluation outcomes relating to implementation, service and clinical/patient outcomes are described in table 1.
Evaluation of primary and secondary outcomes—implementation, service and clinical/patient-related outcomes
Primary outcome
The primary outcome will be the evaluation of the implementation impact of GLA:D Switzerland OA by analysing various factors (acceptability, appropriateness, feasibility, adoption, fidelity, penetration and sustainability).23 The extent of adoption and penetration is influenced by acceptability, appropriateness, feasibility and fidelity. The analysis will allow the prediction of the sustainability of the programme application and the drawing of conclusions on the implementation success.
Secondary outcomes
Service outcomes will be analysed to determine whether GLA:D Switzerland OA offers a good clinical pathway. The service outcomes are largely linked to barriers and facilitators on the level of ‘intervention characteristics’, but also to implementation strategies, for example, utilisation of financial strategies, or reminding clinicians have an impact on service outcomes.
Clinical/patient outcomes are monitored systematically by the IG GLA:D and reported annually on the website of GLA:D Switzerland (www. gladswitzerland.ch). This will help to make sure that the programme’s effects are not compromised through the process of implementation.25
Study population
The study population for this evaluation will consist of GLA:D-certified and ‘usual care’ PTs, referring and non-referring primary care medical doctors, and GLA:D participants. An analysis will be made of the proportional distribution of the representatives of their group, regarding their characteristics (eg, age, gender, type of outpatient setting) in the three Swiss language areas, that is, German, French and Italian
Patient and public involvement
Patients or, in this case, GLA:D participants, are actively involved in the implementation process and evaluation. In the stakeholder dialogue and other implementation activities, the patients were represented by the SLAR. However, the implementation evaluation will include a patient survey to assess the implementation outcomes on the patient level and to see if the programme meets the patients’ needs or if there are possible barriers for adoption of the programme.
Data collection and analysis
The evaluation will involve several data sources. Primary data sources are: (1) the data registry of GLA:D participants, that is, patients and GLA:D-certified PTs; (2) data from surveys (Likert scales and open questions) with representative samples, that is, as far as possible all who participate in/refer to/provide the GLA:D programme during a certain time period. Furthermore, a representative number of patients, PTs, medical specialists, depending on the number of people supporting GLAD, who do not support the programme; and (3) qualitative data from in-depth interviews. For the interviews, data saturation will indicate when there are enough participants. Patient data in the registry will be assigned a study ID number and will be used anonymised for the evaluation. Data from the surveys and the qualitative data will also be anonymised through an assigned study ID number and stored on a local server. All survey participants and interview partners will be asked for permission to use their anonymised data through an informed consent. They will be apprised that participation is voluntary.
For assessing implementation success, surveys will be developed to empirically evaluate acceptability, appropriateness and feasibility in the various stakeholder groups, that is, PTs, patients, medical doctors or institutions and clinics. For the evaluation of adoption, three implementation streams will be assessed, that is, the number of: (1) medical doctors referring patients with OA to GLA:D Switzerland OA; (2) PTs and organisations offering GLA:D Switzerland OA; and (3) patients participating in the GLA:D Switzerland OA programmes. A stratification question at the beginning of the surveys will be posed to ascertain whether the survey participant is still actively involved in GLA:D Switzerland OA. The associated outcomes of adoption and penetration will both be analysed using data from the registry and national statistical data. Fidelity will be tested through observation, based on predefined criteria on a standardised checklist. The outcome of sustainability is determined by the other implementation outcomes over time and, consequently, will be analysed at a later stage (minimum 4 years).
The surveys’ responses and data from the registry will be quantitatively analysed and reported as frequencies, means and SD. Subgroup analysis on participant characteristics (eg, type of practice, age, profession, language area) will be performed to detect possible barriers to adoption or penetration. The characteristics of the GLA:D-participating PTs, patients and medical doctors will be documented and compared for representativeness. Depending on data availability, the representativeness of the participating PTs, patients and medical doctors will be assessed through comparison with their non-participating associates.
The implementation outcomes will be evaluated further through (qualitative) in-depth analyses with selected PTs, patients and medical doctors, where appropriate. The qualitative data will be anonymised, transcribed and digitally recorded for subsequent analysis. These data can be used to explain the results of the surveys and the data registry, or for further exploration of barriers and facilitators. Moreover, they can also be employed to analyse service outcomes.
Secondary outcomes
The service outcome of equity will be studied by analysing patient characteristics from the registry (ie, age, gender and region or language areas) and appropriate in-depth interviews. The patient survey will include questions on timeliness, patients’ centredness, safety and efficiency. PTs will also be approached with a question in the survey on the complications of patient safety during their courses. The outcome of fidelity and appropriateness will provide information on patients’ centredness and safety. These results may be further deepened by qualitative measures.
Clinical/patient outcomes are assessed for each patient participating in the programme. Pain, use of painkillers, functional ability, quality of life and satisfaction are measured within the programme. These outcomes are available from the data registry and are regularly analysed in the GLA:D-programme annual report. Analysis of the annual reports will provide further explanations of the implementation outcomes.
Discussion
The protocol describes the proposed measures, data sources and strategies to evaluate the impact of the GLA:D Switzerland OA programme. The implementation strategy at the different levels aims to improve acceptability among the key stakeholders and, therefore, enhance adoption, penetration and, ideally, long-term sustainability. However, the implementation of a new programme is not a linear process and needs continuous evaluation. The predefined implementation outcomes will help to identify barriers and facilitators systematically, and to explain the reasons for the success or failure of specific elements of the implementation strategy. The results will feed into the planning of further implementation activities. Furthermore, they facilitate the determination of the factors that require more attention for the systematic application of the GLA:D Switzerland OA programme.
Clinical observations confirm that there is usually a wait-and-see strategy in the conservative management of knee OA or patients are simply referred to physiotherapy, which often focusses on hands-on techniques. Therefore, the systematic implementation of the GLA:D Switzerland OA programme was initiated to improve the conservative management of knee OA by enhancing first-line intervention exercise and education. GLA:D is a so-called best-practice exercise and education programme that has already been successfully implemented in other countries. Quality improvements have already been made and lessons have been learnt from prior implementations in other countries.6 This has helped in designing the implementation in Switzerland.
The original GLA:D programme did not focus on weight reduction, but its inclusion could be of importance in the Swiss context, since some 42% and 11% of Swiss adults are considered overweight and obese, respectively, in the year 2020.31 Weight reduction is also one of the first-line intervention recommendations in conservative knee OA management, since overweight and obesity are major risk factors for developing knee OA.1–5
It is seen as a significant strength that the evaluation of the implementation of the GLA:D Switzerland OA programme is based on the use of frameworks and implementation theories. These theories help to structure and guide the planning, execution and evaluation of an implementation project.26 A structured evaluation will be useful in determining the need for and the types of further implementation activities.23 26 Furthermore, the systematic and structured evaluation process, using the IRLM, can be transferred to the development or evaluation of implementation strategies of other projects in chronic care management. The inclusion of the major stakeholders, such as healthcare providers (PTs, referring doctors), their scientific and professional societies, as well as patients in the implementation process is necessary to understanding the reasons, including facilitators and barriers for adoption, penetration and sustainability. The mixed-method approach helps to cover many facets for understanding the context and implementation barriers or facilitators.
Evaluation studies have often described ‘lessons learned’, meaning barriers or facilitators that have emerged during an implementation process.6 To date, no gold standard exists for the evaluation of implementation strategies and no clear-cut decision can be made on whether an implementation was successful.23 Thus, this evaluation of the implementation impact will be the result of combining numerous outcomes with pragmatic explanations of its success or failure in a certain context.23 It is yet unclear how many survey participants or interview partners will be recruited, however, in contrast to previously defined sample sizes in clinical trials, in implementation studies the focus is on selecting representative samples. Therefore, assessing results in heterogeneous, unselected population and real-life clinical setting are important considerations when analysing the representativeness of the results.32
This study protocol for the evaluation of an implementation strategy will help to monitor systematically the impact of the implementation of GLA:D Switzerland OA and to continuously identify and address its barriers and facilitators. The results of the evaluation will assist in determining how the programme contributes to the overall goal of improving the conservative non-pharmacological management of patients with knee OA in Switzerland. Moreover, the acquired knowledge and lessons learnt regarding implementation in this study might also be transferred to other implementation projects in the field of chronic care management.
Ethics and dissemination
The data registry containing data of patients participating in the GLA:D Switzerland OA programme is declared as a quality improvement project by the Zurich ethics committee and does not fall within the scope of the Swiss Human Research Act (BASEC-Nr. Req-2019-00274). However, all participants involved in the evaluation will be asked to give informed written consent.
PTs can only see their own programme participants in the system. All data will be treated according to the privacy regulations applicable for Switzerland. Collected data will be secured against unauthorised access and will be stored and secured by the University of Applied Sciences Zurich. No data that can identify a participant will be processed for this evaluation to protect and respect the privacy of all participants. The main research team including the principal investigator have access to all anonymised data. Manuscripts with research findings will be submitted to relevant peer-reviewed journals.
Ethics statements
Patient consent for publication
References
Supplementary materials
Supplementary Data
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Footnotes
Contributors LE and KN conceptualised and designed the study protocol and drafted the manuscript. MB-H, OG, IN and A-KR-O contributed to subsequent drafts and all authors revised and approved the manuscript for publication.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests KN is head of research GLA:D® Switzerland OA. The symbol ® in GLA:D® stands for ‘quality-controlled programme’, with no commercial interests.
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.
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