| Summary: | Musculoskeletal (MSK) disorders are the top cause of disability in the world with knee osteoarthritis (OA) being one of the fastest growing causes of disability leading to pain, impaired mobility, poor function and quality of life. International guidelines advocate a stepwise approach to manage knee OA starting with pharmacological treatment and lifestyle modifications (physical activity, weight loss) with surgery such as knee replacement surgery reserved for situations where all non-surgical options have been exhausted. Unfortunately, studies are reporting that the majority of patients are receiving suboptimal non-surgical treatment. The rate and absolute number of surgeries for knee OA are rapidly on the rise with an estimated 25-50% of surgeries that potentially could have been delayed or even avoided with optimal non-surgical treatment. There is an urgent need to optimize the non-surgical care model and reduce unnecessary knee replacements.
This thesis chronicles the journey of the Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT) intervention that was developed in response to this need among knee OA patients in Singapore. The thesis is structured based on the Medical Research Council (MRC) Guide on the development and evaluation of complex interventions, grounded on implementation science principles and illustrates the journey moving from (1) development (evidence base, developing the intervention), (2) pilot and feasibility studies, (3) evaluation and (4) implementation.
In Study 1, a scoping review was conducted with the primary aim to map out the latest evidence from randomized controlled trials (RCT) on complex lifestyle and psychosocial care delivery models for knee OA. The secondary aim was to outline the various elements of complex lifestyle and psychosocial care models. 38 articles were selected for this scoping review which highlighted the substantial variation in knee OA lifestyle and psychosocial interventions and the overall lack of quality in the current literature.
Building on the scoping review, CONNACT, a community-based, personalized, multidisciplinary 12-week intervention was developed in conjunction with international and local experts. It comprises of 4 main components (education, exercise, nutrition and psychological support) that were delivered by a multidisciplinary team (orthopaedic surgeon, physiotherapist, dietician, psychologist and social worker). A triaging criterion was designed to individualize treatment where Body Mass Index (BMI) was used to decide the need for dietician intervention and a combination of activation levels, pain intensity and interference and negative affect (depression or anxiety) were used to determine the need for psychological intervention.
In Study 2, a pilot feasibility randomized trial was conducted with the primary aim to determine the feasibility of performing a full RCT. The secondary aim was to optimize the intervention and study design through a process evaluation. A pilot parallel arm, single-blinded randomized trial design using a mixed method approach through semi-structured interviews was utilized. Progression criteria for the primary aim to be fulfilled were developed prior to patient recruitment. 20 patients were recruited (10 intervention, 10 control) with the intervention arm reporting better improvements at 12-weeks compared to the control arm. Themes pertaining to study design feasibility and intervention optimization were explored with 5 out of the 6 progression criteria’s domains met. This pilot demonstrated the feasibility of a full RCT, with the process evaluation results used to improve and modify the intervention and study design for Study 3,4 and 5.
Study 3 to 5 comprised the main Effectiveness-Implementation Hybrid RCT. Study 3 outlines the main RCT itself, Study 4 the process evaluation and Study 5 the economic evaluation. Study 3 was conducted as a pragmatic, parallel-arm, single-blinded superiority RCT comparing CONNACT to usual care. Community ambulant adults with knee OA were enrolled. Exclusion criteria included inflammatory arthritis, significant cognitive impairment, severe comorbidities, and previous knee replacement. The primary outcome was Knee Injury and Osteoarthritis Outcome Score (KOOS4) at 12-months. Secondary outcomes included quality of life (QOL), physical performance measures, symptom satisfaction, psychological outcomes, dietary habits, and global perceived effect at 3,6 and 12-months. Intention to treat analysis using generalized linear model (GLM) and regression modelling were conducted. Subgroup analysis of the different intervention combinations, based on stratification criteria were explored. 110 participants (55 control, 55 intervention) were randomized. The primary outcome of KOOS4 at 12 months, showed no significant between-group difference. Among the secondary outcomes, the CONNACT group demonstrated superior between-group outcomes for positive dietary change over 12 months, improved physical performance measures at 3 and 6 months, symptom satisfaction at 3 months and global perceived effect at 6 months. Within group difference over time, both control and intervention group showed significant improvement over time for KOOS4 and secondary outcomes over 12 months. Subgroup analysis showed those stratified for psychological intervention group had superior improvement in psychological measures. In summary, the CONNACT intervention for knee OA was not shown to be superior to hospital-based usual care on pain, function and quality of life, but demonstrated superior results in physical performance measures, knee satisfaction, global perceived effect and positive dietary change particularly over the short to medium term.
In Study 4, a nested process evaluation was performed in order to contextualise the RCT outcomes and inform large scale implementation opportunities, using an explanatory sequential mixed methods approach underpinned by the RE-AIM framework. Quantitative (eligibility logs) and qualitative data (semi-structured interviews with 22 patients and 14 healthcare professionals) were collected to inform the Reach and other domains, respectively, of RE-AIM. Interviews were recorded, transcribed verbatim and translated for thematic analysis using the framework method and the emergent themes were organised by RE-AIM domain. Reach domain: 55.4% of the patients who met the inclusion criteria participated, with work or family commitments and disinterest in physiotherapy as the commonest reason for declining. Effectiveness results: CONNACT was not superior to control hospital-based usual care on pain, function and quality of life but was shown to be superior in physical performance, knee satisfaction, global perceived effect and positive dietary change. Adoption themes: Strong support for CONNACT among healthcare professionals, proposed changes for long-term sustainability (transdisciplinary approach, expert patients). Implementation themes: Context (pre-existing health belief, treatment expectation) and mechanism of impact (active acceptance, self-efficacy, education and empowerment, group class support and tension, intervention synergy). Maintenance themes: Incorporating exercise into regular routines, community programs and celebrating small wins. The identified themes have allowed a better understanding of the RCT primary and secondary outcomes and informed the next phase of implementation.
In Study 5, the nested economic evaluation was performed of the CONNACT intervention through a societal perspective. Direct costs were identified through validated OA Cost and Consequences Questionnaire (OCC-Q). Indirect costs (absenteeism and presenteeism) were measured with the Work Productivity and Activity Impairment Questionnaire (WPAI). The primary measure of health benefit was Quality of Life Years (QALYs) measured using the EQ-5D. Results showed no difference in health utility measured by EQ-5D across 12 months. While there was no difference between the total overall cost, after the initial higher direct medical cost in the first 3 months contributed by the 12-week CONNACT intervention itself, the intervention patients reported a lower direct medical cost coupled with lower indirect cost from higher productivity levels for employed patients after the first 3 months. The intervention arm had a significantly higher probability of incurring zero or low productivity loss compared to the control arm.
In summary, this thesis demonstrated the journey of the development and evaluation of the CONNACT intervention moving from (1) development (identifying the evidence base through a scoping review, developing the intervention), (2) feasibility and piloting and (3) evaluation through an effectiveness-implementation hybrid RCT with nested process and economic evaluation. The CONNACT intervention has demonstrated the potential to be an effective intervention for knee OA. Guided by the results, in particular the process evaluation, key modifications and changes can help support widespread implementation in the next phase.
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