Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals Trial (CONNACT) – A Feasibility Study in patients with knee osteoarthritis using a mixed method approach

Abstract

Background Osteoarthritis is a leading cause of global disability resulting in significant morbidity and cost to the healthcare system. Current guidelines recommend lifestyle changes such exercises and weight loss as first line treatment prior to surgical consideration. Our current model of care is inefficient with suboptimal allied health intervention for effective behaviour changes. A 12-week community based, individualized, multidisciplinary new model of care for knee osteoarthritis was developed in light of current deficiencies. Methods The primary aim of this study was to determine the feasibility of a full randomized controlled trial evaluating this new model of care using pre-defined progression criteria. The secondary aim was to optimize the intervention and study design through a process evaluation. A pilot randomized trial design using a mixed method approach was utilized. Progression criteria for a full trial including key domains of patient recruitment and retention, outcome measure acceptability and improvement, adverse events were developed. The primary outcome measure was the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and 12-weeks. Secondary outcomes included quality of life, functional and psychological assessments. Semi-structured interviews were conducted with the patients at 12-weeks. Results 20 patients (3 males, 17 females) were randomized (10 intervention, 10 control). Intervention arm patients reported better improvements in their knee function, quality of life, psychological outcome, dietary improvement and weight loss compared to the control arm at 12-weeks. Semi-structured interviews revealed several themes pertaining to feasibility and intervention optimization. 5 out of the 6 progression criteria’s domains were met. Conclusion This pilot has demonstrated the feasibility of a full randomized control trial investigating the potential effectiveness of the new proposed model of care for knee osteoarthritis using pre-defined progression criteria and process evaluation. Results from the qualitative study were used to modify and improve the intervention content, delivery model and study design for a large effectiveness-implementation hybrid randomized control trial that is currently underway.

Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial

“…The development and core principles of the CONNACT MoC has been described as part of the pilot study [ 25 ]. Grounded from a throughout literature search on the best practices in knee OA care [ 3 , 26 ], a review of successful programs [ 11 ], international collaborations and the process evaluation patient interviews from the pilot study has allowed the CONNACT MoC to be further refined and contextualized.…”

“…The sample size needed to detect a 10-point difference between the intervention arm and usual care arm in KOOS 4 was 41 patients in each arm based on a power of 90%, p -value of 0.05 (two-sided) and a standard deviation of 14. The anticipated population KOOS 4 and standard deviations were based on the initial pilot study [ 25 ] done and the minimally clinically important difference on 10-points (MCID) for KOOS [ 24 ]. In order to account for a missing data rate of 20%, 100 patients will be recruited for the study.…”

Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals in Knee Osteoarthritis (CONNACT): Study Protocol for an Effectiveness-Implementation Hybrid Randomized Control Trial

“…The sample size needed to detect a 10-point difference between the intervention arm and usual care arm in KOOS 4 was 41 patients in each arm based on a power of 90%, p-value of 0.05 (two-sided) and a standard deviation of 14. The anticipated population KOOS 4 and standard deviations were based on the initial pilot study (13) done and the minimally clinically important difference on 10-points (MCID) for KOOS (49). In order to account for a missing data rate of 20%, 100 patients will be recruited for the study.…”

“…The Medical Research Council (MRC) Guidance on developing and evaluation such complex interventions was utilized in the CONNACT development, evaluation and eventual planned implementation (12). A feasibility study using a pilot randomized trial design was conducted to determine the feasibility of a full randomized controlled trial (RCT) evaluating the CONNACT MoC as the rst step (13). Results from the feasibility study were instrumental in the design of this study protocol.…”