Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial
Abstract Background Knee Osteoarthritis (OA) is a leading cause of global disability. The Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT) Model of Care (MoC) was developed by optimizing evidence-based non-surgical treatments to deliver value-based care...
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| Format: | Article |
| Language: | English |
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BMC
2020-10-01
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| Series: | BMC Musculoskeletal Disorders |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12891-020-03695-3 |
| _version_ | 1811333309143187456 |
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| author | Bryan Yijia Tan Michelle Jessica Pereira Su-Yin Yang David J. Hunter Soren Thorgaard Skou Julian Thumboo Josip Car |
| author_facet | Bryan Yijia Tan Michelle Jessica Pereira Su-Yin Yang David J. Hunter Soren Thorgaard Skou Julian Thumboo Josip Car |
| author_sort | Bryan Yijia Tan |
| collection | DOAJ |
| description | Abstract Background Knee Osteoarthritis (OA) is a leading cause of global disability. The Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT) Model of Care (MoC) was developed by optimizing evidence-based non-surgical treatments to deliver value-based care for people with knee OA. The primary aim of this study is to determine the clinical effectiveness of the CONNACT MoC (3 months) compared to usual care. The secondary aims are: a) To determine the cost-effectiveness and b) To develop an evaluation and implementation framework to inform large scale implementation for this MoC. Methodology Type 1 Effectiveness-Implementation Hybrid Trial using an explanatory sequential mixed-method approach. The study consists of 3 components. The first component is the pragmatic, parallel-arm, single-blinded randomized control trial. Inclusion criteria are patients with knee OA based on the National Institute of Health and Care Excellence (NICE) criteria with radiographic severity of greater than Kellgren-Lawrence 1, and Knee Injury and OA Outcome Score (KOOS4) of equal or less than 75. Exclusion criteria include other forms of arthritis, history of previous knee arthroplasty or wheelchair-bound patient. KOOS4 is the primary outcome measure at 3 months, 6 months and 1 year. Secondary outcomes include KOOS individual subscales, quality of life scoring, functional performance, global, diet and psychological related outcomes. The second component is an economic evaluation of the cost-effectiveness of the CONNACT MoC using a societal perspective. The third component is an implementation and evaluation framework using process evaluation under the RE-AIM framework using a mixed-method approach. Sample size of 100 patients has been calculated. Discussion CONNACT MoC is a complex intervention. In line with the MRC guidance for developing and evaluating complex interventions, a pilot feasibility study was completed and a comprehensive approach including an RCT, economic evaluation and process evaluation is described in this study protocol. Results from this study will help clinicians, healthcare administrators and policymakers guide the sustainable and effective implementation of the CONNACT MoC for knee OA and serve as a basis for similar multidisciplinary MoC for chronic degenerative musculoskeletal conditions to be developed. Trial registration Clinicaltrials.gov Identifier: NCT03809975 . Registered January 182,019. |
| first_indexed | 2024-04-13T16:51:05Z |
| format | Article |
| id | doaj.art-4406d7b4a5984ee3b51fb370596bd12a |
| institution | Directory Open Access Journal |
| issn | 1471-2474 |
| language | English |
| last_indexed | 2024-04-13T16:51:05Z |
| publishDate | 2020-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Musculoskeletal Disorders |
| spelling | doaj.art-4406d7b4a5984ee3b51fb370596bd12a2022-12-22T02:38:57ZengBMCBMC Musculoskeletal Disorders1471-24742020-10-0121111310.1186/s12891-020-03695-3Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trialBryan Yijia Tan0Michelle Jessica Pereira1Su-Yin Yang2David J. Hunter3Soren Thorgaard Skou4Julian Thumboo5Josip Car6Department of Orthopaedic Surgery, Woodlands Health Campus, National Healthcare GroupHealth Services Outcome Research, National Healthcare GroupDepartment of Orthopaedic Surgery, Woodlands Health Campus, National Healthcare GroupInstitute of Bone and Joint Research, Kolling Institute, University of Sydney and Rheumatology Department, Royal North Shore HospitalDepartment of Sports Science and Clinical Biomechanics, Research Unit for Musculoskeletal Function and Physiotherapy, University of Southern DenmarkSingapore General HospitalLee Kong Chian School of Medicine, Nanyang Technological UniversityAbstract Background Knee Osteoarthritis (OA) is a leading cause of global disability. The Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT) Model of Care (MoC) was developed by optimizing evidence-based non-surgical treatments to deliver value-based care for people with knee OA. The primary aim of this study is to determine the clinical effectiveness of the CONNACT MoC (3 months) compared to usual care. The secondary aims are: a) To determine the cost-effectiveness and b) To develop an evaluation and implementation framework to inform large scale implementation for this MoC. Methodology Type 1 Effectiveness-Implementation Hybrid Trial using an explanatory sequential mixed-method approach. The study consists of 3 components. The first component is the pragmatic, parallel-arm, single-blinded randomized control trial. Inclusion criteria are patients with knee OA based on the National Institute of Health and Care Excellence (NICE) criteria with radiographic severity of greater than Kellgren-Lawrence 1, and Knee Injury and OA Outcome Score (KOOS4) of equal or less than 75. Exclusion criteria include other forms of arthritis, history of previous knee arthroplasty or wheelchair-bound patient. KOOS4 is the primary outcome measure at 3 months, 6 months and 1 year. Secondary outcomes include KOOS individual subscales, quality of life scoring, functional performance, global, diet and psychological related outcomes. The second component is an economic evaluation of the cost-effectiveness of the CONNACT MoC using a societal perspective. The third component is an implementation and evaluation framework using process evaluation under the RE-AIM framework using a mixed-method approach. Sample size of 100 patients has been calculated. Discussion CONNACT MoC is a complex intervention. In line with the MRC guidance for developing and evaluating complex interventions, a pilot feasibility study was completed and a comprehensive approach including an RCT, economic evaluation and process evaluation is described in this study protocol. Results from this study will help clinicians, healthcare administrators and policymakers guide the sustainable and effective implementation of the CONNACT MoC for knee OA and serve as a basis for similar multidisciplinary MoC for chronic degenerative musculoskeletal conditions to be developed. Trial registration Clinicaltrials.gov Identifier: NCT03809975 . Registered January 182,019.http://link.springer.com/article/10.1186/s12891-020-03695-3Study protocolEffectiveness-implementation hybridMixed methodsKnee osteoarthritisModel of careRandomized control trial |
| spellingShingle | Bryan Yijia Tan Michelle Jessica Pereira Su-Yin Yang David J. Hunter Soren Thorgaard Skou Julian Thumboo Josip Car Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial BMC Musculoskeletal Disorders Study protocol Effectiveness-implementation hybrid Mixed methods Knee osteoarthritis Model of care Randomized control trial |
| title | Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial |
| title_full | Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial |
| title_fullStr | Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial |
| title_full_unstemmed | Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial |
| title_short | Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial |
| title_sort | collaborative model of care between orthopaedics and allied healthcare professionals in knee osteoarthritis connact study protocol for an effectiveness implementation hybrid randomized control trial |
| topic | Study protocol Effectiveness-implementation hybrid Mixed methods Knee osteoarthritis Model of care Randomized control trial |
| url | http://link.springer.com/article/10.1186/s12891-020-03695-3 |
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