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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 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.

SUBMITTER: Tan BY

PROVIDER: S-EPMC7568411 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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

Tan Bryan Yijia BY Pereira Michelle Jessica MJ Yang Su-Yin SY Hunter David J DJ Skou Soren Thorgaard ST Thumboo Julian J Car Josip J

BMC musculoskeletal disorders 20201016 1

<h4>Background</h4>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- ...[more]

PMID: 33066746

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Project description:BackgroundOsteoarthritis 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.MethodsThe 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 exploratory, parallel arm, single blinded 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.Results20 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 (recruitment criteria not met).ConclusionThis 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.Trial registrationRetrospectively registered on 18 January 2019 at http://clinicaltrial.gov ID: NCT03809975 .

Project description:BackgroundKnee osteoarthritis (OA) is a leading cause of chronic pain and disability and one of the most common conditions treated in outpatient physical therapy (PT). Because of the high and growing prevalence of knee OA, there is a need for efficient approaches for delivering exercise-based PT to patients with knee OA. A prior randomized controlled trial (RCT) showed that a 6-session Group Physical Therapy Program for Knee OA (Group PT) yields equivalent or greater improvements in pain and functional outcomes compared with traditional individual PT, while requiring fewer clinician hours per patient to deliver. This manuscript describes the protocol for a hybrid type III effectiveness-implementation trial comparing two implementation packages to support delivery of Group PT.MethodsIn this 12-month embedded trial, a minimum of 16 Veterans Affairs Medical Centers (VAMCs) will be randomized to receive one of two implementation support packages for their Group PT programs: a standard, low-touch support based on Replicating Effective Programs (REP) versus enhanced REP (enREP), which adds tailored, high-touch support if sites do not meet Group PT adoption and sustainment benchmarks at 6 and 9 months following launch. Implementation outcomes, including penetration (primary), adoption, and fidelity, will be assessed at 6 and 12 months (primary assessment time point). Additional analyses will include patient-level effectiveness outcomes (pain, function, satisfaction) and staffing and labor costs. A robust qualitative evaluation of site implementation context and experience, as well as site-led adaptations to the Group PT program, will be conducted.DiscussionTo our knowledge, this study is the first to evaluate the impact of tailored, high-touch implementation support on implementation outcomes when compared to standardized, low-touch support for delivering a PT-based intervention. The Group PT program has strong potential to become a standard offering for PT, improving function and pain-related outcomes for patients with knee OA. Results will provide information regarding the effectiveness and value of this implementation approach and a deeper understanding of how healthcare systems can support wide-scale adoption of Group PT.Trial registrationThis study was registered on March 7, 2022 at ClinicalTrials.gov (identifier NCT05282927 ).

Project description:BackgroundAllied Health Professionals (AHPs) commonly use journal clubs (JCs) to support Evidence-Based Practice (EBP). There is however little research regarding implementing and sustaining JCs in the long term, and their impact on EBP use and skills in AHPs. This study investigated the impact of implementing a structured JC format, called "TREAT" (previously only investigated across 6 sessions), over a longer period of 16 sessions for AHPs in a public health service. The study also investigated AHP's attendance, adherence, satisfaction and barriers and enablers to implementing the format.MethodsA mixed methods hybrid-effectiveness implementation design was employed, guided by the Knowledge-to-Action cycle. EBP skills, confidence, use, and attitudes were assessed (Adapted Fresno Test, EBPQ, tailored journal club culture questionnaire) at baseline, and after 10 and 16-monthly sessions. Satisfaction and impact on clinical practice were explored using questionnaires at 10 and 16-months, with free-form responses identifying enablers and barriers to EBP culture and implementation. Data on attendance and adherence to the TREAT format were also collected.ResultsSix JCs comprising a total of 132 unique participants from seven Allied Health professions were assessed across three time points. EBP skills improved on the Adapted Fresno Test after 10-monthly (6.6 points: 95% CI, 0.43 to 12.7) and 16-monthly sessions (7.8 points, 95% CI, 0.85 to 14.7), and on self-reported total EBPQ ratings of confidence at 10-months (4.9 points: 95% CI, 2.2 to 7.5) and 16-months (5.7 points: 95% CI 2.7 to 8.7). Of 132 AHPs, 88 reported adopting new treatments/resources and 64 reported updating clinical procedures. Mean attendance was 5.7 sessions (SD = 3.8). Adherence to TREAT components in each session was 86% (95% CI, 83% to 89%). Most participants recommended the format and reported a desire to continue. Enablers to the JC included using clinically relevant topics and active participation while reported barriers included limited time to prepare.ConclusionsDespite variable attendance, TREAT JCs can continue to be implemented within a service for 16 monthly-sessions, and may contribute to improved EBP skills and confidence and changes in clinical practice over time. Tailoring of implementation strategies was shown to be important to address local enablers and barriers.

Project description:BackgroundActive engagement in research by healthcare organisations and clinicians is associated with improvements in healthcare performance. Barriers to research engagement by clinician allied health (AH) professionals include competing priorities from high clinical workloads, lack of research skills and confidence, and lack of supportive research relationships. Collaboration with universities on joint clinical research projects is well recognised as a means of building health service research capacity. Research projects undertaken by students as part of their qualifying degree represent one such opportunity. However, there are few reports evaluating these collaborations from the health service perspective.MethodsA qualitative study using semi-structured interviews and thematic analysis to explore the experiences of AH professionals in the co-supervision of students completing research placements as part of their professional degree course.ResultsFourteen health service employees from six allied health disciplines described collaborations on research projects with 24 students from four different universities. Student placements and projects varied widely in length of placement, extent of collaboration, supervision structure and study design. Three overarching themes were identified in the AH professional co-supervision experience: 1) Professional growth; 2) Mismatch with expectations; and 3) Focus on the student. Project outcomes were categorised from the health system perspective. These were 1) Healthcare performance improvements, including local increases in staff clinical practice knowledge and wider contributions to the evidence base; 2) Research capacity gains within the health service, including research knowledge and skill development, collaborative linkages and opportunity for future research; and 3) Staff-centred outcomes including increased job satisfaction.ConclusionsThis study demonstrates the potential for AH professional supervision of students on research placements to contribute to healthcare performance improvements and research capacity gains within health services, alongside providing personal benefits for the AH professionals involved. Early consultation with a health service-employed research specialist may support health professional and student learning, team collaboration and project coordination for these student projects.

Project description:BackgroundMany applied postgraduate pain training programs are monodisciplinary, whereas interdisciplinary training programs potentially improve interdisciplinary collaboration, which is favourable for managing patients with chronic pain. However, limited research exists on the development and impact of interdisciplinary training programs, particularly in the context of chronic pain.MethodsThis study aimed to describe the development and implementation of an interdisciplinary training program regarding the management of patients with chronic pain, which is part of a type 1 hybrid effectiveness-implementation study. The targeted groups included medical doctors, nurses, psychologists, physiotherapists, occupational therapists, dentists and pharmacists. An interdisciplinary expert panel was organised to provide its perception of the importance of formulated competencies for integrating biopsychosocial pain management with a cognitive behavioural approach into clinical practice. They were also asked to provide their perception of the extent to which healthcare professionals already possess the competencies in their clinical practice. Additionally, the expert panel was asked to formulate the barriers and needs relating to training content and the implementation of biopsychosocial chronic pain management with a cognitive behavioural approach in clinical practice, which was complemented with a literature search. This was used to develop and adapt the training program to the barriers and needs of stakeholders.ResultsThe interdisciplinary expert panel considered the competencies as very important. Additionally, they perceived a relatively low level of healthcare professionals' possession of the competencies in their clinical practice. A wide variety of barriers and needs for stakeholders were formulated and organized within the Theoretical Domain Framework linked to the COM-B domains; 'capability', 'opportunity', and 'motivation'. The developed interdisciplinary training program, including two workshops of seven hours each and two e-learning modules, aimed to improve HCP's competencies for integrating biopsychosocial chronic pain management with a cognitive behavioural approach into clinical practice.ConclusionWe designed an interdisciplinary training program, based on formulated barriers regarding the management of patients with chronic pain that can be used as a foundation for developing and enhancing the quality of future training programs.

Project description:BACKGROUND:There is a lack of evidence concerning the effectiveness of different strategies to engage healthcare professionals in collaborative processes that seek to optimise clinical practice. The PREDIAPS project aims to assess the effect of different primary health care (PHC) providers' engagement procedures in the creation and execution of a facilitated interprofessional collaborative process to optimise the integration of the recommended clinical practice for the prevention of type-2 diabetes (T2D) in routine PHC. METHODS:This will be a randomised cluster type II hybrid implementation trial. Nine PHC centres from the Basque Health Service (Osakidetza) will be allocated to two different procedures to engage family doctors and nurses and create an interprofessional collaborative practice to optimise the integration of a T2D primary prevention programme. All centres and PHC professionals will receive training on current guidelines in primary prevention of T2D and effective interventions to promote healthy lifestyles. Headed by a local leader and an external facilitator, centres will conduct a collaborative structured process to model and adapt the intervention and its implementation to the specific context of professionals and centres. One of the groups will apply this strategy globally, promoting the cooperation of all health professionals from the beginning. The other will perform it sequentially, centred first on nurses, who will then seek the pragmatic cooperation of doctors. All patients without diabetes aged ??30 years old who attend collaborating centres at least once during the study period and found to be at high risk of developing T2D will be eligible for programme inclusion. The main outcome measures focus on changes observed in indicators of T2D prevention clinical practice at centre level after 12 and 24 months, associated with the application of one or other engagement procedure. Secondary outcomes will compare their clinical effectiveness in changing eligible exposed patients' main lifestyle behaviours and risk factors (physical activity and diet, weight, etc.) after 12 months. DISCUSSION:The PREDIAPS project will generate scientific knowledge on procedures for engaging PHC professional to facilitate feasible and effective adoption of proven interventions for the prevention of T2D in routine clinical practice through the application of implementation strategies. TRIAL REGISTRATION:Clinicaltrials.gov identifier: NCT03254979 . Registered 16 August 2017.

Dataset Information

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

Publications

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

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