Collaborative Model of Care Between Orthopaedics and Allied Healthcare Professionals Trial (CONnACT)

Tan Tock Seng Hospital

Status: Active, not recruiting

Conditions: Osteoarthritis

Treatments: Other: Current model of care; Other: Multidisciplinary Community Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03809975

NTF_JUL2017_I_C2_CQR_01

2018/00408 (Other Identifier)

Details and patient eligibility

About

Osteoarthritis knee is the leading cause of chronic disability among older adults. Our current model of care is doctor-centric and inefficient leading to suboptimal use of allied health intervention for effective lifestyle and behaviour changes resulting in potentially, unnecessary surgery.

The study is designed using an effectiveness-implementation hybrid study design utilizing a mixed methods approach. The hybrid study has dual aims. The primary aim is to evaluate the clinical effectiveness (pain, function and quality of life) of a 12-week multidisciplinary (Orthopaedics, Physiotherapy, Dietetics, Psychology) personalized, community-based program for patients with knee osteoarthritis through a randomized-controlled trial. The secondary aim is to obtain data that will inform the context for implementation and guide future wider scale application. The investigators hypothesize that this multidisciplinary program is clinically more effective in the treatment of knee osteoarthritis at 12 months compared to standard care.

Full description

BACKGROUND With a rapidly aging population, osteoarthritis is expected to become the 4th leading cause of global disability by 2020. Established guidelines for knee osteoarthritis strongly advocate lifestyle changes, such with exercises and weight loss as first line of treatment, whilst reserving surgery as the last resort. Our current model of care is doctor-centric and inefficient leading to suboptimal use of allied health intervention for effective lifestyle and behaviour changes resulting in potentially, unnecessary surgery. Redesigning the model of care by moving away from costly surgical treatment through the optimization and synergizing of proven non-surgical treatments is key to deliver value-based care.

AIMS AND HYPOTHESIS Primary Aim and Hypothesis. Evaluate the clinical effectiveness (pain, function and quality of life) at 12 months of a personalized, community based 3-month multidisciplinary program (Orthopaedics, Physiotherapist, Dietitian and Psychologist) as compared with usual care for patients with knee osteoarthritis. The investigators hypothesize that patients with knee osteoarthritis who undergo a personalized, community based 3-month multidisciplinary program will have better pain, function and quality of life scores at 12 months post initiation of program compared to patients who undergo usual care.

Secondary Aim. Evaluate the cost effectiveness of a personalized, community based 3-month multidisciplinary program (Orthopaedic, Physiotherapist, Dietitian and Psychologist) for patients with knee osteoarthritis. Qualitative assessment of the acceptability, feasibility and scalability of such a program

METHODOLOGY The study will be conducted as a single centre, single-blinded, gender stratified, block permutated randomized controlled trial using a mixed method approach (quantitative and qualitative), comparing a proposed new multidisciplinary personalized community-based model of care and the current model of care.

Patients with suspected knee osteoarthritis who are referred from the Polyclinics in the primary healthcare setting to the Tan Tock Seng Hospital Orthopaedic Specialist Outpatient Clinic. Patients will then be evaluated based on the inclusion and exclusion criteria and subsequently invited to join the study if eligible. Consent for participation into the study will be obtained prior to randomization. Randomization will be done via gender stratified permutated block randomization.

ECONOMIC EVALUATION An economic evaluation from a societal perspective will be undertaken to determine the cost effectiveness of the intervention. The incremental cost effectiveness ratio of this multidisciplinary non-surgical community-based program for knee osteoarthritis compared to routine care will be determined. Cost data will be collected via questionnaires and hospital databases to estimate both the direct medical, direct non-medical and indirect cost. Indirect cost of health-related productivity loss due to knee osteoarthritis will be calculated using a human capital approach. The primary measure of health benefit will be Quality of Life Years measure using the EQ-5D.

QUALITATIVE COMPONENT The qualitative component of our study will employ several qualitative methods such as focus group discussions and individual interviews with a variety of subjects including both patients and stakeholders. The focus will on identifying the potential barriers and facilitators to implementing and upscaling the intervention.

Enrollment: 114 patients

Sex: All

Ages: 45 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. National Institute for Health and Care Excellence (NICE) clinical criteria for knee osteoarthritis
2. Radiographic severity of knee osteoarthritis - Kellgren Lawrence Score > 1
3. Knee Injury and Osteoarthritis Outcome Score (KOOS4) ≤ 75
4. Independent community ambulator with or without walking aid
5. Age ≥ 45 years old
6. Conversant in English/Chinese
7. Subject will need to fulfill all the inclusion criteria for eligibility.

Exclusion Criteria

1. Alternative diagnosis to knee osteoarthritis e.g. referred pain from the spine or hip
2. Secondary arthritis e.g. inflammatory, post-traumatic
3. Inability to comply with study protocol e.g. cognitive impairment
4. Previous knee arthroplasty on the symptomatic knee
5. Wheelchair bound patients
6. Any other medical condition that study team determines may interfere with study involvement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 2 patient groups

Control Arm

Active Comparator group

Description:

Current model of care Patients will undergo the current standard of care in the Orthopaedic Outpatient Clinic in Tan Tock Seng Hospital. Patients will undergo routine consultation with an orthopaedic surgeon and will be provided with standard treatment as necessitated based on the assessment of the orthopaedic surgeon. Subsequent follow up appointments will be scheduled at the discretion of the orthopaedic surgeon. Patients will be referred to the physiotherapists, dietitian and psychologists as necessary for regular or adhoc sessions at the discretion of the allied health professional.

Treatment:

Other: Current model of care

Intervention Arm

Experimental group

Description:

Multidisciplinary Community Program Community based, personalized, structured, 12-week multidisciplinary program that includes Orthopaedics, Physiotherapy, Dietitics, Psychology interventions. This intervention involves the use of formal assessment such as BMI and psychological questionnaires to determine the need for dietetics or psychological intervention. In addition, there are educational sessions to improve patient's understanding of osteoarthritis and improve their activation level. An optional support group session will be arranged at approx. 3-4 months after completion of the 12-week intervention program to improve sustainability of treatment effect.

Treatment:

Other: Multidisciplinary Community Program