Clinical trial NCT03809975: Collaborative Model of Care Between Orthopaedics and Allied Healthcare Professionals Trial (CONnACT)
Official title: Collaborative Model of Care Between Orthopaedics and Allied Healthcare Professionals Trial (CONnACT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Keywords: Knee
Osteoarthritis
Model of care
Multi-disciplinary
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Nanyang Technological University
name: Singapore General Hospital
name: University of Sydney
First posted: 2019-01-18
Enrollment: 114
Sex: ALL
Minimum age (years): 45
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS4)
timeFrame: Assessed at baseline, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Symptoms, Activities of Daily Living, Sports/Recreational Activities, Quality of Life
timeFrame: Assessed at baseline, 3 months, 6 months, 12 months
measure: EuroQol-5 Dimensions (EQ-5D)
timeFrame: Assessed at baseline, 3 months, 6 months, 12 months
measure: Functional Assessment - 30s chair stand test
timeFrame: Assessed at baseline, 3 months, 6 months, 12 months
measure: Functional Assessment - 40m fast-paced walk test
timeFrame: Assessed at baseline, 3 months, 6 months, 12 months
measure: Functional Assessment - 4 stairs climb test
timeFrame: Assessed at baseline, 3 months, 6 months, 12 months
measure: Functional Assessment - Timed up and go test
timeFrame: Assessed at baseline, 3 months, 6 months, 12 months
measure: Patient Health Questionnaire 4 (PHQ-4)
timeFrame: Assessed at baseline, 3 months, 6 months, 12 months
measure: Patient Activation Measure (PAM)
timeFrame: Assessed at baseline, 3 months, 6 months, 12 months
measure: Pain, Enjoyment, General Activity Scale (PEG)
timeFrame: Assessed at baseline, 3 months, 6 months, 12 months
measure: Body Mass Index (BMI)
timeFrame: Assessed at baseline, 3 months, 6 months, 12 months
measure: Total Knee Replacement
timeFrame: Assessed at 3 months, 6 months, 12 months
Other outcomes:
measure: Cumulative Analgesia Consumption Score (CACS)
timeFrame: Assessed at baseline, 3 months, 6 months, 12 months
measure: Semi-Quantitative Food Frequency Questionnaire (FFQ)
timeFrame: Assessed at baseline, 3 months, 6 months, 12 months
measure: Sports Injury Rehabilitation Adherence Scale (SIRAS)
timeFrame: Assessed after each physiotherapist session
measure: Global perceived effect (GPE)
timeFrame: Assessed at 3 months, 6 months, 12 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: Assessed at 3 months, 6 months, 12 months
measure: Patient-reported Treatment failure
timeFrame: Assessed at 3 months, 6 months, 12 months
measure: Costs
timeFrame: Assessed at 3 months, 6 months, 12 months
measure: Adverse Events
timeFrame: Assessed at 3 months, 6 months,12 months
measure: University of California, Los Angeles(UCLA) activity score
timeFrame: Assessed at baseline, 3 months, 6 months and 12 months
Locations:
city: Singapore
country: Singapore
facility: St Luke Eldercare (AMK)
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Bryan Tan, MBBS, MRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark
name: Soren Skou, PT, PhD
role: STUDY_CHAIR
affiliation: Nanyang Technological University
name: Josip Car, MD, PhD
role: STUDY_CHAIR
affiliation: Singapore General Hospital
name: Julian Thumboo, MBBS, FRCP
role: STUDY_CHAIR
affiliation: University of Sydney
name: David Hunter, MBBS, PhD
role: STUDY_CHAIR
References:
citation: Tan BY, Pereira MJ, Yang SY, Hunter DJ, Skou ST, Thumboo J, Car J. 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 Musculoskelet Disord. 2020 Oct 16;21(1):684. doi: 10.1186/s12891-020-03695-3.
citation: Tan BY, Ding BTK, Pereira MJ, Skou ST, Thumboo J, Car J. 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. BMC Musculoskelet Disord. 2020 Sep 4;21(1):592. doi: 10.1186/s12891-020-03611-9.