Predicting Successful Outcome of Interdisciplinary Biopsychosocial Rehabilitation in Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective study is to identify variables that can predict whether an interdisciplinary biopsychosocial intervention for patients with osteoarthritis will be successful. Using an observational design, patients admitted to this program during the 3-year period (2019-2021) will be included and data gathered during routine clinical practice at baseline and end of treatment of patients who gave informed consent, will be used. With these data a prediction model will be build and internal validation with bootstrapping will be done.

Detailed Description
-----------------
Rationale: To predict the probability of a positive outcome of interdisciplinary biopsychosocial intervention in individual patients with osteoarthritis (OA), a prediction model is needed. Research Question/Objective: The overall goal is to develop a clinical prediction model to facilitate decision making in interdisciplinary biopsychosocial rehabilitation in patients with OA. The model will predict the individual probability (in percentage) of a positive response to the treatment (treatment success). Design: A retrospective cohort design. Setting: A Dutch rehabilitation facility. Participants: Patients with OA diagnosed by a medical specialist and consisting at least three months. Intervention and procedures: The intervention of interest is interdisciplinary biopsychosocial rehabilitation. The procedures include the development of a clinical prediction model and assessment of its performance and internal validity. Measurements: Candidate predictors will be carefully selected. The outcome of the model will be treatment success, defined by the change on the Pain Disability Index (PDI). The model will be built with data gathered as part of routine practice. Expected outcome of the research: The deliverable will be a clinical predication model, which can be used in follow-up research.

Official Title
-----------------
Development of a Clinical Prediction Model to Facilitate Decision Making in Interdisciplinary Biopsychosocial Rehabilitation in Patients With Osteoarthritis (OA)

Conditions
-----------------
Chronic Pain, Osteoarthritis, Disability Physical

Intervention / Treatment
-----------------
* Behavioral: interdisciplinary multimodal pain treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic musculoskeletal pain > 3 months and osteoarthritis Large personal and social dysfunction Interplay of biological, social and psychological factors maintaining pain and/or disability Exclusion criteria: Inability to actively participate in treatment (insufficient motivation, limited Dutch language skills, environmental factors, other pending treatments) Disagreement between patient and care providers on content of treatment Pending legal procedures that hinder full cooperation

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| chronic pain osteoarthritis<br>Patients with chronic pain and disability with osteoarthritis | Behavioral: interdisciplinary multimodal pain treatment<br>* A combination of physical and psychosocial treatment methods is employed, including Emotional Awareness and Expression Therapy (EAET), Pain Neuroscience Education (PNE), Acceptance and Commitment Therapy (ACT), graded activity, exposure in vivo, and experiential learning through physical training.<br>* Other names: biopsychosocial treatment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Disability Index | Measures to which degree pain prevents the patient from participating in daily activities. Improvement equal or higher than Minimal Clinically Important Change (MCID; which is 9 points) is defined as successful treatment, and all others as not successful treatment Population will be dichotomized into successful or non-successful treatment and this will be the dependent variable for the logistic regression analysis used to build the prediction model | baseline (start of treatment) and 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multimodal treatment, interdisciplinary, rehabilitation medicine, prediction model, treatment outcome