Predicting Successful Outcome of Interdisciplinary Biopsychosocial Rehabilitation in Osteoarthritis (CIR-predict)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis; Chronic Pain; Disability Physical
• Intervention / Treatment: Behavioral: interdisciplinary multimodal pain treatment

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.

• Study Type: Observational
• Enrollment (Actual): 2309

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025 AX
      • Centrum voor Integrale Revalidatie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Referred by GP, medical specialist or occupation physician to reduce level of disability and improve quality of life of patients fulfilling the eligibility criteria and not having one or more of the exclusion criteria:

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
chronic pain osteoarthritis; Patients with chronic pain and disability with osteoarthritis	Behavioral: interdisciplinary multimodal pain treatment; 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.; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Illness Perception Questionnaire	Measures the cognitive and emotional representation of illness in a patient	Baseline
Pain Self Efficacy Questionnaire	Measures how confident the patient is that he/she will be able to perform daily tasks despite being in pain	baseline
Psychological Inflexibility in Pain Scale	Measures psychological inflexibility (avoidance of pain and cognitive fusion with pain)	Baseline
Symptom Checklist 90	Measures to which degree the patient suffers from 90 different physical and psychological symptoms.	Baseline
Hospital Anxiety and Depression Scale	Measures feelings of fear and depression, without looking at physical complaints	Baseline
General CIR questionnaire	Records general socio-demographic characteristics as well as symptom-related information, co-morbidity and medication levels.	baseline
Pain Catastrophising Scale	Measures degree of catastrophizing	Baseline
Checklist Individual Strength	Measures subjective tiredness	Baseline
Twelve-Item Short Form Health Survey	Measures physical and mental functioning	Baseline
Patient Specific Complaint	Measures a patient's functional status by inquiring for three self-selected daily activities to which degree the patient is limited in this activity by his/her pain complaints	Baseline

Collaborators and Investigators

• Sponsor: Maastricht University
• Collaborators: Pfizer; Centrum voor Integrale Revalidatie (CIR)
• Investigators: Principal Investigator: Rob J Smeets, MD PhD, Maastricht University

Publications and helpful links

General Publications

• Breugelmans L, Scheffer E, Beckers LWME, Oosterwijk RFA, Nijland G, Smeets RJEM. Systematic description of an interdisciplinary multimodal pain treatment programme for patients with chronic musculoskeletal pain, using the TIDieR checklist. BMC Res Notes. 2022 Oct 11;15(1):320. doi: 10.1186/s13104-022-06211-z.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 17, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Estimate): December 22, 2022

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: treatment outcome; interdisciplinary; prediction model; multimodal treatment; rehabilitation medicine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Chronic Pain
• Other Study ID Numbers: CIR-001; 41150323011N (Other Identifier: CAPHRI-Maastricht University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: As data are gathered as routine practice, data are owned by and stored by CIR. In case of any request the PI can be contacted and he will ask CIR whether specific data will be made available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No