RCT Measuring the Effect of the ERVIN Software

NCT04332055 | Completed DMC

• 1 other identifier: 2015-141-ERVIN
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

The randomised clinical trial investigates the effect of using a clinical decision support system (CDSS) aiming to provide the patients and surgeons with greater transparency concerning the obtainable changes in function and health related quality of life (HRQoL) when patients are to decide if they should undergo hip- or knee replacement surgery.

Conditions

Decision Making, Shared; Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip; Osteoarthritis, Knee; Osteoarthritis, Hip; Artificial Intelligence

Outcome Measures

Primary Outcomes (2)

• Oxford Hip Score

  The OHS is a short 12-item PRO questionnaire, which is specifically designed and developed to assess the primary outcome in randomised controlled trials with patients undergoing hip or knee replacement surgery. The questionnaires are reproducible, validated and sensitive to clinically important changes24. The primary outcome measure is the delta value in OHS, or OKS measured at baseline, defined as the first consultation in the clinic, and at 1-year follow-up.

  1 year

• Oxford Knee Score

  The OKS is a short 12-item PRO questionnaire, which is specifically designed and developed to assess the primary outcome in randomised controlled trials with patients undergoing hip or knee replacement surgery. The questionnaires are reproducible, validated and sensitive to clinically important changes24. The primary outcome measure is the delta value in OHS, or OKS measured at baseline, defined as the first consultation in the clinic, and at 1-year follow-up.

  1 year

Secondary Outcomes (2)

• HRQoL

  1 year

• SDM

  2 hours

Study Arms (2)

ERVIN PLUS

EXPERIMENTAL

The doctor and the patient will have access to the ERVIN generated data

Other: ERVIN

ERVIN MINUS

NO INTERVENTION

The doctor and the patient will not have access to the ERVIN generated data

Interventions

ERVIN OTHER

ERVIN is state of the art for IT systems, which uses artificial intelligence (AI) and real-time patient-specific PRO data to support patients and doctors in clinical decision-making. The system is designed for surgical OA treatment of knee and hip replacement, and can be used to predict outcome scores for the actual choice OA patients face in the patient trajectory; to choose surgery or not.

ERVIN PLUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred from a general practitioner in the North Denmark Region to the orthopaedic clinic at Aalborg University Hospital
• Patients with painful OA in hip- or knee joint.

You may not qualify if:

• Patients unable to answer the questions in danish

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead
• Aalborg University: collaborator

Study Sites (1)

Nanna Kastrup

Aalborg, Northern Jutland, 9000, Denmark

Location

Related Publications (1)

• Kastrup N, Bjerregaard HH, Laursen M, Valentin JB, Johnsen SP, Jensen CE. An AI-based patient-specific clinical decision support system for OA patients choosing surgery or not: study protocol for a single-centre, parallel-group, non-inferiority randomised controlled trial. Trials. 2023 Jan 12;24(1):24. doi: 10.1186/s13063-022-07039-5.

  PMID: 36635747 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Nanna Kastrup, MSc

  DCHI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are blinded from the randomisation, and blinding of the consulting surgeon is not possible since the intervention is an interface add-on to the conventional treatment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomised to the two intervention arms using a randomised block design stratified by age, Oxford Hip- or Knee Score at baseline and location of disability. Age and Oxford scores are subdivided into suitable categories20. Randomization will be done using REDCap electronic data capture21. Block sizes will be random with possible volumes of four and eight patients. Patients will be randomised after completion of the survey questions at the ePRO kiosk. Information regarding randomisation will be typed in separate REDCap module by the designated helper, after which a randomisation key is automatically generated, which can then be extracted by the designated helper, but blinded from the patient.

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: April 2, 2020
• Study Start: November 30, 2020
• Primary Completion: April 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 27, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)