Cross-sectorial Use of Patient-Reported Outcomes in Chronic Degenerative Shoulder Conditions

NCT06435494 | Enrolling By Invitation DMC

• 1 other identifier: H-23039139
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 6

Brief Summary

This research project aims to test if systematic (extensive) use of patient-reported outcomes across treatment boundaries can

1. 1.improve patients' and health professionals' understanding of individual patients' conditions and health changes,
2. 2.improve indications for treatment,
3. 3.strengthen patient empowerment, and
4. 4.reduce patients' utilization of health services.

Conditions

Shoulder Disease; Shoulder Impingement; Shoulder Osteoarthritis; Shoulder Frozen; Shoulder Capsulitis; Shoulder Bursitis; Shoulder Impingement Syndrome; Rotator Cuff Syndrome; Rotator Cuff Syndrome of Shoulder and Allied Disorders

Outcome Measures

Primary Outcomes (1)

• Treatment cost per change in life quality

  The treatment cost during the study period expressed as the cost per improvement in life quality, similar to the cost per QALY (quality adjusted life years). The total cost will be calculated from hospital contacts, physiotherapy sessions and primary healthcare contacts. The EQ5D-5L will be used as a generic life quality measure. The primary outcome for the intervention and control group will be compared.

  From inclusion time and the 2 following years.

Secondary Outcomes (11)

• Treatment cost per change in life quality stratisfied according to the specific shoulder diagnosis

  From inclusion time and the 2 following years

• Patient satisfaction with the treatment of their shoulder problem

  From inclusion time and the 2 following years

• Number of patients treated with surgery

  From inclusion time and the 2 following years

• Number of contacts with either the hospital or the family doctor due to problems with the treated shoulder

  From inclusion time and the 2 following years

• Number and types of complications during the treatment of the shoulder problem

  From inclusion time and the 2 following years

Study Arms (2)

Intervention

EXPERIMENTAL

All patients will be asked to complete a number of questionaires: EQ5D-5L, a study specific questionaire (designed specifically for this study) and a shoulder-disease-specific questionaire (the Oxford Shoulder Score). For patients in the intervention group, the results of the questionaires will be accessable for patient and health-care professionals and will be used to illustrate the problems, make a prognostic model for the specific patient based on previous PRO results from other patients and will be used in monitoring the treatment of the patient.

Other: Systematic use of patient reported outcome measures in clinical work with the patients

Control

NO INTERVENTION

All patients will be asked to complete a number of questionaires: EQ5D-5L, a study specific questionaire and a shoulder-disease-specific questionaire. For patients int he control group, this will be collected, but not accessed or used during the treatment of the patient. The data will be used in the final analyses of the study.

Interventions

Systematic use of patient reported outcome measures in clinical work with the patients OTHER

Se description of the arms

Intervention

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• shoulder pain with no acute trauma

You may not qualify if:

• Age \<18 years
• Non-Danish citizenship
• Unable to understand written or spoken Danish
• Inability to master electronic means of communication and/or not having an electronic communication (E-boks)
• Employee at participating centre or other relation to participating health professionals that might affect independent consent
• Psychiatric conditions, mental conditions and substance abuse that might affect the ability to provide informed consent or responding to PROMs
• Disseminated malignant condition, other serious medical conditions or other life crisis where the focus on a shoulder research project is unreasonable
• Already included in the study with the contralateral shoulder

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Rigshospitalet, Denmark: collaborator
• VIVE - The Danish Center for Social Science Research: collaborator
• The Novo Nordic Foundation: collaborator
• Region Capital Denmark: collaborator
• Mit Lægehus, Rødovre, Denmark: collaborator
• Genoptræning og Rehabilitering, Rødovre Kommune, Denmark: collaborator
• Center for Rehabilitering og Forebyggelse, Gentofte Kommune, Denmark: collaborator
• Privathospitalet Danmark: collaborator

Study Sites (6)

Department of Physiotherapy, Univesity Hospital Gentofte

Gentofte Municipality, Hellerup, 2900, Denmark

Location

Genoptræning og Rehabilitering, Rødovre Kommune

Rødovre Municipality, Rødovre, 2610, Denmark

Location

Privathospitalet Danmark

Charlottenlund, 2920, Denmark

Location

Department of rehabilitation, Gentofte Kommune

Hellerup, 2900, Denmark

Location

Division of shoulder and elbow surgery, Department of orthopaedics, Univesity Hospital Gentofte

Hellerup, 2900, Denmark

Location

Mit Lægehus

Rødovre Municipality, 2610, Denmark

Location

Related Publications (1)

• Nyholm AM, Esbensen BA, Westergaard CL, Kjellberg J, Juhl CB, Olsen BS, Odgaard A. Cross-sectoral use of Patient-Reported Outcomes (C-PRO)-the effect on the cost per improvement in quality of life for patients with chronic degenerative shoulder conditions-a protocol for a randomised controlled trial. Trials. 2025 Dec 12. doi: 10.1186/s13063-025-09329-0. Online ahead of print.

  PMID: 41382298 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Officials

• Anders Odgaard, MD, DrMed

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• Anne M Nyholm, MD, PhD

  University Hospital, Gentofte, Copenhagen

  PRINCIPAL INVESTIGATOR

• Bo S Olsen, MD, PhD

  University Hospital, Gentofte, Copenhagen

  STUDY CHAIR

• Carsten B Juhl, PT, MPH, PhD

  University Hospital, Gentofte, Copenhagen

  STUDY CHAIR

• Bente A Esbensen, Cand.cur., PhD

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It is not possible to perform any blinding during collection and use of PRO data as part of the evaluation and treatment of the shoulder condition. However, following the end of PRO collection (and use), the following data collection and evaluation of the use of healthcare services and satisfaction with the treatment given will be performed with information of randomization blinded to the evaluators (VIVE).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Patients evaluated and treated for a degenerative shoulder disorder will be randomised into two groups before first evaluation. For the intervention group, Patient reported outcomes (PRO) will be a part of the evaluation and follow-up of treatment. In the control group, it will not. Evaluation with PRO will be conducted every 3 months for 2 years follow-up.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 30, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (6)