Cross-sectorial Use of Patient-Reported Outcomes in Chronic Degenerative Shoulder Conditions (C-PRO)

University Hospital, Gentofte, Copenhagen

Status: Invitation-only

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06435494

H-23039139

Details and patient eligibility

About

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

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

The study will be performed in the particular context of patients with chronic degenerative conditions of the shoulder. These patients are characterized by contact with numerous health professionals from different health sectors, such as general practitioner, physiotherapists and surgical referral centres, which challenges coherence and communication for the individual treatment decisions. The research project will be performed as a randomized controlled trial (RCT) with a 1-year inclusion period and two years of follow-up.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• shoulder pain with no acute trauma

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

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

Control

No Intervention group

Description:

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.