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

C-PRO - The Effect of Cross-sectorial Use of Patient-Reported Outcomes for Patients With Chronic Degenerative Shoulder Conditions

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Shoulder Impingement Syndrome; Shoulder Osteoarthritis; Shoulder Capsulitis; Shoulder Impingement; Shoulder Bursitis; Shoulder Disease; Rotator Cuff Syndrome; Rotator Cuff Syndrome of Shoulder and Allied Disorders; Shoulder Frozen
• Intervention / Treatment: Other: Systematic use of patient reported outcome measures in clinical work with the patients

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Charlottenlund, Denmark, 2920
    • Privathospitalet Danmark
  • Hellerup, Denmark, 2900
    • Department of rehabilitation, Gentofte Kommune
  • Hellerup, Denmark, 2900
    • Division of shoulder and elbow surgery, Department of orthopaedics, Univesity Hospital Gentofte
  • Rødovre, Denmark, 2610
    • Genoptræning og Rehabilitering, Rødovre Kommune
  • Rødovre, Denmark, 2610
    • Mit Lægehus
  • Hellerup
    • Gentofte, Hellerup, Denmark, 2900
      • Department of Physiotherapy, Univesity Hospital Gentofte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Se description of the arms
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment cost per change in life quality stratisfied according to the specific shoulder diagnosis	The same as primary outcome, but stratified according to the specific shoulder diagnosis	From inclusion time and the 2 following years
Patient satisfaction with the treatment of their shoulder problem	Measured by questionaire (specifically the question "are you satisfied with the treatment fo your shoulder so far"?	From inclusion time and the 2 following years
Number of patients treated with surgery	To evaluate if any difference in referral to surgery occurs between the intervention group and the control group, and analyse if any reasons for a difference can be identified	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	To evaluate if any difference in medical contacts due to the treated shoulder occurs between the intervention and the control groups, and analyse if any reasons for a difference can be identified	From inclusion time and the 2 following years
Number and types of complications during the treatment of the shoulder problem	To evaluate if any difference in complications in relation to the treatment of the shoulder occurs between the intervention and the control groups, and analyse if any reasons for a difference can be identified	From inclusion time and the 2 following years
For patients still working: Number and duration (measured in days) of any periods of sick-leave/unemployment due to the shoulder problem	To evaluate if any difference in employment-status and/or sick-leave occurs between the intervention and the control groups, and analyse if any reasons for a difference can be identified	From inclusion time and the 2 following years
Development in the PRO score, represented by Oxford Shoulder Score, over time for each specific shoulder disease	To evaluate the development of PRO scores during a treatment of the included shoulder diseases with regards to the different treatment options, to create a reference for future treatments of these patients	From inclusion time and the 2 following years
PRO score, represented by Oxford Shoulder Score, as predictors?	To evaluate if a PRO score can differentiate patients with regards to who might benefit from specific treatment regimens/effect of treatments measured by PRO	From inclusion time and the 2 following years
If use of systematic PRO scores, represented by Oxford Shoulder Score, changes the referral-pattern between the involved sectors	To evaluate if PRO scores has the potential to be used to screen patients before making a referral between sectors	From inclusion time and the 2 following years
Health professionals' assessments of history and usefulness of the prognosis tools developed for this study (the Database setup in Procordo).	To evaluate if the involved professionals experience any gain in the use of the PRO scores in the daily treatment of the patients. This will be evaluated at every visit with the patient by a questionaire to the treating professionals.	From inclusion time and the 2 following years
Patient satisfaction with the PRO score system build in the Database system (Procordo)	Satisfaction and qualitative assessment of history and prognosis tool (intervention group only). This will be investigated by questionaire in relation to the completion of the PROs every 3 month during the study period.	From inclusion time and the 2 following years

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborators: Rigshospitalet, Denmark; The Novo Nordic Foundation; Region Capital Denmark; VIVE - The Danish Center for Social Science Research; Mit Lægehus, Rødovre, Denmark; Genoptræning og Rehabilitering, Rødovre Kommune, Denmark; Center for Rehabilitering og Forebyggelse, Gentofte Kommune, Denmark; Privathospitalet Danmark
• Investigators: Study Director: Anders Odgaard, MD, DrMed, Rigshospitalet, Denmark; Principal Investigator: Anne M Nyholm, MD, PhD, University Hospital, Gentofte, Copenhagen; Study Chair: 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 record dates

Study Major Dates

• Study Start (Actual): August 12, 2024
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Musculoskeletal Diseases; Wounds and Injuries; Pathologic Processes; Joint Diseases; Disease; Rupture; Tendon Injuries; Rotator Cuff Injuries; Syndrome; Bursitis; Shoulder Impingement Syndrome
• Other Study ID Numbers: H-23039139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No