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

Shoulder Impingement Syndrome Clinical Trial

— C-PRO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06435494
• Other study ID #: H-23039139
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: September 1, 2030

Study information

• Verified date: May 2024
• Source: University Hospital, Gentofte, Copenhagen
• Contact: Anne Marie Nyholm, MD, PhD
• Phone: +4538673391
• Email: anne.marie.nyholm.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: September 1, 2030
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Systematic use of patient reported outcome measures in clinical work with the patients
Se description of the arms

Locations

Country	Name	City	State
Denmark	Department of Physiotherapy, Univesity Hospital Gentofte	Gentofte	Hellerup
Denmark	Department of rehabilitation, Gentofte Kommune	Hellerup
Denmark	Division of shoulder and elbow surgery, Department of orthopaedics, Univesity Hospital Gentofte	Hellerup
Denmark	Genoptræning og Rehabilitering, Rødovre Kommune	Rødovre
Denmark	Mit Lægehus	Rødovre

Sponsors (8)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	Center for Rehabilitering og Forebyggelse, Gentofte Kommune, Denmark, Genoptræning og Rehabilitering, Rødovre Kommune, Denmark, Mit Lægehus, Rødovre, Denmark, Region Capital Denmark, Rigshospitalet, Denmark, The Novo Nordic Foundation, VIVE - The Danish Center for Social Science Research

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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