Clinical trial NCT06435494: Cross-sectorial Use of Patient-Reported Outcomes in Chronic Degenerative Shoulder Conditions
Official title: C-PRO - The Effect of Cross-sectorial Use of Patient-Reported Outcomes for Patients With Chronic Degenerative Shoulder Conditions
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
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
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: VIVE - The Danish Center for Social Science Research
name: The Novo Nordic Foundation
name: Region Capital Denmark
name: Mit Lægehus, Rødovre, Denmark
name: Genoptræning og Rehabilitering, Rødovre Kommune, Denmark
name: Center for Rehabilitering og Forebyggelse, Gentofte Kommune, Denmark
name: Privathospitalet Danmark
First posted: 2024-05-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment cost per change in life quality
timeFrame: From inclusion time and the 2 following years.
Secondary outcomes:
measure: Treatment cost per change in life quality stratisfied according to the specific shoulder diagnosis
timeFrame: From inclusion time and the 2 following years
measure: Patient satisfaction with the treatment of their shoulder problem
timeFrame: From inclusion time and the 2 following years
measure: Number of patients treated with surgery
timeFrame: From inclusion time and the 2 following years
measure: Number of contacts with either the hospital or the family doctor due to problems with the treated shoulder
timeFrame: From inclusion time and the 2 following years
measure: Number and types of complications during the treatment of the shoulder problem
timeFrame: From inclusion time and the 2 following years
measure: For patients still working: Number and duration (measured in days) of any periods of sick-leave/unemployment due to the shoulder problem
timeFrame: From inclusion time and the 2 following years
measure: Development in the PRO score, represented by Oxford Shoulder Score, over time for each specific shoulder disease
timeFrame: From inclusion time and the 2 following years
measure: PRO score, represented by Oxford Shoulder Score, as predictors?
timeFrame: From inclusion time and the 2 following years
measure: If use of systematic PRO scores, represented by Oxford Shoulder Score, changes the referral-pattern between the involved sectors
timeFrame: From inclusion time and the 2 following years
measure: Health professionals' assessments of history and usefulness of the prognosis tools developed for this study (the Database setup in Procordo).
timeFrame: From inclusion time and the 2 following years
measure: Patient satisfaction with the PRO score system build in the Database system (Procordo)
timeFrame: From inclusion time and the 2 following years
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Department of Physiotherapy, Univesity Hospital Gentofte
state: Hellerup
city: Charlottenlund
country: Denmark
facility: Privathospitalet Danmark
city: Hellerup
country: Denmark
facility: Department of rehabilitation, Gentofte Kommune
city: Hellerup
country: Denmark
facility: Division of shoulder and elbow surgery, Department of orthopaedics, Univesity Hospital Gentofte
city: Rødovre
country: Denmark
facility: Genoptræning og Rehabilitering, Rødovre Kommune
city: Rødovre
country: Denmark
facility: Mit Lægehus
Study officials:
affiliation: Rigshospitalet, Denmark
name: Anders Odgaard, MD, DrMed
role: STUDY_DIRECTOR
affiliation: University Hospital, Gentofte, Copenhagen
name: Anne M Nyholm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Gentofte, Copenhagen
name: Bo S Olsen, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital, Gentofte, Copenhagen
name: Carsten B Juhl, PT, MPH, PhD
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Bente A Esbensen, Cand.cur., PhD
role: STUDY_CHAIR
References: