An interventional study of Systematic use of patient reported outcome measures in clinical work with the patients in Shoulder Disease, Shoulder Impingement and Shoulder Osteoarthritis, sponsored by University Hospital, Gentofte, Copenhagen. Enrolling by invitation at 6 sites in Denmark. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by University Hospital, Gentofte, Copenhagen · Not applicable, Interventional, and Health services research
This research project aims to test if systematic (extensive) use of patient-reported outcomes across treatment boundaries can
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.
411 studies on the registry are indexed under Bursitis; 112 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 45 across 371 interventional studies indexed under Bursitis.
Browse Bursitis studies →University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Se description of the arms
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.
Time frame: From inclusion time and the 2 following years.
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
Time frame: 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"?
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From inclusion time and the 2 following years
Plan to share: No
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University Hospital, Gentofte, Copenhagen