Cross-sectorial Use of Patient-Reported Outcomes in Chronic Degenerative Shoulder Conditions
- Conditions
- Shoulder CapsulitisShoulder DiseaseShoulder OsteoarthritisShoulder FrozenShoulder BursitisShoulder Impingement SyndromeRotator Cuff SyndromeRotator Cuff Syndrome of Shoulder and Allied DisordersShoulder Impingement
- Interventions
- Other: Systematic use of patient reported outcome measures in clinical work with the patients
- Registration Number
- NCT06435494
- Lead Sponsor
- University Hospital, Gentofte, Copenhagen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1000
- shoulder pain with no acute trauma
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention 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 (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.
- Primary Outcome Measures
Name Time Method Treatment cost per change in life quality From inclusion time and the 2 following years. 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.
- Secondary Outcome Measures
Name Time Method Treatment cost per change in life quality stratisfied according to the specific shoulder diagnosis From inclusion time and the 2 following years The same as primary outcome, but stratified according to the specific shoulder diagnosis
Patient satisfaction with the treatment of their shoulder problem From inclusion time and the 2 following years Measured by questionaire (specifically the question "are you satisfied with the treatment fo your shoulder so far"?
Number of patients treated with surgery From inclusion time and the 2 following years 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
Number and types of complications during the treatment of the shoulder problem From inclusion time and the 2 following years 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
Number of contacts with either the hospital or the family doctor due to problems with the treated shoulder From inclusion time and the 2 following years 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
For patients still working: Number and duration (measured in days) of any periods of sick-leave/unemployment due to the shoulder problem From inclusion time and the 2 following years 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
Development in the PRO score, represented by Oxford Shoulder Score, over time for each specific shoulder disease From inclusion time and the 2 following years 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
If use of systematic PRO scores, represented by Oxford Shoulder Score, changes the referral-pattern between the involved sectors From inclusion time and the 2 following years To evaluate if PRO scores has the potential to be used to screen patients before making a referral between sectors
PRO score, represented by Oxford Shoulder Score, as predictors? From inclusion time and the 2 following years 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
Health professionals' assessments of history and usefulness of the prognosis tools developed for this study (the Database setup in Procordo). From inclusion time and the 2 following years 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.
Patient satisfaction with the PRO score system build in the Database system (Procordo) From inclusion time and the 2 following years 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.
Trial Locations
- Locations (6)
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, Denmark
Privathospitalet Danmark
🇩🇰Charlottenlund, Denmark
Department of Physiotherapy, Univesity Hospital Gentofte
🇩🇰Gentofte, Hellerup, Denmark