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NCT Number: NCT06435494

Cross-sectorial Use of Patient-Reported Outcomes in 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.

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Key information

Conditions

Shoulder Disease Bursitis Joint Diseases Musculoskeletal Diseases Rotator Cuff Syndrome Rotator Cuff Syndrome of Shoulder and Allied Disorders Shoulder Bursitis Shoulder Capsulitis Shoulder Frozen Shoulder Impingement Shoulder Impingement Syndrome Shoulder Injuries Shoulder Osteoarthritis Wounds and Injuries

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physiotherapy, Univesity Hospital Gentofte, Gentofte Municipality, Hellerup, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systematic use of patient reported outcome measures in clinical work with the patients

Other

Se description of the arms

Primary outcomes

  1. Treatment cost per change in life quality

    Time frame: 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 outcomes

  1. Treatment cost per change in life quality stratisfied according to the specific shoulder diagnosis

    Time frame: From inclusion time and the 2 following years

    The same as primary outcome, but stratified according to the specific shoulder diagnosis

  2. Patient satisfaction with the treatment of their shoulder problem

    Time frame: 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"?

  3. Number of patients treated with surgery

    Time frame: 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

  4. Number of contacts with either the hospital or the family doctor due to problems with the treated shoulder

    Time frame: 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

  5. Number and types of complications during the treatment of the shoulder problem

    Time frame: 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

  6. For patients still working: Number and duration (measured in days) of any periods of sick-leave/unemployment due to the shoulder problem

    Time frame: 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

  7. Development in the PRO score, represented by Oxford Shoulder Score, over time for each specific shoulder disease

    Time frame: 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

  8. PRO score, represented by Oxford Shoulder Score, as predictors?

    Time frame: 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

  9. If use of systematic PRO scores, represented by Oxford Shoulder Score, changes the referral-pattern between the involved sectors

    Time frame: 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

  10. Health professionals' assessments of history and usefulness of the prognosis tools developed for this study (the Database setup in Procordo).

    Time frame: 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.

  11. Patient satisfaction with the PRO score system build in the Database system (Procordo)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • Center for Rehabilitering og Forebyggelse, Gentofte Kommune, Denmark
  • Genoptræning og Rehabilitering, Rødovre Kommune, Denmark
  • Mit Lægehus, Rødovre, Denmark
  • Privathospitalet Danmark
  • Region Capital Denmark
  • Rigshospitalet, Denmark
  • The Novo Nordic Foundation
  • VIVE - The Danish Center for Social Science Research

Registry information

Official study title

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

Acronym: C-PRO

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
May 30, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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