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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Treatment cost per change in life quality [Срок оценки: From inclusion time and the 2 following years.]

Вторичные конечные точки (11)

• Treatment cost per change in life quality stratisfied according to the specific shoulder diagnosis [Срок оценки: From inclusion time and the 2 following years]
• Patient satisfaction with the treatment of their shoulder problem [Срок оценки: From inclusion time and the 2 following years]
• Number of patients treated with surgery [Срок оценки: 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 [Срок оценки: From inclusion time and the 2 following years]
• Number and types of complications during the treatment of the shoulder problem [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From inclusion time and the 2 following years]
• PRO score, represented by Oxford Shoulder Score, as predictors? [Срок оценки: 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 [Срок оценки: 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). [Срок оценки: From inclusion time and the 2 following years]
• Patient satisfaction with the PRO score system build in the Database system (Procordo) [Срок оценки: From inclusion time and the 2 following years]

Критерии участия

Критерии включения

• shoulder pain with no acute trauma

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Дания · 6 центров

• Department of Physiotherapy, Univesity Hospital Gentofte — Gentofte Municipality
• Genoptræning og Rehabilitering, Rødovre Kommune — Rødovre Municipality
• Privathospitalet Danmark — Charlottenlund
• Department of rehabilitation, Gentofte Kommune — Hellerup
• Division of shoulder and elbow surgery, Department of orthopaedics, Univesity Hospital Gen — Hellerup
• Mit Lægehus — Rødovre Municipality

Публикации

• Nyholm AM, Esbensen BA, Westergaard CL, Kjellberg J, Juhl CB, Olsen BS, Odgaard A. Cross-sectoral use of Patient-Reported Outcomes (C-PRO)-the effect on the cost per improvement in quality of life for patients with chronic degenerative shoulder conditions-a protocol for a randomised controlled trial. Trials. 2025 Dec 12;27(1):47. doi: 10.1186/s13063-025-09329-0. PMID 41382298

Идентификаторы

NCT: NCT06435494 · H-23039139

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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