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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-12

Study Completion Date

2030-09-01

Brief Summary

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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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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

It is not possible to perform any blinding during collection and use of PRO data as part of the evaluation and treatment of the shoulder condition. However, following the end of PRO collection (and use), the following data collection and evaluation of the use of healthcare services and satisfaction with the treatment given will be performed with information of randomization blinded to the evaluators (VIVE).

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Se description of the arms

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Se description of the arms

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No