NCT03343951

Brief Summary

This study investigates the agreement between extended scope physiotherapists (ESP) and orthopaedic surgeons (OS) on diagnosis and treatment plan in an orthopaedic outpatient shoulder clinic. Furthermore a cost analysis and an evaluation of the interdisciplinary collaboration at the orthopaedic outpatient shoulder clinic (termed shoulder clinic in the following) will be performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

November 17, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2018

Completed
Last Updated

August 15, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

November 10, 2017

Last Update Submit

August 14, 2018

Conditions

Keywords

Physical TherapistsDiagnosisClinical CompetenceInterprofessional RelationsCost Analysis

Outcome Measures

Primary Outcomes (3)

  • Treatment plan - orthopaedic surgeon

    Treatment plan suggested by the OS will be registered in a chart developed for the occasion. The chart has 5 pre-defined categories: 1) referral to physiotherapy, 2) referral to diagnostic examination, 3) steroid injection, 4) surgery and 5) no intervention (categorical)

    Baseline

  • Treatment plan - physiotherapist

    Treatment plan suggested by the ESP will be registered in a chart developed for the occasion. The chart has the same 5 pre-defined categories as for the OS: 1) referral to physiotherapy, 2) referral to diagnostic examination, 3) steroid injection, 4) surgery and 5) no intervention (categorical)

    Baseline

  • Treatment plan - common decision

    The OS and ESP will discuss their results until they agree which treatment plan to offer the patient. Their decision will be registered in a chart developed for the occasion. The chart has the same 5 pre-defined categories as for the individual examinations: 1) referral to physiotherapy, 2) referral to diagnostic examination, 3) steroid injection, 4) surgery and 5) no intervention (categorical)

    Baseline

Secondary Outcomes (8)

  • Diagnosis - orthopaedic surgeon

    Baseline

  • Diagnosis - physiotherapist

    Baseline

  • Diagnosis - common decision

    Baseline

  • New appointment - orthopaedic surgeon

    Baseline

  • New appointment - physiotherapist

    Baseline

  • +3 more secondary outcomes

Other Outcomes (10)

  • Salary - orthopaedic surgeon, first clinical examination

    Baseline

  • Salary - orthopaedic surgeon, planned new appointment

    Baseline

  • Salary - extended scope physiotherapist, first clinical examination

    Baseline

  • +7 more other outcomes

Study Arms (1)

Shoulder patients

Shoulder patients referred to examination at the shoulder clinic, Silkeborg Regional Hospital.

Other: Examination

Interventions

Patients will be examined twice the same day by an extended scope physiotherapist (ESP) and an orthopaedic surgeon (OS) in random order. They will independently and blinded to each other's opinion register * diagnosis and treatment plan (including need for further diagnostic examinations - i.e. imaging) * if the patient needs a new appointment at the shoulder clinic * if they under usual conditions would discuss their results with the opposite health professional before deciding diagnosis and treatment plan. After the individual examinations the ESP and OS discuss their results and come to an agreement (common decision) regarding the patient's diagnosis, treatment plan and need of a new appointment. Patients will be informed only of the common decision of the ESP and OS.

Shoulder patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with shoulder problems referred to the shoulder clinic at Silkeborg Regional Hospital.

You may qualify if:

  • Above the age of 18 years
  • Referred to The Shoulder Clinic at Silkeborg Regional Hospital
  • Considered equally appropriate to be examined by an ESP or an OS
  • Ability to read and understand Danish

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

Related Publications (1)

  • Madsen MN, Kirkegaard ML, Klebe TM, Linnebjerg CL, Villumsen SMR, Due SJ, Trostrup J, Rossen CB, Birk HO, Elmengaard B, Mikkelsen LR. Inter-professional agreement and collaboration between extended scope physiotherapists and orthopaedic surgeons in an orthopaedic outpatient shoulder clinic - a mixed methods study. BMC Musculoskelet Disord. 2021 Jan 4;22(1):4. doi: 10.1186/s12891-020-03831-z.

MeSH Terms

Conditions

Shoulder InjuriesDiseaseShoulder PainMusculoskeletal Pain

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsMuscular Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Merete N Madsen, MSc

    Silkeborg Regional Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 17, 2017

Study Start

November 17, 2017

Primary Completion

April 13, 2018

Study Completion

June 19, 2018

Last Updated

August 15, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations