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CompletedNCT03343951Updated Aug 15, 2018

Evaluation of Extended Scope Physiotherapists in an Orthopaedic Outpatient Shoulder Clinic

An observational study in Shoulder Injuries and Disorders, Shoulder Pain and Musculoskeletal Pain, sponsored by Central Jutland Regional Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-15.

Sponsored by Central Jutland Regional Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
69
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

According to current practice, patients referred from a general practitioner (GP) to the Orthopaedic Outpatient Shoulder Clinic, Silkeborg Regional Hospital (SRH), Denmark, will be examined by either an orthopaedic surgeon (OS) or an extended scope physiotherapist (ESP), as these two groups of health professionals share this assignment. The decision on, which health professional is considered most appropriate to examine the patient, is done by a senior orthopaedic surgeon based on the available information in the referral letter from the GP. Three categories of appropriateness are used: most appropriate to be examined by an OS, most appropriate to be examined by an ESP and equally appropriate to be examined by an ESP or an OS.

The overall purpose of this study is to evaluate the quality of the shared assignment investigated through both professional and organisational outcomes. The following three subsidiary objectives are used:

  1. To estimate the agreement between ESP's and OS's on diagnosis and treatment plan (primary subsidiary objective)
  2. To estimate direct hospital costs of an examination performed by an ESP and an OS, respectively, and to estimate the difference in costs.
  3. To describe the interdisciplinary collaborative practice including evaluation of the extent of relational coordination.

Methods are described underneath related to each subsidiary objective.

  1. The study is conducted at the shoulder clinic, SRH. Eligibility criteria, intervention and outcomes are described elsewhere.

    Primary analysis:

    Agreement between ESP and OS in choice of treatment plan (three categories: 1) referral to physiotherapy, 2) need of further diagnostic examination, steroid injection or surgery and 3) no intervention) will be evaluated by estimating the proportion of agreement between

    • The individual registrations of the ESP and OS
    • The individual registration of the ESP and the common decision
    • The individual registration of the OS and the common decision Furthermore, McNemar's test will be used to compare the individual registrations of the ESP and OS, respectively, against the common decision

    Secondary analyses:

    Agreement between ESP and OS in choice of treatment plan (five categories: as described in the outcome section) will be evaluated the same way as described above.

    Agreement between ESP and OS in diagnosis of the patient will be evaluated by estimating both the proportion of total agreement and partial agreement between the two health professionals. Total agreement is defined as ESP and OS having registered the same primary diagnosis. Partial agreement is defined as ESP and OS having registered the same diagnosis but one of them considers it the primary diagnosis while the other considers it a secondary diagnosis.

  2. Mean hospital costs of an examination of a shoulder patient will be estimated based on the cohort used to evaluate agreement on diagnosis and treatment plan. Mean hospital costs per patient in the cohort will be estimated separately for ESP's and OS's based on salaries for the health professionals and amount of ordered supplemental diagnostic examinations (X-ray, MR imaging, MR arthrography, CT imaging, ENG, EMG) in each group. Difference in costs will be estimated.
  3. Relational coordination in interdisciplinary collaborative practice will be described through separate semi-structured group interviews with ESP's and OS's, respectively.

The Association of Danish Physiotherapists is partly funding the salary for the principal investigator.

02

Conditions studied

  • Shoulder Injuries and Disorders
  • Shoulder Pain
  • Musculoskeletal Pain

Keywords

  • Physical Therapists
  • Diagnosis
  • Clinical Competence
  • Interprofessional Relations
  • Cost Analysis
03

In context

Shoulder Injuries

118 studies on the registry are indexed under Shoulder Injuries; 32 are open to participants now.

This study's enrollment of 69 is above the median of 60 across 45 observational studies indexed under Shoulder Injuries.

Browse Shoulder Injuries studies →

Lead sponsor

Central Jutland Regional Hospital is the lead sponsor of 32 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
69 participants (actual)
Patient registry
No

Groups and cohorts

  • Shoulder patients

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

    Other: Examination

Interventions

  • OtherExamination

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline

  2. 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)

    Time frame: Baseline

  3. 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)

    Time frame: Baseline

Secondary outcomes

  1. Diagnosis - orthopaedic surgeon

    One primary diagnosis (and if relevant secondary diagnoses) suggested by the OS will be registered in a chart developed for the occasion. The chart has 9 pre-defined categories of diagnoses: 1) impingement, 2) rotator cuff injury, 3) glenohumeral instability, 4) glenohumeral osteoarthritis, 5) periarthritis humeroscapularis, 6) scapular instability, 7) fracture sequelae, 8) acromioclavicular joint disorder, 9) non-related shoulder diagnoses (categorical).

    Time frame: Baseline

  2. Diagnosis - physiotherapist

    One primary diagnosis (and if relevant secondary diagnoses) suggested by the ESP will be registered in a chart developed for the occasion. The chart has the same 9 pre-defined categories of diagnoses as for the OS (categorical).

    Time frame: Baseline

  3. Diagnosis - common decision

    The OS and ESP will discuss their results until they agree on patient diagnosis. Their decision will be registered in a chart developed for the occasion. The chart has the same 9 pre-defined categories of diagnoses as for the individual examinations (categorical).

    Time frame: Baseline

  4. New appointment - orthopaedic surgeon

    The OS registers whether he considers, that the patient should be offered a new appointment at the shoulder clinic (categorical, yes/no)

    Time frame: Baseline

  5. New appointment - physiotherapist

    The ESP registers whether he/she considers, that the patient should be offered a new appointment at the shoulder clinic (categorical, yes/no)

    Time frame: Baseline

  6. New appointment - common decision

    The OS and ESP will discuss their results until they agree, whether the patient should have a new appointment at the shoulder clinic or not. Their decision will be registered (categorical, yes/no)

    Time frame: Baseline

  7. Discussion needed - orthopaedic surgeon

    The OS registers whether he under usual conditions would discuss his results with an ESP before making a decision on diagnosis or treatment plan (categorical, yes/no).

    Time frame: Baseline

  8. Discussion needed - physiotherapist

    The ESP registers whether he/she under usual conditions would discuss his/her results with an OS before making a decision on diagnosis or treatment plan (categorical, yes/no).

    Time frame: Baseline

Other outcomes

  1. Salary - orthopaedic surgeon, first clinical examination

    Mean expenditure on salary for an OS performing a clinical examination of a shoulder patient at the first visit. The estimate will be calculated based on time spent on the examination and mean salary for an OS (information on mean salary will be obtained from statistics at the finance department at the hospital)

    Time frame: Baseline

  2. Salary - orthopaedic surgeon, planned new appointment

    Mean expenditure on salary for an OS performing a follow up appointment with a shoulder patient. The estimate will be calculated based on time spent on the appointment and mean salary for an OS (information on mean salary will be obtained from statistics at the finance department at the hospital)

    Time frame: Baseline

  3. Salary - extended scope physiotherapist, first clinical examination

    Mean expenditure on salary for an ESP performing a clinical examination of a shoulder patient at the first visit. The estimate will be calculated based on time spent on the examination and mean salary for an ESP (information on mean salary will be obtained from statistics at the finance department at the hospital)

    Time frame: Baseline

  4. Salary - extended scope physiotherapist, planned new appointment

    Mean expenditure on salary for an ESP performing a follow up appointment with a shoulder patient. The estimate will be calculated based on time spent on the appointment and mean salary for an ESP (information on mean salary will be obtained from statistics at the finance department at the hospital)

    Time frame: Baseline

  5. Costs - computed tomography (CT) imaging

    Expenditure on CT imaging. Estimate obtained from the finance department at the hospital.

    Time frame: Baseline

  6. Costs - magnetic resonance (MR) imaging

    Expenditure on MR imaging. Estimate obtained from the finance department at the hospital.

    Time frame: Baseline

  7. Costs - MR arthrography

    Expenditure on MR arthrography. Estimate obtained from the finance department at the hospital.

    Time frame: Baseline

  8. Costs - electroneurography (ENG)

    Expenditure on ENG. Estimate obtained from the finance department at the hospital.

    Time frame: Baseline

  9. Costs - electromyography (EMG)

    Expenditure on EMG. Estimate obtained from the finance department at the hospital.

    Time frame: Baseline

  10. Costs - X-ray

    Expenditure on X-ray. Estimate obtained from the finance department at the hospital.

    Time frame: Baseline

07

Study locations

1 site
  • Silkeborg Regional Hospital
    Silkeborg, 8600, Denmark
08

References and documents

Publications

  • 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. PubMed 33397350 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Apr 2018, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 10, 2017
First posted
Nov 17, 2017
StartActual
Nov 17, 2017
Primary completionActual
Apr 13, 2018
CompletionActual
Jun 19, 2018
Last update
Aug 15, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03343951
Lead sponsor
Central Jutland Regional Hospital
Responsible party
Sponsor
First posted
Nov 17, 2017
Start date
Nov 17, 2017
Primary completion
Apr 13, 2018
Completion
Jun 19, 2018
Last update
Aug 15, 2018

Study contacts

Merete N Madsen, MSc
principal investigator · Silkeborg Regional Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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