Shoulder Injuries and DisordersNCT03343951
Evaluation of Extended Scope Physiotherapists in an Orthopaedic Outpatient Shoulder Clinic
An observational study of Shoulder Injuries and Disorders and Shoulder Pain, run by Central Jutland Regional Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Injuries and Disorders, Shoulder Pain, Musculoskeletal Pain
- What is being tested?
- Examination
- How many people
- 69 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Nov 2017to 19 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with shoulder problems referred to the shoulder clinic at Silkeborg Regional Hospital.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Examination by Extended Scope Physiotherapists and Orthopaedic Surgeons in an Outpatient Shoulder Clinic: Agreement on Diagnosis and Treatment Plan and Evaluation of Costs and Organisation
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:
- To estimate the agreement between ESP's and OS's on diagnosis and treatment plan (primary subsidiary objective)
- To estimate direct hospital costs of an examination performed by an ESP and an OS, respectively, and to estimate the difference in costs.
- To describe the interdisciplinary collaborative practice including evaluation of the extent of relational coordination.
Methods are described underneath related to each subsidiary objective.
- 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.
- 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.
- 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.
- Being tested
- Examination
- Keywords
- Physical Therapists, Diagnosis, Clinical Competence, Interprofessional Relations, Cost Analysis
- Medical subject headings
- Shoulder Injuries, Disease, Shoulder Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExaminationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder patients | Shoulder patients referred to examination at the shoulder clinic, Silkeborg Regional Hospital. Receives: Other: Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Baseline
Secondary outcomes (8)
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).
Measured: Baseline
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).
Measured: Baseline
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).
Measured: Baseline
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)
Measured: Baseline
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)
Measured: Baseline
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)
Measured: Baseline
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).
Measured: Baseline
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start17 Nov 2017
- Primary completion13 Apr 2018
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder Injuries and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merete N Madsen, MSc, Principal investigator, Silkeborg Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343951
- Sponsor's protocol ID
- 654821
- Status last verified
- Feb 2018
- First submitted
- 10 Nov 2017
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Examination by Extended Scope Physiotherapists and Orthopaedic Surgeons in an Outpatient Shoulder Clinic: Agreement on Diagnosis and Treatment Plan and Evaluation of Costs and Organisation
- ClinicalTrials.gov ID
- NCT03343951
- Acronym / sponsor ID
- 654821
- Keywords
- Physical Therapists, Diagnosis, Clinical Competence, Interprofessional Relations, Cost Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To estimate the agreement between ESP's and OS's on diagnosis and treatment plan (primary subsidiary objective)
- To estimate direct hospital costs of an examination performed by an ESP and an OS, respectively, and to estimate the difference in costs.
- To describe the interdisciplinary collaborative practice including evaluation of the extent of relational coordination.
Methods are described underneath related to each subsidiary objective.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder patients | – | Other: ExaminationShoulder patients referred to examination at the shoulder clinic, Silkeborg Regional Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with shoulder problems referred to the shoulder clinic at Silkeborg Regional Hospital.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExaminationPatients 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. | Other | Shoulder patients |
Primary outcome
Treatment plan - orthopaedic surgeon
Time frame: Baseline
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)
Treatment plan - physiotherapist
Time frame: Baseline
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)
Treatment plan - common decision
Time frame: Baseline
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)
8 secondary outcomes
Diagnosis - orthopaedic surgeon
Time frame: Baseline
Diagnosis - physiotherapist
Time frame: Baseline
Diagnosis - common decision
Time frame: Baseline
New appointment - orthopaedic surgeon
Time frame: Baseline
New appointment - physiotherapist
Time frame: Baseline
New appointment - common decision
Time frame: Baseline
Discussion needed - orthopaedic surgeon
Time frame: Baseline
Discussion needed - physiotherapist
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Derived from this study: PubMed 33397350Madsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete N Madsen, MSc principal investigator
Silkeborg Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Injuries and Disorders and Shoulder Pain, run by Central Jutland Regional Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment plan - orthopaedic surgeon (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03343951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.