Osteoarthritis, KneeNCT06187116
Physiotherapist Led Triage in Primary Care for Patients With Hip or Knee OA
A study testing Physiotherapist consultation and Orthopaedic surgeon consultation in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Vastra Gotaland Region.
Trial summary
The overall aim with the study is to evaluate physiotherapist led triage in primary care compared to usual care (assessment by an orthopaedic surgeon in an orthopaedic department) for patients with hip or knee osteoarthritis referred for orthopaedic consultation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Physiotherapist consultation and Orthopaedic surgeon consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- primary OA in hip or knee
- understands and speak Swedish
Who cannot join
- Previously been assessed for the same condition by an orthopaedic surgeon
- Referred by an orthopaedic surgeon
- Secondary OA due to fractures or osteonecrosis of the femoral head
- Referral to a specific orthopaedic surgeon
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Physiotherapist Led Triage in Primary Care for Patients With Hip or Knee Osteoarthritis
The overall aim with the study is to evaluate physiotherapist led triage in primary care compared to usual care (assessment by an orthopaedic surgeon in an orthopaedic department) for patients with hip or knee osteoarthritis referred for orthopaedic consultation.
Read the detailed description
The primary aim of the study is to evaluate if there is any difference in perceived quality of care using the item "I received the best possible examination and treatment (as far as I can tell)" between physiotherapist led (PT led) triage in primary care compared to usual care (assessment by an orthopaedic surgeon (OS) in an orthopaedic department) for patients with hip or knee osteoarthritis (OA) referred for orthopaedic consultation. Furthermore, to evaluate whether there is any difference in 2) perceived quality of care as a whole, 3) management outcome and hip/knee replacement surgery conversion rate, 4) patient reported outcome measures such as health related quality, pain and function in short and long term and 5) costs between the two care models.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Physiotherapist consultation, Orthopaedic surgeon consultation
- Keywords
- Physiotherapist, Orthopaedic triage, Quality of care, Surgery Conversion rate
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapist consultationOther
The consultation with the PT is 40-45 minutes long according to usual care and includes patient history, assessment and management according to an assessment template. If the patient is found not to be appropriate for surgery they can receive the following; 1) self-care without follow up appointment, 2) referral to PT in primary care for rehabilitation, 3) referral back to general practitioner (GP) for new tests/assessments/medication. If the patient is found to be appropriate for surgery, and wishes to undergo surgery, or if the PT in the study wants a second opinion, the patient is 4) referred for orthopaedic consultation for surgical consideration.
Orthopaedic surgeon consultationOther
The consultation with the OS is 20-30 minutes long and includes medical history, assessment and management plan, all according to usual care. It the patient is found not to be appropriate for surgery they can receive the following; 1) self-care without follow up appointment, 2) referral to PT in primary care for rehabilitation, 3) referral back to GP for new tests/assessments/medication. If the patient is found appropriate for surgery, and wishes to undergo surgery, the patient is 4) scheduled for surgery.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapist led orthopaedic triage | Experimental | Patients who are randomised to PT led triage will be scheduled for a consultation with a physiotherapist (PT) at a rehabilitation clinic in primary care in the Region Västra Götaland. Receives: Other: Physiotherapist consultation |
| Usual care | Active comparator | Patients who are randomised to usual care will be sceduled according to standard procedure for an orthopaedic surgeon (OS) consultation at the orthopaedic department of a hospital in the Region Västra Götaland. Receives: Other: Orthopaedic surgeon consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
"I received the best possible examination and treatment (as far as I can tell)"
One item from the questionnaire Quality from the Patients Perspective (QPP). The patients rate how they perceive the quality of care on a 4-point Likert scale ranging from 1 (do not agree at all) to 4 (completely agree).
This item was chosen as main outcome since it was found the be representative of quality of care, and as it assess the desired outcome, by the subjective judgement of experts in the field (five physiotherapists and one orthopaedic surgeon).
Measured: Within a week after assessment
Secondary outcomes (13)
Quality from the Patients Perspective (QPP)
Patient perception of the care quality as a whole using the questionnaire Quality from the Patient Perspective (QPP). A valid and reliable measure of patients' perception of quality of care regarding four dimensions: caregivers' medical-technical competence; care organizations' physical-technical conditions; degree of identity-orientation in the caregivers' attitudes and actions; and the care organizations' socio-cultural atmosphere. Each item is evaluated in two ways using a 4-point Likert scale; first the patients rate how they perceive the quality of care ranging from 1 (do not agree at all) to 4 (completely agree). The patients then rate how important that aspect of care is ranging from 1 (little or no importance) to 4 (of the very highest importance). Each item also has a "not applicable" response option.
Measured: Within a week after assessment
Waiting times
Waiting time from the day of referral to the day of assessment for assessment with PT and OS respectively, measured in days.
Measured: 12 months after the assessment
Management outcome incl Surgery Conversion Rate (SCR)
The number of patients who receive; advice on self-care without follow up appointment (1), referral to physiotherapist in primary care for rehabilitation (2), referral back to the GP (3) or (4) referral for orthopaedic surgery and Surgery Conversion Rate (The number of patients referred for orthopaedic consultation compared with the number of patients who were appropriate for surgery).
Measured: 12 months after the assessment
EuroQol 5 D (EQ-5D-5L)
Patient reported Quality of life will be measured using the EuroQol 5 D (EQ-5D-5L), a valid and reliable measure of health-related quality of life and consists of 5 items. General health is measured using a VAS scale (0 to 100) with 100 being the best possible health state.
Measured: Baseline
EuroQol 5 D (EQ-5D-5L)
Patient reported Quality of life will be measured using the EuroQol 5 D (EQ-5D-5L), a valid and reliable measure of health-related quality of life and consists of 5 items. General health is measured using a VAS scale (0 to 100) with 100 being the best possible health state.
Measured: Change from baseline to three months after assessment
EuroQol 5 D (EQ-5D-5L)
Patient reported Quality of life will be measured using the EuroQol 5 D (EQ-5D-5L), a valid and reliable measure of health-related quality of life and consists of 5 items. General health is measured using a VAS scale (0 to 100) with 100 being the best possible health state.
Measured: Change from baseline to 12 months after assessment
Forgotten Joint Score (FJS)
Patient reported pain and function will be measured using the Forgotten Joint Score (FJS), a valid and reliable questionnaire that was developed to find subtle differences between patients who grade their hip / knee as "very good" and "excellent". The score is graded from 0 to 100, where a high score is better.
Measured: Baseline
Forgotten Joint Score (FJS)
Patient reported pain and function will be measured using the Forgotten Joint Score (FJS), a valid and reliable questionnaire that was developed to find subtle differences between patients who grade their hip / knee as "very good" and "excellent". The score is graded from 0 to 100, where a high score is better.
Measured: Change from baseline to three months after assessment
Forgotten Joint Score (FJS)
Patient reported pain and function will be measured using the Forgotten Joint Score (FJS), a valid and reliable questionnaire that was developed to find subtle differences between patients who grade their hip / knee as "very good" and "excellent". The score is graded from 0 to 100, where a high score is better.
Measured: Change from baseline to 12 months after assessment
Hip / Knee injury and Osteoarthritis Outcome Score (HOOS-12/KOOS-12)
Patient reported pain and function will be measured using the The 12-item short form of the Hip / Knee injury and Osteoarthritis Outcome Score (HOOS-12/KOOS-12), a valid and reliable short form questionnaires with 12 of the 42-item HOOS/KOOS that provides pain, function and quality of life scale scores and a summary hip/knee impact score. Each item is graded on a 5-point likert scale as well as a summated score graded from 0 to 100, with 100 being the best possible score.
Measured: Baseline
Hip / Knee injury and Osteoarthritis Outcome Score (HOOS-12/KOOS-12)
Patient reported pain and function will be measured using the The 12-item short form of the Hip / Knee injury and Osteoarthritis Outcome Score (HOOS-12/KOOS-12), a valid and reliable short form questionnaires with 12 of the 42-item HOOS/KOOS that provides pain, function and quality of life scale scores and a summary hip/knee impact score. Each item is graded on a 5-point likert scale as well as a summated score graded from 0 to 100, with 100 being the best possible score.
Measured: Change from baseline to three months after assessment
Hip / Knee injury and Osteoarthritis Outcome Score (HOOS-12/KOOS-12)
Patient reported pain and function will be measured using the The 12-item short form of the Hip / Knee injury and Osteoarthritis Outcome Score (HOOS-12/KOOS-12), a valid and reliable short form questionnaires with 12 of the 42-item HOOS/KOOS that provides pain, function and quality of life scale scores and a summary hip/knee impact score. Each item is graded on a 5-point likert scale as well as a summated score graded from 0 to 100, with 100 being the best possible score.
Measured: Change from baseline to 12 months after assessment
Costs
Healthcare consumption (such as visits, further investigations, surgical costs) in primary and secondary healthcare in connection to the patients hip/knee osteoarthritis will be collected from the Swedish Västra Götaland database VEGA. Standard costs for primary care visits will be used to analyse costs. Costs per patient for secondary care will be collected from the Västra Götaland Region database KPP. Sick leave costs will be collected from the Swedish Social Insurance Agency.
Measured: Within 24 months after assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187116
- Sponsor's protocol ID
- PT-triage primary care OA
- Status last verified
- Dec 2023
- First submitted
- 22 May 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapist Led Triage in Primary Care for Patients With Hip or Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06187116
- Acronym / sponsor ID
- PT-triage primary care OA
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Physiotherapist, Orthopaedic triage, Quality of care, Surgery Conversion rate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 2 Jan 2024 (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.
The overall aim with the study is to evaluate physiotherapist led triage in primary care compared to usual care (assessment by an orthopaedic surgeon in an orthopaedic department) for patients with hip or knee osteoarthritis referred for orthopaedic consultation.
Detailed description
The primary aim of the study is to evaluate if there is any difference in perceived quality of care using the item "I received the best possible examination and treatment (as far as I can tell)" between physiotherapist led (PT led) triage in primary care compared to usual care (assessment by an orthopaedic surgeon (OS) in an orthopaedic department) for patients with hip or knee osteoarthritis (OA) referred for orthopaedic consultation. Furthermore, to evaluate whether there is any difference in 2) perceived quality of care as a whole, 3) management outcome and hip/knee replacement surgery conversion rate, 4) patient reported outcome measures such as health related quality, pain and function in short and long term and 5) costs between the two care models.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapist led orthopaedic triage | Experimental | Other: Physiotherapist consultationPatients who are randomised to PT led triage will be scheduled for a consultation with a physiotherapist (PT) at a rehabilitation clinic in primary care in the Region Västra Götaland. |
| Usual care | Active comparator | Other: Orthopaedic surgeon consultationPatients who are randomised to usual care will be sceduled according to standard procedure for an orthopaedic surgeon (OS) consultation at the orthopaedic department of a hospital in the Region Västra Götaland. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary OA in hip or knee
- understands and speak Swedish
Key exclusion criteria (4 listed)
- Previously been assessed for the same condition by an orthopaedic surgeon
- Referred by an orthopaedic surgeon
- Secondary OA due to fractures or osteonecrosis of the femoral head
- Referral to a specific orthopaedic surgeon
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 |
|---|---|---|
| Physiotherapist consultationThe consultation with the PT is 40-45 minutes long according to usual care and includes patient history, assessment and management according to an assessment template. If the patient is found not to be appropriate for surgery they can receive the following; 1) self-care without follow up appointment, 2) referral to PT in primary care for rehabilitation, 3) referral back to general practitioner (GP) for new tests/assessments/medication. If the patient is found to be appropriate for surgery, and wishes to undergo surgery, or if the PT in the study wants a second opinion, the patient is 4) referred for orthopaedic consultation for surgical consideration. | Other | Physiotherapist led orthopaedic triage |
| Orthopaedic surgeon consultationThe consultation with the OS is 20-30 minutes long and includes medical history, assessment and management plan, all according to usual care. It the patient is found not to be appropriate for surgery they can receive the following; 1) self-care without follow up appointment, 2) referral to PT in primary care for rehabilitation, 3) referral back to GP for new tests/assessments/medication. If the patient is found appropriate for surgery, and wishes to undergo surgery, the patient is 4) scheduled for surgery. | Other | Usual care |
Primary outcome
"I received the best possible examination and treatment (as far as I can tell)"
Time frame: Within a week after assessment
One item from the questionnaire Quality from the Patients Perspective (QPP). The patients rate how they perceive the quality of care on a 4-point Likert scale ranging from 1 (do not agree at all) to 4 (completely agree). This item was chosen as main outcome since it was found the be representative of quality of care, and as it assess the desired outcome, by the subjective judgement of experts in the field (five physiotherapists and one orthopaedic surgeon).
13 secondary outcomes
Quality from the Patients Perspective (QPP)
Time frame: Within a week after assessment
Waiting times
Time frame: 12 months after the assessment
Management outcome incl Surgery Conversion Rate (SCR)
Time frame: 12 months after the assessment
EuroQol 5 D (EQ-5D-5L)
Time frame: Baseline
EuroQol 5 D (EQ-5D-5L)
Time frame: Change from baseline to three months after assessment
EuroQol 5 D (EQ-5D-5L)
Time frame: Change from baseline to 12 months after assessment
Forgotten Joint Score (FJS)
Time frame: Baseline
Forgotten Joint Score (FJS)
Time frame: Change from baseline to three months after assessment
Forgotten Joint Score (FJS)
Time frame: Change from baseline to 12 months after assessment
Hip / Knee injury and Osteoarthritis Outcome Score (HOOS-12/KOOS-12)
Time frame: Baseline
Hip / Knee injury and Osteoarthritis Outcome Score (HOOS-12/KOOS-12)
Time frame: Change from baseline to three months after assessment
Hip / Knee injury and Osteoarthritis Outcome Score (HOOS-12/KOOS-12)
Time frame: Change from baseline to 12 months after assessment
Costs
Time frame: Within 24 months after assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapist consultation and Orthopaedic surgeon consultation in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Vastra Gotaland Region.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karin S Samsson, PhD (+46702526260, karin.samsson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"I received the best possible examination and treatment (as far as I can tell)" (time frame: Within a week after assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2024.