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NCT Number: NCT06187116

Physiotherapist Led Triage in Primary Care for Patients With Hip or Knee OA

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients with hip or knee OA assessed by a GP at any of the included health care centers in the study, and referred on for orthopaedic consultation to any of the included hospitals in the Västra Götaland.

Inclusion criteria

  • primary OA in hip or knee
  • understands and speak Swedish

Exclusion criteria

(if stated in the referral)

  • 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

Treatment and study plan

Physiotherapist consultation

Other

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 consultation

Other

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.

Primary outcomes

  1. "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).

Secondary outcomes

  1. Quality from the Patients Perspective (QPP)

    Time frame: Within a week after assessment

    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.

  2. Waiting times

    Time frame: 12 months after the assessment

    Waiting time from the day of referral to the day of assessment for assessment with PT and OS respectively, measured in days.

  3. Management outcome incl Surgery Conversion Rate (SCR)

    Time frame: 12 months after the assessment

    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).

  4. EuroQol 5 D (EQ-5D-5L)

    Time frame: Baseline

    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.

  5. EuroQol 5 D (EQ-5D-5L)

    Time frame: Change from baseline to three months after assessment

    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.

  6. EuroQol 5 D (EQ-5D-5L)

    Time frame: Change from baseline to 12 months after assessment

    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.

  7. Forgotten Joint Score (FJS)

    Time frame: Baseline

    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.

  8. Forgotten Joint Score (FJS)

    Time frame: Change from baseline to three months after assessment

    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.

  9. Forgotten Joint Score (FJS)

    Time frame: Change from baseline to 12 months after assessment

    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.

  10. Hip / Knee injury and Osteoarthritis Outcome Score (HOOS-12/KOOS-12)

    Time frame: Baseline

    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.

  11. Hip / Knee injury and Osteoarthritis Outcome Score (HOOS-12/KOOS-12)

    Time frame: Change from baseline to three months after assessment

    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.

  12. Hip / Knee injury and Osteoarthritis Outcome Score (HOOS-12/KOOS-12)

    Time frame: Change from baseline to 12 months after assessment

    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.

  13. Costs

    Time frame: Within 24 months after assessment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Karin S Samsson, PhD

CONTACT

[email protected]

+46702526260

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

Physiotherapist Led Triage in Primary Care for Patients With Hip or Knee Osteoarthritis

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jan 2, 2024
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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