Clinical trial NCT04170218: Quality of Care for Knee and Hip Osteoarthritis in Elderly Patients
Official title: Quality of Care for Knee and Hip Osteoarthritis in Elderly Patients: a Multicentric Observational Study in France Using Quality Indicators Assessed by Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Hip Osteoarthritis
Quality of Healthcare
Elderly
Keywords: knee osteoarthritis
hip osteoarthritis
quality of healthcare
elderly
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 405
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized in seven geriatric departments of three hospitals of "Assistance Publique - Hôpitaux de Paris", for any cause of admission

Brief summary: Introduction: Hip and knee osteoarthritis (OA) was ranked in 2010 as the eleventh highest contributor to global disability. In France in 2014, non-spinal OA was the leading self-reported cause of morbidity among adults over sixty-five years of age, with a prevalence of 49.5 per cent. OA is known to be the first cause of disability in activities of daily life and a risk factor of frailty among people over seventy-five years of age. Despite its major impact on the elderly population's quality of life and health, quality of care for OA in elderly patients remains understudied.

Objective: The study aims to assess the quality of care for knee and hip OA in patients aged 75 years and over.

Detailed description: Method: This prospective multicentric observational cohort study enrolls participants of 75 years and over with symptomatic hip or knee OA for more than three months, hospitalized in seven geriatric departments of three hospitals of "Assistance Publique - Hôpitaux de Paris", for any cause of admission. Quality of care for OA before hospitalization is assessed by the Assessing Care of Vulnerable Elderly's (ACOVE) quality indicators (QI) for OA, using a questionnaire. The primary endpoint is the pass rate for the ACOVE's QI about referral to an orthopedic surgeon for patients with severe functionally compromising knee or hip OA. The secondary endpoints are the pass rates for the six others ACOVE's QI for OA (annual assessment of functional status and degree of pain ; exercise therapy for patients with newly diagnosed knee OA ; education regarding the natural history, treatment, and self- management of OA ; acetaminophen as first-line pharmacologic therapy ; advising patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) of their risks ; offering prophylaxis with a proton-pump inhibitor or misoprostol to patients treated with non-selective NSAIDs) and other elements of hip or knee OA care not assessed by the seven QI (including use of opioid analgesics, NSAIDs, intra-articular infiltrations, joint replacements). The sample is described with a rheumatologic assessment including Western Ontario and MACmaster universities osteoarthritis index (WOMAC) and Kellgren-Laurence classification, and with a geriatric assessment including nutritional status, Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) scores, Mini Mental State Examination (MMSE) score, Timed Up and Go walking test, modified Short Emergency Geriatric Assessment (mSEGA) scale and Cumulative Illness Rating Scale for Geriatrics (CIRS-G). Participants also complete the 12-Item Short Form Survey version 2 (SF-12v2) quality of life questionnaire. They receive a call twelve months after inclusion to collect vital status, orthopedic consultation and joint replacement during the last year.

Eligibility criteria: Inclusion Criteria:

* patients aged seventy-five years or over
* with symptomatic hip or knee osteoarthritis according to the American College of Rheumatology criteria
* with pain for more than three months
* affiliated to French social security
* having given their oral non-opposition to participate (or oral non-opposition of the guardian in case of legal guardianship)

Exclusion Criteria:

* clinical or radiological sign suggesting a differential diagnosis for hip or knee pain
* acute disease with clinical repercussion on walking
* life-threatened patients

Primary outcomes:
measure: number of participants referred to an orthopedic surgeon as assessed by ACOVE's quality indicator questionnaire
timeFrame: at enrollment
Secondary outcomes:
measure: rate of eligible patients who passed the quality indicator about annual assessment of functional status and degree of pain, assessed by questionnaire
timeFrame: at enrollment
measure: rate of eligible patients who passed the quality indicator about exercise therapy for patients with newly diagnosed knee osteoarthritis, assessed by questionnaire
timeFrame: at enrollment
measure: rate of eligible patients who passed the quality indicator about education regarding the natural history, treatment, and self- management of osteoarthritis, assessed by questionnaire
timeFrame: at enrollment
measure: rate of eligible patients who passed the quality indicator about acetaminophen as first-line pharmacologic therapy, assessed by questionnaire
timeFrame: at enrollment
measure: rate of eligible patients who passed the quality indicator about advising patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) of their risks, assessed by questionnaire
timeFrame: at enrollment
measure: rate of eligible patients who passed the quality indicator about offering prophylaxis with a proton-pump inhibitor or misoprostol to patients treated with non-selective NSAIDs, assessed by questionnaire
timeFrame: at enrollment
measure: percentage of patients taking non-steroidal anti-inflammatory drugs for their hip or knee osteoarthritis, assessed by questionnaire and reading current medical prescription
timeFrame: at enrollment
measure: percentage of patients taking opioid analgesics for their hip or knee osteoarthritis, assessed by reading current medical prescription
timeFrame: at enrollment
measure: percentage of patients taking symptomatic slow-acting anti-arthritics, assessed by assessed by reading current medical prescription
timeFrame: at enrollment
measure: percentage of patients taking non-steroidal anti-inflammatory topically applied, assessed by assessed by reading current medical prescription
timeFrame: at enrollment
measure: percentage of patients treated with intra-articular infiltration of corticosteroid, assessed by questionnaire
timeFrame: at enrollment
measure: percentage of patients treated with intra-articular infiltration of visco-supplementation, assessed by questionnaire
timeFrame: at enrollment
measure: percentage of patients who consulted a rheumatologist for their knee or hip osteoarthritis, assessed by questionnaire
timeFrame: at enrollment
measure: percentage of patients who beneficiate from a modification of their medical prescription related to their knee or hip osteoarthritis treatment during or after their stay in the inclusion geriatric department, assessed by reading the medical record
timeFrame: after the patient discharge
measure: percentage of patients referred to an orthopedic surgeon during or after their stay in the inclusion geriatric department, assessed by reading the medical record
timeFrame: after the patient discharge
measure: percentage of patients referred to an orthopedic surgeon who really consulted the orthopedic surgeon, assessed by calling the patient one year after inclusion
timeFrame: one year after inclusion
measure: percentage of patients referred to an orthopedic surgeon who beneficiated from a joint replacement for their hip or knee, assessed by calling the patient one year after inclusion
timeFrame: one year after inclusion
measure: vital status at one year
timeFrame: one year after inclusion
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Study officials:
name: Jean-Philippe David, PhD
role: STUDY_DIRECTOR
References: