Knee OsteoarthritisQSAMISANCT04170218
Quality of Care for Knee and Hip Osteoarthritis in Elderly Patients
An observational study of Knee Osteoarthritis and Hip Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Knee Osteoarthritis, Hip Osteoarthritis, Quality of Healthcare
- How many people
- 405 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2019to 1 Dec 2022
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients hospitalized in seven geriatric departments of three hospitals of "Assistance Publique - Hôpitaux de Paris", for any cause of admission
Who may be able to join
- 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)
Who cannot join
- clinical or radiological sign suggesting a differential diagnosis for hip or knee pain
- acute disease with clinical repercussion on walking
- life-threatened patients
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, 94010
About this study
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
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.
Read the 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.
- Keywords
- knee osteoarthritis, hip osteoarthritis, quality of healthcare, elderly
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants referred to an orthopedic surgeon as assessed by ACOVE's quality indicator questionnaire
Measured: at enrollment
Secondary outcomes (18)
rate of eligible patients who passed the quality indicator about annual assessment of functional status and degree of pain, assessed by questionnaire
The eligibility criterion is answer "yes" to the question "Do you have pain in your joints that bothers you a lot on most days?". The pass criterion is a "yes" response to either of the two questions "In the past 12 months, has any doctor or nurse asked you about the severity of your joint pain?" "In the past 12 months, has any doctor or nurse asked you if your joint pain affects the things you like or need to do?". The rate is calculated using the numerator as the number of eligible patients who passed the quality indicator and the denominator as the number of patients eligible for the quality indicator.
Measured: at enrollment
rate of eligible patients who passed the quality indicator about exercise therapy for patients with newly diagnosed knee osteoarthritis, assessed by questionnaire
The eligibility criteria are knee pain that had lasted at least 3 months, health did not limit the patient's ability to bathe or dress, and patients or surrogates indicated that the patient did not have severe dementia. The pass criterion is a "yes" response to the question "Have you ever been sent to physical therapy or an exercise group or class for your knee pain?". The rate is calculated using the numerator as the number of eligible patients who passed the quality indicator and the denominator as the number of patients eligible for the quality indicator
Measured: at enrollment
rate of eligible patients who passed the quality indicator about education regarding the natural history, treatment, and self- management of osteoarthritis, assessed by questionnaire
The eligibility criterion is pain in any joint lasting at least 6 months. The pass criterion is a a "yes" response to at least 1 of the 3 questions "Has any doctor or nurse ever talked to you about what your arthritis or joint pain will be like as time goes on, or the natural history of arthritis?" "Has any doctor or nurse ever talked to you about how to keep your arthritis or joint pain from getting worse?" "Has any doctor or nurse ever talked to you about how your arthritis can be treated?". The rate is calculated using the numerator as the number of eligible patients who passed the quality indicator and the denominator as the number of patients eligible for the quality indicator.
Measured: at enrollment
rate of eligible patients who passed the quality indicator about acetaminophen as first-line pharmacologic therapy, assessed by questionnaire
The eligibility criterion is a "yes" response to the question "Has any doctor or nurse recommended any treatments for your joint pain?". The pass criterion is a "yes" response to the question "Did any doctor or nurse recommend you try acetaminophen before other medications for your joint pain?". Trade names of acetaminophen are mentioned to help participants. The rate is calculated using the numerator as the number of eligible patients who passed the quality indicator and the denominator as the number of patients eligible for the quality indicator.
Measured: at enrollment
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
The eligibility criteria are NSAID on medication list, or a "yes" response to the question "Do you take any medications like aceclofenac, celecoxib, diclofenac, etoricoxib, ibuprofene, indometacine, ketoprofene, naproxene or piroxicam ? These medications are known as non-steroidal anti-inflammatory drugs". Corresponding trade names are mentioned to help participants. The pass criterion is a "yes" response to the question "Did any doctor or nurse or pharmacist tell you about the possible side effects or risks from taking this medication?". The rate is calculated using the numerator as the number of eligible patients who passed the quality indicator and the denominator as the number of patients eligible for the quality indicator.
Measured: at enrollment
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
The eligibility criteria are NSAID on medication list, or a "yes" response to the question "Do you take any medications like aceclofenac, diclofenac, ibuprofene, indometacine, ketoprofene, naproxene or piroxicam?". Corresponding trade names are mentioned to help participants. The pass criterion is a "yes" response to the question "Did any doctor or nurse recommend you take another medication to protect your stomach or intestines or from developing an ulcer? For example omeprazole, esomeprazole, pantoprazole, lansoprazole or misoprostol". Corresponding trade names are mentioned to help participants. The rate is calculated using the numerator as the number of eligible patients who passed the quality indicator and the denominator as the number of patients eligible for the quality indicator.
Measured: at enrollment
percentage of patients taking non-steroidal anti-inflammatory drugs for their hip or knee osteoarthritis, assessed by questionnaire and reading current medical prescription
Measured: at enrollment
percentage of patients taking opioid analgesics for their hip or knee osteoarthritis, assessed by reading current medical prescription
Measured: at enrollment
percentage of patients taking symptomatic slow-acting anti-arthritics, assessed by assessed by reading current medical prescription
Measured: at enrollment
percentage of patients taking non-steroidal anti-inflammatory topically applied, assessed by assessed by reading current medical prescription
Measured: at enrollment
percentage of patients treated with intra-articular infiltration of corticosteroid, assessed by questionnaire
Measured: at enrollment
percentage of patients treated with intra-articular infiltration of visco-supplementation, assessed by questionnaire
Measured: at enrollment
percentage of patients who consulted a rheumatologist for their knee or hip osteoarthritis, assessed by questionnaire
Measured: at enrollment
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
Measured: after the patient discharge
percentage of patients referred to an orthopedic surgeon during or after their stay in the inclusion geriatric department, assessed by reading the medical record
Measured: after the patient discharge
percentage of patients referred to an orthopedic surgeon who really consulted the orthopedic surgeon, assessed by calling the patient one year after inclusion
Measured: one year after inclusion
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
Measured: one year after inclusion
vital status at one year
Measured: one year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe David, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170218
- Sponsor's protocol ID
- APHP190201
- Acronym
- QSAMISA
- Status last verified
- Oct 2019
- First submitted
- 25 Oct 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04170218
- Acronym / sponsor ID
- QSAMISA / APHP190201
- Keywords
- knee osteoarthritis, hip osteoarthritis, quality of healthcare, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 20 Nov 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients hospitalized in seven geriatric departments of three hospitals of "Assistance Publique - Hôpitaux de Paris", for any cause of admission
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- clinical or radiological sign suggesting a differential diagnosis for hip or knee pain
- acute disease with clinical repercussion on walking
- life-threatened patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of participants referred to an orthopedic surgeon as assessed by ACOVE's quality indicator questionnaire
Time frame: at enrollment
18 secondary outcomes
rate of eligible patients who passed the quality indicator about annual assessment of functional status and degree of pain, assessed by questionnaire
Time frame: at enrollment
rate of eligible patients who passed the quality indicator about exercise therapy for patients with newly diagnosed knee osteoarthritis, assessed by questionnaire
Time frame: at enrollment
rate of eligible patients who passed the quality indicator about education regarding the natural history, treatment, and self- management of osteoarthritis, assessed by questionnaire
Time frame: at enrollment
rate of eligible patients who passed the quality indicator about acetaminophen as first-line pharmacologic therapy, assessed by questionnaire
Time frame: at enrollment
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
Time frame: at enrollment
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
Time frame: at enrollment
percentage of patients taking non-steroidal anti-inflammatory drugs for their hip or knee osteoarthritis, assessed by questionnaire and reading current medical prescription
Time frame: at enrollment
percentage of patients taking opioid analgesics for their hip or knee osteoarthritis, assessed by reading current medical prescription
Time frame: at enrollment
percentage of patients taking symptomatic slow-acting anti-arthritics, assessed by assessed by reading current medical prescription
Time frame: at enrollment
percentage of patients taking non-steroidal anti-inflammatory topically applied, assessed by assessed by reading current medical prescription
Time frame: at enrollment
percentage of patients treated with intra-articular infiltration of corticosteroid, assessed by questionnaire
Time frame: at enrollment
percentage of patients treated with intra-articular infiltration of visco-supplementation, assessed by questionnaire
Time frame: at enrollment
percentage of patients who consulted a rheumatologist for their knee or hip osteoarthritis, assessed by questionnaire
Time frame: at enrollment
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
Time frame: after the patient discharge
percentage of patients referred to an orthopedic surgeon during or after their stay in the inclusion geriatric department, assessed by reading the medical record
Time frame: after the patient discharge
percentage of patients referred to an orthopedic surgeon who really consulted the orthopedic surgeon, assessed by calling the patient one year after inclusion
Time frame: one year after inclusion
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
Time frame: one year after inclusion
vital status at one year
Time frame: one year after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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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.
Jean-Philippe David, PhD study director
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 Knee Osteoarthritis and Hip Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Nov 2019. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valeriane Reau (33776698321, reau.valeriane@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants referred to an orthopedic surgeon as assessed by ACOVE's quality indicator questionnaire (time frame: at enrollment). 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 20 Nov 2019.