Arthroplasty, Replacement, HipNCT06208553
Testing Implementation of Total Joint Replacement Rehabilitation Quality Indicator Toolkits
A study testing QI toolkit implementation in people with Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by University of British Columbia at 1 site in Canada.
Trial summary
The goal of this feasibility study is to test the procedures for implementing quality indicator toolkits for hip and knee replacement rehabilitation in clinical settings. The main questions it aims to answer are: Are the EQUIP (for patients) and QUICK (for clinicians) toolkit resources feasible (accessible… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- What is being tested?
- QI toolkit implementation
- How many people
- 135 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2024to Dec 2024
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinician participants
- Physical therapists, rehabilitation assistants, students, and other rehabilitation providers at the study clinical site who provide direct patient care after total joint replacement
- Patient participants
- Adults ages 19 and older
- Primary total hip or knee replacement for osteoarthritis
- No significant co-morbidities or peri-operative complications that markedly prolonged acute hospital stay or delayed the start of post-acute rehabilitation
- Sufficient English language skills to provide informed consent and complete questionnaires (with/without help from a family member)
- Completed their course of supervised rehabilitation at study site
Who cannot join
- Unwilling or unable to provide written informed consent
- Had another lower limb joint replacement in the previous 6 months
- Received some of their post-acute rehabilitation at another clinical facility other than the two study sites
- Received fewer than 3 post-acute rehabilitation visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Moving Towards Equity in Hip and Knee Replacement Rehabilitation: A Feasibility Study to Test Implementation of Online Quality Indicator Toolkits
The goal of this feasibility study is to test the procedures for implementing quality indicator toolkits for hip and knee replacement rehabilitation in clinical settings. The main questions it aims to answer are:
- Are the EQUIP (for patients) and QUICK (for clinicians) toolkit resources feasible (accessible, acceptable, usable) in real world clinical settings?
- Are study procedures including recruitment and retention, informed consent, clinical site tracking, audit and feedback, training and data collection feasible?
- What effect does toolkit implementation have on patient experiences, quality of care and patient-reported outcomes? Participants will be asked to provide consent at time of discharge from rehabilitation to have their clinical records audited and to complete an online questionnaire about their physical function, quality of care they received, and overall rehabilitation experience and satisfaction. Rehabilitation providers will also be asked to complete a questionnaire on their adherence to ten post-acute rehabilitation quality indicators after a 3-month baseline period and 6-month implementation phase.
Read the detailed description
Most people do some form of supervised rehabilitation after hip and knee replacement surgery. Rehabilitation includes assessing pain, mobility, strength, and day-to-day physical function and then prescribing exercises and other interventions to help patients achieve their goals for recovery. Rehabilitation care differs across hospitals, jurisdictions and countries. This can result in some people not receiving the recommended standard of care and not achieving satisfactory outcomes. Study investigators developed 10 quality indicators (QIs) that reflect research-based standards of rehabilitation care after elective hip and knee replacement. The investigators then created a variety of QI resources, in the form of 'toolkits', to share with patients and rehabilitation providers. A feasibility study is being conducted to see if implementing these online toolkits affects the quality and consistency of care patients receive during their rehabilitation at two clinical sites and with up to 135 patients.
As a feasibility study, the investigators are testing the study plan and determining whether enough participants will join a larger study and accept the study procedures.
Clinicians at the two study sites will be asked to:
- Complete a clinician QI questionnaire twice to monitor any change in self-reported adherence to the quality indicators
- Participate in an initial focus group at the start of the 3-month control phase to identify potential barriers and facilitators to using online best practice resources such as QI toolkits and explore the evidence-based practice culture at each site.
- Participate in a 1-hour online training session to introduce QUICK toolkit resources, have questions answered, and receive clinic-level audit and feedback results to better understand any care gaps or areas for improvement.
- Login and access the online QUICK toolkit within the first 3 months of the implementation phase and continue to use throughout the remaining study period. Use of the toolkit is not prescriptive and clinicians can select resources that are most relevant or helpful to them.
- At end of the 9-month study, clinicians will be invited to participate in another focus group meeting to share their views on the toolkits and any challenges to implementing the QIs.
- Throughout the 9-month study, notify the site coordinator when a potentially eligible patient is nearing discharge from their rehabilitation program to facilitate screening and recruitment.
The site-specific clinical champions/site coordinators will provide patients with a postcard with study information and with patient permission, provide contact information to the research assistant. Patients can also opt to contact the study team directly to determine study eligibility and undertake the informed consent process.
Patients at participating sites will be asked to:
- Give consent to have their clinical records (physical therapy notes) audited by trained, independent physical therapy auditors to assess adherence to the quality indicators AND
- Complete an online or paper questionnaire consisting of three separate questionnaires: 1) perception of quality of rehabilitation care; 2) self-reported ability to do every day activities, and 3) rehabilitation experience and satisfaction with care and outcomes. These can be done at home after completion of supervised rehabilitation and will take 15-20 minutes to complete. There is no further follow-up with patients.
- If receiving rehabilitation services after the 3-month control phase, patients will have access to the online EQUIP toolkit (no registration required) and will be encouraged to view resources that are helpful to them for the duration of the study period.
Demographic, clinic and feasibility data will be analyzed descriptively and reported at the clinic level to protect the privacy of participating clinicians. Adherence to the QIs will be examined descriptively and by comparing pooled mean QI adherence pre- and post-implementation using a multiple regression model adjusting for site and baseline patient characteristics: sex, gender, age, surgery (TKR vs THR), co-morbidities, other lower limb involvement, body mass index and education level. Exploratory analysis will include determining level of agreement in QI adherence between data collection tools (e.g., agreement between linked audit tool and patient questionnaire) as well as any signal of quality of care being associated with patient-self reported function and experience. Focus groups will be recorded and transcribed verbatim for thematic analysis and to assist with interpretation of findings.
- Being tested
- QI toolkit implementation
- Keywords
- Rehabilitation, Physical therapy, Quality indicators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QI toolkit implementationOther
Patients and clinicians will have access to online toolkits of resources (e.g., video, checklist, rehabilitation tracker, quick guides) reflecting quality indicators for rehabilitation care after total hip and knee replacement surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality indicator adherence - chart audits
Standardized, purpose-built online audit tool to capture adherence to 10 quality indicators, measured as number of QIs met out of 10, expressed as percentage
Measured: Continuous data collection over 9-month study (through study completion)
Secondary outcomes (4)
Quality indicator adherence - patient questionnaire
Online patient self-report of rehabilitation adherence to 10 quality indicators, measured as number of QIs met out of 10, expressed as percentage
Measured: Continuous data collection over 9-month study (through study completion)
Quality indicator adherence - clinician questionnaire
Online clinician self-report of adherence to 10 quality indicators, measured as number of QIs met out of 10, expressed as percentage
Measured: End of baseline (3 month control period) and end of study (9 months)
Knee injury and Osteoarthritis Outcome Score (KOOS)
Self-reported outcome measures assessing patient's opinion about their pain, other symptoms, daily function and quality of life in past week.
Measured: Continuous data collection over 9-month study (through study completion)
Hip disability and Osteoarthritis Outcome Score (HOOS)
Self-reported outcome measures assessing patient's opinion about their pain, other symptoms, daily function and quality of life in past week.
Measured: Continuous data collection over 9-month study (through study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single phase (step) of larger stepped-wedge cluster randomized trial design in which 3-month baseline period serves as pre-test after which implementation intervention is introduced (intervention phase) and then post-test data collected (similar to time series design).
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- The Arthritis Society, Canada, Centre for Aging SMART, Centre for Advancing Health Outcomes
- Responsible party
- Principal investigator, Marie Westby, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208553
- Sponsor's protocol ID
- SOG-21-0115)
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moving Towards Equity in Hip and Knee Replacement Rehabilitation: A Feasibility Study to Test Implementation of Online Quality Indicator Toolkits
- ClinicalTrials.gov ID
- NCT06208553
- Acronym / sponsor ID
- SOG-21-0115)
- Keywords
- Rehabilitation, Physical therapy, Quality indicators
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- The Arthritis Society, Canada, Centre for Aging SMART, Centre for Advancing Health Outcomes
- Study start
- Jan 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 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 goal of this feasibility study is to test the procedures for implementing quality indicator toolkits for hip and knee replacement rehabilitation in clinical settings. The main questions it aims to answer are:
- Are the EQUIP (for patients) and QUICK (for clinicians) toolkit resources feasible (accessible, acceptable, usable) in real world clinical settings?
- Are study procedures including recruitment and retention, informed consent, clinical site tracking, audit and feedback, training and data collection feasible?
- What effect does toolkit implementation have on patient experiences, quality of care and patient-reported outcomes? Participants will be asked to provide consent at time of discharge from rehabilitation to have their clinical records audited and to complete an online questionnaire about their physical function, quality of care they received, and overall rehabilitation experience and satisfaction. Rehabilitation providers will also be asked to complete a questionnaire on their adherence to ten post-acute rehabilitation quality indicators after a 3-month baseline period and 6-month implementation phase.
Detailed description
Most people do some form of supervised rehabilitation after hip and knee replacement surgery. Rehabilitation includes assessing pain, mobility, strength, and day-to-day physical function and then prescribing exercises and other interventions to help patients achieve their goals for recovery. Rehabilitation care differs across hospitals, jurisdictions and countries. This can result in some people not receiving the recommended standard of care and not achieving satisfactory outcomes. Study investigators developed 10 quality indicators (QIs) that reflect research-based standards of rehabilitation care after elective hip and knee replacement. The investigators then created a variety of QI resources, in the form of 'toolkits', to share with patients and rehabilitation providers. A feasibility study is being conducted to see if implementing these online toolkits affects the quality and consistency of care patients receive during their rehabilitation at two clinical sites and with up to 135 patients.
As a feasibility study, the investigators are testing the study plan and determining whether enough participants will join a larger study and accept the study procedures.
Clinicians at the two study sites will be asked to:
- Complete a clinician QI questionnaire twice to monitor any change in self-reported adherence to the quality indicators
- Participate in an initial focus group at the start of the 3-month control phase to identify potential barriers and facilitators to using online best practice resources such as QI toolkits and explore the evidence-based practice culture at each site.
- Participate in a 1-hour online training session to introduce QUICK toolkit resources, have questions answered, and receive clinic-level audit and feedback results to better understand any care gaps or areas for improvement.
- Login and access the online QUICK toolkit within the first 3 months of the implementation phase and continue to use throughout the remaining study period. Use of the toolkit is not prescriptive and clinicians can select resources that are most relevant or helpful to them.
- At end of the 9-month study, clinicians will be invited to participate in another focus group meeting to share their views on the toolkits and any challenges to implementing the QIs.
- Throughout the 9-month study, notify the site coordinator when a potentially eligible patient is nearing discharge from their rehabilitation program to facilitate screening and recruitment.
The site-specific clinical champions/site coordinators will provide patients with a postcard with study information and with patient permission, provide contact information to the research assistant. Patients can also opt to contact the study team directly to determine study eligibility and undertake the informed consent process.
Patients at participating sites will be asked to:
- Give consent to have their clinical records (physical therapy notes) audited by trained, independent physical therapy auditors to assess adherence to the quality indicators AND
- Complete an online or paper questionnaire consisting of three separate questionnaires: 1) perception of quality of rehabilitation care; 2) self-reported ability to do every day activities, and 3) rehabilitation experience and satisfaction with care and outcomes. These can be done at home after completion of supervised rehabilitation and will take 15-20 minutes to complete. There is no further follow-up with patients.
- If receiving rehabilitation services after the 3-month control phase, patients will have access to the online EQUIP toolkit (no registration required) and will be encouraged to view resources that are helpful to them for the duration of the study period.
Demographic, clinic and feasibility data will be analyzed descriptively and reported at the clinic level to protect the privacy of participating clinicians. Adherence to the QIs will be examined descriptively and by comparing pooled mean QI adherence pre- and post-implementation using a multiple regression model adjusting for site and baseline patient characteristics: sex, gender, age, surgery (TKR vs THR), co-morbidities, other lower limb involvement, body mass index and education level. Exploratory analysis will include determining level of agreement in QI adherence between data collection tools (e.g., agreement between linked audit tool and patient questionnaire) as well as any signal of quality of care being associated with patient-self reported function and experience. Focus groups will be recorded and transcribed verbatim for thematic analysis and to assist with interpretation of findings.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Single phase (step) of larger stepped-wedge cluster randomized trial design in which 3-month baseline period serves as pre-test after which implementation intervention is introduced (intervention phase) and then post-test data collected (similar to time series design).
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinician participants
- Physical therapists, rehabilitation assistants, students, and other rehabilitation providers at the study clinical site who provide direct patient care after total joint replacement
- Patient participants
- Adults ages 19 and older
- Primary total hip or knee replacement for osteoarthritis
Key exclusion criteria (4 listed)
- Unwilling or unable to provide written informed consent
- Had another lower limb joint replacement in the previous 6 months
- Received some of their post-acute rehabilitation at another clinical facility other than the two study sites
- Received fewer than 3 post-acute rehabilitation visits
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 |
|---|---|---|
| QI toolkit implementationPatients and clinicians will have access to online toolkits of resources (e.g., video, checklist, rehabilitation tracker, quick guides) reflecting quality indicators for rehabilitation care after total hip and knee replacement surgery. | Other | – |
Primary outcome
Quality indicator adherence - chart audits
Time frame: Continuous data collection over 9-month study (through study completion)
Standardized, purpose-built online audit tool to capture adherence to 10 quality indicators, measured as number of QIs met out of 10, expressed as percentage
4 secondary outcomes
Quality indicator adherence - patient questionnaire
Time frame: Continuous data collection over 9-month study (through study completion)
Quality indicator adherence - clinician questionnaire
Time frame: End of baseline (3 month control period) and end of study (9 months)
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Continuous data collection over 9-month study (through study completion)
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: Continuous data collection over 9-month study (through study completion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QI toolkit implementation in people with Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by University of British Columbia at 1 site in Canada.
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 8 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. 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 Canada. 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 Marie Westby, PhD (604-875-4111 ext. 68834, marie.westby@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality indicator adherence - chart audits (time frame: Continuous data collection over 9-month study (through study completion)). 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 17 Jan 2024.