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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Canada1 site
  • Centre for Aging SMART

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

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.

  1. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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.

  1. First posted17 Jan 2024
  2. Study startJan 2024 (estimated)
  3. Primary completionOct 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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)
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

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.

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