Clinical trial NCT06208553: Testing Implementation of Total Joint Replacement Rehabilitation Quality Indicator Toolkits
Official title: Moving Towards Equity in Hip and Knee Replacement Rehabilitation: A Feasibility Study to Test Implementation of Online Quality Indicator Toolkits
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Keywords: Rehabilitation
Physical therapy
Quality indicators
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: The Arthritis Society, Canada
name: Centre for Aging SMART
name: Centre for Advancing Health Outcomes
First posted: 2024-01-17
Enrollment: 135
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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, 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quality indicator adherence - chart audits
timeFrame: Continuous data collection over 9-month study (through study completion)
Secondary outcomes:
measure: Quality indicator adherence - patient questionnaire
timeFrame: Continuous data collection over 9-month study (through study completion)
measure: Quality indicator adherence - clinician questionnaire
timeFrame: End of baseline (3 month control period) and end of study (9 months)
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Continuous data collection over 9-month study (through study completion)
measure: Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: Continuous data collection over 9-month study (through study completion)
Other outcomes:
measure: Patient rehabilitation experience questionnaire
timeFrame: Continuous data collection over 9-month study (through study completion)
measure: Patient feasibility outcomes (patient recruitment rate, consent rate, questionnaire completion rate)
timeFrame: Continuous data collection over 9-month study (through study completion)
measure: Clinician feasibility outcomes (clinician consent rate, training completion rate, toolkit registration rate, focus group participation rate)
timeFrame: Continuous data monitoring over 9-month study (through study completion)
measure: Toolkit user metrics - page views
timeFrame: Continuous data collection during month 4 to 9 (post-intervention)
measure: Toolkit user metrics - average time on page
timeFrame: Continuous data collection during month 4 to 9 (post-intervention)
measure: Toolkit user metrics - page downloads
timeFrame: Continuous data collection during month 4 to 9 (post-intervention)
Locations:
city: Vancouver
country: Canada
facility: Centre for Aging SMART
state: British Columbia
Study officials:
References: