Testing Implementation of Total Joint Replacement Rehabilitation Quality Indicator Toolkits

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Moving Towards Equity in Hip and Knee Replacement Rehabilitation: A Feasibility Study to Test Implementation of Online Quality Indicator Toolkits

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06208553
• Other study ID #: SOG-21-0115)
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of British Columbia
• Contact: Marie Westby, PhD
• Phone: 604-875-4111
• Email: marie.westby[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 135
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Arthroplasty, Replacement, Knee

Intervention

Other:
• QI toolkit implementation
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.

Locations

Country	Name	City	State
Canada	Centre for Aging SMART	Vancouver	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of British Columbia	Centre for Advancing Health Outcomes, Centre for Aging SMART, The Arthritis Society, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient rehabilitation experience questionnaire	Study-specific, pilot-tested questionnaire to capture patients' views on overall experience (10 items) and satisfaction with outcomes (8 items) using a 4-point ordinal scale (Not at all, Somewhat, For the most part, Definitely)	Continuous data collection over 9-month study (through study completion)
Other	Patient feasibility outcomes (patient recruitment rate, consent rate, questionnaire completion rate)	Percentage of patient participants who: are recruited at time of discharge (Denominator: number of TJR patients discharged from clinical site); meet eligibility criteria (Denominator: number screened for participation); provide informed consent (Denominator: number eligible to participate); and complete study questionnaires (Denominator: number sent questionnaires).	Continuous data collection over 9-month study (through study completion)
Other	Clinician feasibility outcomes (clinician consent rate, training completion rate, toolkit registration rate, focus group participation rate)	Percentage of clinician participants who: consent to participate (Denominator: number of eligible clinicians in clinic); complete study training (Denominator: number who consented to participate); register to access QUICK toolkit; (Denominator: number who consented to participate); and participate in baseline and end of study focus groups (Denominator: number who consented to participate).	Continuous data monitoring over 9-month study (through study completion)
Other	Toolkit user metrics - page views	Number of views for each page of the EQUIP and QUICK toolkits.	Continuous data collection during month 4 to 9 (post-intervention)
Other	Toolkit user metrics - average time on page	Average time spent on each page of the EQUIP and QUICK toolkits.	Continuous data collection during month 4 to 9 (post-intervention)
Other	Toolkit user metrics - page downloads	Number of times each page was downloaded from the EQUIP and QUICK toolkits.	Continuous data collection during month 4 to 9 (post-intervention)
Primary	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	Continuous data collection over 9-month study (through study completion)
Secondary	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	Continuous data collection over 9-month study (through study completion)
Secondary	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	End of baseline (3 month control period) and end of study (9 months)
Secondary	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.	Continuous data collection over 9-month study (through study completion)
Secondary	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.	Continuous data collection over 9-month study (through study completion)