Testing Implementation of Total Joint Replacement Rehabilitation Quality Indicator Toolkits

NCT ID: NCT06208553

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2024-12-31

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.

Conditions

Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Arthritis Society, Canada

OTHER

Sponsor Role: collaborator

Centre for Aging SMART

UNKNOWN

Sponsor Role: collaborator

Centre for Advancing Health Outcomes

UNKNOWN

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Marie Westby

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre for Aging SMART

Vancouver, British Columbia, Canada

Countries

Canada

Central Contacts

Marie Westby, PhD

Role: CONTACT

marie.westby@ubc.ca

604-875-4111 ext. 68834

Mourad Guirguis, MD

Role: CONTACT

mourad.guirguis@ubc.ca

604 875-4111 ext. 52588

Other Identifiers

SOG-21-0115)

Identifier Type: -

Identifier Source: org_study_id