NCT06208553

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

December 18, 2023

Last Update Submit

January 5, 2024

Conditions

Keywords

RehabilitationPhysical therapyQuality indicators

Outcome Measures

Primary Outcomes (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

    Continuous data collection over 9-month study (through study completion)

Secondary Outcomes (4)

  • Quality indicator adherence - patient questionnaire

    Continuous data collection over 9-month study (through study completion)

  • Quality indicator adherence - clinician questionnaire

    End of baseline (3 month control period) and end of study (9 months)

  • Knee injury and Osteoarthritis Outcome Score (KOOS)

    Continuous data collection over 9-month study (through study completion)

  • Hip disability and Osteoarthritis Outcome Score (HOOS)

    Continuous data collection over 9-month study (through study completion)

Other Outcomes (6)

  • Patient rehabilitation experience questionnaire

    Continuous data collection over 9-month study (through study completion)

  • Patient feasibility outcomes (patient recruitment rate, consent rate, questionnaire completion rate)

    Continuous data collection over 9-month study (through study completion)

  • Clinician feasibility outcomes (clinician consent rate, training completion rate, toolkit registration rate, focus group participation rate)

    Continuous data monitoring over 9-month study (through study completion)

  • +3 more other outcomes

Interventions

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.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Aging SMART

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Central Study Contacts

Marie Westby, PhD

CONTACT

Mourad Guirguis, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Patient and clinician outcome measures are self-reported and therefore not blinded to study phase. Chart auditors will not be blinded to study phase.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 17, 2024

Study Start

January 1, 2024

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations