Brief Summary

The goal of this clinical trial is to learn if nurse-led telehealth consultations can help detect complications and support recovery after total knee replacement surgery. The study will compare telehealth nursing consultations to traditional in-person nursing visits.

The main questions it aims to answer are:

• Can nurse-led telehealth detect post-surgery complications as well as or better than in-person consultations?
• Does telehealth nursing support better or equivalent recovery outcomes and patient satisfaction compared to in-person care?

Participants will:

• Be adults who had their first total knee replacement surgery.
• Receive follow-up care either through telehealth consultations using the HA Go mobile app or through traditional face-to-face nurse visits in the outpatient clinic.
• Attend scheduled consultations and provide information about their recovery and any complications they experience.
• Complete surveys about their satisfaction with the care they receive.

This study will help determine if telehealth nursing consultations can provide safe, effective, and convenient follow-up care for patients after knee replacement surgery, potentially improving access and reducing travel burdens.

Detailed Description This study is a randomized controlled trial designed to evaluate the clinical effectiveness and feasibility of nurse-led telehealth consultations compared to traditional in-person nursing consultations for post-operative care following total knee replacement (TKR) surgery.

Background and Rationale Total knee replacement is a common surgical intervention for end-stage knee osteoarthritis, offering significant pain relief and improved function. Post-operative follow-up is essential to monitor recovery, detect complications early, and support rehabilitation. However, traditional in-person consultations can pose logistical challenges for patients, including mobility limitations, travel burden, and time constraints. Telehealth has emerged as a promising alternative by enabling remote clinical assessments and patient monitoring, especially amplified by recent advances and adoption during the COVID-19 pandemic.

While telehealth models led by physicians have been studied extensively, there is a relative lack of evidence regarding nurse-led telehealth consultations in the orthopedic post-operative setting. Nurses play a crucial role in patient education, symptom monitoring, and care coordination, making nurse-led telehealth a potentially efficient and scalable solution. This study aims to fill this gap by rigorously evaluating whether nurse-led telehealth consultations can detect complications and support recovery as effectively as standard in-person visits.

Study Design

This is an open-label, parallel-group randomized controlled trial with two arms:

• Intervention arm: Nurse-led telehealth consultations delivered via a secure, hospital-approved mobile platform (the HA Go app).
• Control arm: Traditional in-person nursing consultations conducted at the Specialist Outpatient Department (SOPD).

Randomization will be performed using computer-generated block randomization with allocation concealment ensured through sealed opaque envelopes. Blinded outcome assessment and data analysis will be conducted to minimize bias.

Participants The trial will enroll adult patients (≥18 years old) who undergo first-time unilateral total knee replacement surgery at Tseung Kwan O Hospital. Eligible participants must be medically stable for discharge, have access to the necessary technology for telehealth, and provide informed consent. Patients with revision surgery, bilateral TKR, severe systemic disease (ASA Class III or above), or insufficient technological capacity will be excluded.

Interventions

Nurse-Led Telehealth:

Participants randomized to the telehealth arm will receive scheduled virtual consultations through the HA Go app. Consultations will include remote symptom assessment, wound evaluation via video, patient education on recovery and rehabilitation exercises, and management of minor complications. An executive assistant will provide technical support to patients unfamiliar with the app.

In-Person Nursing Consultation:

Participants assigned to the control group will attend face-to-face follow-up visits at the SOPD, receiving standard nursing care including physical examinations, education, and complication management.

Outcome Assessments The primary outcome is the rate of timely detection and management of post-operative complications within four weeks post-surgery. Secondary outcomes include functional recovery (assessed by validated scales such as KOOS), patient satisfaction, healthcare utilization (unplanned readmissions and emergency visits), and cost-effectiveness analyses encompassing travel and consultation time savings.

Data Collection and Management Data will be collected prospectively via electronic medical records, patient questionnaires, and telehealth system logs. Missing data will be managed using multiple imputation techniques under the assumption of missing at random. Security and confidentiality will be maintained according to Hospital Authority policies, with data encrypted and access restricted to authorized study personnel.

Significance By rigorously comparing nurse-led telehealth to traditional care, this study will generate high-quality evidence to inform post-operative management in TKR patients. Positive findings could support wider implementation of nurse-led telehealth services, improving accessibility, reducing patient burden, and optimizing healthcare resources. This model may be generalizable to other orthopedic and chronic disease care pathways.

Trial Registration and Ethics The study will be registered prior to recruitment, with ethical approval obtained from the Hospital Authority Central Institutional Review Board. Participants will provide informed consent, and the trial will adhere to CONSORT and Good Clinical Practice guidelines.

Inclusion Criteria:

• Adults aged 18 years or older
• Undergoing their first total knee replacement surgery
• Within 4 weeks after surgery
• Medically stable for discharge and suitable for home-based follow-up care
• Have access to a smartphone and internet (for telehealth participants)
• Able to communicate effectively in Cantonese
• Provide informed consent to participate in the study

Exclusion Criteria:

• Undergoing bilateral or revision total knee replacement surgery
• Require immediate or intensive medical attention post-surgery (e.g., severe infection, hospitalization over 7 days)
• Have severe systemic disease (ASA physical status classification III or higher)
• Lack the technical ability or resources to participate in telehealth consultations
• Unable to communicate effectively in Cantonese
• Undergoing surgeries other than first-time total knee replacement

Demographics and Baseline Data: Including age, sex, and pre-operative ASA status.

Primary Outcome: Data on the detection of post-operative complications within four weeks.

Secondary Outcomes: Knee Injury and Osteoarthritis Outcome Score (KOOS) results , Mobile Health App Usability Questionnaire (I-C-MAUQ) scores , patient satisfaction surveys , healthcare utilization (unplanned readmissions, A&E visits) , and cost-effectiveness data (travel/consultation time).

Adherence Data: Participant attendance and completion rates for scheduled consultations.

Start Date:

Data will be available beginning 6 months after the publication of the primary manuscript.

Justification: This is a standard academic practice that allows the primary research team a fair and exclusive period to analyze and publish their main findings before sharing the data.

End Date:

Data will be available for five years following the study's completion date (as defined in this registry).

Access will be granted to qualified academic researchers for legitimate research purposes. Approved requesters will receive the de-identified IPD set, Study Protocol, Statistical Analysis Plan (SAP), and a blank Informed Consent Form (ICF).

To request access, researchers must submit a formal proposal to the Principal Investigator. All requests require review by the study team and final approval from the Hospital Authority Central Institutional Review Board (HA Central IRB). An executed data-sharing agreement is mandatory before data transfer. Upon full approval, data will be shared via a secure, encrypted method.