Digital Patient Journey Solution for Patients Undergoing Elective Hip and Knee Arthroplasty Dueto Primary Osteoarthritis

Study Overview
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Brief Summary
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This is an interventional study which aims at assessing the effects of a digital patient journey solution in patients undergoing elective hip and knee arthroplasty due to primary osteoarthritis.

Detailed Description
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Traditionally, pre- and postoperative education has been provided face-to-face by paper-based methods for patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA). Digital patient journey solution has potential to enhance adherence to preoperative preparation and postoperative rehabilitation, and further improve patient experience, while reducing potential adverse events. The purpose of this study is to assess a digital patient journey solution developed for patients undergoing elective hip and knee arthroplasty. The digital solution aims to support patient's preparation to and recovery from a hip and knee arthroplasty through provision of timely information and support related to preoperative preparation and postoperative rehabilitation. The information on the application is aligned with the patient's individual needs and requirements, and contains exercises to be completed daily for the duration of the program.

Official Title
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Digital Patient Journey Solution for Patients Undergoing Elective Hip and Knee Arthroplasty Due to Primary Osteoarthritis

Conditions
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Primary Elective Hip Arthroplasty (THA), Primary Elective Total Knee Arthroplasty (TKA)

Intervention / Treatment
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* Device: Digital Patient Journey Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Undergoing primary elective total hip or knee arthroplasty Diagnosis of primary osteoarthritis of hip or knee (M16.0, M16.1, M17.0, M17.1) Ability to speak, read and understand Finnish Access to a web-based device Exclusion Criteria: Undergoing a total hip or knee arthroplasty revision A bilateral total hip or knee arthroplasty Total hip or knee arthroplasty following a rheumatoid arthritis Inability to walk with use of walking aids Unable to see or hear that impede the use of the digital patient journey solution

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Patient Journey Solution<br>Patients in the intervention arm are provided with a digital patient journey solution used on a mobile device. The application is intended to be used during the whole care path. The patient can familiarize him-/herself to the phases of care through visual timeline representation of the care path, get information on how to prepare for a surgery, receive reminders, fill in questionnaire forms, communicate with the care personnel via messaging functionality and video calls, and search information from frequently asked questions. The application contains information about the preparation, forms for anamnesis, anesthesia and treatment follow-up, information videos and pictures, and timely and individually-tailored reminders, e.g., on when to stop eating and drinking before the surgery. In addition, the application provides instructions on how to arrive to the treatment unit and comprehensive guidance for wound care and rehabilitation at home after the operation. | Device: Digital Patient Journey Solution<br>* Patients in the intervention arm are provided with a digital patient journey solution used on a mobile device. The application is intended to be used during the whole care path. The patient can familiarize him-/herself to the phases of care through visual timeline representation of the care path, get information on how to prepare for a surgery, receive reminders, fill in questionnaire forms, communicate with the care personnel via messaging functionality and video calls, and search information from frequently asked questions. The application contains information about the preparation, forms for anamnesis, anesthesia and treatment follow-up, information videos and pictures, and timely and individually-tailored reminders, e.g., on when to stop eating and drinking before the surgery. In addition, the application provides instructions on how to arrive to the treatment unit and comprehensive guidance for wound care and rehabilitation at home after the operation.<br>|
| No Intervention: Conventional care group<br>Conventional care consists of specialist assessment in conjunction with pre-operative surgical visits and patient education. Patients in the conventional care group are provided with pre- and postoperative information face-to-face by paper-based method. Patients will be admitted and mobilised on the day of the surgery, and discharged one to three days after surgery. The follow-up visit, conducted by a physiotherapist, is conducted after 6 to 8 weeks post-discharge for patients with TKA and after 8 to 12 weeks for patients with THA. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health-related quality of life measured with EuroQol EQ-5D-5L | EuroQol EQ-5D-5L is a 5-level 5-dimensional standardized assessment tool. The index score (range 0-1 with 1 indicating perfect health and 0 indicating death) is used in the analyses. | Change from baseline up to 6-8 weeks after TKA or at 8-12 weeks after THA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) | WOMAC is a disease-specific, self-administered health status instrument assessing pain, stiffness, and function in patients with osteoarthritis. Three subscale summary scores are used in the analysis: Pain (range:0-20), Stiffness (range: 0-8), Physical function (range 0-68) with lower scores indicating better health. | Change from baseline up to 6-8 weeks after TKA or at 8-12 weeks after THA | 
| Patient experience post surgery | An 18-item questionnaire developed for the purposes of this study. The questionnaire entails 17 statements answered on a Likert scale and one open question for additional feedback. The questionnaire is compiled based on the following questionnaires: 11-scale by National Institute for Health and Welfare of Finland, NORPEQ, GS-PEQ and PPE- 15 | At discharge (1-3 days after the surgery) | 
| Patient experience post intervention | An 18-item questionnaire developed for the purposes of this study. The questionnaire entails 17 statements answered on a Likert scale and one open question for additional feedback. The questionnaire is compiled based on the following questionnaires: 11-scale by National Institute for Health and Welfare of Finland, NORPEQ, GS-PEQ and PPE- 15 | 6-8 weeks after TKA or at 8-12 weeks after THA | 
| Application user experience | A 28-item questionnaire developed for the purposes of the study. The questionnaire includes questions with regard to, e.g., perceived usefulness, ease of use, ease of taking into use, and trust. The questions are drawn from Technology Acceptance Model for Mobile Services (TAMM). The questionnaire is asked from the intervention group only. | 6-8 weeks after TKA or at 8-12 weeks after THA | 
| Technological self-efficacy | Technological self-efficacy is measured with the Healthcare Technology Self-Efficacy (HTSE) -instrument adapted to the context of digital health services. | At baseline, and 6-8 weeks after TKA or at 8-12 weeks after THA | 
| Self-efficacy regarding preoperative preparation | Self-efficacy is measured using a self-reported survey item developed for the purposes of this study. | At baseline | 
| Self-efficacy regarding postoperative preparation | Self-efficacy is measured using a self-reported survey item developed for the purposes of this study. | At discharge (1-3 days after the surgery) | 
| Self-efficacy during postoperative rehabilitation | Self-efficacy during rehabilitation is measured using self-reported survey items developed for the purposes of this study. | At 1, 3, and 5 weeks after THA/TKA for the intervention group only | 
| Change in Oxford Hip Score (OHS) | OHS is a patient-reported outcome measure tool designed to assess disability in patients undergoing total hip replacement. The summary score (range: 12-60) is used in the analyses with higher scores indicating most difficulty. OHS is collected routinely as a part of the care path. For the study purposes these data are obtained post study from the existing medical records. | 60 days prior surgery and 120 days after the surgery | 
| Change Oxford Knee Score (OKS) | OKS is a patient-reported outcome measure tool designed to assess disability in patients undergoing total knee replacement. The summary score (range: 12-60) is used in the analyses with higher scores indicating most difficulty. OKS is collected routinely as a part of the care path. For the study purposes, these data are obtained post study from the existing medical records. | 60 days prior surgery and 120 days after the surgery | 
| Preoperative adherence | Percentage of completed instruction sheets (denominator is the number of all instruction sheets provided to the patient through the application) | From baseline until the date of the surgery for the intervention group only | 
| Postoperative adherence | The proportion of completed exercises (denominator is the number of all exercises provided to the patient through the application) | From discharge (1-3 days after the surgery) until 6-8 weeks after TKA or at 8-12 weeks after THA for the intervention group only |