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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Elective Hip Arthroplasty (THA); Primary Elective Total Knee Arthroplasty (TKA)
• Intervention / Treatment: Device: Digital Patient Journey Solution

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90220
    • Oulu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Patient Journey Solution; 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; 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.
No Intervention: Conventional care group; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presurgical outpatient visits	The number of presurgical outpatient visits	From baseline until the date of the surgery. The data are collected post study from the existing medical records
Cancellation of surgery	Cancellation or postponement of surgery (yes/no)	From baseline until the date of the surgery. The data are collected post study from the existing medical records
Cancellation of postoperative follow-up visit	Cancellation or postponement of the postoperative follow-up visit (yes/no)	From the date of surgery until 6-8 weeks after TKA or at 8-12 weeks after THA. The data are collected post study from the existing medical records
Hospital length of stay	Hospital length of stay after TKA or THA (days)	From the date of surgery until hospital discharge (after the surgery). The data are collected post study from the existing medical records
Hospital readmission	The number and date(s) for readmission(s) to the hospital	From discharge (1-3 days after the surgery) until 6-8 weeks after TKA or at 8-12 weeks after THA. The data are collected post study from the existing medical records

Collaborators and Investigators

• Sponsor: VTT Technical Research Centre of Finland
• Collaborators: Oulu University Hospital; Tampere University; University of Oulu; Buddy Healthcare Ltd; Solteq Ltd; Near Real Ltd
• Investigators: Principal Investigator: Minna Pikkarainen, PhD, University of Oulu

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Actual): May 4, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Icory

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No