An Integrated Model of Intelligent Medical Service for Total Joint Replacement

December 24, 2018 updated by: Chang Gung Memorial Hospital

With the aging population, the needs for total joint replacement are increasing. A successful recovery after joint replacement surgery depends on timely and active physical therapy in the early postoperative period. To accomplish it, an integrated care model based on clinical pathway has been implemented to secure the medical quality and patient safety. Recently, the emerging technology of electronic medical record and medical informatics have made challenges to the traditional health care models such as the clinical pathway. As a matter of fact, the integration of informatics technology also provides an opportunity to modernize the clinical pathway and make it smarter. By bridging the HIS system and the medical cloud of a virtual platform of interactive clinical pathway, the quality of care and patient safety can be better secured and the performance can be stored for analysis.

The project " The effects of intelligent clinical pathway for total joint replacement" is a subproject of the integrated project " An integrated model of intelligent medical service for total joint replacement". It will be carried out in a facility built with intelligent environment (Kaohsiung CGMH) and the data will be stored and computed in the medical care cloud and specialist system server. Collaborating with subproject 2 and 4 (smart wearing device) and subproject 3 (total nursing care), this project is intended to set the milestones for the postoperative recovery after total joint replacement. Supplemented with the specialist system and interactive programs, it will be implemented in total joint replacement patients as an vehicle for perioperative assessment, follow-up, monitoring, and instruction. The big data of the objective analytic results and feedback from the patients will be the important reference for medical and health promotion.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

With the aging population, the needs for total joint replacement are increasing. On the basis of 2000-to-2014 data from National Inpatient Sample (NIS), primary total knee arthroplasty (TKA) is projected to grow by 85% to 1.26 million procedures in the United States by 2030. In a 2012 report of Orthopaedic Industry, and the global sales of joint replacement products exceeded $49.3 billion, with knees taking about half of them. The high financial burden of joint replacement surgery on health care system highlights the importance of cost containment without compromising the quality of patient care.

Clinical pathways for total joint arthroplasty can reduce care variability and improve the quality of care. Taiwan's Bureau of National Health Insurance (BNHI) has initiated a prospective payment system for TKA under diagnosis-related group (DRG) since 1997. It was found the length of hospital stay, and the medical expenditure could be reduced because standard clinical pathways were implemented in most hospitals. However, to optimize the results and meet with patients' expectation are more challenging currently than before because the length of hospitalization is markedly reduced and the standard care processes are accelerated. The accelerated programs for total joint arthroplasty are revolutionizing the standard clinical pathways. Patients can even be discharged from the hospital within one day after the surgery. While a successful joint replacement surgery depends on well-practiced clinical pathways delivered in a timely manner, patient's medical literacy should also have a significant impact for his or her recovery. Unfortunately, patients may acquire incorrect information from the internet or have unrealistic expectations before or during the hospitalization that may compromise the decision making and clinical results.

Recently, the emerging technologies of the electronic medical record and medical informatics have made challenges to the traditional healthcare models such as the clinical pathways. The integration of informatics technology also provides an opportunity to modernize the clinical pathways. But the effect of an interactive infotainment system on TKA is unknown. The purpose of this study was to analyze whether the implementation of an interactive infotainment system into a standard clinical pathway of TKA could influence the hospital course and the medical quality in an arthroplasty specialty ward.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admission to the hospital, scheduled for total joint replacement surgery
  • Sign informed consent form

Exclusion Criteria:

  • In-patient, not scheduled for total joint replacement surgery
  • Any psychological condition or other condition that may influence the study result

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard clinical pathway
A standard clinical pathway for TKA has been compulsively implemented for medical cost containment and quality assurance to meet with the Taiwan Diagnosis-Related Groups (TW-DRGs) payment system since 1997. The clinical pathway for TKA undertakes with preadmissions, anesthetic, surgery, and physiotherapy assessment. Medical, nursing, and physiotherapy assessment were put down for each postadmission day. The time from admission to surgery, the use of intravenous antibiotics injection and intravenous fluid were all assessed. Discharge criteria were active knee flexion to 90 degrees, having the ability to walk with aids and clean wound condition with any infection sign. The pathway was initially set for a 6-day postoperative length of stay.
Experimental: Patient Infotainment Terminal
Patients who have additional access to an integrated infotainment system and are cared by a standard clinical pathway. The patient infotainment system is a quasi-interactive computer program connected to a server that pushes messages and educational programs ordered from the caring physicians or on-demand by the patients. The server has parallel data exchange gateways to the Hospital Information System (HIS), Picture Archiving Communication System (PACS), and can record the patients' responses to surveys and questionnaires.
The patient infotainment system is a quasi-interactive computer program connected to a server that pushes messages and educational programs ordered from the caring physicians or on-demand by the patients. The server has parallel data exchange gateways to the Hospital Information System (HIS), Picture Archiving Communication System (PACS), and can record the patients' responses to surveys and questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: up to 10 days
in hospital stay (days)
up to 10 days
30-day return to emergency room
Time Frame: within 30 days after discharge
Patients who will return to the emergency room within 30 days after discharge
within 30 days after discharge
30-day readmission after discharge
Time Frame: within 30 days after discharge
Patients who will readmit within 30 days after discharge
within 30 days after discharge
90-day return to emergency room
Time Frame: within 90 days after discharge
Patients who will return to the emergency room within 90 days after discharge
within 90 days after discharge
90-day readmission after discharge
Time Frame: within 90 days after discharge
Patients who will readmit within 90 days after discharge
within 90 days after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
medical expenditure
Time Frame: up to 10 days
The total medical cost in the hospital
up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mel S Lee, MD,PhD, Chang Gung memorial hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2016

Primary Completion (Actual)

July 19, 2017

Study Completion (Actual)

March 7, 2018

Study Registration Dates

First Submitted

December 13, 2018

First Submitted That Met QC Criteria

December 24, 2018

First Posted (Actual)

December 28, 2018

Study Record Updates

Last Update Posted (Actual)

December 28, 2018

Last Update Submitted That Met QC Criteria

December 24, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 104-8598B

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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