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An Integrated Model of Intelligent Medical Service for Total Joint Replacement

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ClinicalTrials.gov Identifier: NCT03788798
Recruitment Status : Completed
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Health Knowledge, Attitudes, Practice Device: Patient infotainment system Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: An Integrated Model of Intelligent Medical Service for Total Joint Replacement
Actual Study Start Date : March 8, 2016
Actual Primary Completion Date : July 19, 2017
Actual Study Completion Date : March 7, 2018

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.
Device: Patient infotainment system
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.




Primary Outcome Measures :
  1. Length of stay [ Time Frame: up to 10 days ]
    in hospital stay (days)

  2. 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

  3. 30-day readmission after discharge [ Time Frame: within 30 days after discharge ]
    Patients who will readmit within 30 days after discharge

  4. 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

  5. 90-day readmission after discharge [ Time Frame: within 90 days after discharge ]
    Patients who will readmit within 90 days after discharge


Secondary Outcome Measures :
  1. medical expenditure [ Time Frame: up to 10 days ]
    The total medical cost in the hospital



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788798


Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 83301
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Mel S Lee, MD,PhD Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03788798     History of Changes
Other Study ID Numbers: 104-8598B
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No