NCT03788798

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
Last Updated

December 28, 2018

Status Verified

March 1, 2018

Enrollment Period

1.4 years

First QC Date

December 13, 2018

Last Update Submit

December 24, 2018

Conditions

Outcome Measures

Primary Outcomes (5)

  • Length of stay

    in hospital stay (days)

    up to 10 days

  • 30-day return to emergency room

    Patients who will return to the emergency room within 30 days after discharge

    within 30 days after discharge

  • 30-day readmission after discharge

    Patients who will readmit within 30 days after discharge

    within 30 days after discharge

  • 90-day return to emergency room

    Patients who will return to the emergency room within 90 days after discharge

    within 90 days after discharge

  • 90-day readmission after discharge

    Patients who will readmit within 90 days after discharge

    within 90 days after discharge

Secondary Outcomes (1)

  • medical expenditure

    up to 10 days

Study Arms (2)

Standard clinical pathway

NO INTERVENTION

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.

Patient Infotainment Terminal

EXPERIMENTAL

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

Interventions

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.

Patient Infotainment Terminal

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Mel S Lee, MD,PhD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2018

First Posted

December 28, 2018

Study Start

March 8, 2016

Primary Completion

July 19, 2017

Study Completion

March 7, 2018

Last Updated

December 28, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations