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Comparing Effects of Patient-specific Versus Non-patient-specific Computerized Reminder System

Primary Purpose

Radiographic Contrast Agent Nephropathy

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Patient-specific computerized reminder
Non-patient-specific computerized reminder
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Radiographic Contrast Agent Nephropathy focused on measuring Clinical Decision Support Systems, Contrast-induced nephropathy

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Our intervention targets are physicians but not patients. All physicians working in the hospital may join this trial.

Exclusion Criteria:

  • The physician who never orders a CT scan or IVU study will be excluded
  • The physician who never operates the CPOE by himself or herself will be excluded

Sites / Locations

  • Taipei medical university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Patient-specific reminder

Non-patient-specific reminder

Control Arm

Arm Description

Intervention: Patient-specific computerized reminder. The physicians assigned to this arm will use the patient-specific CDSS on CPOE. The patient-specific reminder is designed as a real-time CDSS implemented on CPOE to monitor physician's contrast-enhanced image study orders. Computerized pop-up reminders provide the patient-specific CIN risk profile and optimal decision options which are generated when patients with high risk or with unknown risk of CIN are encountered.

Intervention: Non-patient-specific Computerized reminder. The physicians assigned to this arm will use the Non-patient-specific reminders through CPOE. Non-patient-specific reminders always pops up to remind physicians to check their patient's CIN risk no matter what CIN risk is.

The physicians assigned to this arm will not use and any computerized reminder.

Outcomes

Primary Outcome Measures

The percentage of contrast-enhanced imaging(CEI) orders with high CIN risk
The number of CEI ordered for patients at high CIN risk, divided by the total number of CEI orders. [CEI]: contrast-enhanced image studies,such as CT or IVU. [CIN]: contrast-induced nephropathy

Secondary Outcome Measures

The order elimination rate of high CIN risk orders attributed to the computerized reminder
The number of CEI orders with high CIN risk cancelled by the physician attributed to our computerized reminder, divided by the total number of CEI orders with high CIN risk.

Full Information

First Posted
December 26, 2012
Last Updated
February 5, 2013
Sponsor
Taipei Medical University
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01778140
Brief Title
Comparing Effects of Patient-specific Versus Non-patient-specific Computerized Reminder System
Official Title
Randomized Controlled Trial: Comparing Effects of Patient-Specific Versus Non-Patient-Specific Computerized Reminder System to Reduce Contrast-Induced Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators hypothesize that a Clinical Decision Support System (CDSS) designed with "Patient-Specific" reminders yields superior performance than that with "Non-patient-specific" reminders in preventing contrast-induced nephropathy.
Detailed Description
We hypothesize that a clinical decision support system (CDSS) designed with "Patient-specific" reminders yields superior performance than that with "Non-patient-specific" reminders in preventing contrast-induced nephropathy. A 3-arm randomized controlled trial (RCT) will be performed by cluster randomization using physicians as the unit of allocation. Physicians in 3 university medical centers will be randomly assigned into 1) patient-specific arm with Anti Contrast-Induced-Nephropathy(Anti-CIN) reminder, 2) non-patient-specific reminder arm, and 3) the control arm without any reminders, respectively. The patient-specific alert, Anti-CIN system, is designed as a real-time CDSS implementation on CPOE for monitoring physician's contrast-enhanced CT and IVP orders. Computerized pop-up reminders provide the patient-specific encounters with optimal decision options when patients are at a high CIN risk or patients with unknown risk factors are encountered. Non-patient-specific reminders always pop up no matter whether the patient is at a high risk or not.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiographic Contrast Agent Nephropathy
Keywords
Clinical Decision Support Systems, Contrast-induced nephropathy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient-specific reminder
Arm Type
Experimental
Arm Description
Intervention: Patient-specific computerized reminder. The physicians assigned to this arm will use the patient-specific CDSS on CPOE. The patient-specific reminder is designed as a real-time CDSS implemented on CPOE to monitor physician's contrast-enhanced image study orders. Computerized pop-up reminders provide the patient-specific CIN risk profile and optimal decision options which are generated when patients with high risk or with unknown risk of CIN are encountered.
Arm Title
Non-patient-specific reminder
Arm Type
Active Comparator
Arm Description
Intervention: Non-patient-specific Computerized reminder. The physicians assigned to this arm will use the Non-patient-specific reminders through CPOE. Non-patient-specific reminders always pops up to remind physicians to check their patient's CIN risk no matter what CIN risk is.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
The physicians assigned to this arm will not use and any computerized reminder.
Intervention Type
Other
Intervention Name(s)
Patient-specific computerized reminder
Other Intervention Name(s)
Patient-specific CDSS
Intervention Description
The intervention targets are physicians,not patients. This CDSS alerts physicians only when the patient with high risk of contrast-induced-nephropathy(CIN) is encountered. On the contrast, the CDSS will not alert when the patient without CIN risk is encountered.
Intervention Type
Other
Intervention Name(s)
Non-patient-specific computerized reminder
Other Intervention Name(s)
Non-patient-specific CDSS
Intervention Description
The non-patient-specific computerized reminder always pops up to remind physicians to check their patient's CIN risk no matter what CIN risk is.
Primary Outcome Measure Information:
Title
The percentage of contrast-enhanced imaging(CEI) orders with high CIN risk
Description
The number of CEI ordered for patients at high CIN risk, divided by the total number of CEI orders. [CEI]: contrast-enhanced image studies,such as CT or IVU. [CIN]: contrast-induced nephropathy
Time Frame
Physicains who participated in this trial will be followed for an expected average of 12 months
Secondary Outcome Measure Information:
Title
The order elimination rate of high CIN risk orders attributed to the computerized reminder
Description
The number of CEI orders with high CIN risk cancelled by the physician attributed to our computerized reminder, divided by the total number of CEI orders with high CIN risk.
Time Frame
Physicains who participated in this trial will be followed for an expected average of 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Our intervention targets are physicians but not patients. All physicians working in the hospital may join this trial. Exclusion Criteria: The physician who never orders a CT scan or IVU study will be excluded The physician who never operates the CPOE by himself or herself will be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Chuan Li
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei medical university hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Comparing Effects of Patient-specific Versus Non-patient-specific Computerized Reminder System

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