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

Randomized Controlled Trial: Comparing Effects of Patient-Specific Versus Non-Patient-Specific Computerized Reminder System to Reduce Contrast-Induced Nephropathy

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.

Study Overview

• Status: Unknown
• Conditions: Radiographic Contrast Agent Nephropathy
• Intervention / Treatment: Other: Patient-specific computerized reminder; Other: Non-patient-specific computerized reminder

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient-specific reminder; 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.	Other: Patient-specific computerized reminder; 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.; Other Names: Patient-specific CDSS
Active Comparator: Non-patient-specific reminder; 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.	Other: Non-patient-specific computerized reminder; 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.; Other Names: Non-patient-specific CDSS
No Intervention: Control Arm; The physicians assigned to this arm will not use and any computerized reminder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Physicains who participated in this trial will be followed for an expected average of 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Physicains who participated in this trial will be followed for an expected average of 12 months

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: National Science Council, Taiwan
• Investigators: Principal Investigator: Yu-Chuan Li, Taipei Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: December 26, 2012
• First Submitted That Met QC Criteria: January 24, 2013
• First Posted (Estimate): January 29, 2013

Study Record Updates

• Last Update Posted (Estimate): February 6, 2013
• Last Update Submitted That Met QC Criteria: February 5, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Contrast-induced nephropathy; Clinical Decision Support Systems
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: NSC100-2320-B-038-034