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

Radiographic Contrast Agent Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01778140
• Other study ID #: NSC100-2320-B-038-034
• Status: Active, not recruiting
• Phase: N/A
• First received: December 26, 2012
• Last updated: February 5, 2013
• Start date: January 2012
• Est. completion date: August 2013

Study information

• Verified date: February 2013
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Kidney Diseases
• Radiographic Contrast Agent Nephropathy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Taipei medical university hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes