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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Taipei Medical University
ClinicalTrials.gov Identifier:
NCT01778140
First received: December 26, 2012
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Radiographic Contrast Agent Nephropathy
Other: Patient-specific computerized reminder
Other: Non-patient-specific computerized reminder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Randomized Controlled Trial: Comparing Effects of Patient-Specific Versus Non-Patient-Specific Computerized Reminder System to Reduce Contrast-Induced Nephropathy

Further study details as provided by Taipei Medical University:

Primary Outcome Measures:
  • The percentage of contrast-enhanced imaging(CEI) orders with high CIN risk [ Time Frame: Physicains who participated in this trial will be followed for an expected average of 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Physicains who participated in this trial will be followed for an expected average of 12 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 90
Study Start Date: January 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Non-patient-specific CDSS
No Intervention: Control Arm
The physicians assigned to this arm will not use and any 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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01778140

Locations
Taiwan
Taipei medical university hospital
Taipei, Taiwan, 110
Sponsors and Collaborators
Taipei Medical University
National Science Council, Taiwan
Investigators
Principal Investigator: Yu-Chuan Li Taipei Medical University
  More Information

No publications provided

Responsible Party: Taipei Medical University
ClinicalTrials.gov Identifier: NCT01778140     History of Changes
Other Study ID Numbers: NSC100-2320-B-038-034
Study First Received: December 26, 2012
Last Updated: February 5, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University:
Clinical Decision Support Systems
Contrast-induced nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014