Radiographic Contrast Agent NephropathyNCT01778140
Comparing Effects of Patient-specific Versus Non-patient-specific Computerized Reminder System
A study testing Patient-specific computerized reminder and Non-patient-specific computerized reminder in people with Radiographic Contrast Agent Nephropathy, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiographic Contrast Agent Nephropathy
- What is being tested?
- Patient-specific computerized reminder and Non-patient-specific computerized reminder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Our intervention targets are physicians but not patients. All physicians working in the hospital may join this trial.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Radiographic Contrast Agent Nephropathy
- Being tested
- Patient-specific computerized reminder, Non-patient-specific computerized reminder
- Keywords
- Clinical Decision Support Systems, Contrast-induced nephropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-specific computerized reminderOther
Also called Patient-specific CDSS
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 reminderOther
Also called Non-patient-specific CDSS
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient-specific reminder | Experimental | 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. Receives: Other: Patient-specific computerized reminder |
| Non-patient-specific reminder | Active comparator | 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. Receives: Other: Non-patient-specific computerized reminder |
| Control Arm | No intervention | The physicians assigned to this arm will not use and any computerized reminder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Physicains who participated in this trial will be followed for an expected average of 12 months
Secondary outcomes (1)
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.
Measured: Physicains who participated in this trial will be followed for an expected average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionJul 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiographic Contrast Agent NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Yu-Chuan Li, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778140
- Sponsor's protocol ID
- NSC100-2320-B-038-034
- Status last verified
- Feb 2013
- First submitted
- 26 Dec 2012
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Comparing Effects of Patient-Specific Versus Non-Patient-Specific Computerized Reminder System to Reduce Contrast-Induced Nephropathy
- ClinicalTrials.gov ID
- NCT01778140
- Acronym / sponsor ID
- NSC100-2320-B-038-034
- Conditions
- Radiographic Contrast Agent Nephropathy
- Keywords
- Clinical Decision Support Systems, Contrast-induced nephropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient-specific reminder | Experimental | Other: Patient-specific computerized reminderIntervention: 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. |
| Non-patient-specific reminder | Active comparator | Other: Non-patient-specific computerized reminderIntervention: 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. |
| Control Arm | No intervention | –The physicians assigned to this arm will not use and any computerized reminder. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Our intervention targets are physicians but not patients. All physicians working in the hospital may join this trial.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-specific computerized reminderAlso: Patient-specific CDSSThe 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 | Patient-specific reminder |
| Non-patient-specific computerized reminderAlso: Non-patient-specific CDSSThe 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 | Non-patient-specific reminder |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chuan Li principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-specific computerized reminder and Non-patient-specific computerized reminder in people with Radiographic Contrast Agent Nephropathy, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013; AzTrials last refreshed its copy on 30 Oct 2026.