Elderly; Renal InsufficiencyNCT00297869
Using Informatics to Enhance Care of Older Emergency Department Patients
A study testing Computer-Assisted Decision Support in people with Elderly; Renal Insufficiency, run by Indiana University at 1 site in United States.
Trial summary
The subjects in this study are physicians working in the Wishard Emergency Department. The purpose of this study is to measure the extent to which information technology (i.e.-computers) improves emergency department care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Elderly; Renal Insufficiency
- What is being tested?
- Computer-Assisted Decision Support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,350 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jun 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The subjects of this study will be physician providers and residents and medical students practicing under the supervision of a faculty emergency physician. Specific study subjects will include emergency medicine faculty physicians; emergency medicine and internal medicine residents; emergency medicine, surgery, and internal medicine interns; and medical students taking care of patients in our emergency department.
Who cannot join
- We will not include the members of the research team in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wishard Memorial Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Computer-Assisted Decision Support to Increase the Safety of Prescribing to Older Emergency Department Patients
The subjects in this study are physicians working in the Wishard Emergency Department. The purpose of this study is to measure the extent to which information technology (i.e.-computers) improves emergency department care. The objective of our study is to evaluate the use of informatics in the emergency department and specifically to determine if computer reminder systems: 1) reduce the number of unsafe medications prescribed to older adults, 2) assist in more safely dosing of medications to adults of all ages, and 3) increase influenza immunization of eligible older patients in the emergency department.
Interventions: The interventions in this study are computer reminders. When releasing patients from the emergency department, physicians currently write all release orders, including prescriptions, on a computer order entry system that is linked to the Regenstrief Medical Record System. The computerized order entry system will be programmed so that physicians randomized (randomly placed) into the intervention group, the group that will receive the intervention, they will receive one of three types of reminders:
Read more
- The medication prescribed is generally considered unsafe for use in older patients. The reminder will then list appropriate alternatives for this medication.
- The dose of the prescribed medication is excessive and should be adjusted for the patient's creatinine clearance (or kidney function).
- This patient may be eligible for influenza vaccination.
The physician will then choose to order or disregard the recommendation. The computer system will automatically record what the physician selected to do. The general outcome of interest is the extent to which the electronic reminders successfully improved physician practice in the emergency department setting. This outcome will be compared to physicians who were randomized to the group that did not receive the reminders (the control group).
- Conditions
- Elderly; Renal Insufficiency
- Being tested
- Computer-Assisted Decision Support
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted Decision SupportProcedure or surgery
Electronic warnings when providers prescribe a potentially inappropriate medication or an excessively dosed medication (based on estimated creatinine clearance)
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Experimental | Electronic warnings when providers prescribe a potentially inappropriate medication or an excessively dosed medication (based on estimated creatinine clearance) Receives: Procedure: Computer-Assisted Decision Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of older ED patients who receive a potentially inappropriate medication
Measured: During discharge home from the ED
Secondary outcomes (1)
Proportion of ED patients who receive an excessive dose of a medication that requires dosage adjustment for renal insufficiency
Measured: During discharge home from the ED
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study startJan 2005
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elderly; Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin M. Terrell, DO, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297869
- Sponsor's protocol ID
- 0311-04B
- Other IDs
- 2004 Jahnigen Career Award
- Status last verified
- Oct 2016
- First submitted
- 27 Feb 2006
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Terrell KM, Perkins AJ, Dexter PR, Hui SL, Callahan CM, Miller DK. Computerized decision support to reduce potentially inappropriate prescribing to older emergency department patients: a randomized, controlled trial. J Am Geriatr Soc. 2009 Aug;57(8):1388-94. doi: 10.1111/j.1532-5415.2009.02352.x. Epub 2009 Jun 22.
PubMed 19549022
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted Decision Support to Increase the Safety of Prescribing to Older Emergency Department Patients
- ClinicalTrials.gov ID
- NCT00297869
- Acronym / sponsor ID
- 0311-04B
- Conditions
- Elderly; Renal Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,350 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 1 Mar 2006 (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 subjects in this study are physicians working in the Wishard Emergency Department. The purpose of this study is to measure the extent to which information technology (i.e.-computers) improves emergency department care. The objective of our study is to evaluate the use of informatics in the emergency department and specifically to determine if computer reminder systems: 1) reduce the number of unsafe medications prescribed to older adults, 2) assist in more safely dosing of medications to adults of all ages, and 3) increase influenza immunization of eligible older patients in the emergency department.
Interventions: The interventions in this study are computer reminders. When releasing patients from the emergency department, physicians currently write all release orders, including prescriptions, on a computer order entry system that is linked to the Regenstrief Medical Record System. The computerized order entry system will be programmed so that physicians randomized (randomly placed) into the intervention group, the group that will receive the intervention, they will receive one of three types of reminders:
- The medication prescribed is generally considered unsafe for use in older patients. The reminder will then list appropriate alternatives for this medication.
- The dose of the prescribed medication is excessive and should be adjusted for the patient's creatinine clearance (or kidney function).
- This patient may be eligible for influenza vaccination.
The physician will then choose to order or disregard the recommendation. The computer system will automatically record what the physician selected to do. The general outcome of interest is the extent to which the electronic reminders successfully improved physician practice in the emergency department setting. This outcome will be compared to physicians who were randomized to the group that did not receive the reminders (the control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Experimental | Procedure: Computer-Assisted Decision SupportElectronic warnings when providers prescribe a potentially inappropriate medication or an excessively dosed medication (based on estimated creatinine clearance) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The subjects of this study will be physician providers and residents and medical students practicing under the supervision of a faculty emergency physician. Specific study subjects will include emergency medicine faculty physicians; emergency medicine and internal medicine residents; emergency medicine, surgery, and internal medicine interns; and medical students taking care of patients in our emergency department.
Key exclusion criteria (1 listed)
- We will not include the members of the research team in this study.
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 |
|---|---|---|
| Computer-Assisted Decision SupportElectronic warnings when providers prescribe a potentially inappropriate medication or an excessively dosed medication (based on estimated creatinine clearance) | Procedure or surgery | 2 |
Primary outcome
Proportion of older ED patients who receive a potentially inappropriate medication
Time frame: During discharge home from the ED
1 secondary outcome
Proportion of ED patients who receive an excessive dose of a medication that requires dosage adjustment for renal insufficiency
Time frame: During discharge home from the ED
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Derived from this study: PubMed 19549022Terrell KM, Perkins AJ, Dexter PR, Hui SL, Callahan CM, Miller DK. Computerized decision support to reduce potentially inappropriate prescribing to older emergency department patients: a randomized, controlled trial. J Am Geriatr Soc. 2009 Aug;57(8):1388-94. doi: 10.1111/j.1532-5415.2009.02352.x. Epub 2009 Jun 22.
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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.
Kevin M. Terrell, DO, MS principal investigator
Indiana 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 Computer-Assisted Decision Support in people with Elderly; Renal Insufficiency, run by Indiana University at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 5 Oct 2016. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of older ED patients who receive a potentially inappropriate medication (time frame: During discharge home from the ED). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00297869, which also lists 1 linked publication.
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 5 Oct 2016.