Elderly; Renal Insufficiency Clinical Trial
Official title:
Computer-Assisted Decision Support to Increase the Safety of Prescribing to Older Emergency Department Patients
| Verified date | October 2016 |
| Source | Indiana University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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:
1. The medication prescribed is generally considered unsafe for use in older patients. The
reminder will then list appropriate alternatives for this medication.
2. The dose of the prescribed medication is excessive and should be adjusted for the
patient's creatinine clearance (or kidney function).
3. 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).
| Status | Completed |
| Enrollment | 1350 |
| Est. completion date | June 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - We will not include the members of the research team in this study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Wishard Memorial Hospital | Indianapolis | Indiana |
| Lead Sponsor | Collaborator |
|---|---|
| Indiana University School of Medicine |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of older ED patients who receive a potentially inappropriate medication | During discharge home from the ED | Yes | |
| Secondary | Proportion of ED patients who receive an excessive dose of a medication that requires dosage adjustment for renal insufficiency | During discharge home from the ED | Yes |