HIPKey Generation

Demographics

Arrival/Discharge

Q:  If the subject goes to the CDU/Observation Unit from the ED, is this considered an admission?
A:   Technically, CDU and chest pain units (or any observation status for that matter) are not considered admissions by CMS. The definition is based on the status that the transfer occurs. It is not a geographical consideration, as you can admit a patient to any hospital ward as observation status and they aren't considered an admission. So if it is observation status, it’s considered an outpatient visit, no matter where the patient is in the hospital.

Q:  In Arrival/Discharge, if the patient wasn’t admitted, why do we have to enter number of days in ICU, discharge date, etc?
A:  All questions require an answer, except for date admitted. This will be resolved with the next changes made to InSpire.

Q:  Will there be a calculation error if the patient arrived at 11pm on day 1, and was discharged at 1am on day 2?  Will that be calculated as one day in the hospital, even thought he patient as actually only there for 2 hours?
A:  There is no time captured for admission or discharge; there is no automated calculation for this.  We capture time of ED arrival and time of ED disposition decision (Primary Endpoint).  We ask for “# days” in ICU, CCU or Telemetry.  The definition for “day” is wherever that patient was at midnight.

Q:  I am being asked on the Arrival/Discharge page asking me if the patient died after being admitted to the hospital after I answered that the patient was discharged from the hospital.  What should I do?
A:  Just close the query.  This will be resolved with the next changes made to InSpire.

Q:  How do I record if a subject has both private insurance and Medicare?  
A:  Enter the primary insurance - in most cases if the subject has Medicare and a secondary insurance, the Medicare is the primary.   

Signs and Symptoms

Q:  When entering temperature, why do we have to round to a whole number for Celsius?  Can’t we add a single decimal point to the entry screen (since this is typical clinical practice)?  If the study wants to round, we can have that done in the background, but this would make coordinator entry easier. 
A:  With the next change made to the InSpire system, a decimal point will be added to the temperature.

Q:  If there are discordant records (the ED note resident note says one thing, but the admission history and physical written by the Cardiology resident contradicts it), which one should we use? 
A:  Please enter the ED note.

Q:  Not all of our subjects have the onset of ischemic symptoms time recorded.  We have been putting 00:00 as the time -- is this OK? 
A:  No.  Please estimate a time that is closest to the time that the symptoms occurred.  Does the chart note how many hours ago the chest pain started?  If so, please estimate using this time.  You could also use the time that the subject called 911 or decided to come into the ED.  If the symptoms are stuttering then use the time that the symptoms became severe.

Q:  What if the time that the symptoms started is not recorded anywhere in the records?  What time should we enter for the onset of the ischemic event?
A:  Add approximately 1 hour to the time that the subject arrived in the ED.

Cardiopulmonary Exam

Q:  If there are discordant records (the ED note resident note says one thing, but the admission history and physical written by the Cardiology resident contradicts it), which one should we use? 
A:  Please enter the ED note.

 

Medical History

Emergency Department Laboratory Assessments

Q:  How should we enter troponin results of <0.01, since I have not found a way to display this?
A:  Enter “0.01” for results that are < 0.01 since you would be unable to enter the < sign.

Q:  We had a subject with a troponin of 18 that we couldn't enter.  Is there a restriction on what values are acceptable?  What should we do in cases like this in the future? 
A:  We are aware that there is a problem with entering the troponin.  This will be changed in the neat future when we revise the InSpire system.  Please leave this blank for the time being.

Q:  If the Troponin results are <0.50 how should it be entered?
A:  Enter “0.05” on the Lab page since you can not enter the “<” sign.

12 Lead Electrocardiogram

Q:  Do you want the initial or the second ECG recorded on the 12 Lead ECG page?
A:  We would like all ECGs that were done in the ED.  On the ECG form, on the left, under “FORMS,” there is an “add” button.  Click on that and you get another ECG form.  You can actually put in as many ECGs as you have for each patient.

PRIME ECG

Q:  The PRIME ECG page asks for a rhythm but that information is not included in the PRIME printout.
A:  Please resolve this by either entering the rhythm from the standard ECG or answering the query by saying that there is no data/that information is not available.  Other information on this page should be answered with "yes" or "no" depending on if it is documented on the PRIME printout.  This will be resolved with future InSpire changes.

Q:  The Diagnostic Categorization of the PRIME ECG on the Inspire does not match the options that are available on the printout which are "Normal", "Abnormal", or "Acute MI". 
A:  Please give the best answer based on the answers in the Additional Indications on the PRIME printout.  If nothing matches the choices, then answer the query with the best answer.  This will be changed as well with the future InSpire changes.

Concurrent Meds

Q:  I have a patient that is on home Hydralazine.  Where should this be entered on the Concurrent Meds page?
A:  There is no drug category for this medication.  Since this is a registry, not all medications will be captured.

Disposition

Diagnosis

Q:  How should the diagnosis of CAD be captured on the Diagnosis Page of InSpire?
A:  Choose the most appropriate diagnosis “ACS-Unstable Angina” or “No Definitive Diagnosis, Discharged for Out Patient Evaluation”.  There will be other choices added to the diagnosis page in the future:  “Other Cardiac Diagnosis” and “Stable Angina”.

Q:  We are having some trouble with the ED discharge diagnosis options (unknown; non-cardiac diagnosis; no definitive diagnosis, discharged for outpatient evaluation; no definitive diagnosis, not discharged (kept for additional testing); ACS (unstable angina); NSTEMI; STEMI).  Most of our ED chest pain patients are discharged from the ED to the hospital with a diagnosis of "Chest pain. 12 lead EKG performed." (which means that the subject was admitted to the hospital for a cardiac workup).  What should we choose for those subjects? 
A:  Enter the choice:  "no definitive diagnosis not discharged (kept for additional testing)".  There will be other choices added to the diagnosis page in the future:

Q:  If a subject's hospital discharge diagnosis is "Chest pain, not otherwise specified" should that be recorded as non-cardiac diagnosis? 
A:  Enter:  "discharged for outpatient evaluation; no definitive diagnosis" OR “Unknown" whichever is most appropriate.  There will be other choices added to the diagnosis page in the future:

Imaging

Q:  Should the SPECT MPI be results from a specific machine, or are similar procedures ok?
A:  The SPECT MPI would be for documenting any nuclear stress tests done using thallium, sestamibi or Myoview on any piece of equipment.

Q:  If they have cardiac testing done within 30 days of the enrollment visit (on an ED visit or hospitalization other than the initial visit), should we record it in the CRF? 
A:  Yes if the testing was scheduled as a result of this episode of chest pain.

Q:  Should we only use echocardiograms done as part of a stress test?  
A:  No.   Any echocardiogram that was done can be entered.

Q:  The echo results (Ischemia, Scar, Non-diagnostic, and Normal) are not well suited to resting echos that are done for reasons other than as a stress test. 
A:  Use the best option.

Coronary CT

Q:  If they have cardiac testing done within 30 days of the enrollment visit (on an ED visit or hospitalization other than the initial visit), should we record it in the CRF? 
A:  Yes if the testing was scheduled as a result of this episode of chest pain.

Cardiac Catheterization

Q:  How do we get past the EF on the cardiac catheterization page when the patient doesn't have EF results?
A:  We are aware that there is a query that is being generated on the cardiac cath page when this is not entered.  This will be resolved in the near future when InSpire is revised.  For the present please close the query that is generated in this way:  Click on the query view tab at the bottom of the page and answer the query with "The EF was not done".  There is a check box for query review to the left of the word "Resolve".  Place a check in the box and then submit and this will resolve the issue.

Q:  If they have cardiac testing done within 30 days of the enrollment visit (on an ED visit or hospitalization other than the initial visit), should we record it in the CRF? 
A:  Yes if the testing was scheduled as a result of this episode of chest pain.

Q:  On the Cardiac Cath page -- We don't have time of sheath insertion available to us with the medical record, so we will be getting these approx. 1 month after initial data entry.  For now we put 00:00, is that OK? 
A:  No.  Wait until you have all information before completing the page.

Mortality Status

Miscellaneous

Q:  Can I use another patient that meets the inclusion criteria and delete an entry that was created if I cannot complete all CRF pages of InSpire?
A:  Once a casebook is created, the data cannot be deleted. You will have to keep the original subject and complete as much as possible.

Q:  Can we use Day/Month/Year instead of Month/Day/Year for date entries since it seems to increase the odds of error for entry?  
A:  No.  The date convention used is standard for most trials.  This is how InSpire has been set up.

Q:  When entering the date, can’t we just enter “08” instead of having to enter “2008”?  
A:  No.  The date convention used is standard for most trials.  This is how InSpire has been set up.
Q:  When entering time, can’t we just enter 4 numbers (rather than having to enter the colon as well)?
A:  No.  This is how InSpire has been set up.

Q:  Can I enter the same subject more than once in the InSpire system?
A:  If the same patient had more than 1 ED visit for chest pain, they can be entered more than once.  Check to be sure that the date and time of arrival at the ED are different.

Q:  Our institution uses cardiac MRI and there is no place to record these results in the CRF. 
A:  That is correct; we are not collecting that information.