ICON NAME PROTOCOL –DATE
TITLE
PRINCIPAL INVESTIGATOR:
NAME OF RESIDENT ADVISOR(S)
CO-INVESTIGATOR:
RESIDENT INVESTIGATOR:
NAME OF RESIDENT(S)
ICON SPONSOR:
LSU ICON PERSONNEL OVERSEEING PROJECT
BACKGROUND:
DESCRIPTION OF CLINICAL OR PUBLIC HEALTH PROBLEM
LITERATURE SEARCH IMPORTANT TO THE PROJECT WITH REFERENCES
RATIONALE:
BRIEF SUMMARY/DESCRIPTION OF PROJECT
The primary outcome of this retrospective observational study will be
SPECIFIC AIMS:
DETAILED IDENTIFICATION AND EXPLANATION OF THE SPECIFIC AREAS TO BE
ASSESSED/EVALUATED. THESE SHOULD CORRELATE TO THE STATISTICAL ANALYSIS
The study has the following specific aims:
AIM 1:
AIM 2:
AIM 3:
AIM 4:
AIM 5:
ELIGIBILITY:
CLEAR AND DETAILED IDENTIFICATION OF THE PATIENT POPULATION REQUIRED FOR
THE PROJECT. SHOULD INCLUDE AGE RANGE, DATES OF SERVICE, PATIENT
LOCATION/PROJECT SITES, DISEASE STATE OR DIAGNOSIS
Inclusion Criteria: Patients age 18 years and older who had visits to LSU HCSD Medical Home clinics
between January 1, 2004 and June 15, 2013.
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ICON NAME PROTOCOL –DATE
Exclusionary Criteria:
STATISTICAL ANALYSES:
DETAILED IDENTIFICATION AND EXPLANATION AS TO HOW THE DATA WILL BE
SECURED, REVIEWED AND ANALYZED
The analyses will be entirely retrospective and will use data extracted from the LSU HCSD DMED.
Analysis for Aim 1:
Analysis for Aim 2:
Analysis for Aim 3:
Analysis for Aim 4:
Analysis for Aim 5:
DATA:
EXPLANATION AS TO WHERE THE DATA IS LOCATED, WHO WILL
EXTRACT THE DATA, HOW THE DATA WILL BE PROTECTED/STORED
The LSU HCSD data warehouse contains the data required for this project The required data
will be compiled by the LSU ICON Medical Informatics Group. No overt patient identifiers will
be included in the extracted data (names, addresses, phone numbers, zip codes, email addresses,
medical record numbers or internal LSU HCSD patient numbers). Since the proposed project
may require linking of patient information, the LSU ICON Medical Informatics Group will add
artificial codes to the extracted files to support such linkages. These artificial codes will not be
directly derived from any actual identifier, but rather randomly assigned.
Since the de-identified data will be shared with the project personnel, a Data Use Agreement
(DUA) will be executed, after IRB approval, by those with access to the de-identified data. The
DUA serves as a legally binding contract between LSU HCSD and project personnel that all data
will be accessed only by those listed in the DUA. The DUA also states that the data is owned by
LSU HCSD and will be used only for the purposes stated in this protocol.
REFERENCES:
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