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Evaluation of VLER-Indiana Health Information Exchange Demonstration Project (VLER-IHIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01446705
Recruitment Status : Completed
First Posted : October 5, 2011
Results First Posted : January 29, 2016
Last Update Posted : August 15, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

Three out of four Veterans receive a portion of their care from non-VA providers. On April 9, 2009, President Barack Obama directed the Department of Veterans Affairs and the Department of Defense to create the Virtual Lifetime Electronic Record (VLER). On August 2010, Secretary of Veterans Affairs Eric K. Shinseki visited Indianapolis, and after visiting with leaders from the VA Health Services Research & Development (HSR&D) Center of Excellence and the Regenstrief Institute, he made the following public comments regarding the latest partnership between the two institutions: "This new technology allows safer, more secure, and private access to electronic health information which, in turn, enhances our ability to continue providing Veterans with the quality care that they have earned."

This new technology refers to the VLER HEALTH program that the Indianapolis VA is now implementing in partnership with the Regenstrief Institute and Indiana Health Information Exchange (IHIE). This VA-IHIE demonstration project is intended to create the capacity for VA institutions to exchange health information with community partners.

Investigators from the VA HSR&D Center on Implementing Evidence-Based Practice are active collaborators in building and implementing this program. The VA-IHIE program provides the bi-directional exchange of health information between VA and non-VA providers. Based on our pilot study of linked VA-IHIE data, investigators are conducting an evaluation of the impact of the VA-IHIE demonstration project upon health care quality and cost of Veterans by taking advantage of the initiation of the implementation as a natural experiment.

Condition or disease Intervention/treatment
Diabetes Mellitus Asthma Cardiovascular Diseases Heart Failure Osteoporosis Other: Active Health Information Exchange Other: Non-Active Health Information exchange

Detailed Description:
This study will perform a pre-post evaluation of the VA-IHIE implementation, with a concurrent control group, among Veterans seen at the Indianapolis VA. Data on care received by Veterans will be obtained for one year before, and one year after, VA-IHIE enrollment. Patients will be recruited into the VA-IHIE program in a rolling manner over the course of a year, and thus will have different calendar intervals of follow-up. For purposes of evaluation, investigators will approach the VA-IHIE implementation as a patient-directed intervention given that additional information available from the exchange is available only on a patient-by-patient basis, i.e., a provider cannot use exchange information available for one patient in the care of another. Although the VA-IHIE program will be implemented at the site level, patients will be enrolled individually.

Study Design

Study Type : Observational
Actual Enrollment : 57073 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of VLER_Indiana Health Information Exchange Demonstration Project
Study Start Date : December 2012
Primary Completion Date : June 2015
Study Completion Date : January 2016
Groups and Cohorts

Group/Cohort Intervention/treatment
No Exchange
Patients in this arm will represent Veterans seen at the Indianapolis VA Medical Center (VAMC) for whom information exchange has not been activated.
Other: Non-Active Health Information exchange
Patients not selecting to share data
Enrolled in Exchange
Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to "opt-in."
Other: Active Health Information Exchange
Patients selected to share data between the VA & external healthcare agencies.

Outcome Measures

Primary Outcome Measures :
  1. Understanding Utilization of Healthcare Procedures by Veterans According to Source of Data [ Time Frame: 2 years ]
    Determining rates of usage of healthcare by veterans by source of data. This will clue us into any differences in utilization patterns between groups.

  2. Effect of Health Information Exchange on Cost [ Time Frame: 2 Years ]
    Before after analysis of the presence of health information exchange on costs within the VA healthcare system; Measure is cost, unadjusted, in dollars for the year post enrollment in the health information exchange

  3. Health Care Quality: Ambulatory Care Performance Measures [ Time Frame: 3 years ]
    This study will measure the impact of HIE upon health care quality the underuse of ambulatory care services. Measurements of underuse before and after implementation will detect improvements in the quality of care. To measure underuse, the study employs a measurement set that is sensitive to the potential effects and feasible for electronic data capture. 15 measures have been chosen, falling in the areas of prevention, diabetes, asthma, cardiovascular disease, congestive heart failure, mental health and osteoporosis.

Secondary Outcome Measures :
  1. Health Care Quality: Care Sensitive Admissions [ Time Frame: 3 years ]
    This study will use the Agency for Healthcare Research and Quality's (AHRQ) Prevention Quality Indicators (PQI) to calculate the outcome measure. The PQIs are a set of measures used with hospital inpatient data to identify ambulatory care sensitive conditions. The PQIs consist of 14 conditions. The study will adopt 12 that are commonly used for adult patients: angina, asthma, bacterial pneumonia, chronic obstructive pulmonary disease, congestive heart failure, dehydration, diabetes long-term complications, diabetes short-term complications, diabetes uncontrolled, hypertension, lower-limb amputation among diabetes patients, and urinary infection.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Veteran's receiving care at the Indianapolis VAMC

Inclusion Criteria:

  • Veteran's receiving care at the Indianapolis VAMC at least one year prior and one year post VA-IHIE enrollment
  • Veteran's receiving care from a facility other than the Indianapolis VAMC one year prior and one year post VA-IHIE enrollment

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446705

United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
VA Office of Research and Development
Regenstrief Institute, Inc.
Principal Investigator: David A Haggstrom, MD Richard L. Roudebush VA Medical Center, Indianapolis, IN
More Information

Byrne C, Hunolt E, Bouhaddou O, Pan E, Botts NE, Mercincavage L, Olinger L, Banty K, Bennett J, Weiner M, Haggstrom DA, Cromwell T. Performance evaluation framework for the Virtual Lifetime Electronic Record (VLER) health information exchange pilot program. AMIA ... Annual Symposium proceedings / AMIA Symposium. AMIA Symposium. 2013 Nov 16; 1(1):162.
Dixon BE, Miller T, Overhage JM. Barriers to achieving the last mile in health information exchange: A survey of small hospitals and physician practices. Jounal of Healthcare Information Management. 2013 Oct 3; 27(4):53-58.

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01446705     History of Changes
Other Study ID Numbers: IIR 11-058
First Posted: October 5, 2011    Key Record Dates
Results First Posted: January 29, 2016
Last Update Posted: August 15, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases