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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01446705
Other study ID # IIR 11-058
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2012
Est. completion date January 2016

Study information

Verified date May 2019
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 57073
Est. completion date January 2016
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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:

None

Study Design


Intervention

Other:
Active Health Information Exchange
Patients selected to share data between the VA & external healthcare agencies.
Non-Active Health Information exchange
Patients not selecting to share data

Locations

Country Name City State
United States Richard L. Roudebush VA Medical Center, Indianapolis, IN Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
VA Office of Research and Development Regenstrief Institute, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

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 progra

Dixon BE, Barboza K, Jensen AE, Bennett KJ, Sherman SE, Schwartz MD. Measuring Practicing Clinicians' Information Literacy. An Exploratory Analysis in the Context of Panel Management. Appl Clin Inform. 2017 Feb 15;8(1):149-161. doi: 10.4338/ACI-2016-06-RA — View Citation

Dixon BE, Haggstrom DA, Weiner M. Implications for informatics given expanding access to care for Veterans and other populations. J Am Med Inform Assoc. 2015 Jul;22(4):917-20. doi: 10.1093/jamia/ocv019. Epub 2015 Mar 31. — View Citation

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.

Dixon BE, Ofner S, Perkins SM, Myers LJ, Rosenman MB, Zillich AJ, French DD, Weiner M, Haggstrom DA. Which veterans enroll in a VA health information exchange program? J Am Med Inform Assoc. 2017 Jan;24(1):96-105. doi: 10.1093/jamia/ocw058. Epub 2016 Jun — View Citation

French DD, Dixon BE, Perkins SM, Myers LJ, Weiner M, Zillich AJ, Haggstrom DA. Short-Term Medical Costs of a VHA Health Information Exchange: A CHEERS-Compliant Article. Medicine (Baltimore). 2016 Jan;95(2):e2481. doi: 10.1097/MD.0000000000002481. — View Citation

French DD, Margo CE, Campbell RR. Enhancing postmarketing surveillance: continuing challenges. Br J Clin Pharmacol. 2015 Oct;80(4):615-7. doi: 10.1111/bcp.12658. Epub 2015 Jun 1. — View Citation

Kho AN, Cashy JP, Jackson KL, Pah AR, Goel S, Boehnke J, Humphries JE, Kominers SD, Hota BN, Sims SA, Malin BA, French DD, Walunas TL, Meltzer DO, Kaleba EO, Jones RC, Galanter WL. Design and implementation of a privacy preserving electronic health record — View Citation

Nguyen KA, Haggstrom DA, Ofner S, Perkins SM, French DD, Myers LJ, Rosenman M, Weiner M, Dixon BE, Zillich AJ. Medication Use among Veterans across Health Care Systems. Appl Clin Inform. 2017 Mar 8;8(1):235-249. doi: 10.4338/ACI-2016-10-RA-0184. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Understanding Utilization of Healthcare Procedures by Veterans According to Source of Data 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 years
Primary Effect of Health Information Exchange on Cost 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 2 Years
Primary Health Care Quality: Affect of HIE on LDL Levels of Participants. This study will measure the impact of HIE upon health care quality the underuse of ambulatory care services for diabetics. 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. In this specific instance, we expect the LDL levels to reflect lower numbers among diabetics due to greater health management via information sharing. 3 years
Secondary Health Care Quality: Care Sensitive Admissions 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. 3 years
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