Diabetes MellitusVLER-IHIENCT01446705

Evaluation of VLER-Indiana Health Information Exchange Demonstration Project

An observational study of Diabetes Mellitus and Asthma, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Diabetes Mellitus, Asthma, Cardiovascular Diseases
What is being tested?: Active Health Information Exchange and Non-Active Health Information exchange
How many people: 57,073 participants
Where: 1 siteUnited States
Study dates: Dec 2012to Jan 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Veteran's receiving care at the Indianapolis VAMC

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884

Other trials in United States

About this study

Official title: Evaluation of VLER_Indiana Health Information Exchange Demonstration Project

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.

Read the 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.

Conditions: Diabetes Mellitus, Asthma, Cardiovascular Diseases, Heart Failure, Osteoporosis
Being tested: Active Health Information Exchange, Non-Active Health Information exchange
Medical subject headings: Diabetes Mellitus, Asthma, Cardiovascular Diseases, Heart Failure, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active Health Information ExchangeOther
Patients selected to share data between the VA \& external healthcare agencies.
Non-Active Health Information exchangeOther
Patients not selecting to share data

Study groups in NCT01446705
Study group	Role	What they receive
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. Receives: Other: Non-Active Health Information exchange
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." Receives: Other: Active Health Information Exchange

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 years
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
Measured: 2 Years
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.
Measured: 3 years

Secondary outcomes (1)

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.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Jan 2016

First posted5 Oct 2011 (estimated)
Study startDec 2012
Primary completionJun 2015
Study completionJan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 57,073 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01446705
Sponsor's protocol ID: IIR 11-058
Acronym: VLER-IHIE
Status last verified: May 2019
First submitted: 27 Apr 2011
Last updated: 16 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 25833394
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 linkage tool in Chicago. J Am Med Inform Assoc. 2015 Sep;22(5):1072-80. doi: 10.1093/jamia/ocv038. Epub 2015 Jun 23.
PubMed 26104741
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. No abstract available.
PubMed 25869078
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.
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.
PubMed 26765453
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 6.
PubMed 27274014
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-0083.
PubMed 28197620
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.
PubMed 28271121

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of VLER_Indiana Health Information Exchange Demonstration Project
ClinicalTrials.gov ID: NCT01446705
Acronym / sponsor ID: VLER-IHIE / IIR 11-058
Conditions: Diabetes Mellitus, Asthma, Cardiovascular Diseases, Heart Failure, Osteoporosis
Study type: Observational
Recruitment status: Completed
Enrolment: 57,073 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: Regenstrief Institute, Inc.
Study start: Dec 2012
Primary completion: Jun 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 5 Oct 2011 (estimated)
Results: Posted 29 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
No Exchange	–	Other: Non-Active Health Information exchangePatients in this arm will represent Veterans seen at the Indianapolis VA Medical Center (VAMC) for whom information exchange has not been activated.
Enrolled in Exchange	–	Other: Active Health Information ExchangePatients 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."

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Veteran's receiving care at the Indianapolis VAMC

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active Health Information ExchangePatients selected to share data between the VA \& external healthcare agencies.	Other	Enrolled in Exchange
Non-Active Health Information exchangePatients not selecting to share data	Other	No Exchange

Primary outcome

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.
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
Health Care Quality: Affect of HIE on LDL Levels of Participants.
Time frame: 3 years
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.

1 secondary outcome

Health Care Quality: Care Sensitive Admissions
Time frame: 3 years

Results and safety

Results posted to the registry on 29 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Controls in Study (Not Enrolled in Health Care Exchange)	50,446	50,446
Patients Enrolled in HIE	6,627	6,627

Primary outcome: Understanding Utilization of Healthcare Procedures by Veterans According to Source of Data

Time frame: 2 years. Number. Unit: participants

Measure	Controls in Study (Not Enrolled in Health Care Exchange) n = 50446	Enrolled in HIE n = 6627
VA Data Only	41982	5073
Data in Both Sources	8358	1497
Data only in Outside Source	20	37
No Data	86	20

Population analysed: Veterans divided into enrolled and non-enrolled in HIE groups

Primary outcome: Effect of Health Information Exchange on Cost

Time frame: 2 Years. Median (Standard Deviation). Unit: $ per year unadjusted total VA cost

Measure	Controls in Study (Not Enrolled in Health Care Exchange) n = 45700	Enrolled in HIE n = 6104
Value	6,529 (9,153)	9,915 (12,386)

Population analysed: 5269 individuals were excluded due to lacking cost information.

Primary outcome: Health Care Quality: Affect of HIE on LDL Levels of Participants.

Time frame: 3 years. Least squares mean (95% Confidence Interval). Unit: mg/dL of LDL

Measure	Control Prior to Intervention n = 1445	Enrolled Prior to Intervention n = 338	Controls Post Intervention n = 1445	Enrolled Post Intervention n = 338
Value	86.308 (85.677 to 86.938)	85.263 (83.762 to 86.763)	83.957 (83.321 to 84.592)	82.640 (81.12 to 84.155)

Population analysed: These are diabetics within the cohort defined as being diagnosed, alive, and being aged 18-75. Specifically looking at LDL

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Controls in Study (Not Enrolled in Health Care Exchange)	0 of 50,446 (0%)	0 of 50,446 (0%)	Not reported
Patients Enrolled in HIE	0 of 6,627 (0%)	0 of 6,627 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25833394Dixon 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.
Results publication: PubMed 26104741Kho 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 linkage tool in Chicago. J Am Med Inform Assoc. 2015 Sep;22(5):1072-80. doi: 10.1093/jamia/ocv038. Epub 2015 Jun 23.
Results publication: PubMed 25869078French 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. No abstract available.
Results publicationByrne 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.
Results publicationDixon 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.
Results publication: PubMed 26765453French 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.
Results publication: PubMed 27274014Dixon 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 6.
Results publication: PubMed 28197620Dixon 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-0083.
Results publication: PubMed 28271121Nguyen 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.
Individual participant dataSharing planned: No

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David A Haggstrom, MD principal investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus and Asthma, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Understanding Utilization of Healthcare Procedures by Veterans According to Source of Data (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01446705, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.