Health Information TechnologyVHRNCT01147328
Assessing the Impact of Health Information Exchange (HIE) on Healthcare Utilization
An observational study of Health Information Technology and Health Information Exchange, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial summary
The purpose of this study is to assess usage of the virtual health record (VHR), and determine the effects of this technology on healthcare utilization. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Information Technology, Health Information Exchange, Virtual Health Record
- What is being tested?
- Virtual Health Record (VHR)
- How many people
- 218,766 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2011to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with concurrent controls who have consented to have their clinical data viewed by their providers using the VHR portal provided by RHIOs. Providers who are participating in the Regional Health Information Exchange (RHIO).
Who may be able to join
- Patients that are aged 18 and older who have consented during the year 2009 to allow their provider use of their VHR data and had at least one visit to a healthcare provider that is a VHR user within 6 months after they consented to allow their provider use of their VHR data. (Note: we only wish to include individuals who have had the opportunity for their data to be viewed using the VHR web portal). Providers who are participating in the Regional Health Information Exchange (RHIO).
Who cannot join
- Patients and providers who do not meet the above criteria
Trial locations and contacts
3 sites in 1 country.
United States3 sites
HealtheLink
Buffalo, New York, 14225
Weill Medical College of Cornell University
New York, New York, 10065
Rochester RHIO
Rochester, New York, 14614
About this study
The purpose of this study is to assess usage of the virtual health record (VHR), and determine the effects of this technology on healthcare utilization.
Read the detailed description
National efforts are underway to support the implementation of technology that enables providers to electronically access and view community-wide clinical information for their patients, which has the potential to improve quality of care and reduce health care costs by providing timely and complete health information at the point of care. However, few empirical studies have been conducted to evaluate the economic effects of this technology. Along with other stakeholders, New York State is funding regional health information organizations (RHIOs) to deploy a virtual health record (VHR), which is technology that enables providers to electronically access community-wide clinical data for patients who have consented to have their clinical data accessed via a web portal. RHIOs bring together multiple stakeholders, including physician practices, hospitals, pharmacies, and laboratories, for the purpose of exchanging clinical information electronically across communities. The investigators will conduct a multi-RHIO retrospective pre-post, cohort study of adult patients who have consented to have their clinical data viewed by their providers using the VHR portal. Examining the effects of electronically accessing clinical data on healthcare utilization across multiple settings and communities can help inform the national health IT initiative that is underway and allow assessment of the economic value of these technologies.
- Conditions
- Health Information Technology, Health Information Exchange, Virtual Health Record, Health Care Utilization
- Being tested
- Virtual Health Record (VHR)
- Keywords
- Health information technology, Health information exchange, Virtual health record, Health care utilization
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Health Record (VHR)Other
Technology that enables providers to electronically access community-wide clinical data for patients who have consented to have their clinical data accessed via a web portal.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients who did not have their data accessed in the VHR by a provider within 6 months after they consented will be part of the control group Receives: Other: Virtual Health Record (VHR) | |
| 2 | Patients who had their data accessed in the VHR by a provider within 6 months after they consented will be part of the intervention group Receives: Other: Virtual Health Record (VHR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VHR Usage
Data from the VHR web portal database which records patient consent and provider usage of the web portal
Measured: 1 year
Changes in Healthcare Utilization
A retrospective set of claims data will be used to characterize healthcare utilization and describe the study population
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2011
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Information TechnologyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- 218,766 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Department of Health
- Responsible party
- Sponsor
- Investigators
- Lisa Kern, MD, MPH, Study chair, Weill Medical College of Cornell UniversityYolanda Barron, MS, Study chair, Weill Medical College of Cornell UniversityAlison Edwards, MStat, Study chair, Weill Medical College of Cornell UniversityRanjit Singh, MD, MA, MBA, Study chair, Weill Medical College of Cornell UniversityRenny Varghese, MPH, Study chair, Weill Medical College of Cornell UniversityVaishali Patel, PhD, MPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147328
- Sponsor's protocol ID
- 0708160258-08
- Acronym
- VHR
- Status last verified
- Aug 2018
- First submitted
- 16 Jun 2010
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Health Information Exchange (HIE) on Healthcare Utilization
- ClinicalTrials.gov ID
- NCT01147328
- Acronym / sponsor ID
- VHR / 0708160258-08
- Conditions
- Health Information Technology, Health Information Exchange, Virtual Health Record, Health Care Utilization
- Keywords
- Health information technology, Health information exchange, Virtual health record, Health care utilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218,766 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- New York State Department of Health
- Study start
- Jun 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess usage of the virtual health record (VHR), and determine the effects of this technology on healthcare utilization.
Detailed description
National efforts are underway to support the implementation of technology that enables providers to electronically access and view community-wide clinical information for their patients, which has the potential to improve quality of care and reduce health care costs by providing timely and complete health information at the point of care. However, few empirical studies have been conducted to evaluate the economic effects of this technology. Along with other stakeholders, New York State is funding regional health information organizations (RHIOs) to deploy a virtual health record (VHR), which is technology that enables providers to electronically access community-wide clinical data for patients who have consented to have their clinical data accessed via a web portal. RHIOs bring together multiple stakeholders, including physician practices, hospitals, pharmacies, and laboratories, for the purpose of exchanging clinical information electronically across communities. The investigators will conduct a multi-RHIO retrospective pre-post, cohort study of adult patients who have consented to have their clinical data viewed by their providers using the VHR portal. Examining the effects of electronically accessing clinical data on healthcare utilization across multiple settings and communities can help inform the national health IT initiative that is underway and allow assessment of the economic value of these technologies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Virtual Health Record (VHR)Patients who did not have their data accessed in the VHR by a provider within 6 months after they consented will be part of the control group |
| 2 | – | Other: Virtual Health Record (VHR)Patients who had their data accessed in the VHR by a provider within 6 months after they consented will be part of the intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with concurrent controls who have consented to have their clinical data viewed by their providers using the VHR portal provided by RHIOs. Providers who are participating in the Regional Health Information Exchange (RHIO).
Key inclusion criteria (1 listed)
- Patients that are aged 18 and older who have consented during the year 2009 to allow their provider use of their VHR data and had at least one visit to a healthcare provider that is a VHR user within 6 months after they consented to allow their provider use of their VHR data. (Note: we only wish to include individuals who have had the opportunity for their data to be viewed using the VHR web portal). Providers who are participating in the Regional Health Information Exchange (RHIO).
Key exclusion criteria (1 listed)
- Patients and providers who do not meet the above criteria
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 |
|---|---|---|
| Virtual Health Record (VHR)Technology that enables providers to electronically access community-wide clinical data for patients who have consented to have their clinical data accessed via a web portal. | Other | 1, 2 |
Primary outcome
VHR Usage
Time frame: 1 year
Data from the VHR web portal database which records patient consent and provider usage of the web portal
Changes in Healthcare Utilization
Time frame: 1 year
A retrospective set of claims data will be used to characterize healthcare utilization and describe the study population
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
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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.
Lisa Kern, MD, MPH study chair
Weill Medical College of Cornell University
Yolanda Barron, MS study chair
Weill Medical College of Cornell University
Alison Edwards, MStat study chair
Weill Medical College of Cornell University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Information Technology and Health Information Exchange, run by Weill Medical College of Cornell University at 3 sites 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 1 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VHR Usage (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2018.