Quality of Health CareNCT00571376
Evaluating the Impact on Quality and Costs of Regional Clinical Data Exchange Programs in New York State
An observational study of Quality of Health Care and Health Care Costs, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to measure the financial effects of health information technology and health information exchange in regional health information organizations in New York State. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Quality of Health Care, Health Care Costs
- What is being tested?
- Health information technology and exchange
- How many people
- 218,766 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients and health care providers in the Rochester, NY community
Who may be able to join
- Patients and health care providers participating in regional health information organizations or their affiliate institutions.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to measure the financial effects of health information technology and health information exchange in regional health information organizations in New York State.
Read the detailed description
In 2004, the federal government set an ambitious goal of ensuring that most Americans have electronic health records within 10 years and the presence of a widespread clinical information exchange capability will greatly facilitate this goal. Through HEAL NY, New York State is currently awarding millions of dollars in grants to support health information technology initiatives across the state through regional clinical information exchanges. The financial success of these initiatives is expected to result from improvements in health care quality and efficiency. However, whether these initiatives will be cost saving, as experts assert, and what the return-on-investments of these initiatives will be are unknown. Answering these questions will provide critical information to the nation as we progress towards a national health information network. We will conduct a multi-center financial evaluation of regional clinical information exchanges. The results of the financial evaluations proposed in this study will provide a framework and standardized methodology including metrics for financial evaluations of regional health information organizations and return-on-investment analyses from the perspectives of providers and payers. We will consider the financial effects as driven by changes in quality, safety, and efficiency.
The most advanced community we studied was Rochester, NY, and studying this community allowed us to measure the effects of health information technology and health information exchange on 3 major utilization outcomes (hospital admissions, hospital re-admissions, and repeat medical imaging).
- Conditions
- Quality of Health Care, Health Care Costs
- Being tested
- Health information technology and exchange
- Keywords
- Quality of health care, Health care costs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health information technology and exchangeOther
Health information technology includes electronic health records, electronic prescribing, and electronic results notification and/or viewers. Health information exchange includes use of central repositories of data and peer-to-peer models.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Those exposed to health information technology or health information exchange Receives: Other: Health information technology and exchange | |
| 2 | Those not exposed to health information technology or health information exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admissions
Measured: 2 years
Hospital re-admissions
Measured: 2 years
Repeat medical imaging
Measured: 2 years
Secondary outcomes (4)
Usage of health information technology and health information exchange
Measured: 2 years
Changes in health care quality
Measured: 2 years
Changes in patient safety
Measured: 2 years
Changes in health care efficiency
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Health CareStudies 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
- Prospective
- Enrolment
- 218,766 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- The Commonwealth Fund
- Responsible party
- Sponsor
- Investigators
- Rainu Kaushal, MD, MPH, Principal investigator, Weill Medical College of Cornell UniversityLisa M Kern, MD, MPH, Study director, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571376
- Sponsor's protocol ID
- 20060550
- Status last verified
- Feb 2017
- First submitted
- 11 Dec 2007
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact on Quality and Costs of Regional Clinical Data Exchange Programs in New York State
- ClinicalTrials.gov ID
- NCT00571376
- Acronym / sponsor ID
- 20060550
- Conditions
- Quality of Health Care, Health Care Costs
- Keywords
- Quality of health care, Health care costs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218,766 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- The Commonwealth Fund
- Study start
- Jan 2009 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Dec 2007 (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 measure the financial effects of health information technology and health information exchange in regional health information organizations in New York State.
Detailed description
In 2004, the federal government set an ambitious goal of ensuring that most Americans have electronic health records within 10 years and the presence of a widespread clinical information exchange capability will greatly facilitate this goal. Through HEAL NY, New York State is currently awarding millions of dollars in grants to support health information technology initiatives across the state through regional clinical information exchanges. The financial success of these initiatives is expected to result from improvements in health care quality and efficiency. However, whether these initiatives will be cost saving, as experts assert, and what the return-on-investments of these initiatives will be are unknown. Answering these questions will provide critical information to the nation as we progress towards a national health information network. We will conduct a multi-center financial evaluation of regional clinical information exchanges. The results of the financial evaluations proposed in this study will provide a framework and standardized methodology including metrics for financial evaluations of regional health information organizations and return-on-investment analyses from the perspectives of providers and payers. We will consider the financial effects as driven by changes in quality, safety, and efficiency.
The most advanced community we studied was Rochester, NY, and studying this community allowed us to measure the effects of health information technology and health information exchange on 3 major utilization outcomes (hospital admissions, hospital re-admissions, and repeat medical imaging).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Health information technology and exchangeThose exposed to health information technology or health information exchange |
| 2 | – | –Those not exposed to health information technology or health information exchange |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients and health care providers in the Rochester, NY community
Key inclusion criteria (1 listed)
- Patients and health care providers participating in regional health information organizations or their affiliate institutions.
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 |
|---|---|---|
| Health information technology and exchangeHealth information technology includes electronic health records, electronic prescribing, and electronic results notification and/or viewers. Health information exchange includes use of central repositories of data and peer-to-peer models. | Other | 1 |
Primary outcome
Hospital admissions
Time frame: 2 years
Hospital re-admissions
Time frame: 2 years
Repeat medical imaging
Time frame: 2 years
4 secondary outcomes
Usage of health information technology and health information exchange
Time frame: 2 years
Changes in health care quality
Time frame: 2 years
Changes in patient safety
Time frame: 2 years
Changes in health care efficiency
Time frame: 2 years
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 23 Feb 2017.
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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.
Rainu Kaushal, MD, MPH principal investigator
Weill Medical College of Cornell University
Lisa M Kern, MD, MPH study director
Weill Medical College of Cornell University
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 Quality of Health Care and Health Care Costs, run by Weill Medical College of Cornell University 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 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 23 Feb 2017. 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?
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?
Hospital admissions (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?
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 23 Feb 2017.