Evaluating the Impact on Quality and Costs of Regional Cl... | NCT00571376

Studies
Evaluating the Impact on Quality and Costs of Regional Clinical Data Exchange Programs in New York State

NCT00571376

Sponsor

Weill Medical College of Cornell University

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

218,766Actual

Phase

Not provided

Conditions

Quality of Health Care
Health Care Costs

Interventions

Health information technology and exchange

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009Actual

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Dec 11, 2007

First Submission Date that Met QC Criteria

Dec 11, 2007

First Posted Date

Dec 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2017

Last Update Posted Date

Feb 23, 2017Actual

Name	Class
The Commonwealth Fund	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

218,766Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Those exposed to health information technology or health information exchange	Other: Health information technology and exchange
2		Those not exposed to health information technology or health information exchange

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Health information technology and exchange	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital admissions		2 years
Hospital re-admissions		2 years
Repeat medical imaging		2 years

Secondary Outcomes

Measure	Description	Time Frame
Usage of health information technology and health information exchange		2 years
Changes in health care quality		2 years
Changes in patient safety

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients and health care providers participating in regional health information organizations or their affiliate institutions.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients and health care providers in the Rochester, NY community

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rainu Kaushal, MD, MPH	Weill Medical College of Cornell University	Principal Investigator
Lisa M Kern, MD, MPH	Weill Medical College of Cornell University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rochester RHIO		Rochester	New York	14614	United States