Health Records, PersonalNCT01250288
Usage of Health Information Exchange (HIE) Technologies
An observational study of Health Records, Personal, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial summary
The purpose of this research study is to describe the usage of consumers and providers when using a novel technology designed to give consumers the ability to manage and access their health information. This is a quantitative descriptive analysis study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Records, Personal
- What is being tested?
- Personal Health Management System
- How many people
- 7,800 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2011to Oct 2012
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Consumers (patients and their proxies) and their healthcare providers who are being exposed to a novel interoperable personal health management system in the Brooklyn community.
Who may be able to join
- Consumers: Consumers (patients or their designated proxies)who are 18 years of age or older and who have registered for either BHIX's personal health record system or LIPIX's secure messaging system.
- Providers: Healthcare Providers who are authorized to view Health Information Exchange data of BHIX or LIPIX.
Who cannot join
- Anyone that does not fall into the above inclusion category.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brooklyn Health Information Exchange (BHIX)
Brooklyn, New York, 11219
Weill Cornell Medical College
New York, New York, 10065
Long Island Patient Information Xchange (LIPIX)
Rockville Centre, New York, 11570
About this study
Official title: Patient Adoption and Use of Health Information Exchange (HIE) Technologies
The purpose of this research study is to describe the usage of consumers and providers when using a novel technology designed to give consumers the ability to manage and access their health information. This is a quantitative descriptive analysis study.
Read the detailed description
New York State has awarded grants to several regional health information exchange organizations (RHIOs), organizations established to create the technical and policy infrastructure needed to exchange health data between providers, payers, and public health agencies within a particular geographic region, to build an interoperable system for people to manage their own health information. Two of these grant recipients are the Brooklyn Health Information Exchange (BHIX) and Long Island Patient Information Xchange (LIPIX).
Since no off-the shelf technology currently exists to create such a system, BHIX is working with a commercial vendor to develop a unique system that is tailored toward the needs of their consumers and providers, while LIPIX is developing their own unique system in-house. Both BHIX's and LIPIX's interoperable personal health management systems will offer various features to consumers and providers in their community. Consumers may be able to perform tasks such as viewing their lab results, scheduling an appointment, or sending a message directly to their physician through a SMS. Conversely, the PHR can also allow physicians to engage in communications with their patient, release data to their patient(s) (e.g. lab test result); and view patient inputted-data.
The usage patterns of these personal health managements systems is not well understood (Ralson et al., 2009; Kim et al., 2007). Understanding consumers and providers' use of these interoperable systems can help aid in improving current systems and developing future systems.
Specific Aims
The specific aims of this study are to describe the usage of BHIX's and LIPIX's novel interoperable personal health management systems, specifically:
- To quantify adoption of and frequency of use of novel technological platforms designed to give consumers (patients) access to RHIO-based health information exchange (HIE) data;
- To quantify usage of HIE-specific data elements within these platforms;
- To explore associations between usage and user demographics/clinical characteristics;
- To explore trends in usage over time.
- Conditions
- Health Records, Personal
- Being tested
- Personal Health Management System
- Keywords
- Health Information Technology, Health Records, Personal, Hospital Information Systems, Patient Access to Records, Medical Records, Medical Record Systems, Computerized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Health Management SystemOther
BHIX and LIPIX are offering novel personal health management system to members of its community. These community members, also referred to as consumers, will include patients \& their designated proxies. BHIX's system will allow patients to perform various tasks, including, but not limited to, viewing medications, medical allergies and lab results. LIPIX's system is primarily a mechanism forc consumers/patients to communicate directly with their physician through a secure messaging portal. Healthcare providers of these patients, who are affiliated with BHIX, will also be able to view the data entered by consumers in this personal health management system through the RHIO's health information exchange. Thus, the intervention of a personal health management system is being offered to both groups, however in different forms.
| Study group | Role | What they receive |
|---|---|---|
| Consumers | Consumers (patients or their designated proxies) who have registered to use the personal health management technology platform offered by the Brooklyn Health Information Xchange (BHIX) or Long Island Patient Information Xchange (LIPIX). Receives: Other: Personal Health Management System | |
| Providers | Providers who are authorized to view the data entered by consumers in either (1) BHIX's personal health management system, along with BHIX health information exchange data; OR LIPIX's secure messaging system (SMS), along with LIPIX health information exchange data. Receives: Other: Personal Health Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understand Usage Patterns of a Novel Health Information Exchange (HIE) Technology Platform
To describe \& quantify the usage of a novel Health Information Exchange (HIE) technology platform in order to understand usage patterns, e.g. frequency of system use; frequency of data element use within theses platforms; associations between usage and user demographics/clinical characteristics. This information can be useful in helping to improve current systems and develop future systems.
Measured: 1 year
Secondary outcomes (1)
Understand Trends in Usage over Time
To describe trends in the usage of a novel HIE technology platform over time. This information can be useful in helping to improve current systems and develop future systems.
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 posted30 Nov 2010 (estimated)
- Study startApr 2011
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Records, PersonalStudies 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
- 7,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Department of Health, Maimonides Medical Center
- Responsible party
- Sponsor
- Investigators
- Jessica S Ancker, MPH, PhD, Study chair, Weill Medical College of Cornell UniversityRainu Kaushal, MD, MPH, Study director, Weill Medical College of Cornell UniversityMelissa C Miller, MPH, Principal investigator, Weill Medical College of Cornell UniversityAlison Edwards, MStat, Principal investigator, Weill Medical College of Cornell UniversityYolanda Barron, MS, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250288
- Sponsor's protocol ID
- C023699-16
- Status last verified
- Dec 2012
- First submitted
- 29 Nov 2010
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Adoption and Use of Health Information Exchange (HIE) Technologies
- ClinicalTrials.gov ID
- NCT01250288
- Acronym / sponsor ID
- C023699-16
- Conditions
- Health Records, Personal
- Keywords
- Health Information Technology, Health Records, Personal, Hospital Information Systems, Patient Access to Records, Medical Records, Medical Record Systems, Computerized
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,800 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- New York State Department of Health, Maimonides Medical Center
- Study start
- Apr 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 Nov 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 research study is to describe the usage of consumers and providers when using a novel technology designed to give consumers the ability to manage and access their health information. This is a quantitative descriptive analysis study.
Detailed description
New York State has awarded grants to several regional health information exchange organizations (RHIOs), organizations established to create the technical and policy infrastructure needed to exchange health data between providers, payers, and public health agencies within a particular geographic region, to build an interoperable system for people to manage their own health information. Two of these grant recipients are the Brooklyn Health Information Exchange (BHIX) and Long Island Patient Information Xchange (LIPIX).
Since no off-the shelf technology currently exists to create such a system, BHIX is working with a commercial vendor to develop a unique system that is tailored toward the needs of their consumers and providers, while LIPIX is developing their own unique system in-house. Both BHIX's and LIPIX's interoperable personal health management systems will offer various features to consumers and providers in their community. Consumers may be able to perform tasks such as viewing their lab results, scheduling an appointment, or sending a message directly to their physician through a SMS. Conversely, the PHR can also allow physicians to engage in communications with their patient, release data to their patient(s) (e.g. lab test result); and view patient inputted-data.
The usage patterns of these personal health managements systems is not well understood (Ralson et al., 2009; Kim et al., 2007). Understanding consumers and providers' use of these interoperable systems can help aid in improving current systems and developing future systems.
Specific Aims
The specific aims of this study are to describe the usage of BHIX's and LIPIX's novel interoperable personal health management systems, specifically:
- To quantify adoption of and frequency of use of novel technological platforms designed to give consumers (patients) access to RHIO-based health information exchange (HIE) data;
- To quantify usage of HIE-specific data elements within these platforms;
- To explore associations between usage and user demographics/clinical characteristics;
- To explore trends in usage over time.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consumers | – | Other: Personal Health Management SystemConsumers (patients or their designated proxies) who have registered to use the personal health management technology platform offered by the Brooklyn Health Information Xchange (BHIX) or Long Island Patient Information Xchange (LIPIX). |
| Providers | – | Other: Personal Health Management SystemProviders who are authorized to view the data entered by consumers in either (1) BHIX's personal health management system, along with BHIX health information exchange data; OR LIPIX's secure messaging system (SMS), along with LIPIX health information exchange data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consumers (patients and their proxies) and their healthcare providers who are being exposed to a novel interoperable personal health management system in the Brooklyn community.
Key inclusion criteria (2 listed)
- Consumers: Consumers (patients or their designated proxies)who are 18 years of age or older and who have registered for either BHIX's personal health record system or LIPIX's secure messaging system.
- Providers: Healthcare Providers who are authorized to view Health Information Exchange data of BHIX or LIPIX.
Key exclusion criteria (1 listed)
- Anyone that does not fall into the above inclusion category.
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 |
|---|---|---|
| Personal Health Management SystemBHIX and LIPIX are offering novel personal health management system to members of its community. These community members, also referred to as consumers, will include patients \& their designated proxies. BHIX's system will allow patients to perform various tasks, including, but not limited to, viewing medications, medical allergies and lab results. LIPIX's system is primarily a mechanism forc consumers/patients to communicate directly with their physician through a secure messaging portal. Healthcare providers of these patients, who are affiliated with BHIX, will also be able to view the data entered by consumers in this personal health management system through the RHIO's health information exchange. Thus, the intervention of a personal health management system is being offered to both groups, however in different forms. | Other | Consumers, Providers |
Primary outcome
Understand Usage Patterns of a Novel Health Information Exchange (HIE) Technology Platform
Time frame: 1 year
To describe \& quantify the usage of a novel Health Information Exchange (HIE) technology platform in order to understand usage patterns, e.g. frequency of system use; frequency of data element use within theses platforms; associations between usage and user demographics/clinical characteristics. This information can be useful in helping to improve current systems and develop future systems.
1 secondary outcome
Understand Trends in Usage over Time
Time frame: 1 year
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 24 Dec 2012.
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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.
Jessica S Ancker, MPH, PhD study chair
Weill Medical College of Cornell University
Rainu Kaushal, MD, MPH study director
Weill Medical College of Cornell University
Melissa C Miller, MPH principal investigator
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 Records, Personal, 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 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 24 Dec 2012. 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?
Understand Usage Patterns of a Novel Health Information Exchange (HIE) Technology Platform (time frame: 1 year). 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 24 Dec 2012.