Impact of Health Information Exchange on Patient CareNCT00978744
Evaluation of a Regional Electronic Health Information Exchange's Clinical Health Record
An observational study of Impact of Health Information Exchange on Patient Care and (Focus on Diabetes, Asthma, Hypertension, CHF, COPD, CAD,, run by Brigham and Women's Hospital.
Trial summary
The Shared Health CHR™ (Clinical Health Record) offers point-of-care clinical reporting and decision support based primarily on patient claims data aggregated across various health care settings, and is one example of the types of health information data exchange efforts being implemented across the country. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impact of Health Information Exchange on Patient Care, (Focus on Diabetes, Asthma, Hypertension, CHF, COPD, CAD,, Gastroenteritis, Seizures, and Bacterial Pneumonia)
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Jun 2014
- 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: Patients are not being enrolled as subjects; their deidentified data will be reviewed only if their associated physicians and practices are participating as subjects in the study. Physicians, staff, and patients within the study population are representative of the practices we are going to study. Patients' data will be included in the intervention study to the extent that they are part of Shared Health's CHR system, are receiving care at one of the selected practices, and meet eligibility requirements.
Who may be able to join
- Participants must be primary care clinicians (nurse practitioner, physician assistant, or physician) who have registered to use the CHR at a practice that is enrolled in the study.
Who cannot join
- Specialty clinicians are excluded.
- Primary care clinicians who have not registered to use the CHR at an enrolled practice.
About this study
The Shared Health CHR™ (Clinical Health Record) offers point-of-care clinical reporting and decision support based primarily on patient claims data aggregated across various health care settings, and is one example of the types of health information data exchange efforts being implemented across the country. This study will evaluate how the CHR is used and its clinical and financial impact to better understand the CHR's value, and to identify opportunities to enhance the system to support patient care and practice efficiency. In addition, the results from this study will help to inform the national debate about the effectiveness of these types of tools to maximize patient quality of care, patient safety, and practice efficiency.
Read the detailed description
Missing information at the point of care is frustrating for both physicians and patients and can lead to unnecessary tests or suboptimal or even inappropriate and potentially harmful treatment. In addition to the risks of poorer quality of care, this fragmentation of incomplete or unavailable clinical data may result in increased costs to the healthcare system. Patient health records, when electronically shared across a spectrum of patient care settings, offer the possibility of improving healthcare outcomes, including patient safety and quality of care, and increasing efficiency, as well as cost-effectiveness.
This overall study will consist of two analyses. First, we will conduct a before-and-after, or pre-post study. The clinical practices consenting to participate will serve as their own controls during the baseline period. During the baseline period for which data will be retrospectively captured, physicians will have been conducting "business as usual" without the use of the CHR. The intervention will consist of participants accessing CHR to assist with medical decisions and patient care. Secondly, we will conduct a concurrent matched cohort comparison of patients within practices. We will compare outcomes and gaps in care for patients whose care is associated with very frequent CHR use and less frequent CHR use to matched control patients whose care is not associated with CHR use.
Safety, quality, and cost outcomes will be compared using the two described approaches. First, we will compare outcomes and gaps in care for the intervention patients whose care involved active CHR use in the intervention period to the care these same patients received during the baseline periods (pre/post analyses). Secondly, we will compare outcomes and gaps in care of the intervention active patients, both super-active and less active, to the matched control patients whose care during the study did not involve any CHR use during the intervention period (matched cohort analysis).
In order to study the relationship of CHR use to clinical, financial, and office efficiency outcomes within the study's timeline, we will limit our study to pre-existing patients and new patients who have had at least one encounter during the study period. Hospital admission data will also be analyzed as part of the cost and outcomes analysis.
We plan to study the effects of CHR on several conditions among the AHRQ's Ambulatory Care Sensitive (ACS) Conditions. We will study conditions that are common, high-risk, and resource dependent where clinical management may be improved with access to a CHR including chronic obstructive pulmonary disease/asthma, congestive heart failure, angina/coronary artery disease, and diabetes mellitus. In addition, other conditions determined to be of value in evaluating the impact of the CHR may be added, or may replace some of the existing conditions. These conditions will be chosen based on our early work in the study once we learn more about the number of eligible patients and the numbers of clinical interactions. The new conditions, yet to be determined, may also include non-chronic, or acute, diagnoses.
- Conditions
- Impact of Health Information Exchange on Patient Care, (Focus on Diabetes, Asthma, Hypertension, CHF, COPD, CAD,, Gastroenteritis, Seizures, and Bacterial Pneumonia)
- Keywords
- Clinical Health Record, Computerized Decision Support, Patient Safety, Resource Utilization
- Medical subject headings
- Diabetes Mellitus, Asthma, Hypertension, Heart Failure, Pulmonary Disease, Chronic Obstructive, Gastroenteritis, Seizures, Pneumonia, Bacterial
What is being measured
The primary outcome is the main question the study is designed to answer.
Gaps in care; compliance with quality measures
Data are collected from Shared Health about the outcome measures for baseline period (calendar year 2008) and for the intervention period which is 2009-2010 phased across the participating practices depending on when they implemented the clinical health record.
Measured: 2008 baseline, 2009-2010 intervention
Secondary outcomes (1)
Costs of care
Costs of care are being evaluated for the baseline period of 2008 and for the intervention period of 2009-2010 which is phased across participating practices depending on when they implemented the clinical health record.
Measured: 2008 baseline, 2009-2010 intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startDec 2008
- Primary completionJan 2012
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of Health Information Exchange on Patient CareStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shared Health, Chattanooga, TN
- Responsible party
- Principal investigator, Jeffrey Rothschild, MD, Brigham and Women's Hospital
- Investigators
- Jeffrey Rothschild, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978744
- Sponsor's protocol ID
- 2007-P-002256/1; BWH
- Status last verified
- Jan 2014
- First submitted
- 15 Sep 2009
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Regional Electronic Health Information Exchange's Clinical Health Record
- ClinicalTrials.gov ID
- NCT00978744
- Acronym / sponsor ID
- 2007-P-002256/1; BWH
- Conditions
- Impact of Health Information Exchange on Patient Care, (Focus on Diabetes, Asthma, Hypertension, CHF, COPD, CAD,, Gastroenteritis, Seizures, and Bacterial Pneumonia)
- Keywords
- Clinical Health Record, Computerized Decision Support, Patient Safety, Resource Utilization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Shared Health, Chattanooga, TN
- Study start
- Dec 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2014 (estimated)
- First posted
- 17 Sep 2009 (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 Shared Health CHR™ (Clinical Health Record) offers point-of-care clinical reporting and decision support based primarily on patient claims data aggregated across various health care settings, and is one example of the types of health information data exchange efforts being implemented across the country. This study will evaluate how the CHR is used and its clinical and financial impact to better understand the CHR's value, and to identify opportunities to enhance the system to support patient care and practice efficiency. In addition, the results from this study will help to inform the national debate about the effectiveness of these types of tools to maximize patient quality of care, patient safety, and practice efficiency.
Detailed description
Missing information at the point of care is frustrating for both physicians and patients and can lead to unnecessary tests or suboptimal or even inappropriate and potentially harmful treatment. In addition to the risks of poorer quality of care, this fragmentation of incomplete or unavailable clinical data may result in increased costs to the healthcare system. Patient health records, when electronically shared across a spectrum of patient care settings, offer the possibility of improving healthcare outcomes, including patient safety and quality of care, and increasing efficiency, as well as cost-effectiveness.
This overall study will consist of two analyses. First, we will conduct a before-and-after, or pre-post study. The clinical practices consenting to participate will serve as their own controls during the baseline period. During the baseline period for which data will be retrospectively captured, physicians will have been conducting "business as usual" without the use of the CHR. The intervention will consist of participants accessing CHR to assist with medical decisions and patient care. Secondly, we will conduct a concurrent matched cohort comparison of patients within practices. We will compare outcomes and gaps in care for patients whose care is associated with very frequent CHR use and less frequent CHR use to matched control patients whose care is not associated with CHR use.
Safety, quality, and cost outcomes will be compared using the two described approaches. First, we will compare outcomes and gaps in care for the intervention patients whose care involved active CHR use in the intervention period to the care these same patients received during the baseline periods (pre/post analyses). Secondly, we will compare outcomes and gaps in care of the intervention active patients, both super-active and less active, to the matched control patients whose care during the study did not involve any CHR use during the intervention period (matched cohort analysis).
In order to study the relationship of CHR use to clinical, financial, and office efficiency outcomes within the study's timeline, we will limit our study to pre-existing patients and new patients who have had at least one encounter during the study period. Hospital admission data will also be analyzed as part of the cost and outcomes analysis.
We plan to study the effects of CHR on several conditions among the AHRQ's Ambulatory Care Sensitive (ACS) Conditions. We will study conditions that are common, high-risk, and resource dependent where clinical management may be improved with access to a CHR including chronic obstructive pulmonary disease/asthma, congestive heart failure, angina/coronary artery disease, and diabetes mellitus. In addition, other conditions determined to be of value in evaluating the impact of the CHR may be added, or may replace some of the existing conditions. These conditions will be chosen based on our early work in the study once we learn more about the number of eligible patients and the numbers of clinical interactions. The new conditions, yet to be determined, may also include non-chronic, or acute, diagnoses.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are not being enrolled as subjects; their deidentified data will be reviewed only if their associated physicians and practices are participating as subjects in the study. Physicians, staff, and patients within the study population are representative of the practices we are going to study. Patients' data will be included in the intervention study to the extent that they are part of Shared Health's CHR system, are receiving care at one of the selected practices, and meet eligibility requirements.
Key inclusion criteria (1 listed)
- Participants must be primary care clinicians (nurse practitioner, physician assistant, or physician) who have registered to use the CHR at a practice that is enrolled in the study.
Key exclusion criteria (2 listed)
- Specialty clinicians are excluded.
- Primary care clinicians who have not registered to use the CHR at an enrolled practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gaps in care; compliance with quality measures
Time frame: 2008 baseline, 2009-2010 intervention
Data are collected from Shared Health about the outcome measures for baseline period (calendar year 2008) and for the intervention period which is 2009-2010 phased across the participating practices depending on when they implemented the clinical health record.
1 secondary outcome
Costs of care
Time frame: 2008 baseline, 2009-2010 intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
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.
Jeffrey Rothschild, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Impact of Health Information Exchange on Patient Care and (Focus on Diabetes, Asthma, Hypertension, CHF, COPD, CAD,, run by Brigham and Women's Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Gaps in care; compliance with quality measures (time frame: 2008 baseline, 2009-2010 intervention). 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 Jan 2014.