Clinical Trials Logo

Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT00978744
Other study ID # 2007-P-002256/1; BWH
Secondary ID
Status Unknown status
Phase N/A
First received September 15, 2009
Last updated January 23, 2014
Start date December 2008
Est. completion date June 2014

Study information

Verified date January 2014
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Shared Health CHRâ„¢ (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.


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.


Recruitment information / eligibility

Status Unknown status
Enrollment 113
Est. completion date June 2014
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Specialty clinicians are excluded.

- Primary care clinicians who have not registered to use the CHR at an enrolled practice.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital Shared Health, Chattanooga, TN

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2008 baseline, 2009-2010 intervention
Secondary 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. 2008 baseline, 2009-2010 intervention