- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00365885
Showing Health Information Value in a Community Network
July 9, 2014 updated by: Duke University
The purpose of this study is to determine the value of shared health information on care quality and costs when this information is used to notify care providers about concerning health events for patients cared for by a community-based network of providers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Project Abstract This three-year project will assess the costs and benefits of health information technology (HIT) in an established community-wide network of academic, private and public healthcare facilities created to share clinical information for the purpose of population-based care management of over 16,000 Medicaid beneficiaries in Durham County, North Carolina.
The area of interest for this project is the impact of information-driven interventions on care quality, patient safety and healthcare costs across the diverse stakeholders participating in this collaborative partnership.
In order to asses HIT value rigorously in the context of a production information system that is under continual development, we propose to conduct a randomized controlled trial.
Specifically, we will randomly assign patients by family unit to either a control group or to an intervention group in which they will initially receive one of 3 information-driven interventions.
The interventions include clinical alerts sent to care providers, performance feedback reports presented to clinic managers, and care reminders sent directly to patients.
The content of the interventions will address "concerning" events (e.g., an emergency room encounter for asthma) and care deficiencies (e.g., delinquency on biannual mammogram) identified from the composite set of clinical data in our information system.
To assess the benefits and burdens of the interventions, combinations of the 3 interventions will be sequentially introduced into the study groups over the course of the project.
The analysis will compare groups receiving various combinations of interventions as well as those receiving no interventions.
At baseline and at six-month intervals throughout the course of the study, we will measure emergency department encounter rates, hospitalization rates, HEDIS (Healthcare Effectiveness Data and Information Set) scores, missed appointment rates, glycated hemoglobin levels in diabetics, and patient satisfaction.
Our assessment will look at the societal value of HIT as well as the value for individual stakeholders including patients, providers, payers, purchasers and policy makers.
From these measures, we will assess the costs and benefits of this community-wide effort to promote interoperability of clinical data exchange in order to increase the understanding of HIT value in a community setting.
In our preliminary studies, we have observed a statistically significant 3-fold reduction in repeat ED (Emergency Department) encounter rates using email alerts alone.
The approach used in this project is able to be generalized across geographic areas and healthcare settings and can, therefore, serve to promote the dissemination of HIT to other communities.
Study Type
Interventional
Enrollment (Actual)
20108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Enrollment in the Community Care of North Carolina Medicaid program in Durham County North Carolina
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
electronic mail notifications to care managers about sentinel health events
|
computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
Other Names:
|
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Experimental: 2
feedback reports with notifications to clinic managers about sentinel health events
|
computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
Other Names:
|
|
Experimental: 3
letters to patients with notifications about sentinel health events
|
computer decision support system that generates notifications about sentinel health events and communicates this information via electronic mail to care managers, feedback reports to clinical managers, and letters to patients
Other Names:
|
|
No Intervention: 4
electronic mail notifications to care managers about sentinel health events -- generated but withheld
|
|
|
No Intervention: 5
feedback reports with notifications to clinic managers about sentinel health events -- generated but withheld
|
|
|
No Intervention: 6
letters to patients with notifications about sentinel health events -- generated but withheld
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Emergency department utilization rates and hospitalization rates
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
ED encounter rates for low severity conditions
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
ED encounter rates for asthma
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
ED encounter rates for diabetes
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Hospitalization rates
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Hospitalization rates for asthma (also PQI)
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Hospitalization rates for diabetes (also PQI)
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Glycemic control (hemoglobin A1c)
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
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Medication contraindications
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
HEDIS - Preventive services
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
HEDIS - # WCC visits
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
AHRQ Prevention Quality Indicators
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
HEDIS - Asthma and diabetes
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
# of messages triggered for health risks
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
# of messages triggered for barriers to care
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Missed appointment rates
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
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Primary care appointment rates
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
F/U rates post-partum
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Patient satisfaction instruments (CHAPS)
Time Frame: at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
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at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
|
|
EuroQoL
Time Frame: at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
|
at 6 to 9 months after the intervention has been introduced and then at 3 to 6-month intervals as the intervention is sequentially enhanced.
|
|
Provider opinion surveys
Time Frame: At conclusion of study
|
At conclusion of study
|
|
Costs of ED utilization for all causes
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Costs of ED use for asthma
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Costs of ED use for diabetes
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Costs of ED use for low severity visits
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Hospitalization costs for all causes
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Hospitalization costs for asthma
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
Hospitalization costs for diabetes
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
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Reimbursement for labs+other ancillary services
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
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Primary care reimbursement
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
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at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
|
ED rates for recurrent ED encounters
Time Frame: at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David F Lobach, MD, PhD, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
August 16, 2006
First Submitted That Met QC Criteria
August 16, 2006
First Posted (Estimate)
August 18, 2006
Study Record Updates
Last Update Posted (Estimate)
July 11, 2014
Last Update Submitted That Met QC Criteria
July 9, 2014
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00006833
- R01HS015057 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.