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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00365885
Other study ID # Pro00006833
Secondary ID R01HS015057
Status Completed
Phase N/A
First received August 16, 2006
Last updated July 9, 2014
Start date August 2006
Est. completion date August 2008

Study information

Verified date December 2012
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20108
Est. completion date August 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Enrollment in the Community Care of North Carolina Medicaid program in Durham County North Carolina

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Computer-based clinical decision support.
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

Locations

Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Eisenstein EL, Anstrom KJ, Macri JM, Crosslin DR, Johnson FS, Kawamoto K, Lobach DF. Assessing the potential economic value of health information technology interventions in a community-based health network. AMIA Annu Symp Proc. 2005:221-5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Emergency department utilization rates and hospitalization rates at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary ED encounter rates for low severity conditions at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary ED encounter rates for asthma at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary ED encounter rates for diabetes at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Hospitalization rates at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Hospitalization rates for asthma (also PQI) at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Hospitalization rates for diabetes (also PQI) at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Glycemic control (hemoglobin A1c) at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Medication contraindications at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary HEDIS - Preventive services at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary HEDIS - # WCC visits at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary AHRQ Prevention Quality Indicators at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary HEDIS - Asthma and diabetes at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary # of messages triggered for health risks at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary # of messages triggered for barriers to care at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Missed appointment rates at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Primary care appointment rates at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary F/U rates post-partum at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Patient satisfaction instruments (CHAPS) 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. No
Secondary EuroQoL 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. No
Secondary Provider opinion surveys At conclusion of study No
Secondary Costs of ED utilization for all causes at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Costs of ED use for asthma at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Costs of ED use for diabetes at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Costs of ED use for low severity visits at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Hospitalization costs for all causes at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Hospitalization costs for asthma at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Hospitalization costs for diabetes at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Reimbursement for labs+other ancillary services at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary Primary care reimbursement at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
Secondary ED rates for recurrent ED encounters at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced. No
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