Showing Health Information Value in a Community Network

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00365885
First received: August 16, 2006
Last updated: July 9, 2014
Last verified: December 2012
  Purpose

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.


Condition Intervention
Clinical Decision Support
Medical Informatics Interventions
Population Health Management
Quality of Healthcare
Other: Computer-based clinical decision support.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Showing Health Information Value in a Community Network

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • # 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. ] [ Designated as safety issue: No ]
  • # 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Provider opinion surveys [ Time Frame: At conclusion of study ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 20108
Study Start Date: August 2006
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
electronic mail notifications to care managers about sentinel health events
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
Other Name: Decision support engine is called SEBASTIAN
Experimental: 2
feedback reports with notifications to clinic managers about sentinel health events
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
Other Name: Decision support engine is called SEBASTIAN
Experimental: 3
letters to patients with notifications about sentinel health events
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
Other Name: Decision support engine is called SEBASTIAN
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00365885

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: David F Lobach, MD, PhD Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00365885     History of Changes
Other Study ID Numbers: Pro00006833, R01-HS015057
Study First Received: August 16, 2006
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Medical Informatics
Decision Support Systems, Clinical
Community Health Services
Costs and Cost analysis

ClinicalTrials.gov processed this record on September 15, 2014