NCT00365885

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,108

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

July 11, 2014

Status Verified

December 1, 2012

Enrollment Period

1.9 years

First QC Date

August 16, 2006

Last Update Submit

July 9, 2014

Conditions

Clinical Decision SupportMedical Informatics InterventionsPopulation Health ManagementQuality of Healthcare

Keywords

Medical InformaticsDecision Support Systems, ClinicalCommunity Health ServicesCosts and Cost analysis

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (30)

  • 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.

  • 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.

  • 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.

  • Hospitalization rates

    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)

    at 9 months after the intervention has been introduced and then at 6-month intervals as the intervention is sequentially enhanced.

  • +25 more secondary outcomes

Study Arms (6)

1

EXPERIMENTAL

electronic mail notifications to care managers about sentinel health events

Other: Computer-based clinical decision support.

2

EXPERIMENTAL

feedback reports with notifications to clinic managers about sentinel health events

Other: Computer-based clinical decision support.

3

EXPERIMENTAL

letters to patients with notifications about sentinel health events

Other: Computer-based clinical decision support.

4

NO INTERVENTION

electronic mail notifications to care managers about sentinel health events -- generated but withheld

5

NO INTERVENTION

feedback reports with notifications to clinic managers about sentinel health events -- generated but withheld

6

NO INTERVENTION

letters to patients with notifications about sentinel health events -- generated but withheld

Interventions

Computer-based clinical decision support.OTHER

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

Also known as: Decision support engine is called SEBASTIAN
123

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related 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;2005:221-5.

    PMID: 16779034BACKGROUND

Study Officials

  • David F Lobach, MD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 18, 2006

Study Start

August 1, 2006

Primary Completion

July 1, 2008

Study Completion

August 1, 2008

Last Updated

July 11, 2014

Record last verified: 2012-12

Locations

US(1)