NCT01039324

Brief Summary

The purpose of this study is to improve patient care and safety while decreasing ED visit rates by sending specific information about care transitions related to hospital admission and discharge and emergency department and specialty care visits to primary care practices, care managers and patients with the use of health information technology (HIT) shared across a community-based network of providers. Cycle 1 focuses on the impact of notices about ED encounters and hospitalizations derived from billing data that are sent to care managers for all 47,000 patients in the Northern Piedmont Community Care Network (NPCCN). Cycle 2 explores the impact of letters sent to patients, and care event reports sent to a patient's medical home in addition to notices sent to care managers about ED encounters, hospitalization and specialty care based on ADT (Admission Discharge Transfer) and billing data on 4,600 patients with complex health needs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8,422

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable asthma

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

December 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 15, 2014

Status Verified

February 1, 2014

Enrollment Period

2.2 years

First QC Date

December 23, 2009

Last Update Submit

May 14, 2014

Conditions

Keywords

Complex patientsCare transitionsPatient safetyPatient careHealth Information TechnologyHealth Information ExchangeClinical Decision SupportCare coordinationData sharing

Outcome Measures

Primary Outcomes (1)

  • Emergency department encounter rates among patients in the study population.

    6 months

Secondary Outcomes (22)

  • Emergency department encounter rates for low severity diagnoses among all patients.

    6 months

  • Total emergency department encounter rates among patients for whom intervention was appropriate.

    6 months

  • Total emergency department encounter rates among all patients.

    6 months

  • Hospitalization rates among patients for whom intervention was appropriate.

    6 months

  • Hospitalization rates among all patients.

    6 months

  • +17 more secondary outcomes

Study Arms (3)

Intermediate Intervention (arm #1)

EXPERIMENTAL

Care transition reports sent to primary care clinics, care transition letters sent to patients, release of information requests about care transitions sent on behalf of primary care clinics.

Other: Reports

Full Intervention (arm #2)

EXPERIMENTAL

E-mail notices sent to care managers about care transitions plus care transition reports sent to primary care clinics, care transition reports sent to patients, release of information requests about care transitions sent on behalf of primary care clinics.

Other: Reports and Notices

Control (arm #3)

EXPERIMENTAL

Subjects assigned to the control group will receive "usual care" which is the standard of care coordination currently existent between patients, providers and care managers.

Other: Usual care

Interventions

ReportsOTHER

Primary care event reports and patient letters

Intermediate Intervention (arm #1)

Primary care event reports, patient letters and care manager notices

Full Intervention (arm #2)

This is the study's control group

Control (arm #3)

Eligibility Criteria

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

You may qualify if:

  • North Carolina Medicaid beneficiary enrolled in the Northern Piedmont Community Care Network (NPCCN)
  • Has complex healthcare needs as defined by having two or more IOM (Institute of Medicine) priority conditions (hypertension, coronary artery disease, congestive heart failure, stroke, asthma, diabetes) OR one of the following: moderate to severe mental health diagnosis (schizophrenic disorder, episodic mood disorder, delusional disorder, non-organic psychosis, anxiety, dissociative-somatoform disorder, personality disorder), end-stage renal disease, sickle cell disease
  • Continuous enrollment in NPCCN for 10 of the previous 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center (Division of Clinical Informatics)

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

AsthmaCoronary Artery DiseaseDiabetes MellitusHypertensionHeart Failure

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Eric Eisenstein, DBA

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2009

First Posted

December 24, 2009

Study Start

December 1, 2009

Primary Completion

March 1, 2012

Study Completion

September 1, 2012

Last Updated

May 15, 2014

Record last verified: 2014-02

Locations