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Care Transitions for Complex Patient - Cycle 1 and Cycle 2

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01039324
First Posted: December 24, 2009
Last Update Posted: May 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Northern Piedmont Carolina Community Care Partners
North Carolina Division of Medical Assistance
Information provided by (Responsible Party):
Duke University
  Purpose

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.


Condition Intervention
Asthma Coronary Artery Disease Diabetes Hypertension Congestive Heart Failure Other: Reports Other: Reports and Notices Other: Usual care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Care Transitions for Complex Patients Through Decision Support

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Emergency department encounter rates among patients in the study population. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Emergency department encounter rates for low severity diagnoses among all patients. [ Time Frame: 6 months ]
  • Total emergency department encounter rates among patients for whom intervention was appropriate. [ Time Frame: 6 months ]
  • Total emergency department encounter rates among all patients. [ Time Frame: 6 months ]
  • Hospitalization rates among patients for whom intervention was appropriate. [ Time Frame: 6 months ]
  • Hospitalization rates among all patients. [ Time Frame: 6 months ]
  • Hospital readmission rates within 30 days after hospitalization among patients for whom intervention was appropriate. [ Time Frame: 6 months ]
  • Hospital readmission rates within 30 days after hospitalization among all patients. [ Time Frame: 6 months ]
  • Primary care visit rates among patients following an emergency department encounter or hospitalization for whom intervention was appropriate. [ Time Frame: 6 months ]
  • Primary care visit rates among all patients following an emergency department encounter or hospitalization. [ Time Frame: 6 months ]
  • Rates of completion of medically-indicated post hospitalization studies or procedures among patients for whom intervention was appropriate. [ Time Frame: 6 months ]
  • Rates of completion of medically-indicated post hospitalization studies or procedures among all patients. [ Time Frame: 6 months ]
  • Total medical costs among patients for whom intervention was appropriate. [ Time Frame: 6 months ]
  • Total medical costs among all patients. [ Time Frame: 6 months ]
  • Emergency department costs among patients for whom intervention was appropriate. [ Time Frame: 6 months ]
  • Emergency department costs among all patients. [ Time Frame: 6 months ]
  • Hospitalization costs among patients for whom intervention was appropriate. [ Time Frame: 6 months ]
  • Hospitalization costs among all patients. [ Time Frame: 6 months ]
  • Outpatient costs among patients for whom intervention was appropriate. [ Time Frame: 6 months ]
  • Outpatient costs among all patients. [ Time Frame: 6 months ]
  • Patient satisfaction among patients for whom intervention was appropriate. [ Time Frame: 6 months ]
  • Patient-reported quality of life among patients for whom intervention was appropriate. [ Time Frame: 6 months ]
  • Provider satisfaction among providers with contact with patients for whom intervention was appropriate. [ Time Frame: 6 months ]

Enrollment: 8422
Study Start Date: December 2009
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intermediate Intervention (arm #1)
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
Primary care event reports and patient letters
Experimental: Full Intervention (arm #2)
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
Primary care event reports, patient letters and care manager notices
Experimental: Control (arm #3)
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
This is the study's control group

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039324


Locations
United States, North Carolina
Duke University Medical Center (Division of Clinical Informatics)
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Northern Piedmont Carolina Community Care Partners
North Carolina Division of Medical Assistance
Investigators
Principal Investigator: Eric Eisenstein, DBA Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01039324     History of Changes
Other Study ID Numbers: Pro00010738
R18HS017795 ( U.S. AHRQ Grant/Contract )
First Submitted: December 23, 2009
First Posted: December 24, 2009
Last Update Posted: May 15, 2014
Last Verified: February 2014

Keywords provided by Duke University:
Complex patients
Care transitions
Patient safety
Patient care
Health Information Technology
Health Information Exchange
Clinical Decision Support
Care coordination
Data sharing

Additional relevant MeSH terms:
Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases