search
Back to results

Care Transitions for Complex Patient - Cycle 1 and Cycle 2

Primary Purpose

Asthma, Coronary Artery Disease, Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reports
Reports and Notices
Usual care
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Complex patients, Care transitions, Patient safety, Patient care, Health Information Technology, Health Information Exchange, Clinical Decision Support, Care coordination, Data sharing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center (Division of Clinical Informatics)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Intermediate Intervention (arm #1)

Full Intervention (arm #2)

Control (arm #3)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Emergency department encounter rates among patients in the study population.

Secondary Outcome Measures

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

Full Information

First Posted
December 23, 2009
Last Updated
May 14, 2014
Sponsor
Duke University
Collaborators
Northern Piedmont Carolina Community Care Partners, North Carolina Division of Medical Assistance
search

1. Study Identification

Unique Protocol Identification Number
NCT01039324
Brief Title
Care Transitions for Complex Patient - Cycle 1 and Cycle 2
Official Title
Improving Care Transitions for Complex Patients Through Decision Support
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Northern Piedmont Carolina Community Care Partners, North Carolina Division of Medical Assistance

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This three-year project seeks to improve outcomes, quality and coordination of care for patients with complex healthcare needs by facilitating the availability of information following three types of care transitions into the ambulatory care setting. Specific information regarding care transitions will be made available to patients, primary care practitioners and care managers following hospitalizations, emergency department (ED) encounters, and specialty clinic evaluations. This project will build upon a regional Health Information Exchange (HIE) network created to connect providers serving 47,000 Medicaid beneficiaries across traditional institutional boundaries from both rural and urban settings in a 6-county region in the Northern Piedmont of North Carolina. This network includes 25 ambulatory care practices, 3 federally qualified health centers, 4 rural health clinics, 3 urgent care facilities, 11 government agencies, 5 hospitals and 2 cross-disciplinary care management teams. Within this HIE network, 4,600 patients with complex healthcare needs have been identified. For this project, a standards-based clinical decision support tool will be utilized in order to ensure that the proposed approach is generalized, portable, and scalable; and routinely available claims and scheduling data will be used as the primary data source. This approach will support both traditional clinic-based models of care as well as new care models including population health management and the use of cross-disciplinary teams. Under Aim 1, the existing HIE network and decision support tool will be enhanced to enable detection of transitions in care and delivery of timely, patient-specific information regarding these care transitions to patients, primary care clinicians and multidisciplinary care management team members. Under Aim 2, the impact of the proposed approach will be evaluated in a two-cycle randomized controlled trial primarily involving approximately 47000 Medicaid beneficiaries with a special focus on 4600 patients with complex health needs, 309 primary care clinicians, and 31 care management workers. Cycle 1 will assess only daily notices sent to care managers and will use only billing data. Cycle 2 will evaluate all components of the proposed intervention and us both billing and ADT data (see below). For Cycle 1, patients will be randomly assigned by family unit to either receive or not receive email notices sent to their care managers. For Cycle 2 patients will be randomly assigned to one of three groups: 1) information on care transitions sent to patients and their clinic-based caregivers; 2) information sent to patients, their clinic-based caregivers and their care managers; and 3) no information sent. The primary outcome measure will be the overall rate of ED utilization for each study group. Under Aim 3, the economic attractiveness of the proposed approach will be determined. Under Aim 4, the technology and results of this study will be disseminated through public media, publications and presentations. Information-augmented care transitions between sites should result in improved care coordination, higher quality of care, and more appropriate care. This trial will be deployed in two cycles in order to support the needs of the care management network while the full intervention is developed. Cycle 1 will run from December, 2009 through December, 2010. It will assess the impact of notices about hospital admissions and ED encounters derived from billing data and sent daily to care managers for the 47,000 patients enrolled in NPCCN on the study outcomes. Cycle 2 will run from December, 2010 through December, 2011 and will address AIM 2 of the original grant proposal. For Cycle 2, events detected from ADT and billing data will be generated daily. The events will include hospital admissions, hospital discharges, ED encounters, and specialty care visits. The responses to events will include event summary reports sent to patients' assigned medical homes, letters sent to patients or their guardians, and release of information requests on behalf of a patient's medical home. The response will be generated for 4,600 patients identified as having complex health needs. In addition, notices will be sent to care managers for detected hospital and ED events for all 47,000 patients enrolled in NPCCN. Special priority will be given to patients with complex heath needs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Coronary Artery Disease, Diabetes, Hypertension, Congestive Heart Failure
Keywords
Complex patients, Care transitions, Patient safety, Patient care, Health Information Technology, Health Information Exchange, Clinical Decision Support, Care coordination, Data sharing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8422 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intermediate Intervention (arm #1)
Arm Type
Experimental
Arm Description
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.
Arm Title
Full Intervention (arm #2)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (arm #3)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Reports
Intervention Description
Primary care event reports and patient letters
Intervention Type
Other
Intervention Name(s)
Reports and Notices
Intervention Description
Primary care event reports, patient letters and care manager notices
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
This is the study's control group
Primary Outcome Measure Information:
Title
Emergency department encounter rates among patients in the study population.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Emergency department encounter rates for low severity diagnoses among all patients.
Time Frame
6 months
Title
Total emergency department encounter rates among patients for whom intervention was appropriate.
Time Frame
6 months
Title
Total emergency department encounter rates among all patients.
Time Frame
6 months
Title
Hospitalization rates among patients for whom intervention was appropriate.
Time Frame
6 months
Title
Hospitalization rates among all patients.
Time Frame
6 months
Title
Hospital readmission rates within 30 days after hospitalization among patients for whom intervention was appropriate.
Time Frame
6 months
Title
Hospital readmission rates within 30 days after hospitalization among all patients.
Time Frame
6 months
Title
Primary care visit rates among patients following an emergency department encounter or hospitalization for whom intervention was appropriate.
Time Frame
6 months
Title
Primary care visit rates among all patients following an emergency department encounter or hospitalization.
Time Frame
6 months
Title
Rates of completion of medically-indicated post hospitalization studies or procedures among patients for whom intervention was appropriate.
Time Frame
6 months
Title
Rates of completion of medically-indicated post hospitalization studies or procedures among all patients.
Time Frame
6 months
Title
Total medical costs among patients for whom intervention was appropriate.
Time Frame
6 months
Title
Total medical costs among all patients.
Time Frame
6 months
Title
Emergency department costs among patients for whom intervention was appropriate.
Time Frame
6 months
Title
Emergency department costs among all patients.
Time Frame
6 months
Title
Hospitalization costs among patients for whom intervention was appropriate.
Time Frame
6 months
Title
Hospitalization costs among all patients.
Time Frame
6 months
Title
Outpatient costs among patients for whom intervention was appropriate.
Time Frame
6 months
Title
Outpatient costs among all patients.
Time Frame
6 months
Title
Patient satisfaction among patients for whom intervention was appropriate.
Time Frame
6 months
Title
Patient-reported quality of life among patients for whom intervention was appropriate.
Time Frame
6 months
Title
Provider satisfaction among providers with contact with patients for whom intervention was appropriate.
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Eisenstein, DBA
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center (Division of Clinical Informatics)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Care Transitions for Complex Patient - Cycle 1 and Cycle 2

We'll reach out to this number within 24 hrs