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History of Changes for Study: NCT00244491
The Care Transitions Intervention
Latest version (submitted August 10, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 24, 2005 None (earliest Version on record)
2 May 17, 2006 Study Status and Study Design
3 November 29, 2006 References and Study Status
4 January 4, 2013 Study Design, Study Status and Study Identification
5 August 10, 2015 Study Status and Sponsor/Collaborators
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Study NCT00244491
Submitted Date:  October 24, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2000-0443
Brief Title: The Care Transitions Intervention
Official Title: The Care Transitions Intervention
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2005
Overall Status: Completed
Study Start: September 2002
Primary Completion:
Study Completion: August 2003
First Submitted: October 24, 2005
First Submitted that
Met QC Criteria:
October 24, 2005
First Posted: October 26, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 24, 2005
Last Update Posted: October 26, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Colorado, Denver
Responsible Party:
Collaborators: The John A. Hartford Foundation
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: This intervention tests whether encouraging older patients and their caregivers to assert a more active role in their care transitions could improve clinical outcomes. Patients are supported by a nurse transition coach and specific tools, including a Personal Health Record.
Detailed Description: See above.
Open or close this module Conditions
Conditions: Continuity of Patient Care
Keywords: care transitions
geriatric
care coordination
self-management
chronic illness
patient-centered care
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Educational/Counseling/Training
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 750
Open or close this module Arms and Interventions
Intervention Details:
Behavioral: Care Transitions Intervention
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Rehospitalization rate at 30, 90 and 180 days after index hospitalization.
Secondary Outcome Measures:
1. Rehospitalization rate at 30, 90 and 180 days after index hospitalization. Rehospitalization for the same condition as the index hospital stay, at 30, 90 and 180 days.
Open or close this module Eligibility
Minimum Age: 65 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • To be eligible for this study, patients from the participating delivery system had to: 1) be age 65 years or older, 2) be admitted to one of the participating delivery system's contract hospitals during the study period for a non-psychiatrically-related condition, 3) be community-dwelling (i.e., not from a long-term care facility), 4) reside within a predefined geographic radius of the hospital (thereby making a home visit feasible), 5) have a working telephone, 6) be English-speaking, 7) show no documentation of dementia in the medical record, 8) have no plans to enter hospice, 9) not be participating in another research protocol, and 10) have documented in their medical record at least one of 11 diagnoses, including stroke, congestive heart failure, coronary artery disease, cardiac arrhythmias, chronic obstructive pulmonary disease, diabetes, spinal stenosis, hip fracture, peripheral vascular disease, deep venous thrombosis, or pulmonary embolism.

Exclusion Criteria:

  • Those who did not meet the inclusion criteria.
Open or close this module Contacts/Locations
Study Officials: Eric A. Coleman, MD, MPH
Principal Investigator
University of Colorado, Denver
Locations: United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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