NCT01973296

Brief Summary

The purpose of this study is to determine whether a new way of educating/coaching chronically ill patients discharged from the Emergency Room will help them receive post-ER health care and strengthen their links to a regular, personal doctor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 15, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

1.1 years

First QC Date

October 15, 2013

Last Update Submit

January 22, 2015

Conditions

Keywords

Health LiteracyCare Transition InterventionEmergency Department PopulationAccess to Care

Outcome Measures

Primary Outcomes (1)

  • Timely and appropriate outpatient medical follow-up

    The purpose of this aim is to determine if the ED to home care transition intervention improves patients' access to timely and appropriate outpatient medical follow-up. Patient response to telephone questionnaire will be used to determine time to physician follow-up and type of physician encounter.

    31-60 days after Emergency Department (ED) visit

Secondary Outcomes (1)

  • Patient activation measure (PAM) level

    31-60 days following ED visit

Study Arms (2)

ED to home care transition

EXPERIMENTAL

The ED to home care transition intervention is a 4-week program that uses a Area Agency on Aging coach to conduct a home visit and three follow up phone calls to help patients develop the skills needed for self-management and to communicate with healthcare providers.

Behavioral: ED to home care transition

Usual Care

OTHER

Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care.

Other: Usual Care

Interventions

The CTI coach's role is to build self-management capabilities for the patient and caregiver. During each contact, the coach reviews the four components of the CTI: 1: Follow-up Medical Visit. 2: Knowledge of Red Flag Symptoms. 3: Medication Reconciliation. 4: The Personal Health Record (PHR). The coach assists the patient use the PHR to document and maintain vital information and to communicate with providers.

Also known as: Care Transition Intervention (CTI)
ED to home care transition

Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care.

Usual Care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older,
  • are on Medicare,
  • are community dwelling,
  • reside within the geographical area defined by specific zip codes (to enable home visits),
  • have a working telephone, and
  • have at least one of the following conditions documented in their medical record: congestive heart failure, chronic obstructive pulmonary disease, coronary artery disease, diabetes, stroke, pneumonia, medical and surgical back conditions (predominantly spinal stenosis), hip fracture, peripheral vascular disease, cardiac arrhythmias, deep venous thrombosis, pulmonary embolism, peptic ulcer disease or hemorrhage.
  • health literacy will be assessed with the 66-item Rapid Estimate of Adult Literacy in Medicine (REALM)(Davis, Crouch et al.)

You may not qualify if:

  • current diagnosis of psychosis,
  • active substance abuse related to alcohol or drugs,
  • cancer,
  • dialysis
  • history of organ transplantation,
  • have dementia without a live-in caregiver, or
  • in hospice care,
  • reside outside the defined geographical area,
  • reside in a skilled nursing facility, or
  • assisted living will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UF Health

Gainesville, Florida, 32608, United States

Location

UF Health

Jacksonville, Florida, 32209, United States

Location

Study Officials

  • Donna L Carden, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2013

First Posted

October 31, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations