Implementing an Emergency Department to Home Care Transition Intervention
Primary Purpose
ED Patients With Chronic Medical Illnesses
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ED to home care transition
Usual Care
Sponsored by

About this trial
This is an interventional prevention trial for ED Patients With Chronic Medical Illnesses focused on measuring Health Literacy, Care Transition Intervention, Emergency Department Population, Access to Care
Eligibility Criteria
Inclusion Criteria:
- 60 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.)
Exclusion Criteria:
- 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
Sites / Locations
- UF Health
- UF Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
ED to home care transition
Usual Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient activation measure (PAM) level
The purpose of this aim is to determine if the ED to home care transition intervention improves patients' self management skills as assessed by increased PAM scores.
Full Information
NCT ID
NCT01973296
First Posted
October 15, 2013
Last Updated
January 22, 2015
Sponsor
University of Florida
Collaborators
Emergency Medicine Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01973296
Brief Title
Implementing an Emergency Department to Home Care Transition Intervention
Official Title
Implementing an Emergency Department to Home Care Transition Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Emergency Medicine Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Emergency Room (ER) patients with limited health literacy who agree to participate in this study will be asked to complete a survey about how they feel about their health care and how easy or hard it is to get health care. Patients will also be asked for some basic information about themselves like their age, race, gender, employment and marital status, their overall health and health conditions. The research team will review the electronic medical record for information about participants' health conditions and how sick the ER nurse thought the patient was when they came to the ER.
Patients who decide to participate in the study will also be randomly assigned, much like the flip of a coin to receive either a new way of educating patients (the Care Transition Intervention) or normal care. This means:
If patients receive the new way of educating, a coach will visit the patient at home one time one or two days after the ER visit to see how the patient is doing. He/she will talk with the patient about following up with a regular, personal doctor and symptoms to look out for. He/she will help the patient understand their medicines and help the patient make a personal health record. The coach will also tell the patient about the Area Agency on Aging, also called Elder Options. If the patient receives normal care, the patient will not receive a visit from the coach or hear about the Area Agency on Aging but will be given discharge instructions from the ER nurse and doctor.
If the patient receives the new way of educating (the Care Transition Intervention), the coach will call the patient at least 3 times after the ER visit. He/she will talk with the patient about the same items listed above. If the patient receives normal care, the coach will not call. The patient has a 1 in 2 chance of receiving the new way of educating and a 1 in 2 chance of receiving normal care.
All patients will be asked to complete a phone survey 31-60 days after their ER visit. This survey will ask the patient about follow up with a regular, personal doctor. The survey will also ask the patient how they feel about their health care and how easy or hard it is to get health care after an ER visit.
Some patients will also be asked if they are willing to give a separate interview. The study doctor will ask about what happened when you were in the ER. She will also ask about how things went after your ER visit. If the coach contacted you, she will ask about this as well. This interview will be audio recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ED Patients With Chronic Medical Illnesses
Keywords
Health Literacy, Care Transition Intervention, Emergency Department Population, Access to Care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ED to home care transition
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ED to home care transition
Other Intervention Name(s)
Care Transition Intervention (CTI)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Timely and appropriate outpatient medical follow-up
Description
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.
Time Frame
31-60 days after Emergency Department (ED) visit
Secondary Outcome Measure Information:
Title
Patient activation measure (PAM) level
Description
The purpose of this aim is to determine if the ED to home care transition intervention improves patients' self management skills as assessed by increased PAM scores.
Time Frame
31-60 days following ED visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
60 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.)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna L Carden, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
UF Health
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Implementing an Emergency Department to Home Care Transition Intervention
We'll reach out to this number within 24 hrs