Implementing an Emergency Department to Home Care Transition Intervention

January 22, 2015 updated by: University of Florida
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32608
        • UF Health
      • Jacksonville, Florida, United States, 32209
        • UF Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ED to home care transition
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.
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.
Other Names:
  • Care Transition Intervention (CTI)
Other: Usual Care
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timely and appropriate outpatient medical follow-up
Time Frame: 31-60 days after Emergency Department (ED) visit
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient activation measure (PAM) level
Time Frame: 31-60 days following ED visit
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.
31-60 days following ED visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Donna L Carden, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (Estimate)

October 31, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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