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Implementing an Emergency Department to Home Care Transition Intervention

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ClinicalTrials.gov Identifier: NCT01973296
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : January 26, 2015
Sponsor:
Collaborator:
Emergency Medicine Foundation
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
ED Patients With Chronic Medical Illnesses Behavioral: ED to home care transition Other: Usual Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Implementing an Emergency Department to Home Care Transition Intervention
Study Start Date : November 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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.
Behavioral: ED to home care transition
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 Name: Care Transition Intervention (CTI)

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973296


Locations
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United States, Florida
UF Health
Gainesville, Florida, United States, 32608
UF Health
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
Emergency Medicine Foundation
Investigators
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Principal Investigator: Donna L Carden, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01973296     History of Changes
Other Study ID Numbers: 201200390
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by University of Florida:
Health Literacy
Care Transition Intervention
Emergency Department Population
Access to Care

Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes