Implementing an Emergency Department to Home Care Transition Intervention

ED Patients With Chronic Medical Illnesses Clinical Trial

Official title:

Implementing an Emergency Department to Home Care Transition Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973296
• Other study ID #: 201200390
• Status: Completed
• Phase: N/A
• First received: October 15, 2013
• Last updated: January 22, 2015
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• ED Patients With Chronic Medical Illnesses
• Emergencies

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida
United States	UF Health	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Emergency Medicine Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	31-60 days following ED visit	No