Clinical trial NCT02079987: An Emergency Department-To-Home Intervention to Improve Quality of Life and Reduce Hospital Use
Official title: An Emergency Department-To-Home Intervention to Improve Quality of Life and Reduce Hospital Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ED Patients With Chronic Medical Illnesses
Keywords: Healthcare Coach
Care Transition Intervention
Emergency Department Population
Access to Care
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-03-06
Enrollment: 1101
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if assigning older, chronically ill patients a healthcare coach after they leave the Emergency Department (ED) improves their quality of life and reduces the need for hospital-based care.

Detailed description: Investigators will review the ED electronic medical record in real-time to determine ED patients' study eligibility. Older, chronically ill ED patients who are eligible and agree to participate in the study will be randomly assigned to a healthcare coach and Care Transition Intervention or usual, post-ED care.

At the time of enrollment, all subjects will be asked to provide informed consent for study investigators to request Medicare Claims to determine how many ED visits, hospital admissions and doctor office visits the subject had at least 30 days after the index ED visit. All research participants will be asked basic personal information such as age, race, sex, employment and marital status. All subjects will be asked to complete a baseline survey about their quality of life.

If the subject is assigned to the Care Transition Intervention, the healthcare coach will visit the subject at home within 3 days of the ED visit. The coach will talk with the subject about following up with a regular, personal doctor and symptoms that indicate a worsening health condition. The coach will help the subject understand their medicines and help the subject make a personal health record (PHR). The coach will tell the subject about the Area Agency on Aging. If the subject receives usual care, they but will be given the usual discharge instructions from the ED nurse and doctor. If the subject receives the Care Transition Intervention, the coach will also call the subject at least 3 times after the ED visit and review the same items listed above.

All enrolled subjects will be asked to complete a phone survey within 31-60 days of the ED visit. This survey will again ask subjects about their quality of life.

Eligibility criteria: Inclusion Criteria:

* 60 years of age or older
* Medicare beneficiaries
* Community dwelling
* Reside within defined geographical area (to enable home visits)
* Have a working telephone
* Have at least one of the following conditions documented in their electronic 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

Exclusion Criteria:

* Current diagnosis of psychosis
* Cancer
* Dialysis
* History of organ transplantation
* Dementia without a live-in caregiver, or
* In hospice care
* Reside outside the defined geographical area
* Reside in a skilled nursing or assisted living facility

Primary outcomes:
measure: Change in Physical Function Between Baseline and 60 Days Post-ED Visit
timeFrame: Baseline up to 60 days after index ED Visit
measure: Change in Anxiety Between Baseline and 60 Days Post-ED Visit
timeFrame: Baseline up to 60 days after index ED Visit
measure: Change in Informational Support Between Baseline and 60 Days Post-ED Visit
timeFrame: Baseline up to 60 days after index ED Visit
measure: Number of Participants With Outpatient Visit Claims
timeFrame: Within 30 days after index ED visit
measure: Number of Participants With ED Visit Claims
timeFrame: Within 30 days after index ED visit
measure: Number of Participants With In-patient Admission Claims
timeFrame: Within 30 days after index ED visit
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
city: Jacksonville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Donna L Carden, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schumacher JR, Lutz BJ, Hall AG, Harman JS, Turner K, Brumback BA, Hendry P, Carden DL. Impact of an Emergency Department-to-Home Transitional Care Intervention on Health Service Use in Medicare Beneficiaries: A Mixed Methods Study. Med Care. 2021 Jan;59(1):29-37. doi: 10.1097/MLR.0000000000001452.