An Emergency Department-To-Home Intervention to Improve Quality of Life and Reduce Hospital Use

NCT ID: NCT02079987

Last Updated: 2019-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-03
• Study Completion Date: 2017-03-10

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.

Conditions

ED Patients With Chronic Medical Illnesses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

ED-to-home care transition intervention

The ED-to-home care transition intervention is a coaching intervention. It is a 4-week program that uses an Area Agency on Aging healthcare coach to conduct a home visit and at least 3 follow-up phone calls to help patients develop the skills needed for self-management and to communicate with healthcare providers.

Group Type: EXPERIMENTAL

ED-to-home care transition intervention

Intervention Type: BEHAVIORAL

The Area Agency on Aging coach's role is to build self-management capabilities for the patient and their caregiver. During each contact, the coach reviews the four components of the Care Transition Intervention: 1: Follow-up Medical Visit. 2: Knowledge of Red Flag Symptoms. 3: Medication Reconciliation. 4: The Personal Health Record (PHR). The coach assists patients use the PHR to document and maintain vital information and to communicate with providers.

Usual Care

Patients randomized to usual care will receive verbal and written discharge instructions from the treating ED physician and nurse as is the standard of care.

Group Type: EXPERIMENTAL

Usual Care

Intervention Type: OTHER

Patients randomized to usual care will receive verbal and written discharge instructions from the treating ED physician and nurse as is the standard of care.

Interventions

ED-to-home care transition intervention

The Area Agency on Aging coach's role is to build self-management capabilities for the patient and their caregiver. During each contact, the coach reviews the four components of the Care Transition Intervention: 1: Follow-up Medical Visit. 2: Knowledge of Red Flag Symptoms. 3: Medication Reconciliation. 4: The Personal Health Record (PHR). The coach assists patients use the PHR to document and maintain vital information and to communicate with providers.

Intervention Type: BEHAVIORAL

Usual Care

Patients randomized to usual care will receive verbal and written discharge instructions from the treating ED physician and nurse as is the standard of care.

Intervention Type: OTHER

Other Intervention Names

Care Transition Intervention

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donna L Carden, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health

Gainesville, Florida, United States

UF Health

Jacksonville, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33298706 (View on PubMed)

Other Identifiers

PCORI-1306-01451

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB201400005

Identifier Type: -

Identifier Source: org_study_id