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

NCT02079987 | Completed Results DMC

• 2 other identifiers: IRB201400005PCORI-1306-01451
• Study Type: interventional
• Target: 1,101
• Locations: 1 country
• Sites: 2

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.

Conditions

ED Patients With Chronic Medical Illnesses

Keywords

Healthcare Coach; Care Transition Intervention; Emergency Department Population; Access to Care

Outcome Measures

Primary Outcomes (6)

• Change in Physical Function Between Baseline and 60 Days Post-ED Visit

  PROMIS Physical Function instruments measure self-reported capability. Each of 7-items in the physical function instrument used in this study has five response items ranging in value from one to five. Thus, the minimum score for the Physical Function Instrument used is 7 and the maximum score is 35. The raw score is translated to a T-score using PROMIS conversion tables. The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function, a T-score of 60 is one SD better than average. A Physical Function T-score of 40 is one SD worse than average. Change in Physical Function is the difference between baseline and 60 day T-score.

  Baseline up to 60 days after index ED Visit

• Change in Anxiety Between Baseline and 60 Days Post-ED Visit

  PROMIS Anxiety instruments measure self-reported fear, anxious misery, and hyperarousal. Each of 8-items in the Anxiety Instrument used in this study has five response items ranging in value from one to five. Thus, the minimum score for the Anxiety Instrument used is 8 and the maximum score is 40. The raw score is translated to a T-score using PROMIS conversion tables. The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, a T-score of 60 is one SD worse than average and an Anxiety T-score of 40 is one SD better than average.

  Baseline up to 60 days after index ED Visit

• Change in Informational Support Between Baseline and 60 Days Post-ED Visit

  PROMIS Informational Support instruments measure perceived availability of helpful information or advice. Each of 5-items in the Informational Support Instrument used in this study has five response items ranging in value from one to five. Thus, the minimum score for the Informational Support Instrument used is 5 and the maximum score is 25. The raw score is translated to a T-score using PROMIS conversion tables. The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Informational Support, a T-score of 60 is one SD better than average and a T-score of 40 is one SD worse than average.

  Baseline up to 60 days after index ED Visit

• Number of Participants With Outpatient Visit Claims

  This outcome was determined by assessing the number of participants who had one or more Medicare claims for an outpatient visit in the 30 days after the index ED visit.

  Within 30 days after index ED visit

• Number of Participants With ED Visit Claims

  This outcome was determined by assessing the number of participants who had one or more Medicare claims for an ED visit in the 30 days after the index ED visit.

  Within 30 days after index ED visit

• Number of Participants With In-patient Admission Claims

  This outcome was determined by assessing the number of participants who had one or more Medicare claims for a hospitalization in the 30 days after the index ED visit.

  Within 30 days after index ED visit

Study Arms (2)

ED-to-home care transition intervention

EXPERIMENTAL

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.

Behavioral: ED-to-home care transition intervention

Usual Care

EXPERIMENTAL

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.

Other: Usual Care

Interventions

ED-to-home care transition intervention 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.

Also known as: Care Transition Intervention

ED-to-home care transition intervention

Usual Care 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.

Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

UF Health

Gainesville, Florida, 32608, United States

Location

UF Health

Jacksonville, Florida, 32209, United States

Location

Related Publications (1)

• 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.

  PMID: 33298706 DERIVED

Limitations and Caveats

Intervention uptake was approximately 60%. 25% of participants did not respond to the follow-up quality of life survey and quality of life was assessed at only two time points. Outpatient visits were based on billed claims not provider type.

Results Point of Contact

• Title: Donna L. Carden, MD, MPH
• Organization: University of Florida

dcarden@ufl.edu

352-265-5911

Study Officials

• Donna L Carden, MD, MPH

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: In the ED, a sealed envelope contains the research participants' study assignment. The envelope remains sealed until completion of informed consent and all baseline study procedures after which unmasking occurs.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Study Start: May 3, 2014
• Primary Completion: November 30, 2015
• Study Completion: March 10, 2017
• Last Updated: April 5, 2019
• Results First Posted: April 5, 2019

Record last verified: 2019-01

Locations

US (2)