Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02079987
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Florida

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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: An Emergency Department-To-Home Intervention to Improve Quality of Life and Reduce Hospital Use
Actual Study Start Date : May 3, 2014
Actual Primary Completion Date : November 30, 2015
Actual Study Completion Date : March 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
Other Name: Care Transition Intervention

Experimental: 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.
Other: 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.




Primary Outcome Measures :
  1. Change in Physical Function Between Baseline and 60 Days Post-ED Visit [ Time Frame: Baseline up to 60 days after index 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.

  2. Change in Anxiety Between Baseline and 60 Days Post-ED Visit [ Time Frame: Baseline up to 60 days after index 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.

  3. Change in Informational Support Between Baseline and 60 Days Post-ED Visit [ Time Frame: Baseline up to 60 days after index 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.

  4. Number of Participants With Outpatient Visit Claims [ Time Frame: Within 30 days after index ED visit ]
    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.

  5. Number of Participants With ED Visit Claims [ Time Frame: Within 30 days after index ED visit ]
    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.

  6. Number of Participants With In-patient Admission Claims [ Time Frame: Within 30 days after index ED visit ]
    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.



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.


Layout table for eligibility information
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
  • 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

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): NCT02079987


Locations
Layout table for location information
United States, Florida
UF Health
Gainesville, Florida, United States, 32608
UF Health
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
Patient-Centered Outcomes Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Donna L Carden, MD, MPH University of Florida
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02079987    
Other Study ID Numbers: IRB201400005
PCORI-1306-01451 ( Other Grant/Funding Number: PCORI )
First Posted: March 6, 2014    Key Record Dates
Results First Posted: April 5, 2019
Last Update Posted: April 5, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Healthcare Coach
Care Transition Intervention
Emergency Department Population
Access to Care
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Disease Attributes
Pathologic Processes