ED Patients With Chronic Medical Illnesses Clinical Trial
Official title:
An Emergency Department-To-Home Intervention to Improve Quality of Life and Reduce Hospital Use
Verified date | January 2019 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1101 |
Est. completion date | March 10, 2017 |
Est. primary completion date | November 30, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UF Health | Gainesville | Florida |
United States | UF Health | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Patient-Centered Outcomes Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01973296 -
Implementing an Emergency Department to Home Care Transition Intervention
|
N/A |