Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PCORI-1306-01451 | Other Grant/Funding Number | PCORI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Donna L Carden, MD, MPH | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health | Gainesville | Florida | 32608 | United States | ||
| UF Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33298706 | Derived | 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. |
Not provided
Not provided
1322 subjects signed an informed consent. 221 subjects were not included in the analysis because: 1) they did not have a unique Medicare ID; 2) no claims matching the date of index ED visit (informed consent date); 3) not enrolled in Medicare A & B for 12 months prior to index ED visit and at least 30 days after the ED visit.
Medicare beneficiaries with at least 1 chronic medical condition who presented to the ED during the study period were eligible for study entry. Recruitment dates were 5/3/14-11/30/15. Location types: two hospital EDs in north central Florida
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ED to Home Care Transition | The ED to home care transition intervention is a 4-week program that uses an Area Agency on Aging coach to conduct a home visit and three follow up phone calls to help patients develop self-management skills and to communicate with healthcare providers. ED to home care transition: The Area Agency on Aging coach's role is to build self-management capabilities for the patient and 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 the patient use the PHR to document and maintain vital information and to communicate with providers. |
| FG001 | Usual Care | Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care. Usual Care: Patients randomized to usual care will receive usual, post-ED care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only participants who were continuously enrolled in Medicare parts A & B 12 months prior to admission and had at least 30 days enrollment post index ED visit were included in the analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ED to Home Care Transition | The ED-to-home care transition intervention 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 disease self-management and to communicate with their providers. ED-to-home care transition: The Area Agency on Aging coach's role is to build self-management capabilities for the patient and caregiver. During each contact, the coach reviews the 4 components of the Care Transition Intervention: 1: Follow-up Medical Visits. 2: Knowledge of disease red flags. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Medicare beneficiaries presenting to the ED with at least 1 chronic condition were eligible. 1322 subjects signed an informed consent. 221 subjects were not included in the analysis because: 1) they did not have a unique Medicare ID identified; 2) they had no claims matching the date of index ED visit (informed consent date); 3) they were not enrolled in Medicare A & B for 12 months prior to index ED visit and 30 days after the ED visit. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only study participants who completed the baseline ED and follow-up telephone quality of life surveys were analyzed for this primary outcome measure | Posted | Mean | Standard Error | T-score | Baseline up to 60 days after index ED Visit |
|
30 days after the index ED visit.
Definition of adverse event and/or serious adverse event does not differ from the clinical trials.gov definitions. Adverse event data were collected in participants who were enrolled in Medicare parts A & B in the 12 months before and 30 days after the index ED visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ED to Home Care Transition | The ED to home care transition intervention is a 4-week program that uses an Area Agency on Aging healthcare coach to conduct a home visit and three follow up phone calls to help patients develop self-management skills and to communicate with healthcare providers. ED to home care transition: The Area Agency on Aging coach's role is to build self-management capabilities for the patient and 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 patient use the PHR to document and maintain vital information and to communicate with providers. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All cause mortality + hospitalization | General disorders | Systematic Assessment | 30-day hospitalizations and all cause mortality identified through Medicare Claims. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Return ED Visits | General disorders | Systematic Assessment | Return ED visits within 30 days of index ED visit. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donna L. Carden, MD, MPH | University of Florida | 352-265-5911 | dcarden@ufl.edu |
Not provided
Not provided
Not provided
Not provided
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.
|
|
| 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. |
|
| 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 |
| Jacksonville |
| Florida |
| 32209 |
| United States |
| BG001 | Usual Care | Usual Care: Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Only participants who were continuously enrolled in Medicare parts A & B 12 months prior to index ED visit and had at least 30 days enrollment post index ED visit were included in the health service use analysis. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Only participants who met inclusion criteria, were continuously enrolled in Medicare parts A & B 12 months prior to admission and had at least 30 days enrollment post index ED visit were included in the analysis. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Only participants who met inclusion criteria, were continuously enrolled in Medicare parts A & B 12 months prior to admission and had at least 30 days enrollment post index ED visit were included in the analysis. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Only participants who met inclusion criteria, were continuously enrolled in Medicare parts A & B 12 months prior to admission and had at least 30 days enrollment post index ED visit were included in the analysis. | Count of Participants | Participants |
|
| Region of Enrollment | Only participants who were continuously enrolled in Medicare parts A & B 12 months prior to admission and had at least 30 days enrollment post index ED visit were included in the analysis. | Number | participants |
|
| OG000 | ED to Home Care Transition | The ED to home care transition intervention is a 4-week program that uses a Area Agency on Aging coach to conduct a home visit and three follow up phone calls to help patients develop the skills needed for self-management and to communicate with healthcare providers. ED to home care transition: The Area Agency on Aging patient advocate's role is to build self-management capabilities for the patient and caregiver. During each contact, the patient advocate 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 patient advocate assists the patient use the PHR to document and maintain vital information and to communicate with providers. |
| OG001 | Usual Care | Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care. Usual Care: Patients randomized to usual care will receive usual, post-ED care. |
|
|
|
| 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. | Only participants who completed the baseline ED and follow-up telephone quality of life surveys were analyzed for this primary outcome measure. | Posted | Mean | Standard Error | T-score | 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. | Only participants who completed the baseline ED and follow-up telephone quality of life surveys were analyzed for this primary outcome measure. | Posted | Mean | Standard Error | T-score | 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. | Participants with Medicare Claims available at least 30 days after the index ED visit are included in the analysis. | Posted | Count of Participants | Participants | 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. | Participants with Medicare Claims available at least 30 days after the index ED visit are included in the analysis. | Posted | Count of Participants | Participants | 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. | Participants with Medicare Claims available at least 30 days after the index ED visit are included in the analysis. | Posted | Count of Participants | Participants | Within 30 days after index ED visit |
|
|
|
|
| 16 |
| 557 |
| 103 |
| 557 |
| 135 |
| 557 |
| EG001 | Usual Care | Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care. Usual Care: Patients randomized to usual care will receive usual, post-ED care. | 17 | 544 | 95 | 544 | 124 | 544 |
|
|
Not provided
Not provided