ED Patients With Chronic Medical Illnesses
Conditions
Keywords
Healthcare Coach, Care Transition Intervention, Emergency Department Population, Access to Care
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.
Interventions
BEHAVIORALED-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.
OTHERUsual 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.
Sponsors
Patient-Centered Outcomes Research Institute
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Function Between Baseline and 60 Days Post-ED Visit | 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. |
| Change in Anxiety Between Baseline and 60 Days Post-ED Visit | 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. |
| Change in Informational Support Between Baseline and 60 Days Post-ED Visit | 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. |
| Number of Participants With Outpatient Visit Claims | 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. |
| Number of Participants With ED Visit Claims | 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. |
| Number of Participants With In-patient Admission Claims | 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. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 557 |
| 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. | 544 |
| Total | 1,101 |
Baseline characteristics
| Characteristic | ED to Home Care Transition | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 439 Participants | 424 Participants | 863 Participants |
| Age, Categorical Between 18 and 65 years | 118 Participants | 120 Participants | 238 Participants |
| Age, Continuous | 72.5 years STANDARD_DEVIATION 8.4 | 72.8 years STANDARD_DEVIATION 8.6 | 72.6 years STANDARD_DEVIATION 8.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 14 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 539 Participants | 528 Participants | 1067 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 259 Participants | 244 Participants | 503 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants | 23 Participants | 44 Participants |
| Race (NIH/OMB) White | 277 Participants | 277 Participants | 554 Participants |
| Region of Enrollment United States | 557 participants | 544 participants | 1101 participants |
| Sex: Female, Male Female | 336 Participants | 345 Participants | 681 Participants |
| Sex: Female, Male Male | 221 Participants | 199 Participants | 420 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 16 / 557 | 17 / 544 |
| other Total, other adverse events | 135 / 557 | 124 / 544 |
| serious Total, serious adverse events | 103 / 557 | 95 / 544 |
Outcome results
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.
Time frame: Baseline up to 60 days after index ED Visit
Population: Only participants who completed the baseline ED and follow-up telephone quality of life surveys were analyzed for this primary outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ED to Home Care Transition | Change in Anxiety Between Baseline and 60 Days Post-ED Visit | 1.53 T-score | Standard Error 0.76 |
| Usual Care | Change in Anxiety Between Baseline and 60 Days Post-ED Visit | 0.21 T-score | Standard Error 0.79 |
p-value: 0.23difference-in-difference analysis
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.
Time frame: Baseline up to 60 days after index ED Visit
Population: Only participants who completed the baseline ED and follow-up telephone quality of life surveys were analyzed for this primary outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ED to Home Care Transition | Change in Informational Support Between Baseline and 60 Days Post-ED Visit | -1.45 T-score | Standard Error 0.79 |
| Usual Care | Change in Informational Support Between Baseline and 60 Days Post-ED Visit | -2.84 T-score | Standard Error 0.91 |
p-value: 0.25difference-in-difference analysis
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.
Time frame: Baseline up to 60 days after index ED Visit
Population: Only study participants who completed the baseline ED and follow-up telephone quality of life surveys were analyzed for this primary outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ED to Home Care Transition | Change in Physical Function Between Baseline and 60 Days Post-ED Visit | -1.47 T-score | Standard Error 0.62 |
| Usual Care | Change in Physical Function Between Baseline and 60 Days Post-ED Visit | -0.83 T-score | Standard Error 0.67 |
p-value: 0.49difference-in-difference analysis
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.
Time frame: Within 30 days after index ED visit
Population: Participants with Medicare Claims available at least 30 days after the index ED visit are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ED to Home Care Transition | Number of Participants With ED Visit Claims | 135 Participants |
| Usual Care | Number of Participants With ED Visit Claims | 124 Participants |
p-value: 0.57Chi-squared
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.
Time frame: Within 30 days after index ED visit
Population: Participants with Medicare Claims available at least 30 days after the index ED visit are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ED to Home Care Transition | Number of Participants With In-patient Admission Claims | 87 Participants |
| Usual Care | Number of Participants With In-patient Admission Claims | 78 Participants |
p-value: 0.87Chi-squared
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.
Time frame: Within 30 days after index ED visit
Population: Participants with Medicare Claims available at least 30 days after the index ED visit are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ED to Home Care Transition | Number of Participants With Outpatient Visit Claims | 456 Participants |
| Usual Care | Number of Participants With Outpatient Visit Claims | 417 Participants |
p-value: 0.03Chi-squared