Trial Outcomes & Findings for An Emergency Department-To-Home Intervention to Improve Quality of Life and Reduce Hospital Use (NCT NCT02079987)

NCT ID: NCT02079987

Last Updated: 2019-04-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1101 participants

Primary outcome timeframe

Baseline up to 60 days after index ED Visit

Results posted on

2019-04-05

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
557
544
Overall Study
COMPLETED
557
544
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ED to Home Care Transition
n=557 Participants
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.
Usual Care
n=544 Participants
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.
Total
n=1101 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
118 Participants
n=93 Participants
120 Participants
n=4 Participants
238 Participants
n=27 Participants
Age, Categorical
>=65 years
439 Participants
n=93 Participants
424 Participants
n=4 Participants
863 Participants
n=27 Participants
Age, Continuous
72.5 years
STANDARD_DEVIATION 8.4 • n=93 Participants • 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.
72.8 years
STANDARD_DEVIATION 8.6 • n=4 Participants • 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.
72.6 years
STANDARD_DEVIATION 8.5 • n=27 Participants • 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.
Sex: Female, Male
Female
336 Participants
n=93 Participants • 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.
345 Participants
n=4 Participants • 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.
681 Participants
n=27 Participants • 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.
Sex: Female, Male
Male
221 Participants
n=93 Participants • 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.
199 Participants
n=4 Participants • 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.
420 Participants
n=27 Participants • 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.
Ethnicity (NIH/OMB)
Hispanic or Latino
18 Participants
n=93 Participants • 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.
14 Participants
n=4 Participants • 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.
32 Participants
n=27 Participants • 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.
Ethnicity (NIH/OMB)
Not Hispanic or Latino
539 Participants
n=93 Participants • 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.
528 Participants
n=4 Participants • 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.
1067 Participants
n=27 Participants • 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.
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants • 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.
2 Participants
n=4 Participants • 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.
2 Participants
n=27 Participants • 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.
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants • 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.
0 Participants
n=4 Participants • 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.
0 Participants
n=27 Participants • 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.
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants • 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.
0 Participants
n=4 Participants • 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.
0 Participants
n=27 Participants • 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.
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants • 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.
0 Participants
n=4 Participants • 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.
0 Participants
n=27 Participants • 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.
Race (NIH/OMB)
Black or African American
259 Participants
n=93 Participants • 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.
244 Participants
n=4 Participants • 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.
503 Participants
n=27 Participants • 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.
Race (NIH/OMB)
White
277 Participants
n=93 Participants • 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.
277 Participants
n=4 Participants • 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.
554 Participants
n=27 Participants • 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.
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants • 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.
0 Participants
n=4 Participants • 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.
0 Participants
n=27 Participants • 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.
Race (NIH/OMB)
Unknown or Not Reported
21 Participants
n=93 Participants • 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.
23 Participants
n=4 Participants • 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.
44 Participants
n=27 Participants • 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.
Region of Enrollment
United States
557 participants
n=93 Participants • 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.
544 participants
n=4 Participants • 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.
1101 participants
n=27 Participants • 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.

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure
ED to Home Care Transition
n=384 Participants
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.
Usual Care
n=365 Participants
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.
Change in Physical Function Between Baseline and 60 Days Post-ED Visit
-1.47 T-score
Standard Error 0.62
-0.83 T-score
Standard Error 0.67

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
ED to Home Care Transition
n=384 Participants
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.
Usual Care
n=365 Participants
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.
Change in Anxiety Between Baseline and 60 Days Post-ED Visit
1.53 T-score
Standard Error 0.76
0.21 T-score
Standard Error 0.79

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
ED to Home Care Transition
n=384 Participants
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.
Usual Care
n=365 Participants
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.
Change in Informational Support Between Baseline and 60 Days Post-ED Visit
-1.45 T-score
Standard Error 0.79
-2.84 T-score
Standard Error 0.91

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
ED to Home Care Transition
n=557 Participants
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.
Usual Care
n=544 Participants
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.
Number of Participants With Outpatient Visit Claims
456 Participants
417 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
ED to Home Care Transition
n=557 Participants
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.
Usual Care
n=544 Participants
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.
Number of Participants With ED Visit Claims
135 Participants
124 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
ED to Home Care Transition
n=557 Participants
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.
Usual Care
n=544 Participants
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.
Number of Participants With In-patient Admission Claims
87 Participants
78 Participants

Adverse Events

ED to Home Care Transition

Serious events: 103 serious events
Other events: 135 other events
Deaths: 16 deaths

Usual Care

Serious events: 95 serious events
Other events: 124 other events
Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure
ED to Home Care Transition
n=557 participants at risk
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.
Usual Care
n=544 participants at risk
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.
General disorders
All cause mortality + hospitalization
18.5%
103/557 • Number of events 103 • 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.
17.5%
95/544 • Number of events 95 • 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.

Other adverse events

Other adverse events
Measure
ED to Home Care Transition
n=557 participants at risk
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.
Usual Care
n=544 participants at risk
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.
General disorders
Return ED Visits
24.2%
135/557 • Number of events 135 • 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.
22.8%
124/544 • Number of events 124 • 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.

Additional Information

Donna L. Carden, MD, MPH

University of Florida

Phone: 352-265-5911

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place