Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT02520661
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 1,979
• Locations: 2
• Arms: 2
• Actual Duration (Months): 45.9
• Patients Per Site: 989.5
• Patients Per Site Per Month: 21.6

Study Details

Study Description

Brief Summary

The emergency department (ED) is a common source of acute illness care for older adults. Many older adults who are discharged home from the ED return within 30 days due to numerous challenges faced during the ED-to-home transition. Unless programs to improve the ED-to-home transition are identified, the health and financial costs will only increase as the older adult population doubles by 2040. This study will apply Coleman's Care Transitions Intervention to the ED-to-home transition by adapting the program to account for the unique aspects of the ED setting. The research will evaluate the process, ED use, and cost outcomes of a community-based, paramedic-coordinated Care Transitions Intervention. Upon completion, this study will provide empiric evidence regarding this innovative approach to help the rapidly growing older adult population remain healthy and independent after an ED visit.

Condition or Disease	Intervention/Treatment	Phase
Emergencies; Aging	Behavioral: Care Transitions Intervention	N/A

Detailed Description

Older adults use the emergency department (ED) as an important source of acute care, making 20 million ED visits annually. Most older adults who visit the ED do not have conditions of sufficient severity to warrant hospital admission; thus, they are treated and discharged home. Unfortunately, older adults do poorly after being discharged home from the ED, with 20% having repeat ED visits within 30 days. The ED-to-home transition has been identified as a cause for these avoidable poor outcomes, but ED-focused interventions to improve this transition have had inconclusive outcomes and have suffered from feasibility, sustainability and scalability problems.

Coleman's Care Transition Intervention (CTI) has been validated to improve the hospital-to-home transition, decreasing both hospital readmissions and costs. The CTI uses coaches, usually nurses or social workers, to support patients being discharged home by transferring skills to activate patients. Applying the CTI to the ED-to-home transition is a natural extension, but it has not been evaluated in this unique and demanding setting.

In this study, the investigators will test the hypothesis that the community-based, paramedic-coordinated ED-to-home CTI will improve community-dwelling older adults' post-ED health outcomes and reduce costs. The investigators will evaluate CTI process outcomes by testing if participants randomized to the CTI demonstrate better understanding of red flags that indicate a worsening of their condition, implement medication changes more frequently, and follow up with their primary care physicians more rapidly after ED discharge, as compared to the control group. The investigators will also evaluate the effectiveness and cost-effectiveness of the CTI by testing if participants randomized to the CTI have improved Patient Activation Measure scores 30 days after discharge, have decreased frequency of ED use, and decreased health care costs within 30 days of ED discharge. Additionally, the investigators recognize that the CTI will not eliminate all repeat ED visits. Thus, they will identify factors independently associated with repeat ED visits among CTI recipients such that future programs can ensure their needs are adequately addressed.

This research will provide critical empiric evidence regarding the significant problem of poor ED-to-home transitions. By leveraging the CTI, a widely available and efficient intervention and paramedics, a highly-skilled and respected health care provider present in all communities, the investigators will apply an innovative approach to improve older adults' health following an ED visit. Through rigorous research, they will test the effectiveness and cost-effectiveness of this approach, with a specific focus on ultimate sustainability and dissemination.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1979 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health
• Actual Study Start Date: Feb 3, 2016
• Actual Primary Completion Date: Jul 31, 2019
• Actual Study Completion Date: Nov 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care Older adults discharged from an ED to home who receive the usual processes and services.
Active Comparator: Care Transitions Intervention Older adults discharged from an ED to home who receive the Care Transitions Intervention.	Behavioral: Care Transitions Intervention; The Care Transitions Intervention uses coaches, in this case paramedics, to support patients being discharged home by transferring skills to activate patients.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Returning to the ED Within 30 Days of the Original ED Visit [30 days after emergency department discharge]

   The investigators included all unplanned ED use, regardless of reason, during the 30 days after discharge as abstracted from electronic medical records (with out-of-system ED use identified during participant phone surveys). The investigators constructed dichotomous variables measuring whether or not any ED visits occurred within 14 and 30 days after discharge, with the 30-day interval being the primary prespecified outcome. Control vs Intent-to-Treat vs Per Protocol population reported.

2. Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care [Medical records reviewed for number of participants who followed up within 7 and 30 days, augmented by participant surveys at day 4 and 30 to learn about non-University of Wisconsin hospital visits]

   Follow-up visits, abstracted from participant medical records, included office visits with primary or specialty providers, telephone calls, and online patient portal messaging (excluding automated reminder messages, electronic messages that did not receive a patient response, laboratory testing, and previously scheduled outpatient procedures). Outpatient follow-up was dichotomized by whether or not any contact with outpatient providers occurred within either 7 or 30 days of discharge. This approach allowed us to differentiate follow-up occurring soon after discharge (consistent with most ED discharge instructions) from less-timely contact with outpatient clinics. To conduct a preplanned subanalysis, we also categorized all follow-up as either "in-person" or "electronic." Dichotomous variables were created for each modality at each time point as well as a combined variable representing all forms of contact. Control vs Intent-To-Treat vs Per Protocol population reported.

3. Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge [up to 30 days]

   Control vs Intent-to-Treat vs Per Protocol Population reported

Secondary Outcome Measures

1. Number of Participants With Medication Changes Implemented [day 4]

   The investigators asked participants to self-report any medication changes (starts, stops, or modifications) they had made since discharge during the 4-day survey. They had to provide the name, classification, or purpose of each medication. Medically trained researchers compared self-reported medication changes to those listed on participants' AVS discharge instructions, excluding those with "as needed" instructions. The dichotomized variable indicates whether or not the participant reported making all recommended medication changes.

2. Number of Participants Who Could Recall Any Specific Red Flag [day 4]

   The discharge instructions from the ED will be abstracted for key red flags. Participants will be asked to list the red flags for which they are monitoring their condition.

3. Level of Participant Activation as Measured by the Perceived Health Competence Survey [30 days after emergency department discharge]

   Perceived Health Competence Score (PHCS) has a total possible range of scores from 8-40 where higher scores indicate a stronger perception of health competency. This is also known as the Wallston score.

4. Median Cost of Healthcare Services Within 30 Days of the Original ED Visit [30 days after emergency department discharge]

Other Outcome Measures

1. Program Satisfaction Survey Score [day 1, day 30]

   Participants and Caregivers were surveyed for their satisfaction with the intervention, on a scale of 0-10 where 0 is the worst experience and 10 is the best experience.

2. Family Caregiver Activation in Transitions (FCAT) [day 1, day 30]

   The Family Caregiver Activation in Transitions survey is a series of statements about challenges commonly faced by those caring for a loved one. It is scored on a 6 point likert scale for a total possible range between 10-60, where higher scores indicate fewer challenges to care.

3. Number of Participants Who Died Within 30 Days of Discharge [up to 30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age≥60 years

2. English speaking

3. Monroe County, New York or Dane County, Wisconsin resident

4. University of Wisconsin or University of Rochester affiliated primary care physician

5. Community dwelling (no prisoners, nursing home, assisted living residents)

6. Discharge home from the ED

Exclusion Criteria:

1. Previous study participation

2. Discharged to hospice

3. Homelessness

4. Followed by transition care team (e.g., from recent hospitalization)

5. Followed by intensive case management program

6. Emergency Severity Index 1 patients (highest acuity, as assigned by ED triage staff)

7. Unable to obtain consent from patient or proxy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Medical Center	Rochester	New York	United States	14642
2	University of Wisconsin	Madison	Wisconsin	United States	53705

Sponsors and Collaborators

• University of Wisconsin, Madison
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Manish N Shah, MD, MPH, University of Wisconsin, Madison

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 10, 2016

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT02520661
• Other Study ID Numbers: 2015-1197; 2015-1197; R01AG050504; A534100; SMPH\EMERG MED
• First Posted: Aug 13, 2015
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Emergencies

Study Results

Participant Flow

Recruitment Details

A single-blind randomized controlled trial conducted at three university-affiliated hospital Emergency Departments: one in Madison, Wisconsin, and two in Rochester, New York. The study was approved by institutional review boards at the University of Wisconsin and University of Rochester with written informed consent. Enrollment and data collection occurred between January 2016 and July 2019.

Pre-assignment Detail

6,102 (11.3 percent) of 53,801 patients greater than or equal to 60 years old presenting during recruitment hours were approached for the study. Primary reasons for exclusion were inpatient admission from ED, not having a primary care provider in the health system, and living in a long-term care/assisted-living facility. After additional eligibility checks and refusals, 1,979 patients (32.4 percent) were consented and randomized into the study.

Arm/Group Title	Usual Care	Care Transitions Intervention
Arm/Group Description	Older adults discharged from an ED to home who receive the usual processes and services.	Older adults discharged from an ED to home who receive the Care Transitions Intervention. Care Transitions Intervention: The Care Transitions Intervention uses coaches, in this case paramedics, to support patients being discharged home by transferring skills to activate patients.
Period Title: Overall Study
STARTED	992	987
Removed Following Randomization	124	99
CTI Home Visit Scheduled	0	863
Participants in Dataset	893	863
Participants Completing Home Visit	0	726
Participants With Primary Outcome Data (ITT)	886	860
Participants With Primary Outcome Data (PP)	886	725
COMPLETED	886	860
NOT COMPLETED	106	127

Baseline Characteristics

Arm/Group Title	Usual Care: Control Group	Care Transitions Intervention (ITT)	Total
Arm/Group Description	Older adults discharged from an ED to home who receive the usual processes and services.	Older adults discharged from an ED to home, intended to receive the Care Transitions Intervention.	Total of all reporting groups
Overall Participants	893	863	1756
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.10 (8.50)	72.69 (8.65)	72.39 (8.58)
Sex: Female, Male (Count of Participants)
Female	480 53.8%	458 53.1%	938 53.4%
Male	413 46.2%	405 46.9%	818 46.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	15 1.7%	12 1.4%	27 1.5%
Not Hispanic or Latino	878 98.3%	851 98.6%	1729 98.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 0.3%	1 0.1%	4 0.2%
Asian	11 1.2%	7 0.8%	18 1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	40 4.5%	36 4.2%	76 4.3%
White	818 91.6%	800 92.7%	1618 92.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	21 2.4%	19 2.2%	40 2.3%
Region of Enrollment (participants) [Number]
United States	893 100%	863 100%	1756 100%
Education (Count of Participants)
Count of Participants [Participants]	352 39.4%	337 39%	689 39.2%
Marital Status (Count of Participants)
Count of Participants [Participants]	352 39.4%	361 41.8%	713 40.6%
Number of Charlson Comorbidities (Charlson Comorbidities) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Charlson Comorbidities]	2.65 (1.69)	2.79 (1.65)	2.72 (1.67)
Number of Participants with Deficiencies in One or more ADL (Count of Participants)
Count of Participants [Participants]	299 33.5%	332 38.5%	631 35.9%
Number of Participants with Cognitive Impairment (Count of Participants)
Count of Participants [Participants]	60 6.7%	67 7.8%	127 7.2%
Number of Participants with Inadequate Health Literacy (Count of Participants)
Count of Participants [Participants]	98 11%	116 13.4%	214 12.2%
Number of Participants with Anxiety per GAD-2 (Count of Participants)
Count of Participants [Participants]	155 17.4%	138 16%	293 16.7%
Number of Participants with Moderate to Severe Depression per PHQ-9 (Count of Participants)
Count of Participants [Participants]	95 10.6%	94 10.9%	189 10.8%
Perceived Health Competence Score (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	29.87 (5.28)	30.31 (5.29)	30.09 (5.29)
Number of Participants with Fair or Poor Overall Health per SF-12 (Count of Participants)
Count of Participants [Participants]	181 20.3%	174 20.2%	355 20.2%
Number of Participants Hospitalized in 30 days prior to Emergency Department (ED) study visit (Count of Participants)
Count of Participants [Participants]	43 4.8%	47 5.4%	90 5.1%
Number of ED visits in 30 days prior to index ED visit (ED visits) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ED visits]	0.12 (0.40)	0.10 (0.34)	0.11 (0.38)

Outcome Measures

1. Primary Outcome

Title	Number of Participants Returning to the ED Within 30 Days of the Original ED Visit
Description	The investigators included all unplanned ED use, regardless of reason, during the 30 days after discharge as abstracted from electronic medical records (with out-of-system ED use identified during participant phone surveys). The investigators constructed dichotomous variables measuring whether or not any ED visits occurred within 14 and 30 days after discharge, with the 30-day interval being the primary prespecified outcome. Control vs Intent-to-Treat vs Per Protocol population reported.
Time Frame	30 days after emergency department discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Care Transitions Intervention (ITT)	Care Transitions Intervention (PP)
Arm/Group Description	Older adults discharged from an ED to home who receive the usual processes and services.	Older adults discharged from an ED to home intended to receive the Care Transitions Intervention.	Older adults discharged from an ED to home receive the Care Transitions Intervention per protocol.
Measure Participants	893	863	726
ED revisits within 14 days	84 9.4%	69 8%	51 2.9%
ED revisits within 30 days	113 12.7%	103 11.9%	81 4.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Care Transitions Intervention (ITT)
	Comments	treatment relevant change in number of ED visits by 14 days
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.62 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Care Transitions Intervention (ITT)
	Comments	treatment relevant change in number of ED visits by 30 days
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care
Description	Follow-up visits, abstracted from participant medical records, included office visits with primary or specialty providers, telephone calls, and online patient portal messaging (excluding automated reminder messages, electronic messages that did not receive a patient response, laboratory testing, and previously scheduled outpatient procedures). Outpatient follow-up was dichotomized by whether or not any contact with outpatient providers occurred within either 7 or 30 days of discharge. This approach allowed us to differentiate follow-up occurring soon after discharge (consistent with most ED discharge instructions) from less-timely contact with outpatient clinics. To conduct a preplanned subanalysis, we also categorized all follow-up as either "in-person" or "electronic." Dichotomous variables were created for each modality at each time point as well as a combined variable representing all forms of contact. Control vs Intent-To-Treat vs Per Protocol population reported.
Time Frame	Medical records reviewed for number of participants who followed up within 7 and 30 days, augmented by participant surveys at day 4 and 30 to learn about non-University of Wisconsin hospital visits

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Care Transitions Intervention (ITT)	Care Transitions Intervention (PP)
Arm/Group Description	Older adults discharged from an ED to home who receive the usual processes and services.	Older adults discharged from an ED to home intended to receive the Care Transitions Intervention.	Older adults discharged from an ED to home to receive the Care Transitions Intervention per protocol.
Measure Participants	893	863	726
All Follow-Up within 7 Days	657 73.6%	664 76.9%	561 31.9%
All Follow-Up within 30 Days	773 86.6%	775 89.8%	653 37.2%
In-Person Follow-Up within 7 days	428 47.9%	456 52.8%	385 21.9%
In-Person Follow-Up within 30 days	698 78.2%	702 81.3%	592 33.7%
Electronic Follow-Up within 7 Days	510 57.1%	524 60.7%	445 25.3%
Electronic Follow-Up within 30 Days	659 73.8%	646 74.9%	548 31.2%

3. Primary Outcome

Title	Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge
Description	Control vs Intent-to-Treat vs Per Protocol Population reported
Time Frame	up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Care Transitions Intervention (ITT)	Care Transitions Intervention (PP)
Arm/Group Description	Older adults discharged from an ED to home who receive the usual processes and services.	Older adults discharged from an ED to home intended to receive the Care Transitions Intervention.	Older adults discharged from an ED to home to receive the Care Transitions Intervention per protocol.
Measure Participants	893	863	726
Urgent Care Visits	24 2.7%	24 2.8%	23 1.3%
Unplanned hospitalization	46 5.2%	45 5.2%	30 1.7%

4. Secondary Outcome

Title	Number of Participants With Medication Changes Implemented
Description	The investigators asked participants to self-report any medication changes (starts, stops, or modifications) they had made since discharge during the 4-day survey. They had to provide the name, classification, or purpose of each medication. Medically trained researchers compared self-reported medication changes to those listed on participants' AVS discharge instructions, excluding those with "as needed" instructions. The dichotomized variable indicates whether or not the participant reported making all recommended medication changes.
Time Frame	day 4

Outcome Measure Data

Analysis Population Description

Only participants with medication-related changes on their AVS instructions were included in this analysis

Arm/Group Title	Usual Care	Care Transitions Intervention (ITT)	Care Transitions Intervention (PP)
Arm/Group Description	Older adults discharged from an ED to home who receive the usual processes and services.	Older adults discharged from an ED to home with intent to receive the Care Transitions Intervention.	Older adults discharged from an ED to home to receive the Care Transitions Intervention per protocol.
Measure Participants	236	233	186
Count of Participants [Participants]	78 8.7%	73 8.5%	65 3.7%

5. Secondary Outcome

Title	Number of Participants Who Could Recall Any Specific Red Flag
Description	The discharge instructions from the ED will be abstracted for key red flags. Participants will be asked to list the red flags for which they are monitoring their condition.
Time Frame	day 4

Outcome Measure Data

Analysis Population Description

Only patients with specific red flags listed on their discharge instructions were included in this analysis (n = 1207).

Arm/Group Title	Usual Care	Care Transitions Intervention (ITT)	Care Transitions Intervention (PP)
Arm/Group Description	Older adults discharged from an ED to home who receive the usual processes and services.	Older adults discharged from an ED to home with intent to receive the Care Transitions Intervention.	Older adults discharged from an ED to home to receive the Care Transitions Intervention per protocol.
Measure Participants	635	572	514
Count of Participants [Participants]	225 25.2%	225 26.1%	215 12.2%

6. Secondary Outcome

Title	Level of Participant Activation as Measured by the Perceived Health Competence Survey
Description	Perceived Health Competence Score (PHCS) has a total possible range of scores from 8-40 where higher scores indicate a stronger perception of health competency. This is also known as the Wallston score.
Time Frame	30 days after emergency department discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Care Transitions Intervention (ITT)	Care Transitions Intervention (PP)
Arm/Group Description	Older adults discharged from an ED to home who receive the usual processes and services.	Older adults discharged from an ED to home intended to receive the Care Transitions Intervention.	Older adults discharged from an ED to home to receive the Care Transitions Intervention per protocol.
Measure Participants	880	850	718
Mean (Standard Deviation) [score on a scale]	30.54 (4.76)	31.12 (4.71)	31.25 (4.77)

7. Secondary Outcome

Title	Median Cost of Healthcare Services Within 30 Days of the Original ED Visit
Time Frame	30 days after emergency department discharge

Outcome Measure Data

Analysis Population Description

The investigators made an informed decision not to collect cost data.

Arm/Group Title	Usual Care	Care Transitions Intervention
Arm/Group Description	Older adults discharged from an ED to home who receive the usual processes and services.	Older adults discharged from an ED to home who receive the Care Transitions Intervention. Care Transitions Intervention: The Care Transitions Intervention uses coaches, in this case paramedics, to support patients being discharged home by transferring skills to activate patients.
Measure Participants	0	0

8. Other Pre-specified Outcome

Title	Program Satisfaction Survey Score
Description	Participants and Caregivers were surveyed for their satisfaction with the intervention, on a scale of 0-10 where 0 is the worst experience and 10 is the best experience.
Time Frame	day 1, day 30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Other Pre-specified Outcome

Title	Family Caregiver Activation in Transitions (FCAT)
Description	The Family Caregiver Activation in Transitions survey is a series of statements about challenges commonly faced by those caring for a loved one. It is scored on a 6 point likert scale for a total possible range between 10-60, where higher scores indicate fewer challenges to care.
Time Frame	day 1, day 30

Outcome Measure Data

Analysis Population Description

Investigators did not analyze the FCAT because of reliability issues with the instrument that led them to lack confidence in the instrument.

Arm/Group Title	Usual Care	Care Transitions Intervention
Arm/Group Description	Older adults discharged from an ED to home who receive the usual processes and services.	Older adults discharged from an ED to home who receive the Care Transitions Intervention. Care Transitions Intervention: The Care Transitions Intervention uses coaches, in this case paramedics, to support patients being discharged home by transferring skills to activate patients.
Measure Participants	0	0

10. Other Pre-specified Outcome

Title	Number of Participants Who Died Within 30 Days of Discharge
Time Frame	up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Care Transitions Intervention
Arm/Group Description	Older adults discharged from an ED to home who receive the usual processes and services.	Older adults discharged from an ED to home who receive the Care Transitions Intervention. Care Transitions Intervention: The Care Transitions Intervention uses coaches, in this case paramedics, to support patients being discharged home by transferring skills to activate patients.
Measure Participants	893	863
Count of Participants [Participants]	5 0.6%	2 0.2%

Adverse Events

Time Frame	up to 30 days
Adverse Event Reporting Description	Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
Arm/Group Title	Usual Care		Care Transitions Intervention
Arm/Group Description	Older adults discharged from an ED to home who receive the usual processes and services.		Older adults discharged from an ED to home who receive the Care Transitions Intervention.
All Cause Mortality
	Usual Care		Care Transitions Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/992 (0.5%)		2/987 (0.2%)
Serious Adverse Events
	Usual Care		Care Transitions Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	51/992 (5.1%)		51/987 (5.2%)
Blood and lymphatic system disorders
Blood and Lymphatic Disorders	1/992 (0.1%)		0/987 (0%)
Cardiac disorders
Cardiac Disorders	7/992 (0.7%)		11/987 (1.1%)
Gastrointestinal disorders
Gastrointestinal Disorders	8/992 (0.8%)		6/987 (0.6%)
General disorders
General Disorders	3/992 (0.3%)		2/987 (0.2%)
Infections and infestations
Infections and Infestations	4/992 (0.4%)		6/987 (0.6%)
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications	4/992 (0.4%)		0/987 (0%)
Metabolism and nutrition disorders
Metabolism and nutrition disorders	2/992 (0.2%)		1/987 (0.1%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	7/992 (0.7%)		3/987 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified	1/992 (0.1%)		0/987 (0%)
Nervous system disorders
Nervous System Disorders	4/992 (0.4%)		6/987 (0.6%)
Renal and urinary disorders
Renal and urinary disorders	3/992 (0.3%)		4/987 (0.4%)
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders	4/992 (0.4%)		7/987 (0.7%)
Surgical and medical procedures
Surgical and Medical Procedures	0/992 (0%)		1/987 (0.1%)
Vascular disorders
Vascular disorders	3/992 (0.3%)		4/987 (0.4%)
Other (Not Including Serious) Adverse Events
	Usual Care		Care Transitions Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	93/992 (9.4%)		76/987 (7.7%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders	1/992 (0.1%)		1/987 (0.1%)
Cardiac disorders
Cardiac Disorders	13/992 (1.3%)		7/987 (0.7%)
Ear and labyrinth disorders
Ear and labyrinth disorders	0/992 (0%)		1/987 (0.1%)
Endocrine disorders
Endocrine Disorders	0/992 (0%)		2/987 (0.2%)
Gastrointestinal disorders
Gastrointestinal Disorders	9/992 (0.9%)		10/987 (1%)
General disorders
General Disorders	7/992 (0.7%)		5/987 (0.5%)
Hepatobiliary disorders
Hepatobiliary disorders	1/992 (0.1%)		0/987 (0%)
Immune system disorders
Immune System Disorders	1/992 (0.1%)		0/987 (0%)
Infections and infestations
Infections and Infestations	4/992 (0.4%)		3/987 (0.3%)
Injury, poisoning and procedural complications
Injury, poisoning, and procedural complications	7/992 (0.7%)		8/987 (0.8%)
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders	3/992 (0.3%)		4/987 (0.4%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissues disorders	10/992 (1%)		6/987 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified	0/992 (0%)		1/987 (0.1%)
Nervous system disorders
Nervous System Disorders	9/992 (0.9%)		5/987 (0.5%)
Psychiatric disorders
Psychiatric disorders	3/992 (0.3%)		1/987 (0.1%)
Renal and urinary disorders
Renal and Urinary Disorders	4/992 (0.4%)		2/987 (0.2%)
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders	7/992 (0.7%)		13/987 (1.3%)
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders	3/992 (0.3%)		0/987 (0%)
Surgical and medical procedures
Surgical and Medical procedures	3/992 (0.3%)		1/987 (0.1%)
Vascular disorders
Vascular Disorders	8/992 (0.8%)		6/987 (0.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.