Aging, Emergencies
Conditions
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.
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.
Interventions
BEHAVIORALCare Transitions Intervention
The Care Transitions Intervention uses coaches, in this case paramedics, to support patients being discharged home by transferring skills to activate patients.
Sponsors
National Institute on Aging (NIA)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Median Cost of Healthcare Services Within 30 Days of the Original ED Visit | 30 days after emergency department discharge | — |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Participants Who Died Within 30 Days of Discharge | up to 30 days | — |
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care: Control Group Older adults discharged from an ED to home who receive the usual processes and services. | 893 |
| Care Transitions Intervention (ITT) Older adults discharged from an ED to home, intended to receive the Care Transitions Intervention. | 863 |
| Total | 1,756 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Admitted from ED | 49 | 48 |
| Overall Study | ED greater than 24 hours | 29 | 38 |
| Overall Study | Lost to Follow-up | 7 | 3 |
| Overall Study | other ineligibility | 14 | 22 |
| Overall Study | Withdrawal by Subject | 7 | 16 |
Baseline characteristics
| Characteristic | Total | Usual Care: Control Group | Care Transitions Intervention (ITT) |
|---|---|---|---|
| Age, Continuous | 72.39 years STANDARD_DEVIATION 8.58 | 72.10 years STANDARD_DEVIATION 8.5 | 72.69 years STANDARD_DEVIATION 8.65 |
| Education | 689 Participants | 352 Participants | 337 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 15 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1729 Participants | 878 Participants | 851 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marital Status | 713 Participants | 352 Participants | 361 Participants |
| Number of Charlson Comorbidities | 2.72 Charlson Comorbidities STANDARD_DEVIATION 1.67 | 2.65 Charlson Comorbidities STANDARD_DEVIATION 1.69 | 2.79 Charlson Comorbidities STANDARD_DEVIATION 1.65 |
| Number of ED visits in 30 days prior to index ED visit | 0.11 ED visits STANDARD_DEVIATION 0.38 | 0.12 ED visits STANDARD_DEVIATION 0.4 | 0.10 ED visits STANDARD_DEVIATION 0.34 |
| Number of Participants Hospitalized in 30 days prior to Emergency Department (ED) study visit | 90 Participants | 43 Participants | 47 Participants |
| Number of Participants with Anxiety per GAD-2 | 293 Participants | 155 Participants | 138 Participants |
| Number of Participants with Cognitive Impairment | 127 Participants | 60 Participants | 67 Participants |
| Number of Participants with Deficiencies in One or more ADL | 631 Participants | 299 Participants | 332 Participants |
| Number of Participants with Fair or Poor Overall Health per SF-12 | 355 Participants | 181 Participants | 174 Participants |
| Number of Participants with Inadequate Health Literacy | 214 Participants | 98 Participants | 116 Participants |
| Number of Participants with Moderate to Severe Depression per PHQ-9 | 189 Participants | 95 Participants | 94 Participants |
| Perceived Health Competence Score | 30.09 score on a scale STANDARD_DEVIATION 5.29 | 29.87 score on a scale STANDARD_DEVIATION 5.28 | 30.31 score on a scale STANDARD_DEVIATION 5.29 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 76 Participants | 40 Participants | 36 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 | 40 Participants | 21 Participants | 19 Participants |
| Race (NIH/OMB) White | 1618 Participants | 818 Participants | 800 Participants |
| Region of Enrollment United States | 1756 participants | 893 participants | 863 participants |
| Sex: Female, Male Female | 938 Participants | 480 Participants | 458 Participants |
| Sex: Female, Male Male | 818 Participants | 413 Participants | 405 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 992 | 2 / 987 |
| other Total, other adverse events | 93 / 992 | 76 / 987 |
| serious Total, serious adverse events | 51 / 992 | 51 / 987 |
Outcome results
Primary
Number of Participants Returning to the ED Within 30 Days of the Original ED Visit
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | ED revisits within 14 days | 84 Participants |
| Usual Care | Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | ED revisits within 30 days | 113 Participants |
| Care Transitions Intervention (ITT) | Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | ED revisits within 14 days | 69 Participants |
| Care Transitions Intervention (ITT) | Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | ED revisits within 30 days | 103 Participants |
| Care Transitions Intervention (PP) | Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | ED revisits within 14 days | 51 Participants |
| Care Transitions Intervention (PP) | Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | ED revisits within 30 days | 81 Participants |
Comparison: treatment relevant change in number of ED visits by 14 days95% CI: [0.62, 1.22]
Comparison: treatment relevant change in number of ED visits by 30 days95% CI: [0.72, 1.3]
Primary
Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge
Control vs Intent-to-Treat vs Per Protocol Population reported
Time frame: up to 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge | Urgent Care Visits | 24 Participants |
| Usual Care | Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge | Unplanned hospitalization | 46 Participants |
| Care Transitions Intervention (ITT) | Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge | Unplanned hospitalization | 45 Participants |
| Care Transitions Intervention (ITT) | Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge | Urgent Care Visits | 24 Participants |
| Care Transitions Intervention (PP) | Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge | Urgent Care Visits | 23 Participants |
| Care Transitions Intervention (PP) | Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge | Unplanned hospitalization | 30 Participants |
Primary
Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | All Follow-Up within 7 Days | 657 Participants |
| Usual Care | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | All Follow-Up within 30 Days | 773 Participants |
| Usual Care | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | In-Person Follow-Up within 7 days | 428 Participants |
| Usual Care | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | In-Person Follow-Up within 30 days | 698 Participants |
| Usual Care | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | Electronic Follow-Up within 7 Days | 510 Participants |
| Usual Care | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | Electronic Follow-Up within 30 Days | 659 Participants |
| Care Transitions Intervention (ITT) | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | Electronic Follow-Up within 30 Days | 646 Participants |
| Care Transitions Intervention (ITT) | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | All Follow-Up within 7 Days | 664 Participants |
| Care Transitions Intervention (ITT) | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | In-Person Follow-Up within 30 days | 702 Participants |
| Care Transitions Intervention (ITT) | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | Electronic Follow-Up within 7 Days | 524 Participants |
| Care Transitions Intervention (ITT) | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | All Follow-Up within 30 Days | 775 Participants |
| Care Transitions Intervention (ITT) | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | In-Person Follow-Up within 7 days | 456 Participants |
| Care Transitions Intervention (PP) | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | All Follow-Up within 30 Days | 653 Participants |
| Care Transitions Intervention (PP) | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | In-Person Follow-Up within 7 days | 385 Participants |
| Care Transitions Intervention (PP) | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | Electronic Follow-Up within 30 Days | 548 Participants |
| Care Transitions Intervention (PP) | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | In-Person Follow-Up within 30 days | 592 Participants |
| Care Transitions Intervention (PP) | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | All Follow-Up within 7 Days | 561 Participants |
| Care Transitions Intervention (PP) | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | Electronic Follow-Up within 7 Days | 445 Participants |
Secondary
Level of Participant Activation as Measured by the Perceived Health Competence Survey
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Level of Participant Activation as Measured by the Perceived Health Competence Survey | 30.54 score on a scale | Standard Deviation 4.76 |
| Care Transitions Intervention (ITT) | Level of Participant Activation as Measured by the Perceived Health Competence Survey | 31.12 score on a scale | Standard Deviation 4.71 |
| Care Transitions Intervention (PP) | Level of Participant Activation as Measured by the Perceived Health Competence Survey | 31.25 score on a scale | Standard Deviation 4.77 |
Secondary
Median Cost of Healthcare Services Within 30 Days of the Original ED Visit
Time frame: 30 days after emergency department discharge
Population: The investigators made an informed decision not to collect cost data.
Secondary
Number of Participants Who Could Recall Any Specific Red Flag
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
Population: Only patients with specific red flags listed on their discharge instructions were included in this analysis (n = 1207).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Who Could Recall Any Specific Red Flag | 225 Participants |
| Care Transitions Intervention (ITT) | Number of Participants Who Could Recall Any Specific Red Flag | 225 Participants |
| Care Transitions Intervention (PP) | Number of Participants Who Could Recall Any Specific Red Flag | 215 Participants |
Secondary
Number of Participants With Medication Changes Implemented
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
Population: Only participants with medication-related changes on their AVS instructions were included in this analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With Medication Changes Implemented | 78 Participants |
| Care Transitions Intervention (ITT) | Number of Participants With Medication Changes Implemented | 73 Participants |
| Care Transitions Intervention (PP) | Number of Participants With Medication Changes Implemented | 65 Participants |
Other Pre-specified
Family Caregiver Activation in Transitions (FCAT)
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
Population: Investigators did not analyze the FCAT because of reliability issues with the instrument that led them to lack confidence in the instrument.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Family Caregiver Activation in Transitions (FCAT) | Day 1 | — |
| Unknown | Family Caregiver Activation in Transitions (FCAT) | Day 30 | — |
Other Pre-specified
Number of Participants Who Died Within 30 Days of Discharge
Time frame: up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Who Died Within 30 Days of Discharge | 5 Participants |
| Care Transitions Intervention (ITT) | Number of Participants Who Died Within 30 Days of Discharge | 2 Participants |
Other Pre-specified
Program Satisfaction Survey Score
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