- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02520661
Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
New York
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age≥60 years
- English speaking
- Monroe County, New York or Dane County, Wisconsin resident
- University of Wisconsin or University of Rochester affiliated primary care physician
- Community dwelling (no prisoners, nursing home, assisted living residents)
- Discharge home from the ED
Exclusion Criteria:
- Previous study participation
- Discharged to hospice
- Homelessness
- Followed by transition care team (e.g., from recent hospitalization)
- Followed by intensive case management program
- Emergency Severity Index 1 patients (highest acuity, as assigned by ED triage staff)
- Unable to obtain consent from patient or proxy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
The Care Transitions Intervention uses coaches, in this case paramedics, to support patients being discharged home by transferring skills to activate patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Returning to the ED Within 30 Days of the Original ED Visit
Time Frame: 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.
|
30 days after emergency department discharge
|
Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care
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
|
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.
|
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
|
Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge
Time Frame: up to 30 days
|
Control vs Intent-to-Treat vs Per Protocol Population reported
|
up to 30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Medication Changes Implemented
Time Frame: 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.
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day 4
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Number of Participants Who Could Recall Any Specific Red Flag
Time Frame: day 4
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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.
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day 4
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Level of Participant Activation as Measured by the Perceived Health Competence Survey
Time Frame: 30 days after emergency department discharge
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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.
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30 days after emergency department discharge
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Median Cost of Healthcare Services Within 30 Days of the Original ED Visit
Time Frame: 30 days after emergency department discharge
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30 days after emergency department discharge
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Program Satisfaction Survey Score
Time Frame: 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.
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day 1, day 30
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Family Caregiver Activation in Transitions (FCAT)
Time Frame: day 1, day 30
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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.
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day 1, day 30
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Number of Participants Who Died Within 30 Days of Discharge
Time Frame: up to 30 days
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up to 30 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Manish N Shah, MD, MPH, University of Wisconsin, Madison
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-1197 (Other Identifier: IRB Number)
- A534100 (Other Identifier: UW Madison)
- R01AG050504 (U.S. NIH Grant/Contract)
- SMPH\EMERG MED (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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