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

Primary Purpose

Emergencies, Aging

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care Transitions Intervention
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Emergencies

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester Medical Center
  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care

Care Transitions Intervention

Arm 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.

Outcomes

Primary Outcome Measures

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 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.
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

Secondary Outcome Measures

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.
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.
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.
Median Cost of Healthcare Services Within 30 Days of the Original ED Visit

Full Information

First Posted
August 6, 2015
Last Updated
July 19, 2022
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02520661
Brief Title
Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health
Official Title
Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2016 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies, Aging

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1979 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Older adults discharged from an ED to home who receive the usual processes and services.
Arm Title
Care Transitions Intervention
Arm Type
Active Comparator
Arm Description
Older adults discharged from an ED to home who receive the Care Transitions Intervention.
Intervention Type
Behavioral
Intervention Name(s)
Care Transitions Intervention
Intervention Description
The Care Transitions Intervention uses coaches, in this case paramedics, to support patients being discharged home by transferring skills to activate patients.
Primary Outcome Measure Information:
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
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
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
Secondary Outcome Measure Information:
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
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
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
Title
Median Cost of Healthcare Services Within 30 Days of the Original ED Visit
Time Frame
30 days after emergency department discharge
Other Pre-specified Outcome Measures:
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
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
Title
Number of Participants Who Died Within 30 Days of Discharge
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish N Shah, MD, MPH
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29724172
Citation
Mi R, Hollander MM, Jones CMC, DuGoff EH, Caprio TV, Cushman JT, Kind AJH, Lohmeier M, Shah MN. A randomized controlled trial testing the effectiveness of a paramedic-delivered care transitions intervention to reduce emergency department revisits. BMC Geriatr. 2018 May 3;18(1):104. doi: 10.1186/s12877-018-0792-5.
Results Reference
derived

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

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