NCT02520661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,979

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

February 3, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 22, 2022

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

3.5 years

First QC Date

August 6, 2015

Results QC Date

May 26, 2022

Last Update Submit

July 19, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    30 days after emergency department discharge

  • 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.

    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

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

    up to 30 days

Secondary Outcomes (4)

  • Number of Participants With Medication Changes Implemented

    day 4

  • Number of Participants Who Could Recall Any Specific Red Flag

    day 4

  • Level of Participant Activation as Measured by the Perceived Health Competence Survey

    30 days after emergency department discharge

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

    30 days after emergency department discharge

Other Outcomes (3)

  • Program Satisfaction Survey Score

    day 1, day 30

  • Family Caregiver Activation in Transitions (FCAT)

    day 1, day 30

  • Number of Participants Who Died Within 30 Days of Discharge

    up to 30 days

Study Arms (2)

Usual Care

NO INTERVENTION

Older adults discharged from an ED to home who receive the usual processes and services.

Care Transitions Intervention

ACTIVE COMPARATOR

Older adults discharged from an ED to home who receive the Care Transitions Intervention.

Behavioral: Care Transitions Intervention

Interventions

The Care Transitions Intervention uses coaches, in this case paramedics, to support patients being discharged home by transferring skills to activate patients.

Care Transitions Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Manish N. Shah, MD, MPH
Organization
UW School of Medicine and Public Health

Study Officials

  • Manish N Shah, MD, MPH

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 13, 2015

Study Start

February 3, 2016

Primary Completion

July 31, 2019

Study Completion

November 30, 2019

Last Updated

July 22, 2022

Results First Posted

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations