Clinical trial NCT02520661: 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
Overall status: COMPLETED
Phase: NA
Conditions: Emergencies
Aging
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2015-08-13
Enrollment: 1979
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Returning to the ED Within 30 Days of the Original ED Visit
timeFrame: 30 days after emergency department discharge
measure: Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care
timeFrame: 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
measure: Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge
timeFrame: up to 30 days
Secondary outcomes:
measure: Number of Participants With Medication Changes Implemented
timeFrame: day 4
measure: Number of Participants Who Could Recall Any Specific Red Flag
timeFrame: day 4
measure: Level of Participant Activation as Measured by the Perceived Health Competence Survey
timeFrame: 30 days after emergency department discharge
measure: Median Cost of Healthcare Services Within 30 Days of the Original ED Visit
timeFrame: 30 days after emergency department discharge
Other outcomes:
measure: Program Satisfaction Survey Score
timeFrame: day 1, day 30
measure: Family Caregiver Activation in Transitions (FCAT)
timeFrame: day 1, day 30
measure: Number of Participants Who Died Within 30 Days of Discharge
timeFrame: up to 30 days
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Manish N Shah, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.