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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520661
• Other study ID #: 2015-1197
• Secondary ID: 2015-1197R01AG05
• Status: Completed
• Phase: N/A
• Start date: February 3, 2016
• Est. completion date: November 30, 2019

Study information

• Verified date: July 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1979
• Est. completion date: November 30, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Emergencies

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	day 1, day 30
Other	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.	day 1, day 30
Other	Number of Participants Who Died Within 30 Days of Discharge		up to 30 days
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.	30 days after emergency department discharge
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.	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
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	up to 30 days
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.	day 4
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.	day 4
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.	30 days after emergency department discharge
Secondary	Median Cost of Healthcare Services Within 30 Days of the Original ED Visit		30 days after emergency department discharge