Aging Clinical Trial
Official title:
Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health
Verified date | July 2022 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin | Madison | Wisconsin |
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Institute on Aging (NIA) |
United States,
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 |
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