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CompletedNCT02520661Updated Jul 22, 2022Results posted

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

An interventional study of Care Transitions Intervention in Emergencies and Aging, sponsored by University of Wisconsin, Madison. Completed at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-07-22.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,979
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Emergencies
  • Aging

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03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 1,979 is above the median of 145 across 931 interventional studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,979 participants (actual)

Study arms

  • No intervention
    Usual Care

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

  • Active comparator
    Care Transitions Intervention

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

    Behavioral: Care Transitions Intervention

Interventions

  • BehavioralCare Transitions Intervention

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

06

What researchers measure

Primary outcomes

  1. 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 frame: 30 days after emergency department discharge

  2. 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.

    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

  3. 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

    Time frame: up to 30 days

Secondary outcomes

  1. 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.

    Time frame: day 4

  2. 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.

    Time frame: day 4

  3. 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.

    Time frame: 30 days after emergency department discharge

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

    Time frame: 30 days after emergency department discharge

Other outcomes

  1. 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.

    Time frame: day 1, day 30

  2. 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.

    Time frame: day 1, day 30

  3. Number of Participants Who Died Within 30 Days of Discharge

    Time frame: up to 30 days

07

Results

Posted Jul 22, 2022

Participant flow

A single-blind randomized controlled trial conducted at three university-affiliated hospital Emergency Departments: one in Madison, Wisconsin, and two in Rochester, New York. The study was approved by institutional review boards at the University of Wisconsin and University of Rochester with written informed consent. Enrollment and data collection occurred between January 2016 and July 2019.

Participant flow — Overall Study
MilestoneUsual CareCare Transitions Intervention
Started992987
Removed following randomization12499
Cti home visit scheduled0863
Participants in dataset893863
Participants completing home visit0726
Participants with primary outcome data (itt)886860
Participants with primary outcome data (pp)886725
Completed886860
Not completed106127
Withdrew: Lost to follow-up73
Withdrew: Admitted from ed4948
Withdrew: Ed greater than 24 hours2938
Withdrew: Other ineligibility1422
Withdrew: Withdrawal by subject716

Outcome measures

PrimaryNumber 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 frame:
30 days after emergency department discharge
Reported as:
Count of participants · Participants
Number of Participants Returning to the ED Within 30 Days of the Original ED Visit
ParticipantsUsual CareCare Transitions Intervention (ITT)Care Transitions Intervention (PP)
ED revisits within 14 days846951
ED revisits within 30 days11310381
Statistical analysis
  • Usual Care vs Care Transitions Intervention (ITT) · Odds ratio (or): 0.87 · 95% CI 0.62 to 1.22
  • Usual Care vs Care Transitions Intervention (ITT) · Odds ratio (or): 0.97 · 95% CI 0.72 to 1.30
PrimaryTime 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.

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
Reported as:
Count of participants · Participants
Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care
ParticipantsUsual CareCare Transitions Intervention (ITT)Care Transitions Intervention (PP)
All Follow-Up within 7 Days657664561
All Follow-Up within 30 Days773775653
In-Person Follow-Up within 7 days428456385
In-Person Follow-Up within 30 days698702592
Electronic Follow-Up within 7 Days510524445
Electronic Follow-Up within 30 Days659646548
PrimaryNumber of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge

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

Time frame:
up to 30 days
Reported as:
Count of participants · Participants
Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge
ParticipantsUsual CareCare Transitions Intervention (ITT)Care Transitions Intervention (PP)
Urgent Care Visits242423
Unplanned hospitalization464530
SecondaryNumber 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.

Time frame:
day 4
Reported as:
Count of participants · Participants
Number of Participants With Medication Changes Implemented
ParticipantsUsual CareCare Transitions Intervention (ITT)Care Transitions Intervention (PP)
Number of Participants With Medication Changes Implemented787365
SecondaryNumber 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.

Time frame:
day 4
Reported as:
Count of participants · Participants
Number of Participants Who Could Recall Any Specific Red Flag
ParticipantsUsual CareCare Transitions Intervention (ITT)Care Transitions Intervention (PP)
Number of Participants Who Could Recall Any Specific Red Flag225225215
SecondaryLevel 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.

Time frame:
30 days after emergency department discharge
Reported as:
Mean · score on a scale
Level of Participant Activation as Measured by the Perceived Health Competence Survey
score on a scaleUsual CareCare Transitions Intervention (ITT)Care Transitions Intervention (PP)
Level of Participant Activation as Measured by the Perceived Health Competence Survey30.54 ± 4.7631.12 ± 4.7131.25 ± 4.77
SecondaryMedian Cost of Healthcare Services Within 30 Days of the Original ED Visit
Time frame:
30 days after emergency department discharge

No measurements were reported for this outcome.

Other pre-specifiedProgram 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.

Time frame:
day 1, day 30

Results for this outcome have not been posted.

Other pre-specifiedFamily 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.

Time frame:
day 1, day 30

No measurements were reported for this outcome.

Other pre-specifiedNumber of Participants Who Died Within 30 Days of Discharge
Time frame:
up to 30 days
Reported as:
Count of participants · Participants
Number of Participants Who Died Within 30 Days of Discharge
ParticipantsUsual CareCare Transitions Intervention
Number of Participants Who Died Within 30 Days of Discharge52

Adverse events

Collected over up to 30 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Usual Care5/992 (0.5%)51/992 (5.1%)93/992 (9.4%)
Care Transitions Intervention2/987 (0.2%)51/987 (5.2%)76/987 (7.7%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventUsual CareCare Transitions Intervention
Cardiac DisordersCardiac disorders7/99211/987
Gastrointestinal DisordersGastrointestinal disorders8/9926/987
Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders4/9927/987
Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders7/9923/987
Infections and InfestationsInfections and infestations4/9926/987
Nervous System DisordersNervous system disorders4/9926/987
Renal and urinary disordersRenal and urinary disorders3/9924/987
Vascular disordersVascular disorders3/9924/987
Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications4/9920/987
General DisordersGeneral disorders3/9922/987
Most frequent other events
Showing 10 of 20
Most frequent other events
EventUsual CareCare Transitions Intervention
Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders7/99213/987
Cardiac DisordersCardiac disorders13/9927/987
Gastrointestinal DisordersGastrointestinal disorders9/99210/987
Musculoskeletal and connective tissues disordersMusculoskeletal and connective tissue disorders10/9926/987
Nervous System DisordersNervous system disorders9/9925/987
Injury, poisoning, and procedural complicationsInjury, poisoning and procedural complications7/9928/987
Vascular DisordersVascular disorders8/9926/987
General DisordersGeneral disorders7/9925/987
Metabolism and Nutrition DisordersMetabolism and nutrition disorders3/9924/987
Infections and InfestationsInfections and infestations4/9923/987

Baseline characteristics

223 enrolled participants were removed following randomization, see Participant Flow

Age, Continuous
Age, Continuous(years)Usual Care: Control GroupCare Transitions Intervention (ITT)Total
Mean72.10 ± 8.5072.69 ± 8.6572.39 ± 8.58
Sex: Female, Male
Sex: Female, Male(Participants)Usual Care: Control GroupCare Transitions Intervention (ITT)Total
Female480458938
Male413405818
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Usual Care: Control GroupCare Transitions Intervention (ITT)Total
Hispanic or Latino151227
Not Hispanic or Latino8788511729
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Usual Care: Control GroupCare Transitions Intervention (ITT)Total
American Indian or Alaska Native314
Asian11718
Native Hawaiian or Other Pacific Islander000
Black or African American403676
White8188001618
More than one race000
Unknown or Not Reported211940
Region of Enrollment
Region of Enrollment(participants)Usual Care: Control GroupCare Transitions Intervention (ITT)Total
United States8938631756
Education
Education(Participants)Usual Care: Control GroupCare Transitions Intervention (ITT)Total
Count of participants352337689
Marital Status
Marital Status(Participants)Usual Care: Control GroupCare Transitions Intervention (ITT)Total
Count of participants352361713
Number of Charlson Comorbidities
Number of Charlson Comorbidities(Charlson Comorbidities)Usual Care: Control GroupCare Transitions Intervention (ITT)Total
Mean2.65 ± 1.692.79 ± 1.652.72 ± 1.67

9 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
  • University of Wisconsin
    Madison, Wisconsin 53705, United States
09

References and documents

Publications

  • 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. PubMed 29724172 ↗

Study documents

  • Protocol and statistical analysis plan · Oct 10, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02520661
Lead sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Aug 13, 2015
Start date
Feb 3, 2016
Primary completion
Jul 31, 2019
Completion
Nov 30, 2019
Results posted
Jul 22, 2022
Last update
Jul 22, 2022

Study contacts

Manish N Shah, MD, MPH
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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