EmergenciesNCT02520661
Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health
A study testing Care Transitions Intervention in people with Emergencies and Aging, run by University of Wisconsin, Madison at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Emergencies, Aging
- What is being tested?
- Care Transitions Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,979 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Feb 2016to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin
Madison, Wisconsin, 53705
University of Rochester Medical Center
Rochester, New York, 14642
About this study
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.
- Conditions
- Emergencies, Aging
- Being tested
- Care Transitions Intervention
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Transitions InterventionBehavioural
The Care Transitions Intervention uses coaches, in this case paramedics, to support patients being discharged home by transferring skills to activate patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Care Transitions Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: up to 30 days
Secondary outcomes (4)
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.
Measured: day 4
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.
Measured: day 4
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.
Measured: 30 days after emergency department discharge
Median Cost of Healthcare Services Within 30 Days of the Original ED Visit
Measured: 30 days after emergency department discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start3 Feb 2016
- Primary completion31 Jul 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,979 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Manish N Shah, MD, MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520661
- Sponsor's protocol ID
- 2015-1197
- Other IDs
- 2015-1197, R01AG050504, A534100, SMPH\EMERG MED
- Status last verified
- Jul 2022
- First submitted
- 6 Aug 2015
- Last updated
- 22 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health
- ClinicalTrials.gov ID
- NCT02520661
- Acronym / sponsor ID
- 2015-1197
- Conditions
- Emergencies, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,979 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 22 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Older adults discharged from an ED to home who receive the usual processes and services. |
| Care Transitions Intervention | Active comparator | Behavioral: Care Transitions InterventionOlder adults discharged from an ED to home who receive the Care Transitions Intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- Previous study participation
- Discharged to hospice
- Homelessness
- Followed by transition care team (e.g., from recent hospitalization)
- Followed by intensive case management program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care Transitions InterventionThe Care Transitions Intervention uses coaches, in this case paramedics, to support patients being discharged home by transferring skills to activate patients. | Behavioural | Care Transitions Intervention |
Primary outcome
Number of Participants Returning to the ED Within 30 Days of the Original ED Visit
Time frame: 30 days after emergency department discharge
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 to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care
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
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.
Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge
Time frame: up to 30 days
Control vs Intent-to-Treat vs Per Protocol Population reported
4 secondary outcomes
Number of Participants With Medication Changes Implemented
Time frame: day 4
Number of Participants Who Could Recall Any Specific Red Flag
Time frame: day 4
Level of Participant Activation as Measured by the Perceived Health Competence Survey
Time frame: 30 days after emergency department discharge
Median Cost of Healthcare Services Within 30 Days of the Original ED Visit
Time frame: 30 days after emergency department discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29724172Mi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manish N Shah, MD, MPH principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Transitions Intervention in people with Emergencies and Aging, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Returning to the ED Within 30 Days of the Original ED Visit (time frame: 30 days after emergency department discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02520661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.