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
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.
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.
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 →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.
Exclusion Criteria:
Older adults discharged from an ED to home who receive the usual processes and services.
Older adults discharged from an ED to home who receive the Care Transitions 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.
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
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
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
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
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
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
Median Cost of Healthcare Services Within 30 Days of the Original ED Visit
Time frame: 30 days after emergency department discharge
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
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
Number of Participants Who Died Within 30 Days of Discharge
Time frame: up to 30 days
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.
| Milestone | Usual Care | Care Transitions Intervention |
|---|---|---|
| Started | 992 | 987 |
| Removed following randomization | 124 | 99 |
| Cti home visit scheduled | 0 | 863 |
| Participants in dataset | 893 | 863 |
| Participants completing home visit | 0 | 726 |
| Participants with primary outcome data (itt) | 886 | 860 |
| Participants with primary outcome data (pp) | 886 | 725 |
| Completed | 886 | 860 |
| Not completed | 106 | 127 |
| Withdrew: Lost to follow-up | 7 | 3 |
| Withdrew: Admitted from ed | 49 | 48 |
| Withdrew: Ed greater than 24 hours | 29 | 38 |
| Withdrew: Other ineligibility | 14 | 22 |
| Withdrew: Withdrawal by subject | 7 | 16 |
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.
| Participants | Usual Care | Care Transitions Intervention (ITT) | Care Transitions Intervention (PP) |
|---|---|---|---|
| ED revisits within 14 days | 84 | 69 | 51 |
| ED revisits within 30 days | 113 | 103 | 81 |
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.
| Participants | Usual Care | Care Transitions Intervention (ITT) | Care Transitions Intervention (PP) |
|---|---|---|---|
| All Follow-Up within 7 Days | 657 | 664 | 561 |
| All Follow-Up within 30 Days | 773 | 775 | 653 |
| In-Person Follow-Up within 7 days | 428 | 456 | 385 |
| In-Person Follow-Up within 30 days | 698 | 702 | 592 |
| Electronic Follow-Up within 7 Days | 510 | 524 | 445 |
| Electronic Follow-Up within 30 Days | 659 | 646 | 548 |
Control vs Intent-to-Treat vs Per Protocol Population reported
| Participants | Usual Care | Care Transitions Intervention (ITT) | Care Transitions Intervention (PP) |
|---|---|---|---|
| Urgent Care Visits | 24 | 24 | 23 |
| Unplanned hospitalization | 46 | 45 | 30 |
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.
| Participants | Usual Care | Care Transitions Intervention (ITT) | Care Transitions Intervention (PP) |
|---|---|---|---|
| Number of Participants With Medication Changes Implemented | 78 | 73 | 65 |
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.
| Participants | Usual Care | Care Transitions Intervention (ITT) | Care Transitions Intervention (PP) |
|---|---|---|---|
| Number of Participants Who Could Recall Any Specific Red Flag | 225 | 225 | 215 |
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.
| score on a scale | Usual Care | Care Transitions Intervention (ITT) | Care Transitions Intervention (PP) |
|---|---|---|---|
| Level of Participant Activation as Measured by the Perceived Health Competence Survey | 30.54 ± 4.76 | 31.12 ± 4.71 | 31.25 ± 4.77 |
No measurements were reported for this outcome.
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.
Results for this outcome have not been posted.
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.
No measurements were reported for this outcome.
| Participants | Usual Care | Care Transitions Intervention |
|---|---|---|
| Number of Participants Who Died Within 30 Days of Discharge | 5 | 2 |
Collected over up to 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | 5/992 (0.5%) | 51/992 (5.1%) | 93/992 (9.4%) |
| Care Transitions Intervention | 2/987 (0.2%) | 51/987 (5.2%) | 76/987 (7.7%) |
| Event | Usual Care | Care Transitions Intervention |
|---|---|---|
| Cardiac DisordersCardiac disorders | 7/992 | 11/987 |
| Gastrointestinal DisordersGastrointestinal disorders | 8/992 | 6/987 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 4/992 | 7/987 |
| Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders | 7/992 | 3/987 |
| Infections and InfestationsInfections and infestations | 4/992 | 6/987 |
| Nervous System DisordersNervous system disorders | 4/992 | 6/987 |
| Renal and urinary disordersRenal and urinary disorders | 3/992 | 4/987 |
| Vascular disordersVascular disorders | 3/992 | 4/987 |
| Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications | 4/992 | 0/987 |
| General DisordersGeneral disorders | 3/992 | 2/987 |
| Event | Usual Care | Care Transitions Intervention |
|---|---|---|
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 7/992 | 13/987 |
| Cardiac DisordersCardiac disorders | 13/992 | 7/987 |
| Gastrointestinal DisordersGastrointestinal disorders | 9/992 | 10/987 |
| Musculoskeletal and connective tissues disordersMusculoskeletal and connective tissue disorders | 10/992 | 6/987 |
| Nervous System DisordersNervous system disorders | 9/992 | 5/987 |
| Injury, poisoning, and procedural complicationsInjury, poisoning and procedural complications | 7/992 | 8/987 |
| Vascular DisordersVascular disorders | 8/992 | 6/987 |
| General DisordersGeneral disorders | 7/992 | 5/987 |
| Metabolism and Nutrition DisordersMetabolism and nutrition disorders | 3/992 | 4/987 |
| Infections and InfestationsInfections and infestations | 4/992 | 3/987 |
223 enrolled participants were removed following randomization, see Participant Flow
| Age, Continuous(years) | Usual Care: Control Group | Care Transitions Intervention (ITT) | Total |
|---|---|---|---|
| Mean | 72.10 ± 8.50 | 72.69 ± 8.65 | 72.39 ± 8.58 |
| Sex: Female, Male(Participants) | Usual Care: Control Group | Care Transitions Intervention (ITT) | Total |
|---|---|---|---|
| Female | 480 | 458 | 938 |
| Male | 413 | 405 | 818 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care: Control Group | Care Transitions Intervention (ITT) | Total |
|---|---|---|---|
| Hispanic or Latino | 15 | 12 | 27 |
| Not Hispanic or Latino | 878 | 851 | 1729 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Usual Care: Control Group | Care Transitions Intervention (ITT) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 1 | 4 |
| Asian | 11 | 7 | 18 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 40 | 36 | 76 |
| White | 818 | 800 | 1618 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 21 | 19 | 40 |
| Region of Enrollment(participants) | Usual Care: Control Group | Care Transitions Intervention (ITT) | Total |
|---|---|---|---|
| United States | 893 | 863 | 1756 |
| Education(Participants) | Usual Care: Control Group | Care Transitions Intervention (ITT) | Total |
|---|---|---|---|
| Count of participants | 352 | 337 | 689 |
| Marital Status(Participants) | Usual Care: Control Group | Care Transitions Intervention (ITT) | Total |
|---|---|---|---|
| Count of participants | 352 | 361 | 713 |
| Number of Charlson Comorbidities(Charlson Comorbidities) | Usual Care: Control Group | Care Transitions Intervention (ITT) | Total |
|---|---|---|---|
| Mean | 2.65 ± 1.69 | 2.79 ± 1.65 | 2.72 ± 1.67 |
9 further baseline measures are reported on the registry.
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University of Wisconsin, Madison