Trial · NCT02520661
Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health
NCT02520661, Not applicable, Completed, University of Wisconsin, Madison; results first posted 2022-07-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health. Trials, record NCT02520661. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02520661
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health
- NCT number
- NCT02520661
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,979 participants, actual
- Lead sponsor
- University of Wisconsin, Madison
- Conditions
- Emergencies, Aging
- Interventions
- Care Transitions Intervention
- First posted
- 2015-08-13
- Last updated
- 2022-07-22
- Results first posted
- 2022-07-22
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | 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. |
| Primary | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | 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. |
| Primary | Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge | up to 30 days | Control vs Intent-to-Treat vs Per Protocol Population reported |
| Secondary | Number of Participants With Medication Changes Implemented | day 4 | 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. |
| Secondary | Number of Participants Who Could Recall Any Specific Red Flag | day 4 | 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. |
| Secondary | Level of Participant Activation as Measured by the Perceived Health Competence Survey | 30 days after emergency department discharge | 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. |
| Secondary | Median Cost of Healthcare Services Within 30 Days of the Original ED Visit | 30 days after emergency department discharge | |
| Other | Program Satisfaction Survey Score | day 1, day 30 | 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. |
| Other | Family Caregiver Activation in Transitions (FCAT) | day 1, day 30 | 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. |
| Other | Number of Participants Who Died Within 30 Days of Discharge | up to 30 days |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | 30 days after emergency department discharge | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge | up to 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Medication Changes Implemented | day 4 | Only participants with medication-related changes on their AVS instructions were included in this analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Could Recall Any Specific Red Flag | day 4 | Only patients with specific red flags listed on their discharge instructions were included in this analysis (n = 1207). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Level of Participant Activation as Measured by the Perceived Health Competence Survey | 30 days after emergency department discharge | score on a scale | MEAN | |
| SECONDARY | Median Cost of Healthcare Services Within 30 Days of the Original ED Visit | 30 days after emergency department discharge | The investigators made an informed decision not to collect cost data. | ||
| OTHER_PRE_SPECIFIED | Program Satisfaction Survey Score | day 1, day 30 | |||
| OTHER_PRE_SPECIFIED | Family Caregiver Activation in Transitions (FCAT) | day 1, day 30 | Investigators did not analyze the FCAT because of reliability issues with the instrument that led them to lack confidence in the instrument. | ||
| OTHER_PRE_SPECIFIED | Number of Participants Who Died Within 30 Days of Discharge | up to 30 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group43
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | Usual Care | ED revisits within 14 days | 84 | Participants | |
| Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | Care Transitions Intervention (ITT) | ED revisits within 14 days | 69 | Participants | |
| Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | Care Transitions Intervention (PP) | ED revisits within 14 days | 51 | Participants | |
| Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | Usual Care | ED revisits within 30 days | 113 | Participants | |
| Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | Care Transitions Intervention (ITT) | ED revisits within 30 days | 103 | Participants | |
| Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | Care Transitions Intervention (PP) | ED revisits within 30 days | 81 | Participants | |
| Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | Usual Care | All Follow-Up within 7 Days | 657 | Participants | |
| Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | Care Transitions Intervention (ITT) | All Follow-Up within 7 Days | 664 | Participants | |
| Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | Care Transitions Intervention (PP) | All Follow-Up within 7 Days | 561 | Participants | |
| Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | Usual Care | All Follow-Up within 30 Days | 773 | Participants |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Usual Care | 992 | |
| Overall Study | STARTED | Care Transitions Intervention | 987 | |
| Overall Study | Removed Following Randomization | Usual Care | 124 | |
| Overall Study | Removed Following Randomization | Care Transitions Intervention | 99 | |
| Overall Study | CTI Home Visit Scheduled | Usual Care | 0 | |
| Overall Study | CTI Home Visit Scheduled | Care Transitions Intervention | 863 | |
| Overall Study | Participants in Dataset | Usual Care | 893 | |
| Overall Study | Participants in Dataset | Care Transitions Intervention | 863 | |
| Overall Study | Participants Completing Home Visit | Usual Care | 0 | |
| Overall Study | Participants Completing Home Visit | Care Transitions Intervention | 726 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Usual Care | 1 | 992 | |
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Care Transitions Intervention | 1 | 987 | |
| other | Cardiac Disorders | Cardiac disorders | Usual Care | 13 | 992 | |
| other | Cardiac Disorders | Cardiac disorders | Care Transitions Intervention | 7 | 987 | |
| other | Ear and labyrinth disorders | Ear and labyrinth disorders | Usual Care | 0 | 992 | |
| other | Ear and labyrinth disorders | Ear and labyrinth disorders | Care Transitions Intervention | 1 | 987 | |
| other | Endocrine Disorders | Endocrine disorders | Usual Care | 0 | 992 | |
| other | Endocrine Disorders | Endocrine disorders | Care Transitions Intervention | 2 | 987 | |
| other | Gastrointestinal Disorders | Gastrointestinal disorders | Usual Care | 9 | 992 | |
| other | Gastrointestinal Disorders | Gastrointestinal disorders | Care Transitions Intervention | 10 | 987 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Usual Care | 5 | 992 |
| Total, all-cause mortality | Care Transitions Intervention | 2 | 987 |
| Total, other adverse events | Usual Care | 93 | 992 |
| Total, other adverse events | Care Transitions Intervention | 76 | 987 |
| Total, serious adverse events | Usual Care | 51 | 992 |
| Total, serious adverse events | Care Transitions Intervention | 51 | 987 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29724172 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AG050504 | Paramedic-coached ED Care Transitions to Help Older Adults Maintain their Health | SHAH, MANISH N | UNIVERSITY OF WISCONSIN-MADISON | NATIONAL INSTITUTE ON AGING | 2015 to 2019 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Care Transitions Intervention vs Usual Care: Number of Participants Who Died Within 30 Days of Discharge | Trial comparisons |
| Care Transitions Intervention vs Usual Care: deaths from any cause | Trial comparisons |
| Care Transitions Intervention vs Usual Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02520661
GET https://conductscience.org/api/trials/v1/NCT02520661/results?page=2