Trial Outcomes & Findings for Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health (NCT NCT02520661)

NCT ID: NCT02520661

Last Updated: 2022-07-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1979 participants

Primary outcome timeframe

30 days after emergency department discharge

Results posted on

2022-07-22

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.

6,102 (11.3 percent) of 53,801 patients greater than or equal to 60 years old presenting during recruitment hours were approached for the study. Primary reasons for exclusion were inpatient admission from ED, not having a primary care provider in the health system, and living in a long-term care/assisted-living facility. After additional eligibility checks and refusals, 1,979 patients (32.4 percent) were consented and randomized into the study.

Participant milestones

Participant milestones
Measure	Usual Care Older adults discharged from an ED to home who receive the usual processes and services.	Care Transitions Intervention Older adults discharged from an ED to home who receive the Care Transitions Intervention. 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.
Overall Study STARTED	992	987
Overall Study Removed Following Randomization	124	99
Overall Study CTI Home Visit Scheduled	0	863
Overall Study Participants in Dataset	893	863
Overall Study Participants Completing Home Visit	0	726
Overall Study Participants With Primary Outcome Data (ITT)	886	860
Overall Study Participants With Primary Outcome Data (PP)	886	725
Overall Study COMPLETED	886	860
Overall Study NOT COMPLETED	106	127

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Older adults discharged from an ED to home who receive the usual processes and services.	Care Transitions Intervention Older adults discharged from an ED to home who receive the Care Transitions Intervention. 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.
Overall Study Lost to Follow-up	7	3
Overall Study Admitted from ED	49	48
Overall Study ED greater than 24 hours	29	38
Overall Study other ineligibility	14	22
Overall Study Withdrawal by Subject	7	16

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care: Control Group n=893 Participants Older adults discharged from an ED to home who receive the usual processes and services.	Care Transitions Intervention (ITT) n=863 Participants Older adults discharged from an ED to home, intended to receive the Care Transitions Intervention.	Total n=1756 Participants Total of all reporting groups
Age, Continuous	72.10 years STANDARD_DEVIATION 8.50 • n=5 Participants	72.69 years STANDARD_DEVIATION 8.65 • n=7 Participants	72.39 years STANDARD_DEVIATION 8.58 • n=5 Participants
Sex: Female, Male Female	480 Participants n=5 Participants	458 Participants n=7 Participants	938 Participants n=5 Participants
Sex: Female, Male Male	413 Participants n=5 Participants	405 Participants n=7 Participants	818 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	878 Participants n=5 Participants	851 Participants n=7 Participants	1729 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	40 Participants n=5 Participants	36 Participants n=7 Participants	76 Participants n=5 Participants
Race (NIH/OMB) White	818 Participants n=5 Participants	800 Participants n=7 Participants	1618 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment United States	893 participants n=5 Participants	863 participants n=7 Participants	1756 participants n=5 Participants
Education	352 Participants n=5 Participants	337 Participants n=7 Participants	689 Participants n=5 Participants
Marital Status	352 Participants n=5 Participants	361 Participants n=7 Participants	713 Participants n=5 Participants
Number of Charlson Comorbidities	2.65 Charlson Comorbidities STANDARD_DEVIATION 1.69 • n=5 Participants	2.79 Charlson Comorbidities STANDARD_DEVIATION 1.65 • n=7 Participants	2.72 Charlson Comorbidities STANDARD_DEVIATION 1.67 • n=5 Participants
Number of Participants with Deficiencies in One or more ADL	299 Participants n=5 Participants	332 Participants n=7 Participants	631 Participants n=5 Participants
Number of Participants with Cognitive Impairment	60 Participants n=5 Participants	67 Participants n=7 Participants	127 Participants n=5 Participants
Number of Participants with Inadequate Health Literacy	98 Participants n=5 Participants	116 Participants n=7 Participants	214 Participants n=5 Participants
Number of Participants with Anxiety per GAD-2	155 Participants n=5 Participants	138 Participants n=7 Participants	293 Participants n=5 Participants
Number of Participants with Moderate to Severe Depression per PHQ-9	95 Participants n=5 Participants	94 Participants n=7 Participants	189 Participants n=5 Participants
Perceived Health Competence Score	29.87 score on a scale STANDARD_DEVIATION 5.28 • n=5 Participants	30.31 score on a scale STANDARD_DEVIATION 5.29 • n=7 Participants	30.09 score on a scale STANDARD_DEVIATION 5.29 • n=5 Participants
Number of Participants with Fair or Poor Overall Health per SF-12	181 Participants n=5 Participants	174 Participants n=7 Participants	355 Participants n=5 Participants
Number of Participants Hospitalized in 30 days prior to Emergency Department (ED) study visit	43 Participants n=5 Participants	47 Participants n=7 Participants	90 Participants n=5 Participants
Number of ED visits in 30 days prior to index ED visit	0.12 ED visits STANDARD_DEVIATION 0.40 • n=5 Participants	0.10 ED visits STANDARD_DEVIATION 0.34 • n=7 Participants	0.11 ED visits STANDARD_DEVIATION 0.38 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days after emergency department discharge

Outcome measures

Outcome measures
Measure	Usual Care n=893 Participants Older adults discharged from an ED to home who receive the usual processes and services.	Care Transitions Intervention (ITT) n=863 Participants Older adults discharged from an ED to home intended to receive the Care Transitions Intervention.	Care Transitions Intervention (PP) n=726 Participants Older adults discharged from an ED to home receive the Care Transitions Intervention per protocol.
Number of Participants Returning to the ED Within 30 Days of the Original ED Visit ED revisits within 14 days	84 Participants	69 Participants	51 Participants
Number of Participants Returning to the ED Within 30 Days of the Original ED Visit ED revisits within 30 days	113 Participants	103 Participants	81 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=893 Participants Older adults discharged from an ED to home who receive the usual processes and services.	Care Transitions Intervention (ITT) n=863 Participants Older adults discharged from an ED to home intended to receive the Care Transitions Intervention.	Care Transitions Intervention (PP) n=726 Participants Older adults discharged from an ED to home receive the Care Transitions Intervention per protocol.
Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care All Follow-Up within 7 Days	657 Participants	664 Participants	561 Participants
Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care All Follow-Up within 30 Days	773 Participants	775 Participants	653 Participants
Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care In-Person Follow-Up within 7 days	428 Participants	456 Participants	385 Participants
Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care In-Person Follow-Up within 30 days	698 Participants	702 Participants	592 Participants
Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care Electronic Follow-Up within 7 Days	510 Participants	524 Participants	445 Participants
Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care Electronic Follow-Up within 30 Days	659 Participants	646 Participants	548 Participants

PRIMARY outcome

Timeframe: up to 30 days

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

Outcome measures

Outcome measures
Measure	Usual Care n=893 Participants Older adults discharged from an ED to home who receive the usual processes and services.	Care Transitions Intervention (ITT) n=863 Participants Older adults discharged from an ED to home intended to receive the Care Transitions Intervention.	Care Transitions Intervention (PP) n=726 Participants Older adults discharged from an ED to home receive the Care Transitions Intervention per protocol.
Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge Urgent Care Visits	24 Participants	24 Participants	23 Participants
Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge Unplanned hospitalization	46 Participants	45 Participants	30 Participants

SECONDARY outcome

Timeframe: day 4

Population: Only participants with medication-related changes on their AVS instructions were included in this analysis

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.

Outcome measures

Outcome measures
Measure	Usual Care n=236 Participants Older adults discharged from an ED to home who receive the usual processes and services.	Care Transitions Intervention (ITT) n=233 Participants Older adults discharged from an ED to home intended to receive the Care Transitions Intervention.	Care Transitions Intervention (PP) n=186 Participants Older adults discharged from an ED to home receive the Care Transitions Intervention per protocol.
Number of Participants With Medication Changes Implemented	78 Participants	73 Participants	65 Participants

SECONDARY outcome

Timeframe: day 4

Population: Only patients with specific red flags listed on their discharge instructions were included in this analysis (n = 1207).

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.

Outcome measures

Outcome measures
Measure	Usual Care n=635 Participants Older adults discharged from an ED to home who receive the usual processes and services.	Care Transitions Intervention (ITT) n=572 Participants Older adults discharged from an ED to home intended to receive the Care Transitions Intervention.	Care Transitions Intervention (PP) n=514 Participants Older adults discharged from an ED to home receive the Care Transitions Intervention per protocol.
Number of Participants Who Could Recall Any Specific Red Flag	225 Participants	225 Participants	215 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=880 Participants Older adults discharged from an ED to home who receive the usual processes and services.	Care Transitions Intervention (ITT) n=850 Participants Older adults discharged from an ED to home intended to receive the Care Transitions Intervention.	Care Transitions Intervention (PP) n=718 Participants Older adults discharged from an ED to home receive the Care Transitions Intervention per protocol.
Level of Participant Activation as Measured by the Perceived Health Competence Survey	30.54 score on a scale Standard Deviation 4.76	31.12 score on a scale Standard Deviation 4.71	31.25 score on a scale Standard Deviation 4.77

SECONDARY outcome

Timeframe: 30 days after emergency department discharge

Population: The investigators made an informed decision not to collect cost data.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: day 1, day 30

Population: Investigators did not analyze the FCAT because of reliability issues with the instrument that led them to lack confidence in the instrument.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 30 days

Outcome measures

Outcome measures
Measure	Usual Care n=893 Participants Older adults discharged from an ED to home who receive the usual processes and services.	Care Transitions Intervention (ITT) n=863 Participants Older adults discharged from an ED to home intended to receive the Care Transitions Intervention.	Care Transitions Intervention (PP) Older adults discharged from an ED to home receive the Care Transitions Intervention per protocol.
Number of Participants Who Died Within 30 Days of Discharge	5 Participants	2 Participants	—

Adverse Events

Usual Care

Serious events: 51 serious events

Other events: 93 other events

Deaths: 5 deaths

Care Transitions Intervention

Serious events: 51 serious events

Other events: 76 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Usual Care n=992 participants at risk Older adults discharged from an ED to home who receive the usual processes and services.	Care Transitions Intervention n=987 participants at risk Older adults discharged from an ED to home who receive the Care Transitions Intervention.
Blood and lymphatic system disorders Blood and Lymphatic Disorders	0.10% 1/992 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.	0.00% 0/987 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
Cardiac disorders Cardiac Disorders	0.71% 7/992 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.	1.1% 11/987 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
Gastrointestinal disorders Gastrointestinal Disorders	0.81% 8/992 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.	0.61% 6/987 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
General disorders General Disorders	0.30% 3/992 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.	0.20% 2/987 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
Infections and infestations Infections and Infestations	0.40% 4/992 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.	0.61% 6/987 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	0.40% 4/992 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.	0.00% 0/987 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
Metabolism and nutrition disorders Metabolism and nutrition disorders	0.20% 2/992 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.	0.10% 1/987 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	0.71% 7/992 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.	0.30% 3/987 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	0.10% 1/992 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.	0.00% 0/987 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
Nervous system disorders Nervous System Disorders	0.40% 4/992 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.	0.61% 6/987 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
Renal and urinary disorders Renal and urinary disorders	0.30% 3/992 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.	0.41% 4/987 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	0.40% 4/992 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.	0.71% 7/987 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
Vascular disorders Vascular disorders	0.30% 3/992 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.	0.41% 4/987 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
Surgical and medical procedures Surgical and Medical Procedures	0.00% 0/992 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.	0.10% 1/987 • up to 30 days Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.

Other adverse events

Additional Information

Manish N. Shah, MD, MPH

UW School of Medicine and Public Health

Phone: 608-263-6690

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place