NCT01893931

Brief Summary

The purpose of this study is to determine whether a phone call from a nurse within 1-3 days after discharge from the Emergency Department (ED) decreases return visits to the ED/ hospital admissions/ death (combined outcome) in patients age 65 and above. As secondary outcomes, time to follow up appointment with physician and economic impact of this intervention will be assessed. Patients 65 years of age and older will be randomized following discharge from the ED into one of two groups. Group 1(Intervention) will receive a phone call collecting information about understanding of ED discharge instructions and guiding patient through the discharge instructions, and Group 2 (Placebo) will receive a follow up phone call for a satisfaction survey. We hypothesize return visits to the ED and readmission to the hospital will decrease as a result of the nurse phone call intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,003

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

2.8 years

First QC Date

June 24, 2013

Last Update Submit

July 8, 2016

Conditions

Keywords

GeriatricsEmergency MedicineCare Transitions

Outcome Measures

Primary Outcomes (1)

  • Time to the first occurrence of hospital readmission, emergency department visit, or death.

    Measured by (1) Self-report via a phone call to the patient or care giver up to 35 days post-discharge, and (2) Utilization of existing medical records.

    0-35 days

Secondary Outcomes (2)

  • Time elapsed from initial emergency department visit to Physician follow up

    0-35 Days

  • Patient satisfaction as reported by phone survey

    0-35 Days

Study Arms (2)

Satisfaction Survey

PLACEBO COMPARATOR

Within 1-3 days after ED discharge, patients will be called by a nurse to complete a brief satisfaction survey.

Behavioral: Placebo Comparator

ED Discharge and Medication Call

ACTIVE COMPARATOR

Within 1-3 days after ED discharge, patients will receive a follow up phone call from a nurse to review discharge instructions, review medication instructions, and provide any necessary patient navigation.

Behavioral: ED Discharge & Medication Call

Interventions

Patients will receive a follow up phone call from a nurse to review discharge instructions and provide any necessary patient navigation.

ED Discharge and Medication Call
Satisfaction Survey

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • All patients age 65 and above discharged from the ED
  • English speaking

You may not qualify if:

  • Younger than 65 years of age
  • Unable to pass 6-item memory screener
  • Lives in skilled nursing facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Biese KJ, Busby-Whitehead J, Cai J, Stearns SC, Roberts E, Mihas P, Emmett D, Zhou Q, Farmer F, Kizer JS. Telephone Follow-Up for Older Adults Discharged to Home from the Emergency Department: A Pragmatic Randomized Controlled Trial. J Am Geriatr Soc. 2018 Mar;66(3):452-458. doi: 10.1111/jgs.15142. Epub 2017 Dec 22.

Study Officials

  • John S Kizer, M.D.

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR
  • Kevin Biese, M.D.

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2013

First Posted

July 9, 2013

Study Start

August 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

July 11, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations