- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01893931
Use of a Brief Phone Call After ED Discharge
Discharge Planning for Older Adults in the Emergency Department: Use of a Brief Phone Call After Discharge to Decrease Return Visits to the Emergency Department and Re-admissions to the Hospital
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Procedures: All patients age 65 and above will be randomized to one of two groups within 1-3 days after discharge from the UNC ED: 1) Interventional follow-up phone call; or 2) Placebo phone call, implementing only a satisfaction survey.
The intervention phone call will ask whether patients have obtained the newly prescribed medicines, ask if the patient understands the instructions for taking the medicines and inquire if a patient has made an appointment with his/her personal physician. The caller will attempt to answer questions about the medicines, and encourage patients to take the medicines as directed. The caller will also encourage the patients to follow-up with their own physician in a timely manner and offer to help with setting up follow up appointments if needed.
Subsequently, 30-35 days after ED discharge, all patients will receive a phone call to evaluate rates of compliance with medicines and scheduling follow-up appointments. All calls will be made by trained nurses.
Using an α 0.05 and β 0.80 we will need to enroll 2235 patients to detect a decrease in ED return visits/re-admission/ death of 6%. There will be one interim analysis 1 year into the two year planned study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients age 65 and above discharged from the ED
- English speaking
Exclusion Criteria:
- Younger than 65 years of age
- Unable to pass 6-item memory screener
- Lives in skilled nursing facility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Satisfaction Survey
Within 1-3 days after ED discharge, patients will be called by a nurse to complete a brief satisfaction survey.
|
|
Active Comparator: ED Discharge and Medication Call
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.
|
Patients will receive a follow up phone call from a nurse to review discharge instructions and provide any necessary patient navigation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to the first occurrence of hospital readmission, emergency department visit, or death.
Time Frame: 0-35 days
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time elapsed from initial emergency department visit to Physician follow up
Time Frame: 0-35 Days
|
0-35 Days
|
Patient satisfaction as reported by phone survey
Time Frame: 0-35 Days
|
0-35 Days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: John S Kizer, M.D., University of North Carolina, Chapel Hill
- Principal Investigator: Kevin Biese, M.D., University of North Carolina, Chapel Hill
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-1278
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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