Use of a Brief Phone Call After ED Discharge

NCT ID: NCT01893931

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2003 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-05-31

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.

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.

Conditions

Discharge Planning; Emergency Medicine; Geriatrics; Patient Readmission

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Satisfaction Survey

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

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

ED Discharge & Medication Call

Intervention Type: BEHAVIORAL

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

Interventions

ED Discharge & Medication Call

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

Intervention Type: BEHAVIORAL

Placebo Comparator

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The William R. Kenan, Jr. Charitable Trust

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John S Kizer, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Kevin Biese, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29272029 (View on PubMed)

Other Identifiers

12-1278

Identifier Type: -

Identifier Source: org_study_id