NCT03050918

Brief Summary

The goal of this project is to quantify the impact of post-hospital discharge follow-up phone calls on hospital readmission, ED visits, patient satisfaction, and mortality in a general medicine inpatient population. We will obtain exploratory information on patient sub-groups at high risk for hospital readmission and on those experiencing high benefit from the follow-up phone call intervention. In addition, we will obtain data on discharge plan implementation assistance needed to support a successful transition from inpatient to outpatient care among those reached by the intervention phone call.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,054

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

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

February 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

February 20, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 29, 2019

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

February 9, 2017

Results QC Date

March 7, 2019

Last Update Submit

July 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With In-patient Re-admissions

    Number of participants with in-patient re-admissions

    30 days

Secondary Outcomes (7)

  • Patient Satisfaction: Experience

    Within 60 days of Discharge

  • Patient Satisfaction: Likelihood to Recommend the Facility (Top Box Rating)

    Within 60 days of Discharge

  • Patient Satisfaction: Hospital Experience (Top Box Rating)

    Within 60 days of Discharge

  • Patient Satisfaction: Likelihood to Recommend the Facility

    Within 60 days of Discharge

  • VUMC Emergency Department (ED) Visits

    30 days

  • +2 more secondary outcomes

Study Arms (2)

Phone Call Group (Intervention Arm)

ACTIVE COMPARATOR

Follow-up phone call intervention: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care.

Behavioral: Follow-up Phone Call

Usual Care Group (Control Arm)

NO INTERVENTION

Patients assigned to the control group receive standard discharge planning and follow-up per the usual care of their medical providers.

Interventions

Patients will receive a first call attempt within 72 hours discharge.

Phone Call Group (Intervention Arm)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • VUMC patients discharged after an inpatient status hospital stay on a general medicine service.

You may not qualify if:

  • patients who experience in-hospital death
  • patient discharged to any post-acute care facility or inpatient hospice
  • left the hospital against medical advice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

  • Yiadom MYAB, Domenico HJ, Byrne DW, Hasselblad M, Kripalani S, Choma N, Tucker-Marlow S, Gatto CL, Wang L, Bhatia MC, Morrison J, Harrell FE, Hartert TV, Lindsell CJ, Bernard GR. Impact of a Follow-up Telephone Call Program on 30-Day Readmissions (FUTR-30): A Pragmatic Randomized Controlled Real-world Effectiveness Trial. Med Care. 2020 Sep;58(9):785-792. doi: 10.1097/MLR.0000000000001353.

  • Yiadom MYAB, Domenico H, Byrne D, Hasselblad MM, Gatto CL, Kripalani S, Choma N, Tucker S, Wang L, Bhatia MC, Morrison J, Harrell FE, Hartert T, Bernard G. Randomised controlled pragmatic clinical trial evaluating the effectiveness of a discharge follow-up phone call on 30-day hospital readmissions: balancing pragmatic and explanatory design considerations. BMJ Open. 2018 Feb 14;8(2):e019600. doi: 10.1136/bmjopen-2017-019600.

Limitations and Caveats

A data lag due to limited national electronic health record informatics connectivity prevents us from tracking adverse events documented outside of our facility. Unmeasured outcomes should be equally distributed between the randomized groups.

Results Point of Contact

Title
Maame Yaa Yiadom
Organization
Vanderbilt University Medical Center

Study Officials

  • Maame Yaa Yiadom, MD, MPH

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This is a single center, pragmatic, randomized, controlled clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MPH, MSCI, Assistant Professor

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 13, 2017

Study Start

February 20, 2017

Primary Completion

September 28, 2017

Study Completion

April 15, 2018

Last Updated

July 29, 2019

Results First Posted

July 29, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

The study protocol, semi-structured intervention script, randomization code, data flow design have been published to share with other investigators. Individual study data will be available to other investigators upon request per details below.

Shared Documents
STUDY PROTOCOL
Time Frame
The study protocol was published in BMJ Open in 2017 (Yiadom MYAB, Domenico H, Byrne D, et al Randomised controlled pragmatic clinical trial evaluating the effectiveness of a discharge follow-up phone call on 30-day hospital readmissions: balancing pragmatic and explanatory design considerations BMJ Open 2018;8:e019600. doi: 10.1136/bmjopen-2017-019600) A full de-identified version of the database including participate data for this study will be available to other investigators upon request after consideration of their proposed use for the data. We are happy to begin accepting requests starting 12 months following the publication of the manuscript including study results.
Access Criteria
All requests should be directed to the corresponding author (maya.yiadom@vumc.org).

Locations