Discharge Follow-up Phone Call Program (FUTR-30)

A Pragmatic, Randomized, Controlled Trial Examining the Effectiveness of a Hospital Discharge Follow-up Phone Call Program

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.

Study Overview

• Status: Completed
• Conditions: Discharge Follow-up Phone Calls
• Intervention / Treatment: Behavioral: Follow-up Phone Call

Detailed Description

RATIONALE

In the current medical literature, it is unclear how follow-up calls influence these outcomes in a general medical population. Some studies have attempted to address this question, but are limited in that they target very specific patient populations, are of insufficient quality, or evaluated follow-up calls as part of a larger care bundle. We will conduct a high quality, real-time clinical care study to determine the efficacy of a follow-up phone call program.

STUDY DESIGN

This is a single center, pragmatic, randomized, controlled clinical trial to investigate whether a structured post-hospital discharge follow-up phone call can improve patients' transition from in-hospital to outpatient care and improve satisfaction with their care. We will also identify the discharge implementation assistance given to those in the intervention (Phone Call) group.

Outcome Measures Primary outcome for this study is readmission event rate within 30 days. Secondary outcomes include patient satisfaction which will be measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores, all cause VUMC emergency department (ED) visits, the need for assistance with discharge plan implementation, and 30 day mortality.

• Study Type: Interventional
• Enrollment (Actual): 3054
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phone Call Group (Intervention Arm); 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; Patients will receive a first call attempt within 72 hours discharge.
No Intervention: Usual Care Group (Control Arm); Patients assigned to the control group receive standard discharge planning and follow-up per the usual care of their medical providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With In-patient Re-admissions	Number of participants with in-patient re-admissions	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All cause mortality	30 days
Patient Satisfaction: Experience	Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Higher scores indicate more patient satisfaction. Range is 0-9 with 9 being the most satisfied.	Within 60 days of Discharge
Patient Satisfaction: Likelihood to Recommend the Facility (Top Box Rating)	Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Number of patients that reported a score of 3. Range is 0-3 with 3 being highest satisfaction.	Within 60 days of Discharge
Patient Satisfaction: Hospital Experience (Top Box Rating)	Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Number of patients that rated the Hospital Experience as 9. Scale range is 0-9. Higher scores indicate more patient satisfaction.	Within 60 days of Discharge
Patient Satisfaction: Likelihood to Recommend the Facility	Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Scale range is 0-3. Higher scores indicate more patient satisfaction.	Within 60 days of Discharge
VUMC Emergency Department (ED) Visits	All cause ED visits following discharge	30 days
Number of Patient Received Discharge Plan Implementation Assistance	Need for assistance in implementing discharge plan	30 days

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Maame Yaa Yiadom, MD, MPH, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): September 28, 2017
• Study Completion (Actual): April 15, 2018

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 29, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 170019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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.

IPD Sharing 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.

• IPD Sharing Access Criteria: All requests should be directed to the corresponding author (maya.yiadom@vumc.org).
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No