Discharge Follow-up Phone Call Program

NCT ID: NCT03050918

Last Updated: 2019-07-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3054 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2018-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Discharge Follow-up Phone Calls

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a single center, pragmatic, randomized, controlled clinical trial.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Follow-up Phone Call

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Follow-up Phone Call

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maame Yaa A. B. Yiadom

MD, MPH, MSCI, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maame Yaa Yiadom, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32732787 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29444787 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

170019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Telenhealth and Adherence to Stains
NCT05872919 COMPLETED NA
Remote Presence Timely Discharge Management
NCT00364117 WITHDRAWN PHASE2/PHASE3
Stony Brook Telehealth Study
NCT03528850 UNKNOWN NA