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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050918
Recruitment Status : Completed
First Posted : February 13, 2017
Results First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Maame Yaa A. B. Yiadom, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Discharge Follow-up Phone Calls Behavioral: Follow-up Phone Call Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3054 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a single center, pragmatic, randomized, controlled clinical trial.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Pragmatic, Randomized, Controlled Trial Examining the Effectiveness of a Hospital Discharge Follow-up Phone Call Program
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : September 28, 2017
Actual Study Completion Date : April 15, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Number of Participants With In-patient Re-admissions [ Time Frame: 30 days ]
    Number of participants with in-patient re-admissions


Secondary Outcome Measures :
  1. Patient Satisfaction: Experience [ Time Frame: Within 60 days of Discharge ]
    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.

  2. Patient Satisfaction: Likelihood to Recommend the Facility (Top Box Rating) [ Time Frame: Within 60 days of Discharge ]
    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.

  3. Patient Satisfaction: Hospital Experience (Top Box Rating) [ Time Frame: Within 60 days of Discharge ]
    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.

  4. Patient Satisfaction: Likelihood to Recommend the Facility [ Time Frame: Within 60 days of Discharge ]
    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.

  5. VUMC Emergency Department (ED) Visits [ Time Frame: 30 days ]
    All cause ED visits following discharge

  6. Number of Patient Received Discharge Plan Implementation Assistance [ Time Frame: 30 days ]
    Need for assistance in implementing discharge plan

  7. Mortality [ Time Frame: 30 days ]
    All cause mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050918


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Maame Yaa Yiadom, MD, MPH Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Maame Yaa A. B. Yiadom, Vanderbilt University Medical Center:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maame Yaa A. B. Yiadom, MD, MPH, MSCI, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03050918    
Other Study ID Numbers: 170019
First Posted: February 13, 2017    Key Record Dates
Results First Posted: July 29, 2019
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: 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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No