The Impact of Early Follow-up on Readmission Rates in AMI Patients

January 7, 2022 updated by: Duke University

The Impact of Early Versus Standard Post-Discharge Follow-up on Readmission Rates in Patients Admitted With Myocardial Infarction

With no prior prospective study to demonstrate the benefit of an early post-discharge follow-up appointment in reducing readmission rates in the post-myocardial infarction (MI patient population, we propose to conduct the first randomized, prospective trial to better elucidate the association between early and standard follow-up on readmission rates. The investigators hypothesize that unlike heart failure or advanced valvular disease patients, the benefit of early outpatient follow-up in reducing readmission of post-MI patients will be less clear. Thus, the investigators primary aim will be to determine the effect of early outpatient follow-up post-discharge on 90 day all-cause readmission rates (exclusive of planned readmissions known at the time of discharge). Secondary aims are to describe 1) causes of readmissions within 90 days, 2) any cardiovascular-related complications and any deaths that occur from discharge through 90 days, 3) 30-day readmission rates and 4) median time to readmission among those readmitted. Finally, the investigators will examine the distribution of demographic, clinical and socioeconomic characteristic according to readmission vs. no readmission. The investigators do not expect to have sufficient endpoints for full predictive modeling, but believe this exploratory work will provide a foundation for future studies. The investigators postulate that the design and methodology of our current study could be used to answer similar questions in other subsets of patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with acute MI (STEMI or NSTEMI) will be recruited from the PAC-CCU service and may have been admitted through the Duke Emergency Department or transferred from a referring hospital. - Clinical events and treatment during the hospitalization (e.g., medical management versus cardiac catheterization, ICU vs. non-ICU care, choice of medications, etc.) will not influence inclusion in the trial and inclusion in the trial will not influence treatment during hospitalization or during follow up, except for the timing of the follow-up appointment.

Exclusion Criteria:

  • Patients treated with coronary artery bypass grafting will be excluded for the purposes of this trial to avoid conflicts with usual post-operative management.
  • Additionally, patients with features or clinical courses that would preclude the possibility of readmission will be excluded.
  • Examples include transition of care goals to comfort care, transition of care to inpatient or outpatient hospice, or the development of complications during the hospitalization that require early follow up appointments (e.g., diagnosis of malignancy).
  • Patients discharged to skilled nursing facilities will be eligible for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: early follow-up
Follow-up within 7 days after discharge from hospital after having an MI. This will be the early-follow-up or experimental arm.
Behavioral: Follow-up Appointment- early vs standard
Patient will undergo early follow-up (within 7 days of discharge) of discharge
No Intervention: standard follow-up
Follow-up appointment within 14-18 days after discharge from hospital after having an MI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hospital readmission
Time Frame: within 90 days
within 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Kristin Newby, Duke Clinical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

October 1, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 28, 2014

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 7, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00046405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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