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

Primary Purpose

Myocardial Infarction

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Follow-up Appointment- early vs standard
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

early follow-up

standard follow-up

Arm Description

Follow-up within 7 days after discharge from hospital after having an MI. This will be the early-follow-up or experimental arm.

Follow-up appointment within 14-18 days after discharge from hospital after having an MI

Outcomes

Primary Outcome Measures

hospital readmission

Secondary Outcome Measures

Full Information

First Posted
October 1, 2014
Last Updated
January 7, 2022
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02276456
Brief Title
The Impact of Early Follow-up on Readmission Rates in AMI Patients
Official Title
The Impact of Early Versus Standard Post-Discharge Follow-up on Readmission Rates in Patients Admitted With Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early follow-up
Arm Type
Experimental
Arm Description
Follow-up within 7 days after discharge from hospital after having an MI. This will be the early-follow-up or experimental arm.
Arm Title
standard follow-up
Arm Type
No Intervention
Arm Description
Follow-up appointment within 14-18 days after discharge from hospital after having an MI
Intervention Type
Behavioral
Intervention Name(s)
Follow-up Appointment- early vs standard
Intervention Description
Patient will undergo early follow-up (within 7 days of discharge) of discharge
Primary Outcome Measure Information:
Title
hospital readmission
Time Frame
within 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Newby
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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