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

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ClinicalTrials.gov Identifier: NCT02276456
Recruitment Status : Recruiting
First Posted : October 28, 2014
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Behavioral: Follow-up Appointment- early vs standard Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Early Versus Standard Post-Discharge Follow-up on Readmission Rates in Patients Admitted With Myocardial Infarction
Study Start Date : March 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. hospital readmission [ Time Frame: within 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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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): NCT02276456


Contacts
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Contact: Jennifer Rymer, MD 919 668 8002 jennifer.rymer@duke.edu
Contact: Kristin Newby, MD 9196688002 kristin.newby@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Kristin Newby, MD    919-668-8805    kristin.newby@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Kristin Newby Duke Clinical Research Institute
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02276456    
Other Study ID Numbers: Pro00046405
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases