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

NCT02276456 | Terminated DMC

• 1 other identifier: Pro00046405
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• hospital readmission

  within 90 days

Study Arms (2)

early follow-up

EXPERIMENTAL

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

standard follow-up

NO INTERVENTION

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

Interventions

Follow-up Appointment- early vs standard BEHAVIORAL

Patient will undergo early follow-up (within 7 days of discharge) of discharge

early follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Kristin Newby

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 28, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: January 24, 2022

Record last verified: 2022-01

Locations

US (1)