Effects of Nurse-led Case Management Based on Prevention and Control of Acute Myocardial Infarction

May 17, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University

Effects of Nurse-led Case Management Based on Multidisciplinary Collaboration in the Whole Course Prevention and Control of Acute Myocardial Infarction

Acute Myocardial Infarction (AMI) is a major disease that endangers people's health China. At present, clinical emphasis is given to "treatment" rather than "prevention", and a large number of AMI patients are hospitalized repeatedly without systematic and standardized health management after acute stage, falling into a vicious circle of "treatment without recovery". Nurse-led case management based on multidisciplinary collaboration is a new mode of disease management. In 1994, the United States took the lead in applying case management to the acute and chronic care system, providing comprehensive care services and promoting comprehensive recovery through multidisciplinary collaboration led by case managers. At present, the case management model of cardiovascular disease in Europe and the United States has been mature, but it is still in the exploratory stage in China. Through the establishment and application of nurse-led AMI case management program based on multidisciplinary collaboration, this study wants to establish a novel, standardized, and easy to popularize AMI whole-course prevention and control mode, providing theoretical and research basis for AMI disease management.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

There are few domestic studies on cardiovascular disease case management in China, and the studies mainly aimed at the application of case management in out-of-hospital follow-up management. At present, there has been no reports on nurse-led the multidisciplinary whole course case management of AMI patients from admission to discharge, diagnosis and treatment, rehabilitation and secondary prevention. This study would apply case management to the whole course management of AMI patients from admission to 6 months after discharge. Pharmacists, nutritionists, rehabilitation specialists and psychiatrists coordinated by nurse would take the initiative to conduct individualized assessment and health guidance, and case managers would participate in the whole process of inpatient diagnosis and treatment. Coordinating multidisciplinary medical resources to jointly implement diagnosis and treatment and rehabilitation for patients can save medical costs and improve the quality of care.

Study Type

Interventional

Enrollment (Anticipated)

148

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

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 to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • In line with the diagnosis of Chinese 2019 Guidelines for AMI. Age greater than or equal to 18 years old and less than or equal to 75 years old Patients have clear consciousness and agree to participate in this study.

Exclusion Criteria:

  • Verbal communication disorders. Patients have a clear history of allergic constitution, and have allergies or intolerance to the drugs recommended by the guidelines (including antiplatelet drugs, ẞ receptor blockers, statins, various antihypertensive and hypoglycemic drugs, etc.).

Patients have severe heart, brain, liver, kidney, motor dysfunction.

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental
Patients in the experimental group will receive full-course case management from a multidisciplinary team from admission to 6 months after discharge
Other: Nurse -led case management
This study would apply case management to the whole course management of AMI patients from admission to 6 months after discharge. Pharmacists, nutritionists, rehabilitation specialists and psychiatrists led by nurse would take the initiative to conduct individualized assessment and health guidance, and case managers would participate in the whole process of inpatient diagnosis and treatment. Coordinating multidisciplinary medical resources to jointly implement diagnosis and treatment and rehabilitation for patients can improve the quality of care.
ACTIVE_COMPARATOR: Control
Patients in the control group will receive routine inpatient care and post-discharge follow-up management
Other: Routine inpatient care and post-discharge follow-up management
Patients in the control group will receive routine inpatient care and post-discharge follow-up management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The 36-item Short Form Health Survey for HRQoL
Time Frame: from baseline to 6 months after discharge
Health-related quality of life
from baseline to 6 months after discharge
Coronary artery disease self-management scale for self-management behaviors
Time Frame: from baseline to 6 months after discharge
Self-management behaviors
from baseline to 6 months after discharge
the numbers of unplanned readmission
Time Frame: Through study completion, within 6 months post discharge
Unplanned readmission
Through study completion, within 6 months post discharge
the number of deaths from cardiac causes
Time Frame: Through study completion,within 6 months post discharge
Deaths from cardiac causes
Through study completion,within 6 months post discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the numbers of no smoking
Time Frame: from baseline to 6 months after discharge
Smoking
from baseline to 6 months after discharge
systolic and diastolic blood pressure （mmHg）
Time Frame: from baseline to 6 months after discharge
Blood Pressure.
from baseline to 6 months after discharge
Glycated hemoglobin A1c （%）
Time Frame: from baseline to 6 months after discharge
Collect fasting venous blood to measure glycosylated hemoglobin A1c
from baseline to 6 months after discharge
Body mass index (BMI)，kg/m2
Time Frame: from baseline to 6 months after discharge
Measure weight and height，then weight and height will be combined to report BMI in kg/m^2
from baseline to 6 months after discharge
Low-density lipoprotein （mmol/L）
Time Frame: from baseline to 6 months after discharge
Collect fasting venous blood to measure low-density lipoprotein
from baseline to 6 months after discharge
Exercise time every week （min）
Time Frame: from baseline to 6 months after discharge
Inquire the exercise time per week
from baseline to 6 months after discharge

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

May 20, 2022

Primary Completion (ANTICIPATED)

September 15, 2023

Study Completion (ANTICIPATED)

November 15, 2023

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (ACTUAL)

May 20, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2022LSK-169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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