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

NCT05384028 | Unknown

• 1 other identifier: XJTU1AF2022LSK-169
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myocardial Infarction

Keywords

Acute Myocardial Infarction; case management

Outcome Measures

Primary Outcomes (4)

• The 36-item Short Form Health Survey for HRQoL

  Health-related quality of life

  from baseline to 6 months after discharge

• Coronary artery disease self-management scale for self-management behaviors

  Self-management behaviors

  from baseline to 6 months after discharge

• the numbers of unplanned readmission

  Unplanned readmission

  Through study completion, within 6 months post discharge

• the number of deaths from cardiac causes

  Deaths from cardiac causes

  Through study completion,within 6 months post discharge

Secondary Outcomes (6)

• the numbers of no smoking

  from baseline to 6 months after discharge

• systolic and diastolic blood pressure （mmHg）

  from baseline to 6 months after discharge

• Glycated hemoglobin A1c （%）

  from baseline to 6 months after discharge

• Body mass index (BMI)，kg/m2

  from baseline to 6 months after discharge

• Low-density lipoprotein （mmol/L）

  from baseline to 6 months after discharge

Study Arms (2)

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

Control

ACTIVE COMPARATOR

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

Interventions

Nurse -led case management OTHER

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.

Experimental

Routine inpatient care and post-discharge follow-up management OTHER

Patients in the control group will receive routine inpatient care and post-discharge follow-up management

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

Jingwen Hu

Xi'an, Shaanxi, 710061, China

Location

Related Publications (12)

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  PMID: 28917025 BACKGROUND

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  PMID: 25301783 BACKGROUND

• Puymirat E, Bonaca M, Iliou MC, Tea V, Ducrocq G, Douard H, Labrunee M, Plastaras P, Chevallereau P, Taldir G, Bataille V, Ferrieres J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Outcome associated with prescription of cardiac rehabilitation according to predicted risk after acute myocardial infarction: Insights from the FAST-MI registries. Arch Cardiovasc Dis. 2019 Aug-Sep;112(8-9):459-468. doi: 10.1016/j.acvd.2019.04.002. Epub 2019 May 22.

  PMID: 31126738 BACKGROUND

• Li J, Dharmarajan K, Bai X, Masoudi FA, Spertus JA, Li X, Zheng X, Zhang H, Yan X, Dreyer RP, Krumholz HM. Thirty-Day Hospital Readmission After Acute Myocardial Infarction in China. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005628. doi: 10.1161/CIRCOUTCOMES.119.005628.

  PMID: 31092023 BACKGROUND

• DeBusk RF, Miller NH, Superko HR, Dennis CA, Thomas RJ, Lew HT, Berger WE 3rd, Heller RS, Rompf J, Gee D, Kraemer HC, Bandura A, Ghandour G, Clark M, Shah RV, Fisher L, Taylor CB. A case-management system for coronary risk factor modification after acute myocardial infarction. Ann Intern Med. 1994 May 1;120(9):721-9. doi: 10.7326/0003-4819-120-9-199405010-00001.

  PMID: 8147544 BACKGROUND

• Berra K. Does nurse case management improve implementation of guidelines for cardiovascular disease risk reduction? J Cardiovasc Nurs. 2011 Mar-Apr;26(2):145-67. doi: 10.1097/JCN.0b013e3181ec1337.

  PMID: 21076315 BACKGROUND

• Stafford RS, Berra K. Critical factors in case management: practical lessons from a cardiac case management program. Dis Manag. 2007 Aug;10(4):197-207. doi: 10.1089/dis.2007.103624.

  PMID: 17718658 BACKGROUND

• O'Neill JL, Cunningham TL, Wiitala WL, Bartley EP. Collaborative hypertension case management by registered nurses and clinical pharmacy specialists within the Patient Aligned Care Teams (PACT) model. J Gen Intern Med. 2014 Jul;29 Suppl 2(Suppl 2):S675-81. doi: 10.1007/s11606-014-2774-4.

  PMID: 24715403 BACKGROUND

• Huntley AL, Thomas R, Mann M, Huws D, Elwyn G, Paranjothy S, Purdy S. Is case management effective in reducing the risk of unplanned hospital admissions for older people? A systematic review and meta-analysis. Fam Pract. 2013 Jun;30(3):266-75. doi: 10.1093/fampra/cms081. Epub 2013 Jan 12.

  PMID: 23315222 BACKGROUND

• Ensign CM, Hawkins SY. Improving Patient Self-Care and Reducing Readmissions Through an Outpatient Heart Failure Case Management Program. Prof Case Manag. 2017 Jul/Aug;22(4):190-196. doi: 10.1097/NCM.0000000000000232. No abstract available.

  PMID: 28557879 BACKGROUND

• Tosun N, Akbayrak N. Global case management: using the case management model for the care of patients with acute myocardial infarction in a military hospital in Turkey. Lippincotts Case Manag. 2006 Jul-Aug;11(4):207-15. doi: 10.1097/00129234-200607000-00004.

  PMID: 16926693 BACKGROUND

• Chen YC, Chang YJ, Tsou YC, Chen MC, Pai YC. Effectiveness of nurse case management compared with usual care in cancer patients at a single medical center in Taiwan: a quasi-experimental study. BMC Health Serv Res. 2013 May 31;13:202. doi: 10.1186/1472-6963-13-202.

  PMID: 23725552 BACKGROUND

Study Design

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

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 20, 2022
• Study Start: May 20, 2022
• Primary Completion: September 15, 2023
• Study Completion: November 15, 2023
• Last Updated: May 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)