Clinical trial NCT05384028: Effects of Nurse-led Case Management Based on Prevention and Control of Acute Myocardial Infarction
Official title: Effects of Nurse-led Case Management Based on Multidisciplinary Collaboration in the Whole Course Prevention and Control of Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
case management
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The 36-item Short Form Health Survey for HRQoL
timeFrame: from baseline to 6 months after discharge
measure: Coronary artery disease self-management scale for self-management behaviors
timeFrame: from baseline to 6 months after discharge
measure: the numbers of unplanned readmission
timeFrame: Through study completion, within 6 months post discharge
measure: the number of deaths from cardiac causes
timeFrame: Through study completion,within 6 months post discharge
Secondary outcomes:
measure: the numbers of no smoking
timeFrame: from baseline to 6 months after discharge
measure: systolic and diastolic blood pressure （mmHg）
timeFrame: from baseline to 6 months after discharge
measure: Glycated hemoglobin A1c （%）
timeFrame: from baseline to 6 months after discharge
measure: Body mass index (BMI)，kg/m2
timeFrame: from baseline to 6 months after discharge
measure: Low-density lipoprotein （mmol/L）
timeFrame: from baseline to 6 months after discharge
measure: Exercise time every week （min）
timeFrame: from baseline to 6 months after discharge
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Jingwen Hu
state: Shaanxi
Study officials:
References:
citation: Sunamura M, Ter Hoeve N, Geleijnse ML, Steenaard RV, van den Berg-Emons HJG, Boersma H, van Domburg RT. Cardiac rehabilitation in patients who underwent primary percutaneous coronary intervention for acute myocardial infarction: determinants of programme participation and completion. Neth Heart J. 2017 Nov;25(11):618-628. doi: 10.1007/s12471-017-1039-3.
citation: Pocock S, Bueno H, Licour M, Medina J, Zhang L, Annemans L, Danchin N, Huo Y, Van de Werf F. Predictors of one-year mortality at hospital discharge after acute coronary syndromes: A new risk score from the EPICOR (long-tErm follow uP of antithrombotic management patterns In acute CORonary syndrome patients) study. Eur Heart J Acute Cardiovasc Care. 2015 Dec;4(6):509-17. doi: 10.1177/2048872614554198. Epub 2014 Oct 9.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.