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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05384028
Other study ID # XJTU1AF2022LSK-169
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 20, 2022
Est. completion date November 15, 2023

Study information

Verified date April 2022
Source First Affiliated Hospital Xi'an Jiaotong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 148
Est. completion date November 15, 2023
Est. primary completion date September 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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, ? receptor blockers, statins, various antihypertensive and hypoglycemic drugs, etc.). Patients have severe heart, brain, liver, kidney, motor dysfunction.

Study Design


Intervention

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.
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

Locations

Country Name City State
China Jingwen Hu Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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:S675-81. doi: 10.1007/s11606-014-2774-4. — View 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. — View Citation

Puymirat E, Bonaca M, Iliou MC, Tea V, Ducrocq G, Douard H, Labrunee M, Plastaras P, Chevallereau P, Taldir G, Bataille V, Ferrières 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. — View 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. Review. — View 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. — View 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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary The 36-item Short Form Health Survey for HRQoL Health-related quality of life from baseline to 6 months after discharge
Primary Coronary artery disease self-management scale for self-management behaviors Self-management behaviors from baseline to 6 months after discharge
Primary the numbers of unplanned readmission Unplanned readmission Through study completion, within 6 months post discharge
Primary the number of deaths from cardiac causes Deaths from cardiac causes Through study completion,within 6 months post discharge
Secondary the numbers of no smoking Smoking from baseline to 6 months after discharge
Secondary systolic and diastolic blood pressure (mmHg) Blood Pressure. from baseline to 6 months after discharge
Secondary Glycated hemoglobin A1c (%) Collect fasting venous blood to measure glycosylated hemoglobin A1c from baseline to 6 months after discharge
Secondary Body mass index (BMI),kg/m2 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
Secondary Low-density lipoprotein (mmol/L) Collect fasting venous blood to measure low-density lipoprotein from baseline to 6 months after discharge
Secondary Exercise time every week (min) Inquire the exercise time per week from baseline to 6 months after discharge
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