Effectiveness New Health Care Organization Model in Primary Care for Chronic Cardiovascular Disease Patients Based

Ischemic Heart Disease Clinical Trial

— PROPRESE  

Official title:

Effectiveness of a New Health Care Organization Model in Primary Care for Chronic Cardiovascular Disease Patients Based on a Multifactorial Intervention: The PROPRESE Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01826929
• Other study ID #: USI-10-66
• Secondary ID: SM I 14/2010
• Status: Recruiting
• Phase: N/A
• First received: March 25, 2013
• Last updated: April 9, 2013
• Start date: January 2013

Study information

• Verified date: April 2013
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: Domingo Orozco-Beltran
• Phone: 0034 965919309
• Email: dorozcobeltran[@]hotmai.com
• Is FDA regulated: No
• Health authority: Spain: Valencia Regional Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a multifactorial primary care intervention based on chronic models can improve the level of control and reduce the number of hospital admissions in patients with ischemic heart disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with a diagnosis of IHD of any site (ICD-10 codes from 410 to 414 inclusive.

• signed written informed consent

Exclusion Criteria:

• lack of consent

• immobilized patients

• patients with serious health problems or with a low life expectancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Other:
• Therapeutic education

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Country where clinical trial is conducted

Spain, 

References & Publications (20)

Banegas JR, Rodríguez-Artalejo F, Graciani A, Villar F, Herruzo R. Mortality attributable to cardiovascular risk factors in Spain. Eur J Clin Nutr. 2003 Sep;57 Suppl 1:S18-21. — View Citation

Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002 Oct 16;288(15):1909-14. — View Citation

Brotons C, Permanyer G, Pacheco V, Moral I, Ribera A, Cascant P, Pinar J; PREMISE study group. Prophylactic treatment after myocardial infarction in primary care: how far can we go? Fam Pract. 2003 Feb;20(1):32-5. — View Citation

Brotons C, Soriano N, Moral I, Rodrigo MP, Kloppe P, Rodríguez AI, González ML, Ariño D, Orozco D, Buitrago F, Pepió JM, Borrás I; PREseAP study research team. Randomized clinical trial to assess the efficacy of a comprehensive programme of secondary prevention of cardiovascular disease in general practice: the PREseAP study. Rev Esp Cardiol. 2011 Jan;64(1):13-20. doi: 10.1016/j.recesp.2010.07.005. Epub 2010 Dec 30. Erratum in: Rev Esp Cardiol. 2011 Jun;64(6):544. — View Citation

Clark CE, Smith LF, Taylor RS, Campbell JL. Nurse-led interventions used to improve control of high blood pressure in people with diabetes: a systematic review and meta-analysis. Diabet Med. 2011 Mar;28(3):250-61. doi: 10.1111/j.1464-5491.2010.03204.x. Review. — View Citation

Davino-Ramaya C, Krause LK, Robbins CW, Harris JS, Koster M, Chan W, Tom GI. Transparency matters: Kaiser Permanente's National Guideline Program methodological processes. Perm J. 2012 Winter;16(1):55-62. Review. — View Citation

Gil-Guillén V, Orozco-Beltrán D, Márquez-Contreras E, Durazo-Arvizu R, Cooper R, Pita-Fernández S, González-Segura D, Carratalá-Munuera C, Martín de Pablo JL, Pallarés V, Pertusa-Martínez S, Fernández A, Redón J. Is there a predictive profile for clinical inertia in hypertensive patients? An observational, cross-sectional, multicentre study. Drugs Aging. 2011 Dec 1;28(12):981-92. doi: 10.2165/11596640-000000000-00000. — View Citation

Gil-Guillén V, Orozco-Beltrán D, Pérez RP, Alfonso JL, Redón J, Pertusa-Martínez S, Navarro J, Cea-Calvo L, Quirce-Andrés F, Merino-Sánchez J, Carratalá C, Martín-Moreno JM. Clinical inertia in diagnosis and treatment of hypertension in primary care: quantification and associated factors. Blood Press. 2010 Feb;19(1):3-10. doi: 10.3109/08037050903350762. — View Citation

Graham I, Atar D, Borch-Johnsen K, Boysen G, Burell G, Cifkova R, Dallongeville J, De Backer G, Ebrahim S, Gjelsvik B, Herrmann-Lingen C, Hoes A, Humphries S, Knapton M, Perk J, Priori SG, Pyorala K, Reiner Z, Ruilope L, Sans-Menendez S, Scholte op Reimer W, Weissberg P, Wood D, Yarnell J, Zamorano JL, Walma E, Fitzgerald T, Cooney MT, Dudina A; European Society of Cardiology (ESC) Committee for Practice Guidelines (CPG). European guidelines on cardiovascular disease prevention in clinical practice: executive summary: Fourth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (Constituted by representatives of nine societies and by invited experts). Eur Heart J. 2007 Oct;28(19):2375-414. Epub 2007 Aug 28. — View Citation

Kotseva K, Wood D, De Backer G, De Bacquer D, Pyörälä K, Keil U; EUROASPIRE Study Group. Cardiovascular prevention guidelines in daily practice: a comparison of EUROASPIRE I, II, and III surveys in eight European countries. Lancet. 2009 Mar 14;373(9667):929-40. doi: 10.1016/S0140-6736(09)60330-5. — View Citation

Lobos JM, Royo-Bordonada MA, Brotons C, Alvarez-Sala L, Armario P, Maiques A, Mauricio D, Sans S, Villar F, Lizcano A, Gil-Núñez A, de Alvaro F, Conthe P, Luengo E, Del Río A, Cortés O, de Santiago A, Varga MA, Martínez M, Lizarbe V; Comité Español Interdisciplinario para la Prevención Cardiovascular. [European Guidelines on Cardiovascular Disease Prevention in Clinical Practice. CEIPC 2008 Spanish adaptation]. Rev Clin Esp. 2009 Jun;209(6):279-302. Spanish. — View Citation

Lorig KR, Ritter PL, Dost A, Plant K, Laurent DD, McNeil I. The Expert Patients Programme online, a 1-year study of an Internet-based self-management programme for people with long-term conditions. Chronic Illn. 2008 Dec;4(4):247-56. doi: 10.1177/1742395308098886. — View Citation

Márquez-Contreras E, de la Figuera-Von Wichmann M, Franch-Nadal J, Llisterri-Caro JL, Gil-Guillén V, Martín-de Pablos JL, Casado-Martínez JJ, Martell-Claros N. Do Patients With High Vascular Risk Take Antihypertensive Medication Correctly? Cumple-MEMS Study. Rev Esp Cardiol (Engl Ed). 2012 Jun;65(6):544-50. doi: 10.1016/j.recesp.2012.01.018. Epub 2012 Apr 19. — View Citation

Mira JJ, Orozco-Beltrán D, Pérez-Jover V, Martínez-Jimeno L, Gil-Guillén VF, Carratala-Munuera C, Sánchez-Molla M, Pertusa-Martínez S, Asencio-Aznar A. Physician patient communication failure facilitates medication errors in older polymedicated patients with multiple comorbidities. Fam Pract. 2013 Feb;30(1):56-63. doi: 10.1093/fampra/cms046. Epub 2012 Aug 17. — View Citation

Munoz MA, Rohlfs I, Masuet S, Rebato C, Cabañero M, Marrugat J; ICAR Study Group. Analysis of inequalities in secondary prevention of coronary heart disease in a universal coverage health care system. Eur J Public Health. 2006 Aug;16(4):361-7. Epub 2005 Oct 17. — View Citation

Munoz MA, Vila J, Cabañero M, Rebato C, Subirana I, Sala J, Marrugat J; ICAR (Intervención en la Comunidad de Alto Riesgo cardiovascular) investigators. Efficacy of an intensive prevention program in coronary patients in primary care, a randomised clinical trial. Int J Cardiol. 2007 Jun 12;118(3):312-20. Epub 2007 Jan 29. — View Citation

Murphy AW, Cupples ME, Smith SM, Byrne M, Byrne MC, Newell J; SPHERE study team. Effect of tailored practice and patient care plans on secondary prevention of heart disease in general practice: cluster randomised controlled trial. BMJ. 2009 Oct 29;339:b4220. doi: 10.1136/bmj.b4220. — View Citation

Orozco-Beltrán D, Brotons C, Moral I, Soriano N, Del Valle MA, Rodríguez AI, Pepió JM, Pastor A; investigadores del estudio PREseAP. [Factors affecting the control of blood pressure and lipid levels in patients with cardiovascular disease: the PREseAP Study]. Rev Esp Cardiol. 2008 Mar;61(3):317-21. Spanish. — View Citation

Ortiz Tobarra MT, Orozco Beltrán D, Gil Guillén V, Terol Moltó C. [Frequency of attendance and degree of control of type-2 diabetic patients]. Aten Primaria. 2008 Mar;40(3):139-44. Spanish. — View Citation

Selby JV, Schmittdiel JA, Fireman B, Jaffe M, Ransom LJ, Dyer W, Uratsu CS, Reed ME, Kerr EA, Hsu J. Improving treatment intensification to reduce cardiovascular disease risk: a cluster randomized trial. BMC Health Serv Res. 2012 Jul 2;12:183. doi: 10.1186/1472-6963-12-183. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Number of hospitalizations/cause at 12 months		Baseline and 12 months	No
Secondary	Change from baseline Blood pressure	It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.	Baseline, 4 months, 8 months and 12 months.	No
Secondary	Change from baseline LDL cholesterol	It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.	Baseline, 4 months, 8 months and 12 months.	No
Secondary	Change from baseline Body Mass Index	It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.	Baseline, 4 months, 8 months and 12 months	No
Secondary	Change from baseline Basal Blood Glucose	It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.	Baseline, 4 months, 8 months and 12 months	No
Secondary	Change from baseline Healthy Life Habits (exercise, mediterranean diet)	It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.	Baseline, 4 months, 8 months and 12 months	No
Secondary	Change from baseline Number of annual primary care visits		Baseline and 12 months	No