- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00221455
The Potential of Technology to Improve Chronic Disease Management and Quality of Care
Descripción general del estudio
Estado
Condiciones
Descripción detallada
To date, limited research has been conducted to determine if health information technology (HIT) is effective in improving the outcomes for patients with chronic diseases. Research is required to determine if interventions facilitated by an institutional EMR platform can be implemented such that they support patients with chronic diseases to achieve improved outcomes in a cost effective fashion.
At the Cleveland Clinic Foundation (CCF) an ambulatory EMR has been implemented to foster patient safety and institutional best practice guidelines, to facilitate research, and to achieve efficiencies in practice management. Our EMR is the foundation of the CCF patient portal. One of the functions of the portal is to allow patients to enter specific data elements that become part of their permanent medical record. Diabetics can enter and review their home glucometer readings, and view alert messages based on their entries. The entries are transferred to the patient's primary care physician's EMR In-Basket for review.
We recognize that some patients will be more predisposed to technology adoption and some will be more health behavior compliant than others. Therefore, in addition to studying our portal's efficacy in positive diabetic behavior change, we will test if interventions can assist less predisposed and less compliant patients to become more compliant and more inclined to adopt the technology.
The goals of the proposed study are:
1) to assess whether a web portal will improve care outcomes in diabetic patients; 2a) to describe the characteristics of patients whose health behavior improves over the study period; 2b) to describe the characteristics of patients who adopt the web portal-based disease management technology; 3) to develop and test targeted interventions to increase the adoption of the web portal and improve patient health behavior; 4) to monitor the ongoing costs associated with the web portal and patient healthcare resource utilization, and to monitor the incremental costs of the interventions designed to improve utilization of the technology and patient compliance with their diabetic regimens.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- The Cleveland Clinic Foundation
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria: Diabetic patients 18 years of age or older with an established primary care physician at the Cleveland Clinic Foundation
Exclusion Criteria: An individual not meeting the inclusion criteria
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Clinical Outcome Measures: HbA1c, LDL,and the presence or absence of clinically significant proteinuria.
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Medidas de resultado secundarias
Medida de resultado |
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Technology Adoption will be measured by tracking the patient usage of the various portal features
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Martin Harris, MD, MBA, The Cleveland Clinic
- Director de estudio: Holly D Miller, MD, MBA, The Cleveland Clinic
Publicaciones y enlaces útiles
Publicaciones Generales
- Renders CM, Valk GD, Griffin SJ, Wagner EH, Eijk Van JT, Assendelft WJ. Interventions to improve the management of diabetes in primary care, outpatient, and community settings: a systematic review. Diabetes Care. 2001 Oct;24(10):1821-33. doi: 10.2337/diacare.24.10.1821.
- Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic costs of diabetes in the US in 2002. Diabetes Care. 2003 Mar;26(3):917-32. doi: 10.2337/diacare.26.3.917.
- Olivarius NF, Beck-Nielsen H, Andreasen AH, Horder M, Pedersen PA. Randomised controlled trial of structured personal care of type 2 diabetes mellitus. BMJ. 2001 Oct 27;323(7319):970-5. doi: 10.1136/bmj.323.7319.970.
- Chase HP, Pearson JA, Wightman C, Roberts MD, Oderberg AD, Garg SK. Modem transmission of glucose values reduces the costs and need for clinic visits. Diabetes Care. 2003 May;26(5):1475-9. doi: 10.2337/diacare.26.5.1475.
- Friedman RH, Stollerman J, Rozenblyum L, Belfer D, Selim A, Mahoney D, Steinbach S. A telecommunications system to manage patients with chronic disease. Stud Health Technol Inform. 1998;52 Pt 2:1330-4.
- Ralston JD, Revere D, Robins LS, Goldberg HI. Patients' experience with a diabetes support programme based on an interactive electronic medical record: qualitative study. BMJ. 2004 May 15;328(7449):1159. doi: 10.1136/bmj.328.7449.1159.
- Wagner EH, Grothaus LC, Sandhu N, Galvin MS, McGregor M, Artz K, Coleman EA. Chronic care clinics for diabetes in primary care: a system-wide randomized trial. Diabetes Care. 2001 Apr;24(4):695-700. doi: 10.2337/diacare.24.4.695.
- Biermann E, Dietrich W, Standl E. Telecare of diabetic patients with intensified insulin therapy. A randomized clinical trial. Stud Health Technol Inform. 2000;77:327-32.
- Friedman RH, Stollerman JE, Mahoney DM, Rozenblyum L. The virtual visit: using telecommunications technology to take care of patients. J Am Med Inform Assoc. 1997 Nov-Dec;4(6):413-25. doi: 10.1136/jamia.1997.0040413.
- Ajzen, I. (1991). The Theory of Planned Behavior. Organizational Behavior and Human Decision Processes, Vol. 50: 179-211.
- Avital, M., Vandenbosch, B., (2000) IT-Business Ownership: The Missing Link for IT-Driven Value, Administrative Sciences Association of Canada - 2000 Proceedings (Information Systems), Vol. 21(4): 116-125.
- Beckles GL, Engelgau MM, Narayan KM, Herman WH, Aubert RE, Williamson DF. Population-based assessment of the level of care among adults with diabetes in the U.S. Diabetes Care. 1998 Sep;21(9):1432-8. doi: 10.2337/diacare.21.9.1432.
- Chang S., Ryoo S., Yu S., Ahn B., (1999) Development of an Internet-Based Home Monitoring System for Diabetes Mellitus, Proceeding of the 4th IEEE Malaysia International Conference on Communications and 4th IEEE Asia Pacific International Symposium on Consumer Electronics, Maleka, Malaysia, November 1999.
- Eisenberg JM. Ten lessons for evidence-based technology assessment. JAMA. 1999 Nov 17;282(19):1865-9. doi: 10.1001/jama.282.19.1865. No abstract available.
- Fishbein M., Ajzen I., (1975) Belief, Attitude, Intention and Behavior: An Introduction to Theory and Research. Reading, MA: Addison-Wesley.
- Gallagher, K., Vandenbosch, B., (2000) A Systemic View of Continual Change. Best Paper Proceedings of the Sixtieth Annual Meeting of the Academy of Management, August 2000.
- Hailey D, Roine R, Ohinmaa A. Systematic review of evidence for the benefits of telemedicine. J Telemed Telecare. 2002;8 Suppl 1:1-30. doi: 10.1258/1357633021937604.
- Hersh WR, Helfand M, Wallace J, Kraemer D, Patterson P, Shapiro S, Greenlick M. Clinical outcomes resulting from telemedicine interventions: a systematic review. BMC Med Inform Decis Mak. 2001;1:5. doi: 10.1186/1472-6947-1-5. Epub 2001 Nov 26.
- Kwon H., Cho J, Kim H., Song B., Ko S., Lee J., Kim S., Chang S., Kim H., Cha B., Lee K., Son H., Lee J., Lee W., Yoon K., (2004) Establishment of Blood Glucose Monitoring System Using the Internet, Diabetes Care, Vol. 27(2):478-83. Mease A, Whitlock W, Brown A, (2000) Telemedicine Improved Diabetic Management. Military Medicine, Vol. 165:279-284. Neubauer A., Priglinger S., Ehrt O., (2001) Electronic Versus Paper-Based Patient Records: a Cost-Benefit Analysis, Ophthalmologe, Vol. 11:1083-8. Norris S., Engelgau M., Narayan K., (2001) Effectiveness of Self-Managed Training in Type 2 Diabetes: A Systematic Review of Randomized Controlled Trials, Diabetes Care, Vol. 24/3.
- Piette JD, McPhee SJ, Weinberger M, Mah CA, Kraemer FB. Use of automated telephone disease management calls in an ethnically diverse sample of low-income patients with diabetes. Diabetes Care. 1999 Aug;22(8):1302-9. doi: 10.2337/diacare.22.8.1302.
- Renders CM, Valk GD, Franse LV, Schellevis FG, van Eijk JT, van der Wal G. Long-term effectiveness of a quality improvement program for patients with type 2 diabetes in general practice. Diabetes Care. 2001 Aug;24(8):1365-70. doi: 10.2337/diacare.24.8.1365.
- Ross SE, Lin CT. The effects of promoting patient access to medical records: a review. J Am Med Inform Assoc. 2003 Mar-Apr;10(2):129-38. doi: 10.1197/jamia.m1147. Erratum In: J Am Med Inform Assoc. 2003 May-Jun;10(3):294.
- Schultze, U., Vandenbosch, B., (1998) Information Overload in a Groupware Environment: Now You See It, Now You Don't, Journal of Organizational Computing and Electronic Commerce, Vol. 8/2: 127-148.
- Shiffman RN, Liaw Y, Brandt CA, Corb GJ. Computer-based guideline implementation systems: a systematic review of functionality and effectiveness. J Am Med Inform Assoc. 1999 Mar-Apr;6(2):104-14. doi: 10.1136/jamia.1999.0060104.
- Taylor S., Todd P., (1995). Understanding Information Technology Usage: A Test of Competing Models. Information Systems Research, Vol. 6(2), 144-176.
- Tierney WM, Miller ME, Overhage JM, McDonald CJ. Physician inpatient order writing on microcomputer workstations. Effects on resource utilization. JAMA. 1993 Jan 20;269(3):379-83.
- Vandenbosch, B., (1995) Healthcare Data Exchange Corporation, In N. Lorenzi, R.T. Riley, M.J. Ball,& J.V. Douglas (Eds.), Transforming Health Care through Information: Case Studies, New York: Springer-Verlag, 337-350.
- Vandenbosch, B., (1995) What Makes an ESS Successful: Links Between Types of Use and Perceptions of Competitiveness, Administrative Sciences Association of Canada - 1995 Proceedings (Information Systems), Vol. 16/4: 97-106.
- Venkatesh, V. (2000) Determinants of Perceived Ease of Use: Integrating Control, Intrinsic Motivation and Emotion into the Technology Acceptance Model. Information Systems Research, Vol. 11(4) 342-365.
- Wang SJ, Middleton B, Prosser LA, Bardon CG, Spurr CD, Carchidi PJ, Kittler AF, Goldszer RC, Fairchild DG, Sussman AJ, Kuperman GJ, Bates DW. A cost-benefit analysis of electronic medical records in primary care. Am J Med. 2003 Apr 1;114(5):397-403. doi: 10.1016/s0002-9343(03)00057-3.
- Whitten PS, Mair FS, Haycox A, May CR, Williams TL, Hellmich S. Systematic review of cost effectiveness studies of telemedicine interventions. BMJ. 2002 Jun 15;324(7351):1434-7. doi: 10.1136/bmj.324.7351.1434.
- Wickramasinghe, N., Levitan, N., Vandenbosch, B., (1998) University Hospitals Automation, Prentice Hall Case Series in M.I.S.
- Yang, H., Vandenbosch, B., (1998) Visibility as the Basis of a Framework for Identifying Strategic Information Systems, Journal of Information Technology Management, Vol. 9/2, 31-42.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 51760
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