The Potential of Technology to Improve Chronic Disease Management and Quality of Care

Diabetes Mellitus Clinical Trial

Official title:

The Potential of Technology to Improve Chronic Disease Management and Quality of Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221455
• Other study ID #: 51760
• Secondary ID: 51760
• Status: Completed
• Phase: Phase 1
• First received: September 15, 2005
• Last updated: July 25, 2011
• Start date: September 2004
• Est. completion date: September 2007

Study information

• Verified date: July 2011
• Source: Robert Wood Johnson Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

We seek to determine if patient data entry, data entered based alerts, and data review in a secure patient portal may provide a sustainable approach to improve diabetic outcomes in a cost effective manner. We plan to study the extent to which the portal can improve diabetic outcomes and quality of care. We recognize, however, that some patients will be more predisposed to adopting technology and some will be more predisposed to improving their compliance than others. Hence, we will also develop and test interventions that may improve adoption and compliance. 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; and 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus

Intervention

Behavioral:
• Patient diabetic self-management using the diabetic patient portal tools

• A variety of educational interventions for non-adopters of the technology, and for non-compliant patients.

Locations

Country	Name	City	State
United States	The Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

References & Publications (34)

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. — View Citation

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. — View Citation

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.

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. — View Citation

Eisenberg JM. Ten lessons for evidence-based technology assessment. JAMA. 1999 Nov 17;282(19):1865-9. — View Citation

Fishbein M., Ajzen I., (1975) Belief, Attitude, Intention and Behavior: An Introduction to Theory and Research. Reading, MA: Addison-Wesley.

Friedman R., Stollerman J., Rozenblyum L., Beifer D., Selim A., Mahoney D., Stainbach S., (1998) A Telecommunications System to Manage Patients with Chronic Disease, Medinfo '98: Proceedings of the Ninth World Congress on Medical Informatics.

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. — View Citation

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. Review. — View Citation

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. Epub 2001 Nov 26. Review. — View Citation

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. — View Citation

Hogan, P., Dall, T., Nikolov, P., (2003) Economic Costs of Dabetes in the U.S. in 2002, Diabetes Care, Vol 26(4): 917-32.

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.

Olivarius NF, Beck-Nielsen H, Andreasen AH, Hørder M, Pedersen PA. Randomised controlled trial of structured personal care of type 2 diabetes mellitus. BMJ. 2001 Oct 27;323(7319):970-5. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. Erratum in: J Am Med Inform Assoc. 2003 May-Jun;10(3):294. — View Citation

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. Review. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. Review. — View Citation

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.

* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Outcome Measures: HbA1c, LDL,and the presence or absence of clinically significant proteinuria.
Secondary	Technology Adoption will be measured by tracking the patient usage of the various portal features

External Links

•   Patient portal log in page