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

Primary Purpose

Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
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.
Sponsored by
Robert Wood Johnson Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Chronic disease management, Patient portal, Patient empowerment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Cleveland Clinic Foundation

Outcomes

Primary Outcome Measures

Clinical Outcome Measures: HbA1c, LDL,and the presence or absence of clinically significant proteinuria.

Secondary Outcome Measures

Technology Adoption will be measured by tracking the patient usage of the various portal features

Full Information

First Posted
September 15, 2005
Last Updated
July 25, 2011
Sponsor
Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00221455
Brief Title
The Potential of Technology to Improve Chronic Disease Management and Quality of Care
Official Title
The Potential of Technology to Improve Chronic Disease Management and Quality of Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Robert Wood Johnson Foundation

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Diabetes Mellitus, Chronic disease management, Patient portal, Patient empowerment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Patient diabetic self-management using the diabetic patient portal tools
Intervention Type
Behavioral
Intervention Name(s)
A variety of educational interventions for non-adopters of the technology, and for non-compliant patients.
Primary Outcome Measure Information:
Title
Clinical Outcome Measures: HbA1c, LDL,and the presence or absence of clinically significant proteinuria.
Secondary Outcome Measure Information:
Title
Technology Adoption will be measured by tracking the patient usage of the various portal features

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Harris, MD, MBA
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Holly D Miller, MD, MBA
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Director
Facility Information:
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Ajzen, I. (1991). The Theory of Planned Behavior. Organizational Behavior and Human Decision Processes, Vol. 50: 179-211.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
12610059
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. doi: 10.2337/diacare.26.3.917.
Results Reference
background
PubMed Identifier
9727887
Citation
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.
Results Reference
background
PubMed Identifier
11187566
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
12716807
Citation
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.
Results Reference
background
PubMed Identifier
10573279
Citation
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.
Results Reference
background
Citation
Fishbein M., Ajzen I., (1975) Belief, Attitude, Intention and Behavior: An Introduction to Theory and Research. Reading, MA: Addison-Wesley.
Results Reference
background
PubMed Identifier
9391929
Citation
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.
Results Reference
background
PubMed Identifier
10384677
Citation
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
12020415
Citation
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.
Results Reference
background
PubMed Identifier
11737882
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. doi: 10.1186/1472-6947-1-5. Epub 2001 Nov 26.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
11679387
Citation
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.
Results Reference
background
PubMed Identifier
10480775
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. doi: 10.2337/diacare.22.8.1302.
Results Reference
background
PubMed Identifier
15142919
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. doi: 10.1136/bmj.328.7449.1159.
Results Reference
background
PubMed Identifier
11473071
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. doi: 10.2337/diacare.24.8.1365.
Results Reference
background
PubMed Identifier
11574449
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. doi: 10.2337/diacare.24.10.1821.
Results Reference
background
PubMed Identifier
12595402
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. doi: 10.1197/jamia.m1147. Erratum In: J Am Med Inform Assoc. 2003 May-Jun;10(3):294.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
10094063
Citation
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.
Results Reference
background
Citation
Taylor S., Todd P., (1995). Understanding Information Technology Usage: A Test of Competing Models. Information Systems Research, Vol. 6(2), 144-176.
Results Reference
background
PubMed Identifier
8418345
Citation
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.
Results Reference
background
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
11315833
Citation
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.
Results Reference
background
PubMed Identifier
12714130
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. doi: 10.1016/s0002-9343(03)00057-3.
Results Reference
background
PubMed Identifier
12065269
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. doi: 10.1136/bmj.324.7351.1434.
Results Reference
background
Citation
Wickramasinghe, N., Levitan, N., Vandenbosch, B., (1998) University Hospitals Automation, Prentice Hall Case Series in M.I.S.
Results Reference
background
Citation
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.
Results Reference
background
Links:
URL
https://mychart.clevelandclinic.org/default.asp
Description
Patient portal log in page

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