Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01382264
Status:
UNKNOWN
Last Update Posted:
2011-06-27
First Post:
2011-06-23
Brief Title:
Use of a Computer-Assisted Decision Support CADS System in Management of Patients With Type 2 Diabetes
Sponsor:
Walter Reed Army Medical Center
Organization:
Walter Reed Army Medical Center
Study Overview
Official Title:
The Use of a Computer-Assisted Decision Support CADS System to Improve Outcomes in Patients With Type 2 Diabetes
Status:
UNKNOWN
Status Verified Date:
2011-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CADS
Brief Summary:
The primary purpose of this study is to determine whether the use of a computer assisted decision support CADSsystem by primary care providers PCPs for their patients with type 2 diabetes mellitus T2DM changes the quality of care relative to a usual care group in terms of objective outcome measures of glycemic control eg A1C mean blood glucose frequency of hypoglycemic episodes and in terms of subjective ratings by patients
Detailed Description:
Diabetes accounts for an enormous fraction of the cost of health care in the United States and presents a major burden on Military Medical Facilities for care of retirees and dependents There are insufficient endocrinologists and other diabetes specialists to manage all patients with diabetes mellitus DM and a significant fraction of these patients have less than optimal control hemoglobin A1Cs A1Cs over 7 Multiple barriers prevent the necessary improvement in glycemic control that would result in savings in lives and costs The implementation of a telemedicine and web-based approach for patients to send their blood glucose data which when combined with relevant laboratory pharmacy and A1C targets as set individually for each patient by the Primary Care Physician PCP triggers a clinical decision support system DSS for the providers can be expected to improve quality of care and efficiency of care The computer assisted decision support CADS system has been integrated with the Comprehensive Diabetes Management Program CDMP a web-based multi-platform interactive patient and provider tool which is currently operative in the Walter Reed Health Care System WRHCS Wilford Hall Medical Center WHMC at Lackland Air Force Base AFB and five community clinics affiliated with the University of Hawaii UH This existing infrastructure permits CADS to be tested in a multiple sites that are geographically diverse with diverse patient populations
This study will test the safety and efficacy of CADS as used by PCPs in a multi-site ethnically and geographically diverse study in a 12-month open prospective cluster-randomized controlled clinical trial The specific aims of the study are to 1 monitor the impact of the intervention on a measures of glycemic control b the number of diabetes -related hospitalizations and emergency room visits c the control of co-morbidities hyperlipidemia and hypertension d the number of clinic visits e the change in the patients quality of life as a result of the intervention and 2 evaluate the PCPs satisfaction with the technology
We will employ a cluster-randomized controlled clinical trial involving 30 PCPs who will each recruit approximately 19 patients from their respective geographic site After completion of recruitment PCPs and their patients will be randomly assigned to 1 of 2 treatment categories CADS or Usual Care Input data for use by the CADS system will come from the electronic medical record laboratory and pharmacy data and from the PCP who will set goals for each individual patients glycemic control Patients will upload blood glucose data through a modem to a password-protected secure server at least every 2 weeks and receive modification in their treatment regimen at least every three months from their PCP based in part on the recommendations provided by the CADS system to the PCP We will compare quantitative outcome measures of glycemic control the primary outcome is the change in the patients A1C blood pressure and lipid levels from the two treatment groups In addition subjective qualitative data from the patients and providers will be obtained
This study will test the safety and efficacy of CADS as used by PCPs in a multi-site ethnically and geographically diverse study in a 12-month open prospective cluster-randomized controlled clinical trial The specific aims of the study are to 1 monitor the impact of the intervention on a measures of glycemic control b the number of diabetes -related hospitalizations and emergency room visits c the control of co-morbidities hyperlipidemia and hypertension d the number of clinic visits e the change in the patients quality of life as a result of the intervention and 2 evaluate the PCPs satisfaction with the technology
We will employ a cluster-randomized controlled clinical trial involving 30 PCPs who will each recruit approximately 19 patients from their respective geographic site After completion of recruitment PCPs and their patients will be randomly assigned to 1 of 2 treatment categories CADS or Usual Care Input data for use by the CADS system will come from the electronic medical record laboratory and pharmacy data and from the PCP who will set goals for each individual patients glycemic control Patients will upload blood glucose data through a modem to a password-protected secure server at least every 2 weeks and receive modification in their treatment regimen at least every three months from their PCP based in part on the recommendations provided by the CADS system to the PCP We will compare quantitative outcome measures of glycemic control the primary outcome is the change in the patients A1C blood pressure and lipid levels from the two treatment groups In addition subjective qualitative data from the patients and providers will be obtained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None