The Use of a Computer Program to Help Primary Care Providers Treat Patients With Type 2 Diabetes (CADS)

The Use of a Computer Assisted Diabetes Decision Support (CADS) System to Improve Outcomes in Patients With Type 2 Diabetes Who Are Treated by Primary Care Providers

The primary purpose of this study is to determine whether the use of CADS by primary care providers (PCPs) for their patients with type 2 diabetes (T2DM) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic control (e.g., A1c, mean blood glucose, frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.

Study Overview

• Status: Completed
• Conditions: Type II Diabetes Mellitus
• Intervention / Treatment: Other: Computer-Assisted Decision Support

Detailed Description

The CADS software integrates the patient's home blood glucose data with appropriate laboratory data (e.g. A1c, liver function, kidney function), demographic data (age, gender), current and previous medications, and active/inactive medical diagnoses. The software makes a recommendation about what medication changes are appropriate with potential alternates. Providers with their patients are block randomized into CADS or "Usual Care" for 1 year.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-specialist physician (general internist or family practitioner), nurse practitioner, physicians assistant
• Absence of orders for deployment or permanent change of station
• Willingness to recruit up to 19 patients prior to randomization
• Willingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.

Exclusion Criteria:

• Specialist physicians
• Orders for deployment or permanent change of station
• Unwillingness to recruit up to 19 patients prior to randomization
• No prior experience with management of type 2 diabetes in adults
• Unwillingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Computer-Assisted Decision Support; These providers will use the CADS program to treat their enrolled patients.

Other: Computer-Assisted Decision Support; The CADS software makes a recommendation about what medication changes are appropriate with potential alternates. CADS providers will either "accept" or "reject" the recommendation by the software.Providers with their patients are block randomized into CADS or "Usual Care" for 1 year. Patients associated with a CADS provider will upload their blood glucose data weekly and perform a 7-point glucose profile once per month. They will report major hypoglycemic events and hospitalizations at the time of their quarterly visit. Those getting "usual care" will be seen quarterly and will do self-monitoring of blood glucose and have A1c tests as determined by the provider but no less than twice a year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in A1c	Change is A1c will be measured 5 times over the course of the study to compare the patients for whom the provider is using CADS to those patients whose providers are delivering "usual care".	baseline, 12, 24, 36, and 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major events	The number of major ("severe") hypoglycemic events whether subjective (undocumented) or objective (SMBG or other confirmation, need for intervention, seizure, coma), and emergency room visits for DM-related causes.	ongoing
Other DM-related events	Number of ER visits for DM-related causes, DM-related hospitalizations and hospital days, and DM-related clinic visits.	ongoing
Glucose measures	Mean pre-prandial glucose, mean post-prandial glucose, post-prandial glucose excursions	baseline, 12, 24, 36, 48 months
Blood pressure	Clinically significant or statistically detectable changes in BP	baseline, 12, 24, 36, and 48 months
Lipids	Clinically significant or statistically detectable changes in lipid profile.	baseline, 12, 24, 36, and 48 months
Patient satisfaction with treatment	Clinically significant or statistically detectable changes in satisfaction with treatment as measured by the DTSQ.	basline and 48 months
Quality of life	Clinically significant or statistically detectable changes in quality of life for patients with DM as measured by the SF-8.	baseline and 48 months
Degree of Acceptance	The degree of acceptance of CADS by PCPs as measured by a technical assessment questionnaire.	baseline and 48 months
Acceptance of uploading data	The degree of acceptance of uploading the glucose meters by patients as measured by a technical assessment questionnaire.	baseline, 12, 24, 36, and 48 months
Demographic variables	The relationship of the primary and/or secondary outcomes to the type of provider, board-certification or eligibility, years in practice, age and gender.	baseline and 48 months

Collaborators and Investigators

• Sponsor: Walter Reed National Military Medical Center
• Investigators: Principal Investigator: Robert A Vigersky, M.D., Walter Reed National Military Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (Estimate): July 24, 2012

Study Record Updates

• Last Update Posted (Estimate): November 25, 2015
• Last Update Submitted That Met QC Criteria: November 24, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: DM, T2DM, Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 353757