- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00119041
Diabetes Telemedicine Consultation: A Systems Improvement Intervention
Study Overview
Status
Detailed Description
Background:
Diabetes is a national problem that has reached epidemic proportions, according to the U.S. Centers for Disease Control and Prevention. Diabetes has particular importance for the Department of Veterans Affairs (VA) because the prevalence among VA patients -- one in six, or 16 percent -- is substantially higher than in the general population.
Objectives:
The objective of this study was to evaluate and document the processes of outreach consultation through the use of joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes at CBOCs. The intervention consisted of a teleconferenced joint-clinic consultation session involving the patient, Diabetes Specialist Team, the Primary Care Provider (PCP) and other relevant care team members. The impact of the 16-month intervention was assessed based on patients who were involved in the telemedicine clinic and those who were referred to a specialist to be seen on-site at the Cleveland VAMC.
Methods:
Study settings include the CBOCs affiliated with the Cleveland Veterans Affairs Medical Center (VAMC) and involve primary care referrals to see diabetes specialists at the Cleveland VAMC. Inclusion criteria patients(N 282)=included: (i) current prescription of insulin or an oral hypoglycemic agent; (ii) A1c > 7.0%; or (iii) fasting glucose levels> 130 mg/dl; and (iv) referred to see a consultant (beginning three months prior to the active intervention phase and continuing through enrollment for the last month of the active intervention phase). Patients with either Type l or Type II diabetes will be included. Patients referred will be contacted and asked to participate.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48113-0170
- VA Ann Arbor Healthcare System
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Ohio
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Cleveland, Ohio, United States, 44106-3800
- Louis Stokes VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1) Current prescription of insulin or an oral hypoglycemic agent
- 2) A1c > 7.0%
- 3) fasting glucose levels > 130 mg/dl
- 4) referred to see a consultant and are seen during the active intervention phase. Patients with either Type I or Type II DM will be included
A Primary Care Provider for a Cleveland CBOC
Exclusion Criteria:
- 1) primary care obtained at more than one site (based on stop codes with evidence of more than 1 CBOC involved in care during the last 6 months)
- 2) documented dementia, aphasia, and psychosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telemedicine CBOC
Designated CBOC's were involved in the intervention phase where their Diabetes Mellitus (DM) patients were asked to participate in a telemedicine visit. The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference. |
A six question likert scale questionnaire regarding the patients treatment satisfaction.
The responses range from very dissatisfied to very satisfied.
A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes.
The responses range from strongly agree to strongly disagree.
A patient has Diabetes/Endo clinic visit via teleconferencing.
A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.
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No Intervention: Control CBOC
The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
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No Intervention: Provider Interviews
Qualitative interviews with providers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A1c
Time Frame: baseline and 18 months
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Hemoglobin A1c is a measure of glycemic control
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baseline and 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction
Time Frame: Base line and at18 months.
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Diabetes Treatment Satisfaction Questionnaire (DTSQ) consists of 6 questions and ranges from 0-6.
The following aspects of current treatment included were convenience, flexibility, understanding and continuing present form of treatment.
The total range of the DTSQ is the sum of the 6 individual questions scores (i.e.
0-36) Higher scores represent greater satisfaction/convenience.
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Base line and at18 months.
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Collaborators and Investigators
Investigators
- Principal Investigator: David C Aron, MD MS, Louis Stokes VA Medical Center
Publications and helpful links
General Publications
- Tomolo AM, Lawrence RH, Aron DC. A case study of translating ACGME practice-based learning and improvement requirements into reality: systems quality improvement projects as the key component to a comprehensive curriculum. Qual Saf Health Care. 2009 Jun;18(3):217-24. doi: 10.1136/qshc.2007.024729.
- Pogach L, Aron D. Balancing hypoglycemia and glycemic control: a public health approach for insulin safety. JAMA. 2010 May 26;303(20):2076-7. doi: 10.1001/jama.2010.655. No abstract available.
- F O Kern E, Beischel S, Stalnaker R, Aron DC, Kirsh SR, Watts SA. Building a diabetes registry from the Veterans Health Administration's computerized patient record system. J Diabetes Sci Technol. 2008 Jan;2(1):7-14. doi: 10.1177/193229680800200103.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 03-254
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