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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00119041 |
This study seeks to evaluate and document the processes of outreach consultation through joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes at CBOCs.
Condition | Intervention |
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Diabetes Mellitus Type 2 Diabetes Mellitus, Type 1 |
Behavioral: The Diabetes Treatment Satisfaction Questionnaire Behavioral: Diabetes Empowerment Scale Behavioral: CBOC's undergo half-day joint-clinics via teleconference |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Diabetes Telemedicine Consultation: A Systems Improvement Intervention |
Enrollment: | 268 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | June 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.
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Behavioral: The Diabetes Treatment Satisfaction Questionnaire
A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
Behavioral: Diabetes Empowerment Scale
A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
Behavioral: CBOC's undergo half-day joint-clinics via teleconference
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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2: No Intervention
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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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 immediate objective is to evaluate and document the processes of outreach consultation through using joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes at CBOCs. The intervention consists of a teleconferenced joint-clinic consultation session involving the patient, Diabetes Specialist Team, the PCP and other relevant care team members. The impact of the intervention will be assessed using both high-risk patients who are referred to a diabetes specialist for consultation during the 18-month active intervention phase (Cohort I) and other patients with diabetes who are not referred during the intervention phase (Cohort II). The specific aims are:
The long-term objectives are to improve the quality of care delivered and decrease diabetes-related complications.
Methods:
Study settings include the CBOCs and involves primary care referrals to see diabetes specialists at the Cleveland VAMC. Inclusion criteria for Cohort I patients are: (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 I or Type II diabetes will be included. Patients referred will be contacted and asked to participate (N=710 anticipated to complete the study). Cohort II patients will be determined by the above criteria minus referral (N=10,270). All PCP/PC CBOC team members (N=90) and CBOC staff involved in the care of patients will be asked to participate.
Status:
Provider and patient enrollment began in August, 2005. Subsequently, joint-clinic consultations began in September, 2005. Active patient enrollment ended June of 2007. Data is still being collected on enrolled patients and providers.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1) Current prescription of insulin or an oral hypoglycemic agent; 2) A1c > 7.0%; or 3) fasting glucose levels > 130 mg/dl; and 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.
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), and 2) documented dementia, aphasia, and psychosis.
United States, Michigan | |
VA Ann Arbor Healthcare System | |
Ann Arbor, Michigan, United States, 48113-0170 | |
United States, Ohio | |
Louis Stokes VA Medical Center | |
Cleveland, Ohio, United States, 44106-3800 |
Principal Investigator: | David C. Aron, MD MS | Louis Stokes VA Medical Center |
Responsible Party: | Department of Veterans Affairs ( Aron, David - Principal Investigator ) |
Study ID Numbers: | IIR 03-254 |
Study First Received: | July 1, 2005 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00119041 |
Health Authority: | United States: Federal Government |
Diabetes Mellitus Telemedicine Referral Consultation |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |