Diabetes Telemedicine Consultation: A Systems Improvement Intervention

Study Overview
=================
Brief Summary
-----------------
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 mellitus (DM) at a Community Based Outpatient Center (CBOCs).

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.

Official Title
-----------------
Diabetes Telemedicine Consultation: A Systems Improvement Intervention

Conditions
-----------------
Diabetes Mellitus Type 2, Diabetes Mellitus, Type 1, Primary Care Provider

Intervention / Treatment
-----------------
* Behavioral: The Diabetes Treatment Satisfaction Questionnaire
* Behavioral: Diabetes Empowerment Scale
* Behavioral: CBOC's undergo half-day joint-clinics via teleconference


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine CBOC<br>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. | Behavioral: The Diabetes Treatment Satisfaction Questionnaire<br>* A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.<br>Behavioral: Diabetes Empowerment Scale<br>* A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.<br>Behavioral: CBOC's undergo half-day joint-clinics via teleconference<br>* A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.<br>|
| No Intervention: Control CBOC<br>The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education. | |
| No Intervention: Provider Interviews<br>Qualitative interviews with providers | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1c | Hemoglobin A1c is a measure of glycemic control | baseline and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | 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. | Base line and at18 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Telemedicine, Referral, Consultation