Diabetes Telemedicine Consultation: A Systems Improvement Intervention

May 18, 2015 updated by: US Department of Veterans Affairs
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).

Study Overview

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

Interventional

Enrollment (Actual)

304

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48113-0170
        • VA Ann Arbor Healthcare System
    • Ohio
      • Cleveland, Ohio, United States, 44106-3800
        • Louis Stokes VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
No Intervention: Provider Interviews
Qualitative interviews with providers

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David C Aron, MD MS, Louis Stokes VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 1, 2005

First Submitted That Met QC Criteria

July 1, 2005

First Posted (Estimate)

July 12, 2005

Study Record Updates

Last Update Posted (Estimate)

June 15, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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