Diabetes Telemedicine Consultation: A Systems Improvement Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00119041
First received: July 1, 2005
Last updated: April 23, 2015
Last verified: April 2015
  Purpose

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).


Condition Intervention
Diabetes Mellitus Type 2
Diabetes Mellitus, Type 1
Primary Care Provider
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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Diabetes Telemedicine Consultation: A Systems Improvement Intervention

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • A1c [ Time Frame: baseline and 18 months ] [ Designated as safety issue: No ]
    Hemoglobin A1c is a measure of glycemic control


Secondary Outcome Measures:
  • Patient Satisfaction [ Time Frame: Base line and at18 months. ] [ Designated as safety issue: No ]
    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.


Enrollment: 304
Study Start Date: September 2005
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119041

Locations
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
Sponsors and Collaborators
Investigators
Principal Investigator: David C Aron, MD MS Louis Stokes VA Medical Center
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00119041     History of Changes
Other Study ID Numbers: IIR 03-254
Study First Received: July 1, 2005
Results First Received: July 2, 2014
Last Updated: April 23, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Diabetes Mellitus
Telemedicine
Referral
Consultation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on May 27, 2015