Diabetes Telemedicine Consultation: A Systems Improvement Intervention

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Diabetes Telemedicine Consultation: A Systems Improvement Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119041
• Other study ID #: IIR 03-254
• Status: Completed
• Phase: N/A
• First received: July 1, 2005
• Last updated: May 18, 2015
• Start date: September 2005
• Est. completion date: December 2008

Study information

• Verified date: May 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: December 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Primary Care Provider

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan
United States	Louis Stokes VA Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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;1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1c	Hemoglobin A1c is a measure of glycemic control	baseline and 18 months	No
Secondary	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.	No