Clinical trial NCT00119041: Diabetes Telemedicine Consultation: A Systems Improvement Intervention
Official title: Diabetes Telemedicine Consultation: A Systems Improvement Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Diabetes Mellitus, Type 1
Primary Care Provider
Keywords: Diabetes Mellitus
Telemedicine
Referral
Consultation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-07-12
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: A1c
timeFrame: baseline and 18 months
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: Base line and at18 months.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center
state: Ohio
Study officials:
affiliation: Louis Stokes VA Medical Center
name: David C Aron, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
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;18(3):217-24. doi: 10.1136/qshc.2007.024729.
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. No abstract available.
citation: 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. doi: 10.1177/193229680800200103.