NCT00119041

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

May 12, 2015

Completed
Last Updated

June 15, 2015

Status Verified

May 1, 2015

Enrollment Period

2.2 years

First QC Date

July 1, 2005

Results QC Date

July 2, 2014

Last Update Submit

May 18, 2015

Conditions

Keywords

Diabetes MellitusTelemedicineReferralConsultation

Outcome Measures

Primary Outcomes (1)

  • A1c

    Hemoglobin A1c is a measure of glycemic control

    baseline and 18 months

Secondary Outcomes (1)

  • Patient Satisfaction

    Base line and at18 months.

Study Arms (3)

Telemedicine CBOC

EXPERIMENTAL

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 QuestionnaireBehavioral: Diabetes Empowerment ScaleBehavioral: CBOC's undergo half-day joint-clinics via teleconference

Control CBOC

NO INTERVENTION

The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.

Provider Interviews

NO INTERVENTION

Qualitative interviews with providers

Interventions

A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.

Telemedicine CBOC

A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.

Telemedicine CBOC

A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.

Telemedicine CBOC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Current prescription of insulin or an oral hypoglycemic agent
  • \) A1c \> 7.0%
  • \) fasting glucose levels \> 130 mg/dl
  • \) 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

You may not qualify if:

  • \) 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)
  • \) documented dementia, aphasia, and psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48113-0170, United States

Location

Louis Stokes VA Medical Center

Cleveland, Ohio, 44106-3800, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

A potential factor jeopardizing both internal and external validity relates to fact that the consultation process may be very dependent on the particular individuals involved.

Results Point of Contact

Title
David C. Aron, MD, MS
Organization
Louis Stokes VA Medical Center

Study Officials

  • David C Aron, MD MS

    Louis Stokes VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2005

First Posted

July 12, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2008

Last Updated

June 15, 2015

Results First Posted

May 12, 2015

Record last verified: 2015-05

Locations