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Diabetes Telemedicine Consultation: A Systems Improvement Intervention

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Diabetes Treatment Satisfaction Questionnaire
Diabetes Empowerment Scale
CBOC's undergo half-day joint-clinics via teleconference
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus Type 2 focused on measuring Diabetes Mellitus, Telemedicine, Referral, Consultation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Ann Arbor Healthcare System
  • Louis Stokes VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Telemedicine CBOC

Control CBOC

Provider Interviews

Arm Description

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.

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

Qualitative interviews with providers

Outcomes

Primary Outcome Measures

A1c
Hemoglobin A1c is a measure of glycemic control

Secondary Outcome Measures

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.

Full Information

First Posted
July 1, 2005
Last Updated
May 18, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00119041
Brief Title
Diabetes Telemedicine Consultation: A Systems Improvement Intervention
Official Title
Diabetes Telemedicine Consultation: A Systems Improvement Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2, Diabetes Mellitus, Type 1, Primary Care Provider
Keywords
Diabetes Mellitus, Telemedicine, Referral, Consultation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine CBOC
Arm Type
Experimental
Arm Description
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.
Arm Title
Control CBOC
Arm Type
No Intervention
Arm Description
The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
Arm Title
Provider Interviews
Arm Type
No Intervention
Arm Description
Qualitative interviews with providers
Intervention Type
Behavioral
Intervention Name(s)
The Diabetes Treatment Satisfaction Questionnaire
Intervention Description
A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Empowerment Scale
Intervention Description
A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
Intervention Type
Behavioral
Intervention Name(s)
CBOC's undergo half-day joint-clinics via teleconference
Intervention Description
A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.
Primary Outcome Measure Information:
Title
A1c
Description
Hemoglobin A1c is a measure of glycemic control
Time Frame
baseline and 18 months
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
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.
Time Frame
Base line and at18 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Aron, MD MS
Organizational Affiliation
Louis Stokes VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48113-0170
Country
United States
Facility Name
Louis Stokes VA Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-3800
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19468006
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.
Results Reference
result
PubMed Identifier
20501929
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.
Results Reference
result
PubMed Identifier
19885172
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.
Results Reference
result

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Diabetes Telemedicine Consultation: A Systems Improvement Intervention

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