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Diabetes Telemedicine Consultation: A Systems Improvement Intervention

Diabetes Telemedicine Consultation: A Systems Improvement Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00119041
Enrollment
304
Registered
2005-07-12
Start date
2005-09-30
Completion date
2008-12-31
Last updated
2015-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Diabetes Mellitus, Telemedicine, Referral, Consultation

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.

Interventions

BEHAVIORALThe Diabetes Treatment Satisfaction Questionnaire

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

BEHAVIORALDiabetes Empowerment Scale

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

BEHAVIORALCBOC'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.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
A1cbaseline and 18 monthsHemoglobin A1c is a measure of glycemic control

Secondary

MeasureTime frameDescription
Patient SatisfactionBase line and at18 months.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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Telemedicine CBOC
Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit. 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. We did not collect gender and age related data.
199
Control CBOC
The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
83
Provider Interview
Qualitative interviews with providers
22
Total304

Baseline characteristics

CharacteristicTelemedicine CBOCControl CBOCProvider InterviewTotal
Age, Customized
18 years and older
199 participants83 participants22 participants304 participants
Sex/Gender, CustomizedNA participantsNA participantsNA participantsNA participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 1990 / 830 / 22
serious
Total, serious adverse events
0 / 1990 / 830 / 22

Outcome results

Primary

A1c

Hemoglobin A1c is a measure of glycemic control

Time frame: baseline and 18 months

ArmMeasureGroupValue (MEAN)
Telemedicine CBOCA1cbaseline10.1 percentage of Hb that is glycosylated
Telemedicine CBOCA1c18 months8.82 percentage of Hb that is glycosylated
Control CBOCA1cbaseline9.32 percentage of Hb that is glycosylated
Control CBOCA1c18 months8.36 percentage of Hb that is glycosylated
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.

Time frame: Base line and at18 months.

Population: The number subjects was determined on the size of the CBOC.

ArmMeasureGroupValue (MEAN)
Telemedicine CBOCPatient Satisfactionbaseline24.33 units on a scale
Telemedicine CBOCPatient Satisfaction18 months23.55 units on a scale
Control CBOCPatient Satisfactionbaseline23.29 units on a scale
Control CBOCPatient Satisfaction18 months23.9 units on a scale
Comparison: Comparisons were made between the intervention and control groups at baselinep-value: >0.153t-test, 2 sided
Comparison: Comparisons were made between the intervention and control groups at 18 monthsp-value: >0.25t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026