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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00790530
Other study ID # 1-05-JF-40
Secondary ID
Status Completed
Phase N/A
First received November 11, 2008
Last updated November 11, 2008
Start date June 2006
Est. completion date October 2007

Study information

Verified date November 2008
Source Harvard Pilgrim Health Care
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of automated telephone outreach with speech recognition to improve diabetes care.


Description:

Randomly allocate a total of 1200 health plan members with diabetes to automated telephone outreach with speech recognition (ATO-SR; N = 600) or usual care (N = 600). The intervention is a series of three calls, using automated calls, originating from the health plan, using interactive speech recognition technology, spaced approximately 4-6 weeks apart, to encourage participants to fulfill the recommended testing (dilated eye examinations, glycated hemoglobin, LDL-cholesterol, microalbumin) that had not been performed received in the preceding year.


Recruitment information / eligibility

Status Completed
Enrollment 1200
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 years or older

- Diabetes, defined as either 1) filled a prescription for insulin or an oral hypoglycemic agent; or, 2) had two outpatient or one inpatient or two outpatients encounter claims with an ICD9-CM or CPT code indicating diabetes.

- Gap in a key diabetes management metric as evidenced by no claim for a dilated eye examination in the prior 15 months and no claim for one or more of the following tests: glycated hemoglobin, LDL-cholesterol, or microalbumin. (Individuals with evidence of having received ACE-inhibitors or angiotensin receptor blockers were considered to have had a microalbumin test.)

Exclusion Criteria:

- No primary care clinician in the data base

- Those who had previously asked the health plan to exclude them from research or quality improvement

- Women whose claim records contained diagnoses suggesting gestational diabetes

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Automated Telephone Outreach with Speech Recognition
Automated Telephone Outreach with Speech Recognition
Other:
Usual Care
Usual Care

Locations

Country Name City State
United States Harvard Pilgrim Health Care Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Harvard Pilgrim Health Care American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Completion of dilated eye examination 12-months following intervention
Secondary Completion of glycated hemoglobin testing (HbA1c) one-year following intervention
Secondary Completion of LDL-cholesterol testing one year following intervention
Secondary Completion of microalbumin testing one-year following intervention
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