Expired Study
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Boston, Massachusetts 02215


Purpose:

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


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

1-05-JF-40


NCT ID:

NCT00790530


Secondary ID:


Study Acronym:

ATO-SR-DM


Brief Title:

Automated Telephone Outreach With Speech Recognition to Improve Diabetes Care: A Randomized Controlled Study


Official Title:

Automated Telephone Outreach With Speech Recognition to Improve Diabetes Care: A Randomized Controlled Study


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Harvard Pilgrim Health Care


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

1200


Enrollment Type:

Actual


Overall Contact Information

Official Name:Steven R Simon, MD
Principal Investigator
Harvard Pilgrim Health Care

Study Dates

Start Date:June 2006
Completion Date:October 2007
Completion Type:Actual
Primary Completion Date:October 2007
Primary Completion Type:Actual
Verification Date:November 2008
Last Changed Date:November 11, 2008
First Received Date:November 11, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Completion of microalbumin testing
Time Frame:one-year following intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Completion of LDL-cholesterol testing
Time Frame:one year following intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Completion of glycated hemoglobin testing (HbA1c)
Time Frame:one-year following intervention
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Completion of dilated eye examination
Time Frame:12-months following intervention
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Automated Telephone Outreach with Speech Recogniti
Description:Automated Telephone Outreach with Speech Recognition
Arm Name:ATO-SR
Intervention Type:Other
Name:Usual Care
Description:Usual Care
Arm Name:Usual Care

Study Arms

Study Arm Type:Experimental
Arm Name:ATO-SR
Description:Automated Telephone Outreach with Speech Recognition
Study Arm Type:No Intervention
Arm Name:Usual Care
Description:Usual Care

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Harvard Pilgrim Health Care
Agency Class:Other
Agency Type:Collaborator
Agency Name:American Diabetes Association

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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