Automated Telephone Outreach With Speech Recognition to Improve Diabetes Care: A Randomized Controlled Study (ATO-SR-DM)

November 11, 2008 updated by: Harvard Pilgrim Health Care
The purpose of this study is to evaluate the effectiveness of automated telephone outreach with speech recognition to improve diabetes care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Harvard Pilgrim Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Other: Usual Care
Usual Care
Experimental: ATO-SR
Automated Telephone Outreach with Speech Recognition
Behavioral: Automated Telephone Outreach with Speech Recognition
Automated Telephone Outreach with Speech Recognition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Completion of dilated eye examination
Time Frame: 12-months following intervention
12-months following intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Completion of glycated hemoglobin testing (HbA1c)
Time Frame: one-year following intervention
one-year following intervention
Completion of LDL-cholesterol testing
Time Frame: one year following intervention
one year following intervention
Completion of microalbumin testing
Time Frame: one-year following intervention
one-year following intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard Pilgrim Health Care

Collaborators

American Diabetes Association

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

November 11, 2008

First Submitted That Met QC Criteria

November 11, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Estimate)

November 13, 2008

Last Update Submitted That Met QC Criteria

November 11, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-05-JF-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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