NCT00790530

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
Last Updated

November 13, 2008

Status Verified

November 1, 2008

Enrollment Period

1.3 years

First QC Date

November 11, 2008

Last Update Submit

November 11, 2008

Conditions

Keywords

DiabetesInformation TechnologyHealth Plans

Outcome Measures

Primary Outcomes (1)

  • Completion of dilated eye examination

    12-months following intervention

Secondary Outcomes (3)

  • Completion of glycated hemoglobin testing (HbA1c)

    one-year following intervention

  • Completion of LDL-cholesterol testing

    one year following intervention

  • Completion of microalbumin testing

    one-year following intervention

Study Arms (2)

ATO-SR

EXPERIMENTAL

Automated Telephone Outreach with Speech Recognition

Behavioral: Automated Telephone Outreach with Speech Recognition

Usual Care

NO INTERVENTION

Usual Care

Other: Usual Care

Interventions

Automated Telephone Outreach with Speech Recognition

ATO-SR

Usual Care

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard Pilgrim Health Care

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Simon SR, Trinacty CM, Soumerai SB, Piette JD, Meigs JB, Shi P, Ensroth A, Ross-Degnan D. Improving diabetes care among patients overdue for recommended testing: a randomized controlled trial of automated telephone outreach. Diabetes Care. 2010 Jul;33(7):1452-3. doi: 10.2337/dc09-2332. Epub 2010 Mar 31.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Steven R Simon, MD

    Harvard Pilgrim Health Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 13, 2008

Study Start

June 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

November 13, 2008

Record last verified: 2008-11

Locations