NCT00799695

Brief Summary

Diabetic retinopathy is the major cause of blindness in working age Americans, and screening for it is cost-effective. There are a quarter of a million people in Southeast Michigan with diabetes and pre-diabetes. Only half of patients with diabetes are screened regularly for diabetic retinopathy, and this proportion has been difficult to increase despite various interventions. Previous research focused on HMO patient groups because preventative care was thought to decrease plan costs. In addition, it was administratively feasible to track patient-doctor interactions. This project builds on published research and institutional experience to determine an effective method for increasing the screening rate, in a mobile, non-HMO population. It uses administrative methods and information technology infrastructures, such as large scale electronic medical records and patient demographic databases, to identify existing patients requiring examinations. Patients were telephoned by a trained service representative who offered and scheduled firm examination appointment times. Hypothesis: Annual screening rates for diabetic retinopathy can be substantially improved in non-HMO patient groups by directly contacting patients and scheduling firm appointment times.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
561

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable

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

January 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 1, 2008

Completed
Last Updated

December 1, 2008

Status Verified

November 1, 2008

Enrollment Period

4 months

First QC Date

November 26, 2008

Last Update Submit

November 28, 2008

Conditions

Keywords

diabetic retinopathyscreeningannual

Outcome Measures

Primary Outcomes (1)

  • a change in the proportion of diabetic patients who acted as a result of the phone contact, and obtained a retina eye exam.

    3 months

Interventions

A sample of subjects who had not completed their annual diabetic screening exams were contacted by phone and offered appointments for eye exams

Eligibility Criteria

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

You may qualify if:

  • were Henry Ford Health System patients,
  • diabetic
  • using the BCBSM payer plan

You may not qualify if:

  • retina examination in prior year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Robert M Levine,, MD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 26, 2008

First Posted

December 1, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2008

Study Completion

November 1, 2008

Last Updated

December 1, 2008

Record last verified: 2008-11

Locations