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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00799695
Other study ID # F10030
Secondary ID F1003013.13PIRAP
Status Completed
Phase N/A
First received November 26, 2008
Last updated November 28, 2008
Start date January 2008
Est. completion date November 2008

Study information

Verified date November 2008
Source Henry Ford Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 561
Est. completion date November 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- were Henry Ford Health System patients,

- diabetic

- using the BCBSM payer plan

Exclusion Criteria:

- retina examination in prior year

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Henry Ford Health System Detroit Michigan

Sponsors (2)

Lead Sponsor Collaborator
Henry Ford Health System Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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