NCT00119535

Brief Summary

The study's primary objective is to determine whether the PRSS improves the optimal timing of photocoagulation in diabetic patients in VA. Secondary objectives include assessing if the program: (1) leads to improved compliance with retinopathy screening and surveillance visits; (2) improves patient and provider satisfaction with VA diabetic eye care; (3) reduces eye care visit rates among diabetics receiving eye care at VA; (4) decreases health care resource utilization; and (5) improves the cost-effectiveness of eye care for patients with diabetes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

3 active sites

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

August 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2005

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2006

First QC Date

July 1, 2005

Last Update Submit

April 6, 2015

Conditions

Diabetes MellitusDiabetic Retinopathy

Keywords

Diabetes mellitusDiabetic retinopathyOrganizational changeQuality improvementQuasi-experimental

Outcome Measures

Primary Outcomes (1)

  • � Optimal timing of photocoagulation (prior to intervention and 12 months after interventions

Secondary Outcomes (1)

  • � Meeting retinopathy screening and surveillance guidelines � Patient satisfaction with care � Resource utilization (during study and previous 12 months) � Intervention Costs (conclusion of study)

Study Arms (1)

Arm 1

OTHER
Behavioral: Implementation of Proactive Diabetes Eye Care Program

Interventions

Implementation of Proactive Diabetes Eye Care ProgramBEHAVIORAL
Arm 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The population for the project will be all diabetic patients treated at the three VAMCs selected as intervention sites. Therefore, patient recruitment is not required for participation in the initial implementation activities nor in assessing compliance with recommendation for eye examination and treatment. Although the scheduling system will be redesigned and the clinical guidelines will be used to inform eye care clinical decision-making, the final decision about whom should receive diabetes eye care and at what interval will continue to be left to the best clinical judgment of the health care professionals and their patients at each study site. Nothing in this study will preclude a patient and their physician from seeking eye care more frequently or less frequently than recommended by the guidelines. In one regard, this study could be thought of as a study of usual care under two different management and organizational systems without any direct patient-level intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • Krein SL, Bernstein SJ, Fletcher CE, Makki F, Goldzweig CL, Watts B, Vijan S, Hayward RA. Improving eye care for veterans with diabetes: an example of using the QUERI steps to move from evidence to implementation: QUERI Series. Implement Sci. 2008 Mar 19;3:18. doi: 10.1186/1748-5908-3-18.

    PMID: 18353187RESULT

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Officials

  • Steven J. Bernstein, MD MPH

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

  • Rodney A. Hayward, MD

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2005

First Posted

July 13, 2005

Study Start

August 1, 2004

Study Completion

December 1, 2005

Last Updated

April 7, 2015

Record last verified: 2006-04

Locations

US(3)