Improving Access to Eye Care in Glaucoma Patients

December 6, 2023 updated by: L. Jay Katz MD, Wills Eye

Improving Access to Eye Care in Glaucoma Patients a Prospective, Controlled, Randomized Trial

  1. To design and develop a prospective, randomized pilot study utilizing information from electronic medical records to address follow-up adherence and reduce the gap between recommended and actual follow-up adherence in patients with glaucoma.
  2. To evaluate the impact of a telephone-based intervention on follow-up adherence in patients with glaucoma using a randomly assigned comparison with usual care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Wills Eye Health System (WEHS) proposes to conduct a pilot study to evaluate the feasibility and effectiveness of a telephone-based intervention to improve rates of follow-up exams in patients with glaucoma. The prospective, randomized, controlled trial entitled "Improving Access to Eye Care in Patients with Glaucoma" will utilize cohort data from 2013 electronic medical record information to reduce the gap between recommended and actual follow-up utilization of eye care services in glaucoma patients. Patients with glaucoma will be recruited from the Wills Eye Glaucoma clinic who were seen between 3/1/13 and 10/31/13. A recall list will be generated for patients who have scheduled follow-up appointments from 9/1/13 to 11/30/13. These patients will be randomly assigned to the "Usual Care" group or "Intervention" group. The primary outcome will be successful attendance at a follow-up appointment within an appropriate time frame. This intervention is based on a CDC funded project at Wills to improve access to eye care in patients with diabetes. Thus, this pilot study will test the efficacy of a telephone-based intervention to improve follow-up adherence in patients with glaucoma by improving access to eye care.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Attended Wills Eye Glaucoma Clinic from 9/1/12 and 10/31/13

Exclusion Criteria:

  • Any medical condition that would preclude the subject from providing reliable and valid data.
  • Recommended to f/u in less than 1 month time period.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Usual Care
Patients in this group do not receive any letters or phone calls after missing follow-up appointment.
Behavioral: Reminder letter Intervention
Patients in this group receive letters and phone calls to reschedule missed follow-up appointments.
Active Comparator: Reminder Letter Intervention
Patients in this group receive letters and phone calls after missing follow-up appointment to reschedule the appointment.
Behavioral: Reminder letter Intervention
Patients in this group receive letters and phone calls to reschedule missed follow-up appointments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Follow-Up
Time Frame: 28 weeks
Whether patients adhere to follow-up appointments at 28 weeks.
28 weeks

Collaborators and Investigators

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

Sponsor

Wills Eye

Collaborators

Thomas Jefferson University

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

March 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimated)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 410005727

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A total of 8 papers have been published. Results will be uploaded by 2016.

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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