Comparison Study of Glaucoma Eye Care Follow-Up Adherence in a High Risk Population

Glaucoma Clinical Trial

Official title:

Comparison Study of Glaucoma Eye Care Follow-Up Adherence in a High Risk Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02347670
• Other study ID #: IRB#14-380
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2023
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project aims to determine the effectiveness of a patient-centered health care delivery system focused on improving follow-up adherence in patients diagnosed with glaucoma. Over the course of 1 year, a 6-person team comprised of one attending physician; project managers and community health educators, ophthalmic technician, and patient navigators will complete a baseline visit, baseline assessment and 2-3 follow-up visits. The patient navigator will assist participants in community groups and a portion of the office-based participants with scheduling follow-up appointments

Description:

The Partridge Foundation has funded the Wills Eye Hospital Glaucoma Research Center for the project: Comparison Study of Glaucoma Eye Care Follow-up Adherence in a High-Risk Population to continue follow-up eye care for those who received a glaucoma diagnosis during the 2010 Center for Disease Control and Prevention funded cooperative agreement: Improving Access to Eye Care among High-Risk Persons for Glaucoma in Philadelphia Project. The project aims to determine the effectiveness of a patient -centered health care delivery system focused on improving follow-up adherence in patients diagnosed with glaucoma.

There are approximately 700 potentially eligible persons from the 39 community sites, and of that the investigators hope to enroll 250 into 1 of four groups. Eligible participants have participated in the community-based comprehensive eye examination, have received a diagnosis of glaucoma-suspect or any type of glaucoma, including open angle glaucoma, chronic angle closure glaucoma, ocular hypertension, anatomically narrow-angle, pigmentary glaucoma, low tension glaucoma, or pseudoexfoliative glaucoma (identified using International Classification of Diseases (ICD)-9 codes), are recommended for follow-up care and have attended their Center for Disease Control and Prevention 6-month follow-up visit, are willing and able to give informed consent and participate for 1 year, any have undergone laser therapy. Excluded subjects are unwilling to attend randomized site for follow-up visits or prefers to continue follow-up eye care with their personal ophthalmologists.

Over the course of 1 year, a 6-person team comprised of one attending physician; project managers and community health educations, ophthalmic technician, and patient navigators will complete a baseline visit, baseline assessment and 2-3 follow-up visits in community and office-based locations. A leased Wills Eye van will transport the intervention team and all necessary equipment to the site. The equipment will occupy a designated location at each site for 1 to 2 days per month, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. The same team will see participants who are randomized to the Wills Eye Glaucoma Research Center location.

Participants randomized to receiving help in patient navigation protocol at the community and office-based locations will receive more individualized care than others such as assistance with scheduling; a confirmation letter, text or email; a personal phone call the day before the appointment; and assistance with rescheduling appointments as needed and will consistently arrange transportation to appointments as needed, provide materials, and accompany study participants to their follow-up appointments at Wills Eye. Patient navigators, ocular technicians, and physicians will also communicate with family members regarding recommended follow-up visits, medication refills, and laser-therapy recommendations, as needed.

Participants randomized to usual care protocol at the office-based location will receive a phone number to call and schedule an appointment. Prior to the follow-up visit, participants in the usual-care group who have scheduled an appointment will receive an automated phone call similar to the standard appointment-reminding procedure commonly used at the Wills Eye Hospital. If participants do not show-up for their appointment that will be documented. Participants in the usual-care group will receive any necessary interpretation services, educational materials, and referrals to cataract surgery or other eye-care services, as needed. The intervention team will assure that participants with literacy issues can understand all information. This group is a realistic choice currently available for patients and thus will be used to compare with the patient navigator protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Participated in the Wills Eye community-based comprehensive eye examination.

• Have a diagnosis of glaucoma-suspect or any type of glaucoma, including open angle glaucoma, chronic angle closure glaucoma, ocular hypertension, anatomically narrow-angle, pigmentary glaucoma, low tension glaucoma, or pseudoexfoliative glaucoma (identified using ICD-9 codes).

• Are recommended for follow-up care.

• Are willing and able to give informed consent and participate for 1 year.

• May have undergone laser therapy.

Exclusion Criteria:

• Are unwilling to go to any site for follow-up visits.

• Requested to follow-up only with their own ophthalmologist for their glaucoma eye-care.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Behavioral:
• Efficacy-patient navigator to improve follow-up adherence
Over the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. With assistance from the patient navigator, participants will receive assistance with scheduling appointments, arranging transportation, reminder letters, and referral s for ocular care.
• Office-Based Usual Care
Over the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. This intervention group will receive a phone number to schedule an appointment. Participants in the usual-care group who have scheduled an appointment will receive an automated phone call similar to the standard appointment-reminding procedure used at the Wills Eye Hospital.

Locations

Country	Name	City	State
United States	Wills Eye Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wills Eye	Partridge Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hark LA, Johnson DM, Berardi G, Patel NS, Zeng L, Dai Y, Mayro EL, Waisbourd M, Katz LJ. A randomized, controlled trial to test the effectiveness of a glaucoma patient navigator to improve appointment adherence. Patient Prefer Adherence. 2016 Sep 8;10:1739-48. doi: 10.2147/PPA.S108391. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences of baseline patient characteristics of glaucoma severity, vision-related quality of life, and depression.	We will consider whether the effect of the intervention differs by baseline patient characteristics of glaucoma severity, vision-related quality of life, and depression. The primary model will be extended to include the interaction between these variables and randomization assignment to allow for estimation of intervention effects by baseline categories.	1 year
Primary	Efficacy of Patient Navigator in a community setting or office based setting or usual care	Using data from randomized patients only, we will fit population average Poisson regression models using generalized estimating equations to estimate the rates of timely attendance by randomization assignment and assess the efficacy of the interventions while accounting for within-site clustering. The primary analysis will be adjusted for baseline individual characteristics believed to be associated with adherence to follow-up including age, glaucoma diagnosis, geriatric depression score, and overall vision-related quality of life.	Following 1 year
Secondary	Differences between rates of follow-up adherence; Community Groups (1-Main v.s Group 1-Randomized).	This analysis will be primarily descriptive since although we expect follow-up to be higher in Group 1-Main (Main Community Group), we do not expect the difference to be large.	1 Year
Secondary	Effectiveness of the patient navigator intervention on long-term patterns of follow-up.	Additional secondary analysis will consider the effect of intervention on long-term patterns of follow-up. Since the pattern of expected visits differs by severity, we will classify subjects as long-term adherent if they attend all of their recommended follow-up visits and non-adherent otherwise. Analysis will use the same model as the primary outcome analysis.	1 Year